China Medical News

United States-based global pharmaceutical company MSD said on Monday that China's National Medical Products Administration has approved the use of multiple new indications of Gardasil^®9, its nine-valent HPV vaccine, in males between 16 and 26 years old. The approval made the product the first and only nine-valent HPV vaccine approved for use in both males and females in China, marking a new beginning in the "gender-neutral prevention" stage against HPV-related cancers and diseases. With this approval, the vaccine is indicated in males for the prevention of anal cancer, genital warts, and some precancerous or dysplastic lesions caused by certain HPV types.

Anna Van Acker, senior vice-president of MSD and president of MSD in China, said, "Since the first approval of GARDASIL^®9 in China in 2018, we've been committed to providing more health solutions for Chinese populations, empowered by the approvals of the age cohort extension of 9 to 45 years old, the two-dose regimen for those between 9 and 14, and the latest male indication."

"This undoubtedly reflects the government's increasing efforts and commitment to accelerating the elimination of cervical cancer, expanding vaccine accessibility, and providing diverse health choices for the broader Chinese populations," she said.

"HPV infections are not gender-specific. With the approval of the new indication, we hope to not only protect more women, but also benefit more men, more families, more communities and eventually the entire society, and jointly create a future free from HPV-related diseases," she said.

HPV vaccines are the only vaccines that effectively prevent cancers globally so far. By the end of 2024, over 300 million doses of GARDASIL^®9 have been inoculated worldwide. In China alone, more than 33 million women have received the vaccination. (Source: China Daily)

Japanese pharmaceutical company Takeda and domestic biotech company Belief BioMed jointly announced on Thursday that the gene therapy drug Dalnacogene Ponparvovec Injection has received approval from China's National Medical Products Administration for the treatment of moderate to severe hemophilia B in adult patients, marking the first approved gene therapy drug for the disease in the country.

This innovative injection was developed and produced by Belief BioMed, while Takeda China is responsible for its commercialization on the Chinese mainland as well as Hong Kong and Macao. The two parties will leverage their respective strengths to accelerate the provision of this gene therapy to patients and jointly explore new frontiers in hemophilia B treatment.

Professor Zhang Lei from the Blood Disease Hospital of the Chinese Academy of Medical Sciences, who was also the leading investigator of the drug's registration clinical trials, said the approval of the therapy brings revolutionary hope to Chinese patients suffering from the disease. "By receiving a single dosing, patients will have a reduced risk of bleeding and joint damage, and they can potentially overcome the burden of lifelong frequent intravenous injections," said Zhang.

"We believe that with continuous breakthroughs in scientific research and the accumulation of clinical experience, the treatment of hemophilia will enter a new era, offering patients a higher quality of life," he said. (Source: China Daily)

All major hospitals will set up weight management clinics by the end of June this year, according to a notice released by the National Health Commission and the National Administration of Traditional Chinese Medicine on Thursday.

The requirement applies to all general hospitals, pediatric and TCM hospitals under direct administration by the commission, the administration and provincial-level authorities. Other tertiary hospitals sitting on the top of the nation's three-tier hospital system are also encouraged to establish weight management clinics.

Official data shows that the rate of obesity and overweight among Chinese people aged 18 and above has exceeded 50% and the obesity rate among children and teenagers aged six to 17 is close to 20%.

The document said that a weight management clinic should be staffed by specialists in the fields of pediatrics, general practice, endocrinology, nutrition, psychiatry and psychology, cardiovascular medicine, gastroenterology, general surgery, rehabilitation and TCM.

It added that hospitals with strong capabilities are encouraged to establish obesity prevention and control centers and provide hospitalized services. Grassroots healthcare clinics will receive support to establish weight management clinics, with an emphasis on raising awareness, providing follow-up care and health management services, and facilitating referrals to major hospitals. Internet technologies, artificial intelligence and wearable devices can be used by hospitals to help monitor and guide patients, it said. (Source: China Daily)

China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released on Tuesday by the National Medical Products Administration.

The 48 innovative drugs cover nearly 20 therapeutic areas, including oncology, neurological disorders and anti-infective medicines, the report said. The number was the highest in the past five years, compared with 40 in 2023 and 21 in 2022. Among them, 17 received market approval through a priority review pathway, 11 gained conditional market approval and 13 were included in breakthrough therapy programs during clinical trials, according to the report from the administration's drug evaluation center. "The center is guided by clinical value and has implemented various measures to enhance review efficiency and expedite approval of new and effective drugs, so as to provide patients with a broader range of medication options," the report said.

In addition, China approved 106 pediatric medicines, and 35 medications were granted expanded pediatric indications, which is expected to help alleviate the shortage of pediatric medication options, the report said. Furthermore, 55 rare disease medicines were authorized for market last year.

To speed up drug approvals, the administration has set up four accelerated pathways, Yuan Lijia, an official at the center, said in an interview with China Central Television. These pathways include the priority review program, which targets medicines in urgent need or those that treat major infectious diseases and rare diseases, as well as upgraded new drugs, pediatric medications and innovative vaccines. Through the program, the standard review time limit of 200 working days is shortened to 130. For medicines that meet urgent clinical demands and have been approved overseas, the time limit is further reduced to 70 days. "In 2024, the administration completed 110 drug approval applications covering 74 different categories under the priority review pathway, marking a year-on-year increase of 29%," Yuan said. Since China updated its drug registration and administrative rules in 2020, 496 drug approval applications have been placed under the priority review program, with 42.54% treating cancer. (Source: China Daily)

DeltaHealth Hospital·Shanghai has been granted an operating license in Shanghai, making it the city's first wholly foreign-owned hospital and China's first foreign-owned cardiovascular specialty hospital. The license for wholly foreign-owned medical institutions was issued by the Shanghai Municipal Health Commission on Friday, as the latest development following China's expanded opening-up policy in the healthcare sector.

The hospital, established as a joint venture in 2016, specializes in cardiovascular care and was included in Shanghai's medical insurance system in 2018. In May 2024, Swire Pacific Limited completed a transaction to become the largest shareholder of DeltaHealth.

In September 2024, China issued notice of the pilot program for expanding opening-up in the healthcare sector, with Beijing, Shanghai and Tianjin designated among the nine provinces and municipalities to launch wholly foreign-funded hospital trials. Experts believe this will help bring advanced medical technologies and services from overseas, meeting the growing demand for high-quality healthcare in China. (Source: Xinhua)

China's average life expectancy reached 79 years in 2024. The average life expectancy in China increased by 0.4 years from 2023, Lei Haichao, head of the National Health Commission, told the press on the sidelines of the annual national legislative session. This means China has achieved, ahead of schedule, its goal of raising its average life expectancy, which was set out in a national health plan for the 14th Five-Year Plan period (2021-2025), Lei said. According to the plan, the country aims to increase its 2020 life expectancy figure by about one year over the five-year period.

In 2024, China's life expectancy ranked fourth among 53 upper-middle-income countries and 10th among G20 countries, and surpassed the levels of 21 high-income countries, Lei added. He attributed the rise to a series of strategies that prioritize health, including the Healthy China initiative, as well as Chinese people's healthy lifestyles and the influence of traditional culture.

According to Lei, the average life expectancy in eight well-off municipalities and provinces -- Beijing, Tianjin, Shanghai, Shandong, Jiangsu, Zhejiang, Guangdong and Hainan -- has exceeded 80 years. He also said that disparities in health levels among provincial regions are gradually decreasing, indicating that health equity is improving steadily. The health official said that while China still faces challenges from both infectious and chronic non-communicable diseases, there remains significant potential to increase life expectancy. (Source: Xinhua)

China's first wholly foreign-owned tertiary general hospital opened on Wednesday, February 26th, in Tianjin Municipality, marking the latest development following China's expanded opening-up policy in the healthcare sector. The 500-bed hospital, named Perennial General Hospital Tianjin, represents an investment of about 1 billion yuan (roughly 139.4 million U.S. dollars) by Singapore's Perennial Holdings Private Limited. The hospital offers comprehensive medical services to meet the diagnosis and treatment needs of both common and complex diseases. It also has an international department that provides customized healthcare services -- including health management and chronic disease management.

In September 2024, China issued notice of the pilot program for expanding opening up in the healthcare sector, with north China's Tianjin designated as one of the nine provinces and municipalities to launch wholly foreign-funded hospital trials. Pua Seck Guan, executive chairman and chief executive officer of Perennial Holdings, said China has demonstrated a strong and significant determination to open up in the medical and health sector, which sends a positive signal to the international investment community, providing new market opportunities and further promoting the diversified development of China's medical market.

The hospital aims to introduce access to top international medical resources for Chinese patients, while also creating new pathways for foreign patients seeking medical treatment in China, Pua added. The new hospital can more flexibly introduce advanced international medical technologies and management models, facilitating the recruitment of high-end talent and the acquisition of advanced diagnostic and treatment equipment, said Tan Bee Lan, CEO of Perennial Healthcare.

Since 2000, China has allowed the establishment of foreign-funded joint medical institutions. After more than two decades of development, there are currently over 60 foreign-funded joint medical institutions in the country. Perennial General Hospital Tianjin received the first business license for a wholly foreign-owned tertiary general hospital issued by Tianjin authorities in December last year.

Tianjin and Singapore have a long history of cooperation. The local government in Tianjin has standardized approval processes and high work efficiency, leading to a favorable business environment, Pua said. Perennial Holdings will also increase its investment in other Chinese cities including Kunming, Xi'an and Guangzhou, according to Pua, who hoped that foreign investment in healthcare can further stimulate industry innovation and promote the advancement of China's healthcare system towards greater efficiency and inclusiveness.  (Source: Xinhua)

A human-derived, ultra-long-acting GLP-1 injection independently researched and developed by Innogen, a Shanghai-based medical technology enterprise, was recently approved for market by China's National Medical Products Administration for the treatment of type 2 diabetes in adults. This innovative injection, which only needs to be administered once a week to lower blood sugar levels and improve metabolic function for diabetic patients, has also exhibited positive results in achieving weight loss in ongoing clinical trials.

The launch of this medicine allowed Innogen to become Asia's first enterprise and the world's third to possess independent intellectual property rights for a human-derived, long-acting GLP-1 receptor agonist, poised to challenge the leading market position of imported drugs like semaglutide by Danish pharmaceutical company Novo Nordisk and tirzepatide by US pharmaceutical company Eli Lilly.

Home to the largest population of diabetes patients globally, China has an estimated 148 million adult diabetes patients, with over 60% being overweight or obese. By 2030, the number of overweight and obese individuals in the country is projected to reach 610 million, further escalating the risk of diabetes, hypertension and other diseases among the population.

"This innovative injection boasts an average half-life of up to 204 hours in the human body, making it the product with the longest half-life among all GLP-1 drugs in the global market so far," said Wang Qinghua, founder of Innogen.

He added that data from clinical trials showed that in non-diabetic individuals, a four-week use of the medicine resulted in a weight reduction of 4 kilograms. This translates to a weight loss rate of 6.2%, while 71% of trial participants achieved a weight reduction of over 5%, he said. (Source: Xinhua)

US pharmaceutical company Merck & Co said on Wednesday that its four-valent human papillomavirus vaccine has been approved for men aged 9 to 26 by China's top drug regulator. The vaccine that protects against four HPV strains is the first shot for males on the Chinese mainland. It was first authorized for use among females aged 9 to 45 in 2017 in the nation.

The majority of HPV infections are asymptomatic, but they are linked to a higher risk of cervical cancer among females and penile, anal and oropharyngeal cancers among males. Qiao Youlin, a researcher from the School of Population Medicine and Public Health at Peking Union Medical College, said that globally, the prevalence of HPV infection among men is higher than that among women, but less attention has been paid to male infections. International experts have called for delivering HPV vaccines to both genders to expand immunization coverage and better achieve herd immunity. (Source: China Daily)

China will address gaps in pediatric and mental health services from 2025 to 2027, said health authorities. The supply of pediatric services will be improved to achieve "broad coverage" during this period, the National Health Commission (NHC) revealed on Tuesday in a statement on its website. Notably, the country will ensure that more than 90% of these services will be accessible at primary-level healthcare facilities, which include community health stations, township-level health centers, village clinics and outpatient departments.

In a breakdown of the resolution in a separate statement released the same day, the NHC said such services should be made available at all general hospitals at secondary and tertiary levels in 2025. Parents have long complained about overcrowding at major hospitals, particularly in winter when respiratory diseases affect children.

Regarding mental health, the NHC said the country will establish more state and regional centers for mental disorders and actively develop key clinical specialties in this field. Efforts will be made to ensure that outpatient services for mental and sleep disorders are available at a minimum of at least one hospital in each prefecture and city nationwide by 2025. Authorities will also promote the use of the unified mental health hotline, 12356, throughout of the year, according to the NHC. By May 1, 2025, all similar hotlines will be connected to this unified hotline.

Mental health, in particular of children and adolescents, has increasingly come under the spotlight in China in recent years. The prevalence of depression among adolescents stands at around 2 percent in the country, Xie Bin, Party chief of the Shanghai Mental Health Center, said on Dec. 25 at a press conference, citing an authoritative epidemiological survey. By 2025, more than 95% of schools in the country are expected to have a full-time or part-time instructor for mental health education, according to a three-year national action plan launched in 2023.

The NHC has designated 2025-2027 as the "Years of Pediatric and Mental Health Services." To cultivate more professionals, salaries and treatment could potentially be adjusted to tilt the balance toward pediatric and psychiatric departments in hospitals during this period, it said. (Source: Xinhua)

• □　Beclometasone/Formoterol for Inhalation (FOSTAIR) – marketed by Chiesi Farmaceutici S.p.A.
• □　Donanemab Injection (KISUNLA) – marketed by Eli Lilly and Company
• □　Dotinurad Tablets (URECE) – marketed by FUJI YAKUHIN CO., LTD.
• □　Imipenem, Cilastatin and Relebactam for Injection (RECARBRIO) – marketed by MSD B.V.
• □　Lenacapavir Sodium Injection and Tablets (SUNLENCA) – marketed by Gilead Sciences Ireland UC
• □　Loncastuximab Tesirine For Injection (ZYNLONTA) – marketed by ADC Therapeutics SA
• □　Lurbinectedin for Injection (ZEPZELCA) – marketed by PharmaMar AG
• □　Mepolizumab Injection (NUCALA) – marketed by GlaxoSmithKline Trading Services Limited
• □　Mosunetuzumab Injection (LUNSUMIO) – marketed by Roche Pharma (Schweiz) AG
• □　Odevixibat Capsules (BYLVAY) – marketed by Ipsen Pharma
• □　Olaparib Tablets (Brand: N/A) – marketed by M/s Natco Pharma Limited
• □　Osimertinib Mesylate Tablets (TAGRISSO) – marketed by AstraZeneca AB – new indication
• □　Pembrolizumab Injection (KEYTRUDA) – marketed by MSD LLC – new indication
• □　Pretomanid Tablets (DOVPRELA) – marketed by Mylan Ireland Limited
• □　Rilonacept for injection (ARCALYST) – marketed by Kiniksa Pharmaceuticals (UK), Ltd.
• □　Safinamide Mesylate Tablets (XADAGO) – marketed by Zambon S.p.A.
• □　Vamorolone Oral Suspension (AGAMREE) – marketed by Santhera Pharmaceuticals GmbH
• □　Zolbetuximab for Injection (VYLOY) – marketed by Astellas Pharma Europe B.V.
• (Source: BaiPharm)

China aims to keep its HIV prevalence rate below 0.2% by 2030, according to a policy document released this week, as high infection rates among men who have sex with men and covert transmission among heterosexual couples pose significant challenges.

Since around 2012, the country has effectively halted HIV transmission through blood transfusions, reduced mother-to-child transmission and curbed the virus's spread via injection drug use, the State Council General Office said in a plan released Wednesday. "Sexual transmission has become the primary route for the spread of HIV," the document noted.

The mortality rate of HIV/AIDS patients has gradually declined in recent years due to increased access to standardized antiviral treatment. "The overall HIV epidemic in China remains at a low level," it added. However, the control situation remains severe, with high infection rates among men who have sex with men and a rising covert transmission rate among heterosexual couples, making prevention efforts more difficult.

The document outlines several goals and measures to be implemented over the next five years. These include raising public awareness of HIV prevention and treatment to over 90% by the end of next year and curbing high-risk behaviors among men who have sex with men. By the end of next year, comprehensive prevention measures — such as ensuring the availability of condoms in hotels and other public venues and encouraging vulnerable groups to undergo testing — should cover at least 95% of high-risk populations. Additionally, the rate of new infections among people undergoing maintenance therapy for drug addiction should be kept below 0.2%. By 2025, the mother-to-child transmission rate should be reduced to below two percent, and the transmission rate from an HIV-positive partner within a family should be kept under 0.3%, the document added.

Looking ahead to 2030, the plan aims to ensure that at least 95% of people living with HIV are aware of their infection, 95% of diagnosed patients receive sustained antiretroviral therapy, and 95% of patients on treatment achieve viral suppression to levels where they are no longer infectious.

According to data released by the National Administration of Disease Control and Prevention this month, the number of people living with HIV/AIDS in China is rising, although new infections are trending downward. More than 98% of new infections are sexually transmitted, with over 70% occurring among heterosexual couples. The document also emphasizes the importance of reducing HIV infections among teenagers, middle-aged adults and senior citizens. (Source: China Daily)

A total of 13 rare-disease drugs have been added to the latest edition of China's medical insurance drug catalog, bringing the total amount of such medicines covered by medical insurance in the country to more than 90. The newly-added items on the catalog, which was jointly released by the National Healthcare Security Administration (NHSA) and relevant authorities, include drugs for rare diseases such as hypertrophic cardiomyopathy, intractable epilepsy and paroxysmal nocturnal hemoglobinuria.

Due to their ultra-low incidence, a limited amount of patients, and high research and development costs, rare diseases have long remained areas of less focus in the healthcare field. Through inter-agency efforts, China has accelerated the construction of a pathway to prevent and treat such diseases -- with more accessible and affordable drugs now available to patients.

As part of this effort, the NHSA has adjusted the national medical insurance catalog for seven consecutive years since its establishment, expanding the scope of coverage to include rare diseases such as spinal muscular atrophy, Gaucher disease and myasthenia gravis in recent times. "It is an expectation shared by both doctors and patients to see more high-quality and life-saving medicines added to the country's medical insurance," said Zhang Shuyang, president of the Peking Union Medical College Hospital.

In addition to the provision of more reimbursed drugs, China has also advanced its national collaboration network for rare-disease diagnosis and treatment. As of October 2024, more than 400 medical institutions had joined in the network, which features medical referral and telemedicine mechanisms and covers all provincial-level regions across the country. (Source: Xinhua)

• □　Belzutifan Tablets (Brand; WELIREG) – marketed by MERCK SHARP & DOHME (UK) LIMITED
• □　Varenicline Tartrate Nasal Spray (Brand; N/A) – marketed by Oyster Point Pharma, Inc.
• □　Ambroxol Hydrochloride Spray (Brand; N/A) – marketed by GMep Medical Technology GmbH
• □　Minocycline Hydrochloride Foam (Brand; N/A) – marketed by Journey Medical Corporation
• □　Efgartigimod Alfa Injection (SubQ) (Brand; VYVGART HYTRULO) – marketed by argenx BV
• □　Rilonacept for Injection (Brand; ARCALYST) – marketed by Kiniksa Pharmaceuticals (UK)，Ltd.
• □　Mirvetuximab Soravtansine Injection (Brand; ELAHERE) – marketed by ImmunoGen, Inc.
• □　Recombinant Human Papillomavirus Quadrivalent Vaccine (Brand; GARDASIL) – marketed by Merck Sharp & Dohme LLC

(Source: BaiPharm)

China will add 91 drugs to its national medical reimbursement list next year, the National Healthcare Security Administration said on Thursday.

The latest update includes 26 cancer drugs, 17 treatments for diabetes and other chronic diseases, 13 for rare diseases, seven anti-infection medicines and four psychiatric drugs. In the meantime, 43 drugs that have been replaced by more advanced counterparts or that have not been produced for a long time will be removed from the list.

The latest move puts the total number of medicines on the list to 3,159, including 1,765 Western medicines and 1,394 traditional Chinese medicines. Among the newly-added drugs, 89 have been included following price negotiations or bidding with drug manufacturers, resulting in an average price cut of 63%. The new list will take effect on Jan 1, 2025, and is expected to save patients more than 50 billion yuan ($6.9 billion) next year. (Source: China Daily)

The inclusion of chronic obstructive pulmonary disease (COPD) into China's basic public health service program is expected to boost awareness of the disease and improve treatment capabilities on the grassroots level, a senior health expert said on Wednesday.

COPD is a chronic condition that can cause restricted airflow and breathing problems. Common risk factors include smoking and inhalation of fumes, chemicals and dust. In China, the disease affects about 100 million people and kills one million annually.

The burgeoning health burden has prompted authorities to add the disease to the nation's basic public health service program in September. The program already covers high blood pressure and diabetes and promises free access to regular checkups and health management services for patients.

Yang Ting, deputy director of the National Center for Respiratory Medicine, based at the China-Japan Friendship Hospital in Beijing, said that according to a survey carried out about a decade ago, only about nine percent of participants recognized the disease, compared with over 60% for high blood pressure and diabetes. "Adding COPD to the national program will help improve awareness and knowledge about the disease, which is among the first key steps to promote early diagnosis and treatment," she said.

She added that the move is expected to improve diagnosis and treatment capabilities of grassroots health facilities so that not all patients have to swarm to major hospitals to receive standard treatment and asymptomatic patients can be promptly detected.

Yang said that in the past, some patients neglected complying with medicine regimens or health advice after being released from hospitals. "In the most extreme case, I met a patient who was admitted into hospital 13 times a year due to acute exacerbations of symptoms," she said. "If we can connect hospital-based therapies with home-based health management, these patients can be taken care of better."

Yang said the program is also expected to accelerate efforts to integrate healthcare resources for respiratory diseases and public health services. For instance, lung function examinations and questionnaires can be rolled out targeting smokers, so as to look for early signs of the disease and help them quit smoking. (Source: China Daily)

The overall five-year survival rate of cancer in China has been increasing year by year, rising from 30.9% at the beginning of this century to 43.7% by 2022, according to the latest data from the National Cancer Center.

The incidence of cancer in China matches the global average with a slightly higher mortality rate. However, after years of effort, the speed of the overall increase in the cancer survival rate in China has approached that of developed countries, said He Jie, director of the center and president of the Cancer Hospital, Chinese Academy of Medical Sciences, during its academic annual conference in Beijing from Friday to Sunday.

According to monitoring data from 2000 to 2018, the age-standardized incidence and mortality rates of high-incidence tumors such as esophageal and gastric cancer in the Chinese population have been decreasing year by year. Experts said this is directly related to the gradual promotion of upper digestive tract cancer screening in China. He added that the urban early diagnosis and treatment project for cancer promoted by the National Cancer Center has now covered approximately 7 million people in 104 cities across 31 provincial-level regions.

In addition to prevention and early diagnosis and treatment, another key aspect of reducing cancer incidence and mortality rates is standardized treatment. In recent years, the number of specialized cancer departments in national tertiary cancer hospitals and tertiary public comprehensive hospitals has increased, but the distribution is uneven. Some county hospitals are accelerating the establishment of oncology and radiotherapy departments, but there are still quality control issues, experts said.

Cutting-edge cancer prevention and treatment methods are now accessible in China. Data shows that in the past decade, there has been a significant increase in the approval of new anti-cancer drugs in China, with a total of 208 approved. The proportion of domestically developed innovative drugs has also significantly increased, exceeding 60% in 2024.

Besides drugs, more convenient and suitable cancer diagnosis and treatment equipment is also being developed.

Zheng Zhongwei, an official from the National Health Commission, said that relevant departments are reviewing core scientific issues such as tumor immune mechanisms and metabolic mechanisms, preparing to select teams, and conducting organized cancer prevention and treatment technological breakthroughs.

Regarding national cancer prevention, the commission has proposed that by 2030, China's cancer prevention and treatment system will be improved. The comprehensive control of risk factors, cancer screening and early diagnosis and treatment capabilities will be enhanced. The standardized diagnosis and treatment levels will be improved, and the rising trend of cancer incidence and mortality rates will be controlled.

The overall five-year cancer survival rate is expected to reach 46.6% by 2030, effectively controlling the disease burden on patients, according to the commission. (Source: China Daily)

• □　Niraparib Tosylate and Abiraterone Acetate Tablets (Brand; N/A) – marketed by Janssen-Cilag International NV
• □　Pirtobrutinib Tablets (Brand; Jaypirca) – marketed by Eli Lilly Nederland B.V.
• □　Faricimab Injection (Brand; VABYSMO) – new indication for macular edema secondary to CRVO or BRVO – marketed by Roche Pharma (Schweiz) AG
• □　Trastuzumab Deruxtecan for Injection (Brand; You He De) – new indication for unresectable or metastatic NSCLC with HER2 mutations – marketed by Daiichi Sankyo Europe GmbH

(Source: BaiPharm)

The National Healthcare Security Administration said on Friday that 27 provincial-level regions have included fertility treatment in their basic health insurance as part of efforts to tackle an aging society and promote long-term and balanced demographic development.

The administration added that the average time it takes to complete insurance registration for newborns has been reduced from 28.7 to 6.4 working days and the period for processing maternity subsidies has been cut to 10 working days.

From January to September, the nation's maternity insurance fund spent 89.3 billion yuan ($12.5 billion) in total, up by 11.5 percent year-on-year, it said.

The nation's basic healthcare insurance fund spent 1.76 trillion yuan from January to September, up by 10.5 percent from the same period of last year. The growth rate exceeded that of the GDP by 5.7 percentage points.

As of the end of September, about 376 million people had enrolled in the national basic insurance program for employees, up by 2.4 percent year-on-year. (Source: China Daily)

China's National Health Commission has released its first set of guidelines aimed at standardizing the diagnosis and treatment of obesity.

Over past years, China has witnessed an upward trend in the morbidity rate of its overweight and obese population, according to the guidelines issued by the commission. More than half of adults in the country are overweight or obese, and the rate could reach 65.3 percent by 2030, according to a 2020 report from the NHC.

As an independent disease and a major causative factor for multiple chronic diseases, obesity has become a major public health issue in China, ranking as the sixth leading risk factor for death and disability in the country, the guidelines say.

The guidelines address the diagnosis standards, classification and staging of obesity. Its treatment section includes methods for behavioral, psychological and sports-based interventions, medical nutrition therapy, medication treatments, weight-loss and metabolic surgery, as well as approaches from traditional medicine. According to the guidelines, five medications have been approved in China for weight-loss treatment in adults with primary obesity. No medications have been approved for the treatment of inherited obesity in China.

Experts emphasize that most overweight and obese cases are caused by unhealthy lifestyles. The fundamental solution is to maintain a healthy lifestyle, which includes a balanced diet and appropriate exercise to keep weight within a healthy range. (Source: Xinhua)

China has cut its premature death rate from cardiovascular conditions, cancer and other major chronic diseases by nearly 19% in the past decade, and is redoubling efforts in tackling obesity to further curb its incidence, said officials during the weekend.

Cao Xuetao, vice-minister of the National Health Commission, said that the premature death rate for people age 30 to 70% with chronic illnesses — that is, the possibility of them dying from cardiovascular or respiratory diseases, cancer and diabetes — fell from 18.5% in 2015 to 15% last year. Chronic conditions are the biggest killer of Chinese people, accounting for over 80% of deaths annually.

China has made great efforts to boost the prevention and control of chronic diseases at the grassroots level, including building demonstration areas across the nation where comprehensive efforts promoting healthy lifestyles and early screenings have been rolled out. So far, 488 such demonstration areas have been built, covering 17.1% of county-level regions, Cao said during the opening ceremony of the 2024 China Conference on Noncommunicable Diseases Prevention and Control that was held in Beijing on Saturday.

The two-day event was held by the Chinese Preventive Medicine Association and several other national disease research institutions. Shen Hongbing, director of the National Disease Control and Prevention Administration, said that the rates of Chinese people's awareness, treatment and control of high blood pressure and diabetes have all significantly increased. However, he added that the control rate is only growing at a relatively modest pace, signifying that it is important to translate health literacy about these diseases into concrete action to curb them in an effective and scientific manner. "Rapid urbanization, an aging population and lifestyle changes have compounded challenges in tackling chronic diseases, and incidence rates of key chronic diseases are rising or remaining at a high level," he said. "More efforts are needed to intervene in the lifestyles of the public and focus on weight management," said Shen.

Official data shows that about 57%t of Chinese adults are either obese or overweight. From 2013 to last year, the overweight rate for adults rose by 4.5 percentage points, and the obesity rate among adult residents increased by 6 percentage points. As part of efforts to stem obesity, China launched a three-year campaign in June aimed at helping residents achieve a healthy weight and adopt a healthy lifestyle.

Martin Taylor, the World Health Organization's representative to China, said that obesity is not just a chronic disease in itself, but also spikes the risk of diabetes, heart disease and other chronic conditions. "It is encouraging to see weight management placed at the core of China's noncommunicable disease prevention strategy, fostering cross-sectoral collaboration and prioritizing prevention," he said.

In addition to building environments that encourage an active lifestyle, such as creating accessible parks, walking lanes and spaces for sport, dance and exercise, he also suggested enabling consumers to make healthier choices more easily, such as adding clear and interpretive labeling on prepackaged foods and imposing marketing restrictions on unhealthy products.

Besides strengthened prevention action, Taylor said that health systems should be beefed up to ensure the early detection and effective management of obesity and chronic diseases. "This means training healthcare professionals, expanding access to quality services and making essential medicines and technologies available to all who need them," he said.

In a crucial step toward improving the standard diagnosis and treatment of obesity, the National Health Commission released a related guideline on Thursday. Ji Linong, director of the endocrinology department at Peking University People's Hospital, said during an interview with the 21st Century Business Herald that the guideline details different types of interventions and therapies for obesity and is expected to help healthcare workers tailor weight loss plans for different patients. (Source: China Daily)

In its ongoing battle against cervical cancer, China has made free human papillomavirus (HPV) vaccinations accessible to about 40% of girls aged 13 to 14, according to the National Health Commission.

Since 2021, 11 provincial-level regions and multiple cities have provided free vaccination services for girls of eligible age, Shen Haiping, head of the commission's maternal and child health department, said at a press conference on Friday.

A total of 280 million free HPV screenings have been conducted across China, greatly facilitating the early detection, diagnosis and treatment of cervical cancer, Shen said. Health authorities worked with women's federation organizations in providing medical assistance to 275,000 cervical cancer patients in financial difficulties, the official said.

According to the commission, cervical cancer is the most common gynecologic malignancy. In 2022, there were 151,000 new cases of cervical cancer in China, with an incidence rate of 13.8 per 100,000, ranking fifth among cancers in women.

China has attached great importance to the prevention and treatment of cervical cancer, with this disease highlighted in a series of major documents, Shen said.

In 2023, the country launched a campaign to accelerate the elimination of cervical cancer in answer to the international community's call to lower its incidence rate to 4 per 100,000 by the end of the century, Shen added. (Source: Xinhua)

• □　Osilodrostat Phosphate Tablets (Brand; Shi Rui Sa) – marketed by Recordati Rare Diseases
• □　Pembrolizumab Injection (Brand; Keytruda) – new indication for 1L in unresectable or metastatic melanoma - marketed by Merck Sharp & Dohme LLC
• □　Ponatinib Tablets (Brand; ICLUSIsG) – marketed by Otsuka Pharmaceutical Co., Ltd.
• □　Tofersen Injection (Brand; Qalsody) – marketed by Biogen MA Inc.
• □　Turoctocog alfa pegol for injection (Brand; Esperoct) – new indication not yet disclosed - marketed by Novo Nordisk A/S

(Source: BaiPharm)

The National Medical Products Administration, China's top drug regulator, says it will redouble efforts to facilitate research and market registration of homegrown innovative drugs, while speeding up the introduction of novel foreign drugs to the domestic market to meet public demand.

From January to August, the administration approved 31 innovative drugs, a rise of nearly 20% from the same period last year, Li Li, the director of the administration, told a recent news conference in Beijing. It also granted market clearance to 46 innovative medical devices during the same period, a year-on-year increase of more than 12%.

"In the meantime, progress has been made for domestic novel medicines such as molecular targeted therapy, immunotherapy and cell therapy to obtain market registration overseas, while domestic products are gaining increased recognition in the global market," he said. Li added that homegrown, high-end medical equipment, such as surgical robots, artificial hearts and carbon ion treatment systems used to treat some cancer patients, have been approved in recent years, with some being of world-leading quality.

Li said the administration will continue to expedite market application procedures for medical products that can fill unmet, urgent medical needs. In Beijing, Shanghai and other regions, trial programs are underway to halve review periods for innovative medications from 60 to 30 working days.

"To advance opening-up in the pharmaceutical industry, we will also strengthen implementation of common international regulatory rules, support rollouts of international multi-center clinical trials and promote simultaneous research and review of global drugs in China," he said.

Li added that efforts will be made to explore segmented production of biological products, encourage international drugmakers to transfer manufacturing capacity of novel and high-end medical products to China and accelerate foreign novel drugs' market registration for the domestic market.

Regarding the supervision of drug production, the administration said that in the first eight months of the year it had carried out around 21,000 spot checks on drug manufacturers, with a pass rate of 99.43%. (Source: China Daily)

China plans to allow the establishment of wholly foreign-owned hospitals in certain cities and regions across the country, according to an official document unveiled on Sunday.

These hospitals will be permitted to open in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and throughout the island of Hainan, according to a circular jointly issued by the Ministry of Commerce, the National Health Commission, and the National Medical Products Administration on further expanding pilot programs for opening up in the medical field.

The circular noted that the conditions, requirements and procedures for establishing these hospitals will be specified later. (Source: Xinhua)

• □　Aclidinium Bromide Powder for Inhalation (Brand; N/A) – marketed by Covis Pharma Europe B.V.
• □　Atracurium Besilate Injection (Brand; N/A) – marketed by Joint Stock Company “Kalceks”
• □　Benralizumab Injection (Brand; Fasenra) – marketed by AstraZeneca AB
• □　Enfortumab vedotin for Injection (Brand; PADCEV) – marketed by Astellas Pharma Europe B.V.
• □　Estradiol and Dydrogesterone Tablets (Brand; N/A) – marketed by Abbott B.V.
• □　Trastuzumab Deruxtecan for Injection (Brand; Enhertu) – new indication in HER2+ locally advanced or metastatic gastric or GEJ - marketed by Daiichi Sankyo Europe GmbH

• (Source: BaiPharm)

China's average life expectancy has reached a record high of 78.6 years, according to a report released Thursday by the National Health Commission.

Maternal mortality has dropped to 15.1 per 100,000, and infant mortality stands at a low of 4.5 per 1,000, says the statistical report on China's health development in 2023.

The report also reveals a steady increase in healthcare resources, with the total number of medical institutions rising to 1,070,785, the number of hospital beds reaching 10.17 million, and healthcare professionals totaling nearly 12.49 million by the end of 2023.

Additionally, medical services have seen significant improvement, with a total of 9.55 billion consultations recorded — an increase of 1.13 billion from the previous year — while the average resident visited medical facilities 6.8 times. (Source: Xinhua)

The National Health Commission, China's top health authority, will explore the possibility of granting nurses prescription powers, a policy that would bring convenience to patients and help retain nursing talent.

In a statement released on its website on Aug 20, the commission said it was responding to a proposal submitted by a deputy to the National People's Congress during the top legislature's annual meeting in March. The proposal called for formulating rules and regulations to give prescription authority to specialist nurses, allowing them to prescribe certain drugs and order diagnostic tests.

"The commission will fully research and analyze the necessity and significance of giving nurses prescribing powers," the commission said. "Based on extensive research and analysis, the commission will revise relevant regulations at appropriate times and improve related policies."

Prescription authority is currently restricted to registered physicians. "There is no legal basis for giving nurses prescribing rights at present," the commission said. "Nurses are only allowed to provide guidance in diets, workout plans and general disease and health knowledge to patients."

However, calls for expanding prescription powers to nurses have been growing in recent years to give their careers more significance and to improve the effectiveness of medical services. Yao Jianhong, a national political adviser and former Party chief of the Chinese Academy of Medical Sciences, told CPPCC Daily, a newspaper affiliated with the nation's top political advisory body, that some developed countries allow nurses to write prescriptions, and some cities in China have launched trial programs.

In October, Shenzhen, in Guangdong province, put into effect a regulation that authorizes eligible nurses to order examinations, therapies and prescribe topical medications relevant to their area of expertise. According to the regulation, such prescriptions must be based on existing diagnoses issued by physicians, and eligible nurses should have a minimum of five years of work experience and must have attended a training program.

Hu Chunlian, head of the outpatient department at Yueyang People's Hospital in Yueyang, Hunan province, said that because specialist nurses cannot directly give prescriptions or order tests, patients have to book appointments with doctors and wait longer to receive medication.

Common cases involve patients who need certain drugs to treat wounds, as well as patients in need of stoma care or peripherally inserted central catheters, she told CN-healthcare, an online media outlet. "Expanding prescription authority to nurses is bound to be a trend in the future, because such a policy will brighten the career prospects of highly educated nurses and help retain talent," she said.

According to the commission, the number of registered nurses nationwide has been increasing by an average of 8 percent a year over the past decade, with about 300,000 new graduates entering the workforce each year. There are currently more than 5.6 million nurses working in China. (Source: China Daily)

Imported drugs:
□　BIMZELX (bimekizumab) – marketed by UCB Pharma S.A.
□　MOUNJARO (tirzepatide) – new indication - marketed by Eli Lilly and Company
□　SMYRAF (peficitinib) – marketed by Astellas Pharma Inc.
□　VONVENDI (vonicog alfa) – marketed by Takeda Pharmaceuticals U.S.A., Inc.
□　VYVGART HYTRULO (efgartigimod alfa) – marketed by argenx BV
□　Methotrexate injection – marketed by Medac Gesellschaft für klinische Spezialpräparate mbH
□　Ursodeoxycholic acid oral suspension – marketed by Dr. Falk Pharma GmbH

Domestic drugs:
□　Bilessglu (chiglitazar) – new indication - marketed by Chengdu Chipscreen Pharmaceutical Ltd.
□　惠优加 - Hui You Jia (Insulin degludec and insulin aspart Injection) – marketed by Huisheng Bio-pharmacutical Co., Ltd.
□　泰爱 - Tai Ai (telitacicept) – new indication - marketed by RemeGen Co., Ltd.
□　泽元安 - Ze Yuan An (ganaxolone) – marketed by Marinus Pharmaceuticals, Inc.
□　Alfacalcidol drops – marketed by Hubei Jinluo Silk Cloth Co., Ltd.
□　Emtricitabine and tenofovir disoproxil fumarate tablets – marketed by Qilu Pharmaceutical Co., Ltd.
□　Entacapone tablets (II) – marketed by SJZ No.4 Pharmaceutical Co., Ltd.
□　Frovatriptan tablet – marketed by C.P Pharmaceutical (Qingdao) Co. Ltd.
□　Irbesartan and amlodipine besilate tablets (I) and (III) – marketed by Jiangxi Shimei Pharmaceutical Co., Ltd.
□　Meropenem and sodium chloride injection – marketed by Hunan Kelun Pharmaceutical Co., Ltd.
□　Multi-trace elements injection (III) – marketed by Yangpu Jingtai Pharmaceutical Co., Ltd.
□　Vancomycin hydrochloride capsules – marketed by Speed Safety Healthy (Hangzhou) Pharmaceutical Co., Ltd.
 
(Source: BaiPharm)

China's age-standardized 5-year relative survival rate for all cancers combined was 43.7% between 2019 and 2021, according to a report published in the Journal of the National Cancer Center. The survival rate increased by approximately seven percentage points compared to the previous decade, said the report.

The study findings show that China has met the Healthy China Program (2019-2030) interim goal of improving cancer outcomes, which is to achieve a 5-year cancer survival rate of 43.3% for all cancers combined by 2022.

The research team collected data from over 6.41 million newly diagnosed cancer patients from 281 cancer registries across China from 2008 to 2019. The researchers observed significant survival improvements for cancers of the lung, prostate, bone, uterus, breast, cervix, nasopharynx, larynx and bladder during the time between 2008 and 2019.

The improvement in cancer survival rates could be attributed to China's major healthcare reforms and technological advances which enabled earlier diagnosis, more effective treatment, and better cancer care management, said the report.

The study also found that eight types of cancer, including thyroid, breast, testis, bladder, prostate, kidney, uterus, and cervix had a 5-year survival rate of over 60%. Pancreatic cancer had the lowest survival rate (8.5%), while thyroid cancer had the highest survival rate (92.9%) among all the cancer types, according to the report. (Source: Xinhua)

China has released a list of healthcare reform tasks for 2024, including measures related to public healthcare services, the development of public hospitals and reform in relation to medicine.

At a national conference on China's health development and deepening healthcare reform that ended in late June, policymakers and practitioners discussed topics including public hospital reforms, medicine supply and medical insurance. The country will continue enhancing its public healthcare service capacity at the primary level, deepen reform of the payment system at public hospitals, and improve its healthcare insurance systems to better meet people's needs and reduce their medical costs, according to the document.

This year's reform will also give more weight to matters such as medical technological progress, multi-tiered diagnosis and treatment, and digitalized services, said Zhu Hongbiao, an official with the National Health Commission (NHC), at the conference.

Tackling high medical expenses has been an important part of China's medical and healthcare reforms. To that end, China has launched nine rounds of bulk drug procurement programs since 2018 and gradually expanded the price reform of medical services. It is expected that the bulk purchase program will cover 500 medications this year, and pilot price reforms of medical services will be carried out in three provincial-level regions.

Various reforms to optimize hospital services launched over the past decade have also achieved notable results. Long wait times for registration, medical examinations and settling hospital bills were once common grievances among patients. However, recent reforms have resulted in a remarkable transformation. According to the NHC, over 5,500 comprehensive hospitals now provide "one-stop" services, enabling 77.7% of hospitalized patients to settle their bills on the day of discharge.

Furthermore, mutual recognition of medical examination results has been achieved in most public hospitals, reducing the need for repetitive tests at different facilities.

Empowered by the internet, over 3,000 medical institutions in China offer medical and nursing services online for those unable to visit in person, data from the NHC revealed. (Source: CGTN)

China has seen declining incidence rates of hepatitis B and related hepatocellular carcinoma, according to Chinese health authorities.

China has achieved significant progress in increasing the rate of hepatitis B vaccination, containing new hepatitis B infections, and preventing and controlling HCC related to hepatitis B, said Li Bin, deputy head of the National Health Commission, at a conference on the matter on Saturday. Data shows that China's three-dose hepatitis B vaccination rate among newborns has been maintained at over 95% and reached the 2030 goal set by the World Health Organization.

In 2022, around 367,700 new cases of liver cancer were reported in China, with a standardized incidence rate of approximately 15.03 per 100,000 people, revealing a downward trend when compared to historical data.

Zhuang Hui, academician of the Chinese Academy of Engineering, has called for continued efforts to improve hepatitis B diagnosis and treatment rates. The key to eliminating hepatitis B and reducing its mortality rate is vaccinating susceptible adults that do not have immunity against the virus and other groups at risk, Zhuang suggested.

China still faces challenges as it works toward the goal of eliminating hepatitis B by 2030, Li said, adding that more will be done to promote vaccination and optimize testing strategies. (Source: Xinhua)

With half its adult population now rated as overweight or obese, China is promoting weight control through a new public awareness campaign. Launched by the National Health Commission (NHC) this week, the campaign encapsulates weight-control knowledge into eight catchy slogans emphasizing lifelong commitment, active monitoring, a balanced diet, physical activity, good sleep, reasonable targets and family action.

It is part of a three-year government program to help more Chinese people adopt a healthier lifestyle. "Obesity and overweight are a major public health issue," said Guo Yanhong, director of the Health Emergency Response Office of the NHC. "We must intervene and improve the situation."

The government's active intervention highlights a harsh reality: the nation that struggled to feed its people half a century ago is now fighting an uphill battle against excess weight among the population, as living conditions have improved significantly. As an indicator of the gravity of the issue, data shows that 19% of minors aged 6 to 17 and 10% of children under 6 are overweight or obese.

Epidemiologists attributed the problem to substantial changes in Chinese people's dietary patterns, with increased consumption of animal-source foods, refined grains and highly processed, high-sugar and high-fat foods, while physical activity levels have decreased with increasing sedentary behaviors. Obesity and overweight are major risk factors for chronic diseases such as cardiovascular disease, diabetes and certain types of cancer. "Strong evidence from prospective cohort studies has linked overweight and obesity to increased risks of major non-communicable diseases and premature mortality in Chinese populations," said a paper published by The Lancet in 2021.

The government has acted on the problem. Healthy China 2030, a comprehensive national strategy and vision for improving public health and healthcare issued in 2016, explicitly lists curbing overweight and obesity as a major goal, with detailed measures introduced. Guidelines for obesity prevention and control among adults and children have been released, and the "15-minute fitness circles" program, which aims to provide accessible sports facilities within a 15-minute walking or cycling distance from residential areas, is being expanded. Sports facilities across the country have grown rapidly, with the per capita sports area reaching 2.89 square meters in 2023. The total length of fitness trails reached 371,000 kilometers, a 107% increase compared to 2019. To promote healthy diets, provinces such as the rice-producing Heilongjiang are encouraging restaurants and canteens to cut patrons' consumption of salt, cooking oil and alcohol. (Source: Xinhua)

 
Imported drugs:
 
□　Alecensa (alectinib) - new indication - marketed by Roche Registration GmbH
□　Awiqli (insulin icodec) - marketed by Novo Nordisk A/S
□　Budesonide, glycopyrronium bromide and formoterol fumarate inhalation aerosol - marketed by AstraZeneca AB
□　DOPTELET (avatrombopag maleate) - new indication - marketed by AkaRx Inc.
□　Esperoct (turoctocog alfa pegol) - marketed by Novo Nordisk A/S
□　Glucagon nasal powder - marketed by Amphastar Pharmaceuticals, Inc.
□　Icosapent ethyl soft capsules - marketed by Amarin Pharmaceuticals Ireland Ltd.
□　Jakavi (ruxolitinib) - new indication - marketed by Novartis Pharma Schweiz AG
□　Keytruda (pembrolizumab) - new indication - marketed by Merck Sharp & Dohme LLC
□　Methylthioninium chloride enteric-coated sustained-release tablets - marketed by Alfasigma S.p.A.
□　ORKEDIA (eocalcet) - marketed by Kyowa Kirin Co., Ltd.
□　Ozempic (semaglutide) - new indication - marketed by Novo Nordisk Pharma AG
□　REXULTI (brexpiprazole) - marketed by Otsuka Pharmaceutical Co.，Ltd.
□　Tabrecta (capmatinib) - marketed by Novartis Pharma Schweiz AG
□　TAGRISSO (osimertinib mesylate) - new indication - marketed by AstraZeneca AB
□　Tarlige (mirogabalin besilate) - marketed by DAIICHI SANKYO CO., LTD.
□　TECVAYLI (teclistamab) - marketed by Janssen-Cilag International NV
□　XPOVIO (selinexor) - new indication - marketed by Karyopharm Therapeutics Inc.
□　XTANDI (enzalutamide) - new indication - marketed by Astellas Pharma Europe B.V.

 
 
Domestic drugs:
 
□　安洛晴-An Luo Qing (envonalkib citrate) - marketed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
□　百斯锐明-Bai Si Rui Ming (ropeginterferon alfa-2b) – marketed by PharmaEssentia Corporation
□　百泽安-Bai ze An (tislelizumab) – new indication - marketed by BeiGene Ltd.
□　倍长平-Bei Chang Ping (cofrogliptin) - marketed by Haisco Pharmaceutical Group Co., Ltd.
□　贝塔宁-BETAGRIN (bevifibatide citrate) - marketed by Bio-Thera Solutions Inc.
□　Brivaracetam tablets - marketed by Qingfeng Pharmaceutical Group Co. Ltd.
□　Calcipotriol scalp solution - marketed by Sinomune Pharmaceutical Co., Ltd.
□　Calcitriol injection - marketed by Chengdu Gowell Biopharmaceutical Co., Ltd.
□　Carbidopa and levodopa sustained-release tablets - marketed by SJZ No.4 Pharmaceutical Co., Ltd.
□　Cetirizine hydrochloride injection - marketed by Shandong Cosci Med-tech Co., Ltd.
□　恩立妥-En Li Tuo (cetuximab beta) – marketed by Taizhou Mabtech Pharmaceutical Co. Ltd.
□　恩舒幸-En Shu Xing (enlonstobart) - marketed by CSPC Megalith Biopharmaceutial Co., Ltd.
□　Estradiol valerate tablets - marketed by Zhejiang Xianju Pharmaceutical Co., Ltd.
□　Fexofenadine hydrochloride for suspension - marketed by Jumpcan Pharmaceutical Group Co., Ltd.
□　高瑞哲-Gao Rui Zhe (golidocitinib) - marketed by Dizal Pharmaceutical Co.,Ltd.
□　克瑞毕-Ke Ru Bi (zamerovimab and mazorelvimab) - marketed by Synermore Biologics (Suzhou) Co., Ltd.
□　Levofloxacin oral solution - marketed by Hubei Jinluo Silk Cloth Co., Ltd.
□　Metformin hydrochloride and empagliflozin tablets (VI) - marketed by Qilu Pharmaceutical Co., Ltd.
□　Naltrexone hydrochloride implants - marketed by SciencienCare Pharmaceutical Technology Co.,Ltd.
□　Olmesartan medoxomil orally disintegrating tablets - marketed by ApicHope Pharmaceutical Co., Ltd.
□　Oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets - marketed by Shandong Luye Pharmaceutical Co., Ltd.
□　Palbociclib tablets - marketed by CSPC Ouyi Pharmaceutical Co., Ltd.
□ Perfluoropropane-albumin microspheres for injection - marketed by Xiamen Lizhuo Pharmaceutical Co., Ltd.
□　Phloroglucinol orally disintegrating tablets - marketed by Renhe Yikang Group Co., Ltd.
□　Pregabalin orally disintegrating tablets - marketed by DiQi Pharmaceuticals Co.,Ltd.
□　Progesterone injection (II) - marketed by Changchun GeneScience Pharmaceutical Co., Ltd.
□　Rivastigmine bitartrate oral solution - marketed by Shandong Loncom Pharmaceutical Co., Ltd.
□　Rotigotine microspheres for injection - marketed by Luye Jiaao (Shijiazhuang) Pharmaceutical Co., Ltd.
□　瑞沁-Rui Qin (henagliflozin proline) – new indication - marketed by Jiangsu Hengrui Pharmaceuticals Co., Ltd.
□　Salmeterol xinafoate and fluticasone propionate powder for inhalation - marketed by Joincare Pharmaceutical Group Industry Co., Ltd.
□　圣瑞沙-Sheng Rui Sha (rilertinib mesylate) - marketed by Nanjing Sanhome Pharmaceutical Co., Ltd.
□　Sodium dihydrogen phosphate and disodium hydrogen phosphate granules - marketed by Harvest(Hunan) Pharmaceuticals Co.,Ltd.
□　Tafamidis meglumine soft capsules - marketed by Qilu Pharmaceutical Co., Ltd.
□　Technetium [⁹⁹ᵐTc] tetrofosmin injection - marketed by Nanjing JYAMS Electronic Research & Development Co., Ltd.
□　Telmisartan and amlodipine tablets - marketed by Jiangxi Shimei Pharmaceutical Co., Ltd.
□　Ticagrelor dispersible tablets - marketed by Honghe Pharmaceutical Co., Ltd.
□　拓益-Tuo Yi (toripalimab) – new indication - marketed by Shanghai Junshi Biosciences Co., Ltd.
□　Valganciclovir hydrochloride tablets - marketed by Shanghai Zhongxi Sunve Pharmaceutical Co.,Ltd.
□　信立汀-Xin Li Ting (fultagliptin benzoate) - marketed by Shenzhen Salubris Pharmaceuticals Co., Ltd.
 
(Source: BaiPharm)

China has approved 82 innovative drugs and 138 innovative medical devices since 2022, a health official said on Friday. Huang Guo, deputy director of the National Medical Products Administration, said that from January to May of this year, a total of 20 innovative medicines and 21 innovative medical equipment have gained market approval on the mainland. "Among them are CAR-T therapy and monoclonal antibodies that use novel biotechnologies, novel traditional Chinese medicine products, artificial hearts that based on full magnetic levitation technology and CT scan examination software incorporating artificial intelligence," he said during a news conference held by the State Council Information Office. "The quantity and quality of innovative drugs in China are both at a leading level globally," he said.

To accelerate market approval of innovative drugs, vaccines and those in urgent need, Huang said that the administration has devised four expedited, special channels, and assigned dedicated personnel or devised targeted policies to communicate with drug manufacturers. Last year, the administration approved 45 rare diseases drugs, compared with three in 2022. In the first five months of this year, the administration granted market approval to 24 rare disease medicines. Moreover, Huang said that China's drug approval standards have now aligned with the international standard, facilitating foreign drugmakers to apply for market approval more promptly.

The State Council released a guideline on June 6, laying out key tasks for deepening healthcare reform for this year. The document said that the country will continue to accelerate examination and approval of innovative or urgent drugs and medical devices, rare disease therapeutics as well as medical equipment related to infectious disease control. (Source: ChinaDaily)

•  
• Imported drugs:
• □　Botulinum toxin type A for injection marketed by AbbVie Limited
• □　Fludrocortisone acetate tablets marketed by ASPEN PHARMA TRADING LIMITED
• □　Lidocaine cataplasms marketed by Teikoku Pharma USA, Inc.
• □　Octreotide acetate injection (Brand name: Sandostatin) marketed by Novartis Pharma Schweiz AG
• □　Pitolisant hydrochloride tablets marketed by Bioprojet Pharma
• □　Repotrectinib capsules (Brand name: Augtyro) marketed by Bristol-Myers Squibb Company
• □　Sulbactam sodium / durlobactam sodium injection (Brand name: Xacduro) marketed by Entasis Therapeutics, Inc.
• □　Tirzepatide Injection (Brand name: Mounjaro) marketed by Eli Lilly and Company

• Domestic drugs:
• □　Allisartan isoproxil and amlodipine besylate tablets (Brand name: 复立坦 (Fu Li Tan)) marketed by Shenzhen Salubris Pharmaceuticals Co., Ltd.
• □　Anlotinib hydrochloride capsules (Brand name: 福可维 (Fu Ke Wei)) marketed by CTTQ Pharma
• □　Compound sodium acetate and glucose injection marketed by En Tai Pharmaceutical
• □　Crisugabalin besilate capsules (Brand name: 思美宁 (Si Mei Ning)) marketed by Haisco Pharmaceutical Group
• □　Denosumab injection (Brand name: 博洛加 (Bo Luo Jia)) marketed by Boan Biotech
• □　Esomeprazole magnesium and sodium bicarbonate capsules marketed by Encheng Group
• □　Fluocinolone acetonide, hydroquinone and tretinoin cream marketed by Zhejiang Fonow Medicine Co., Ltd.
• □　Fluzoparib capsules (Brand name: 艾瑞颐 (Ai Rui Yi)) marketed by Jiangsu Hengrui Pharmaceuticals Co., Ltd.
• □　Human prothrombin complex marketed by Weiguang Biological
• □　Ivonescimab injection (Brand name: 依达方 (Yi Da Fang)) marketed by Akeso, Inc.
• □　Lansoprazole and sodium bicarbonate capsules marketed by Encheng Group
• □　Metoprolol succinate sustained-release capsules marketed by Cisen Pharmaceutical Co., Ltd.
• □　Mixed protamine zinc recombinant insulin lispro injection (50R) marketed by Wanbang Biopharma
• □　Rezivertinib mesylate capsules (Brand name: 瑞必达 (Rui Bi Da)) marketed by Beta Pharma
• □　Tacrolimus granules marketed by Huadong Medicine Co., Ltd.
• □　Zanubrutinib capsules (Brand name: 百悦泽 (Brukinsa)) marketed by BeiGene, Ltd.

• (Source: BaiPharm)

China records more than 100,000 new cervical cancer cases and around 50,000 related deaths annually. The country also sees an incidence rate that is much higher than four per 100,000 — the threshold determined by the WHO as proof of elimination of the disease.

Qiao Youlin, a professor at the School of Population Medicine and Public Health at the Chinese Academy of Medical Sciences and Peking Union Medical College, said "Through prompt detection and treatment during the process, we can prevent related deaths. However, in less developed regions with poor screening capacity and low health awareness, many women are diagnosed at a late stage and succumb to the disease."

Zhu Lan, head of the obstetrics and gynecology department at Peking Union Medical College Hospital, said that with China's vast territory, it is difficult to improve screening skills in remote areas to the level of major urban hospitals. "Using artificial intelligence and other new technologies to aid screening and diagnosis will be an important approach to controlling cervical cancer in those regions," she said. In addition to beefing up early screening, experts also emphasized expanding coverage of HPV vaccines, which fight the cancer-causing human papillomavirus.

China launched a trial program in 15 cities in 2021 that entails free HPV vaccinations and other innovative approaches, aiming to rein in the incidence of cancer. Since then, nine provincial-level regions have offered HPV vaccines for eligible girls, according to the National Health Commission. Chen Zhao, an official at the National Administration of Disease Control and Prevention, said that the number of HPV doses delivered domestically has been rising steadily, with more than 58 million shots administered nationwide last year.

According to a study released this month by researchers from the Chinese Center for Disease Control and Prevention and local CDC researchers in Fujian province, the annual number of administered HPV doses across the nation has been rising steadily since 2017, when China first approved HPV vaccines for use on the mainland. As of 2022, coverage of the first HPV vaccination dose rose to 10.1%, and three-dose coverage increased to 6%. However, both numbers were lower than the global average, which was estimated in 2019 to stand at 25% for the first dose and 15% for three doses. There is also a large shortfall from the WHO's target of achieving 90% full vaccination among girls under age 15 by 2030, the study said.

The study said that the introduction of two domestically developed HPV vaccines in 2019 and 2022 could help alleviate a shortage of vaccine supplies. It also recommends incorporating HPV vaccines into China's free national immunization program. "This should involve implementing routine vaccinations to rapidly increase coverage among a wide range of ages, reduce regional disparities and ensure equitable access to this important vaccine," it said. (Source: China Daily)

• Imported drugs:
• □　Baricitinib tablets (Brand name: OLUMIANT) marketed by Eli Lilly Nederland B.V.
• □　Cabotegravir injection marketed by ViiV Healthcare BV
• □　Cabotegravir sodium tablets marketed by ViiV Healthcare BV
• □　Faricimab injection (Brand name: VABYSMO) marketed by Roche Pharma (Schweiz) AG
• □　Human follitropin delta injection (Brand name: Rekovelle) marketed by Ferring Pharmaceuticals A/S
• □　Iptacopan hydrochloride capsules (Brand name: FABHALTA) marketed by Novartis Pharma Schweiz AG
• □　Mavacamten capsules (Brand name: CAMZYOS) marketed by Bristol-Myers Squibb Australia Pty Ltd.
• □　Nicorandil for injection marketed by Chugai Pharmaceutical Co.,Ltd.
• □　Perampanel tablets (Brand name: Fycompa) marketed by Eisai Europe Limited
• □　Rituximab subcutaneous injection marketed by Roche Pharma (Schweiz) AG
•  
•  
• Domestic drugs:
• □　Benmelstobart injection (TQB2450) (Brand name: 安得卫 (An De Wei)) marketed by CTTQ Pharma
• □　Bisoprolol fumarate and amlodipine besilate tablets marketed by Chengdu Shuode Pharmaceutical Co., Ltd.
• □　Chidamide tablets (Brand name: 爱谱沙 (Epidaza)) marketed by Chipscreen Biosciences
• □　Dexmedetomidine hydrochloride nasal spray (Brand name: 特美定 (Te Mei Ding)) marketed by Sichuan Purity Pharmaceutical Co., LTD.
• □　Entinostat tablets (Brand name: 景助达 (Jing Zhu Da)) marketed by EOC Pharma
• □　Human thyrotropin injection marketed by Suzhou Smartnuclide Biopharmaceutical Company
• □　Isavuconazonium sulfate for injection marketed by ASK Pharm
• □　Letermovir tablets marketed by CTTQ Pharma
• □　Linezolid oral suspension marketed by SSY Group Limited
• □　Metformin hydrochloride and empagliflozin tablets (III) marketed by Deyuan Pharm
• □　Oxcarbazepine oral suspension marketed by ApicHope Pharmaceutical Co., Ltd.
• □　Penpulimab injection (Brand name: 安尼可 (An Ni Ke)) marketed by CTTQ Pharma
• □　Recombinant human thrombopoietin injection (Brand name: 特比澳 (Te Bi Ao)) marketed by 3SBio Group
• □　Tislelizumab injection (Brand name: 百泽安 (Bai Ze An)) marketed by BeiGene, Ltd.
• □　Toripalimab injection (Brand name: 拓益 (Tuo Yi)) marketed by Junshi Biosciences
• □　Unecritinib fumarate capsules (Brand name: 安柏尼 (An Bo Ni)) marketed by CTTQ Pharma
• □　Vebreltinib enteric capsules (Brand name: 万比锐 (Wan Bi Rui)) marketed by Beijing Purun'ao Biotechnology Co., Ltd.
• (Source: BaiPharm)

China's health literacy has steadily risen and reached 29.7% in 2023, up 1.92 percentage points from the previous year, according to the National Health Commission (NHC) on Wednesday. A NHC survey revealed that the health literacy among Chinese urban residents was 33.25%, and that in rural areas was 26.23%, increasing by 1.31 and 2.45 percentage points, respectively.

Health literacy is an important indicator of economic and social development and people's health level. The NHC monitored health literacy based on people's awareness of health-related problems, including safety and first-aid, medical care as well as chronical and infectious disease prevention and control. (Source: Xinhua)

Thanks to China's drug centralized procurement drive, diabetes patients have access to more affordable and advanced insulin injections, said the National Healthcare Security Administration on Wednesday. China rolled out a bulk buy program targeting insulin injections in late 2021, leading to an average price cut of 48 percent. Insulin products chosen by the program became available at reduced prices in May 2022.

The administration said that about 650 million insulin doses involved in the program have been used at public hospitals nationwide since then. The annual usage amount has reached 350 million, compared with 250 million before the program was launched. "The data suggests that as the financial burden of medications has been alleviated, diabetes patients have easier access to insulin therapies and have complied with standard regimens more strictly," said the administration. The program has also narrowed price differences between advanced, third-generation insulin products and older versions. "The usage ratio of third-generation insulin doses rose from 58 to 78 percent after the program, nearing the level seen in European countries," it said.

The administration also stressed that the bulk buy program is aimed at curbing excessively high drug prices and guiding drugmakers to propose reasonable prices, while the massive domestic market also promises them large contracts. Some industry participants have hyped up the perception that centralized procurement is all about soliciting the lowest bids, resulting in a misunderstanding that the bulk buy drive would affect drug quality due to extremely low prices. The administration said that mainstream pharmaceuticals have all won bids during the program and the overall insulin price in China has dropped to relatively low prices compared to the global average. (Source: China Daily)