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2025

October: China Adds Novel Drugs Catalog to Medical Insurance Talks for the First Time

The annual negotiations between China’s government and pharmaceutical firms to determine which drugs are covered by the national medical insurance scheme opened a new chapter today (October 30, 2025) by adding a new catalog for innovative drugs alongside the standard catalog. According to Yicai, learning from drugmakers taking part in the bargaining, talks for the innovative drugs catalog will take place after those for the basic catalog. The items included in the catalogs will receive differentiated policy support in terms of payment guarantees and clinical use, they said.

Several novel drugs are on this year’s negotiation agenda, including sacituzumab tirumotecan, a next-generation TROP2-targeting antibody-drug conjugate developed by Chengdu-based Kelun-Biotech Biopharmaceutical, as well as new therapies from foreign players such as Novartis and Novo Nordisk. Expensive chimeric antigen receptor T-cell treatments also a high-stakes area in this year’s negotiations. Among the seven CAR-T products approved in China so far, five have applied to be included in the innovative drugs catalog, three of which have also requested to be in the basic catalog.

The national medical insurance catalog is mainly compiled by the National Healthcare Security Administration and includes essential medications for common diseases, chronic conditions, along with some novel drugs, providing basic medical coverage for insured individuals. Negotiations for the innovative drug catalog are also organized by the NHSA, with commercial insurers participating in the pricing process. The drugs included in this catalog will be high-value novel medicines and rare disease treatments that are currently outside the basic catalog

Per past negotiations, the first day mainly focuses on drugs with relatively transparent pricing, such as antiviral, anti-infection, chronic disease, and anesthetic analgesic medications. But it may also include some rare disease drugs. Negotiations for medicines that are more challenging, including cancer therapies, are typically scheduled for later. Pricing lies at the heart of the talks. The National Healthcare Security Fund and pharmaceutical companies need to reach agreement on the eligibility and payment standards for drugs.

Meanwhile, the national centralized drug procurement negotiations launched earlier this month could further lower the buying costs for drugs already in the medical insurance catalog, making it cheaper for patients. Even drugs not yet listed may leverage the bulk-buying program to enlarge their market share. (Source: Yicai Global)

October: China’s Nuclear Medicine Industry Strives for a Breakthrough

Nuclear medicine, formally known as radiopharmaceuticals, is used for disease diagnosis, treatment, or medical research, and is revolutionizing the way diseases are diagnosed and treated, The global nuclear medicine market is projected to grow from $12.6 billion in 2023 to $21 billion by the end of 2029, with a compound annual growth rate of 8.29%. Domestic innovation in nuclear medicine started later than overseas, primarily due to challenges in the development of medical imaging equipment such as SPECT/PET, insufficient local adoption rates, and a shortage of domestic isotope supply.

To address these challenges, policy measures have taken the lead. The 14th Five-Year Plan for the Development of the Medical Equipment Industry and the Medium- and Long-Term Development Plan for Medical Isotopes (2021–2035) have been successively introduced. All parties in the upstream industrial chain have also taken active steps. United Imaging Healthcare has overcome key technological hurdles and promoted the popularization of PET equipment. By 2023, the number of PET devices in China reached 722, an 80.8% increase compared with 2019.

Currently, 205 innovative nuclear drug pipelines are in the clinical stage in China, with multiple listed companies investing in innovative nuclear medicine. Grand Pharma, for example, has established a global R&D and production base. In the first half of 2025, its nuclear medicine segment revenue reached HKD 420 million, a year-on-year increase of 106%. Baheal Pharma Group's Tc-99m RGD peptide injection has completed Phase III clinical trials. Other companies, such as Fosun Pharma and Guangzhou Pharmaceutical Holdings, have also entered the field. (Source: China Economic Net.)

October: China approves world's 1st domestic drug for hepatitis B cure

China has approved the world's first domestically developed drug designed to achieve a functional cure for hepatitis B, marking a significant step in the global fight against the chronic liver infection. The injectable drug, named Pegbing, was developed by Amoytop Biotech based in Xiamen, Fujian province. It has been approved for use in combination with antiviral medication to achieve sustained clearance of the hepatitis B surface antigen in adults with chronic hepatitis B, according to a notice released by the National Medical Products Administration. The Chinese Foundation for Hepatitis Prevention and Control said the approval represents the world's first market authorization for a drug aimed at achieving functional cure for hepatitis B, ushering in a new stage in the global battle against the infectious disease.

Globally, hepatitis B affects about 254 million people and causes over 1 million related deaths annually. China has about 75 million chronic hepatitis B patients. A functional cure for hepatitis B is defined as the sustained loss of the hepatitis B surface antigen after treatment cessation, in contrast to conventional therapies that suppress viral replication but do not eliminate the virus entirely. (Source: China Daily)

September: China's average life expectancy rises to 79

China's top health official on Thursday said the country's average life expectancy has risen to 79 years. The figure, measured by the end of 2024, was 1.1 years higher than that in 2020, said Lei Haichao, head of the National Health Commission, adding that it marked "a notable improvement" for a developing country. Eight provincial-level regions have even recorded an average life expectancy over 80 years, he added. Lei, speaking at a press conference on the country's progress in the health sector during the 14th Five-Year Plan period (2021-25), stated that infant and maternal mortality rates have continued to decline over the past five years, and the overall health level of residents has steadily improved. (Source: Xinhua)

September: China introduces childcare subsidy system in push for population growth

China has introduced a national childcare subsidy system starting this year, as part of efforts to improve the childbirth support system and promote high-quality population development, the country's top health official said on Thursday. From Jan. 1 this year, families will receive an annual childcare subsidy of 3,600 yuan (about 507 US dollars) per child -- whether for a first, second, or third child -- until the child turns three, according to a plan issued earlier by the general offices of the Communist Party of China Central Committee and the State Council. As of Wednesday, over 80% of eligible applicants had completed registration through online and offline channels, Lei Haichao, head of the National Health Commission (NHC), told a press conference on the country's progress in the health sector during the 14th Five-Year Plan period (2021-2025).

Economic support in childcare has been expanded in multiple areas over the five-year period. Childcare for children under three and children's education have been included in additional deductions for individual income tax, with the deduction standard raised from 1,000 yuan per child per month to 2,000 yuan, said Guo Yanhong, deputy head of the NHC. All Chinese provinces now include assisted reproductive technology projects in medical insurance reimbursement, along with other policies such as free preschool education and housing support, Guo added. Nationwide, rates of regular checkups for pregnant women, new mothers and newborns have remained above 90%, Guo said, noting that comprehensive maternal and child services have been further strengthened, including a pregnancy risk screening mechanism and special management for high-risk maternal cases. Chinese parents are also afforded more time to care for their infants and young children. According to Guo, all Chinese provinces have also extended maternity leave and parental childcare leave. (Source: Xinhua)

September: China plans to include HPV vaccines in national immunization program

China plans to include the human papillomavirus vaccine in its national immunization program, Shen Hongbing, head of the National Administration of Disease Control and Prevention and deputy director of the National Health Commission, said on Thursday. Shen said the country would roll out HPV vaccination services this year for all eligible girls, aimed at protecting women's health. So far, at least 17 provincial-level regions have announced that they will provide free HPV vaccines to eligible girls, typically those between the ages of 9 and 14. These programs use domestically developed vaccines that protect against the two most common HPV strains.

Calls to incorporate HPV vaccines into the national immunization program have grown stronger in recent years due to the increasing availability of affordable domestic vaccines, as well as the rising burden of cervical cancer — the fifth most common cancer among women in China. Human papillomavirus infection is the leading cause of cervical cancer. The nation's free immunization program now covers 14 vaccines that can protect against 15 diseases. The program has not been expanded since 2007. (Source: China Daily)

September: China ranks 2nd globally in new drug development, NHC official says

China now ranks second globally in new drug development, accounting for 20% of the world's new pharmaceuticals in the pipeline, a health official said on Thursday. Guo Yanhong, an official of the National Health Commission, said at a press conference that several domestically developed innovative drugs for cancer treatment have received market approval both in China and abroad.

Locally produced human papillomavirus vaccines have also been widely adopted, significantly improving vaccine accessibility. Meanwhile, a range of domestic medical devices — from advanced CT scanners and surgical robots to artificial hearts and proton and heavy ion radiotherapy systems — have been successfully developed and put into clinical use. "The overall capacity of health science and technology has continued to strengthen, resulting in a series of groundbreaking advances and landmark achievements," she added. (Source: China Daily)

July: Over 1 million Chinese benefited from fertility treatment coverage last year

All 31 provincial-level regions on the Chinese mainland have covered assisted reproductive services under their medical insurance programs as part of a broader push to encourage births and build a birth-friendly society, an official said on Thursday. Liu Juan of the National Healthcare Security Administration said that more than 1 million people have benefited from the insurance reimbursement policy for fertility treatment last year.

"Some provinces have also covered pain relief services during labor under insurance programs so as to relieve financial burdens and physical pain of pregnant women," she said. "Meanwhile, we have accelerated formulating pricing guidelines for services such as care for neonatal care and family-accompanied childbirth so as to help improve pediatric and obstetric services and meet diversified fertility needs of the public," she said. (Source: China Daily)

July: Chronic hepatitis B program helps over 10,000 patients get clinical cure

A chronic hepatitis B treatment program has helped over 10,000 patients achieve a functional cure — also known as clinical cure — as of the end of May, the Chinese Foundation for Hepatitis Prevention and Control that initiated the program said recently. A functional cure refers to the clearance of the hepatitis B surface antigen and the suppression of virus replication without the need for continued treatment. China is home to about 75 million chronic hepatitis B patients, and achieving a functional cure for them would lower the risk of developing liver cirrhosis or cancer.

Xie Qing, an infectious disease expert at Ruijin Hospital affiliated with Shanghai Jiao Tong University's School of Medicine, said that advancements in new drugs and optimized treatment plans in recent years have enabled personalized functional cure protocols for patients of different ages and disease stages. As a result, an increasing number of patients have attained a functional cure, she said during an event held by the foundation ahead of this year's World Hepatitis Day, observed annually on July 28. The foundation reported that the program has surpassed its initial target of delivering clinical cure to 8,848 patients.

Gao Zhiliang, an infectious disease specialist from the Third Affiliated Hospital of Sun Yat-Sen University, said that the program has gained recognition from the National Health Commission, China's top health authority, and its treatment protocol is now being promoted nationwide. To date, more than 1,000 hospitals have established dedicated clinical cure clinics for hepatitis B. (Source: China Daily)

July: China issues new rare disease guidelines

The National Health Commission on Thursday released a second batch of diagnosis and treatment guidelines for 86 rare diseases. The batch covers conditions including achondroplasia, a disorder of bone growth that can cause dwarfism; acquired hemophilia; and acromegaly, a hormonal disorder that can lead to the enlargement of body parts. China has about 20 million patients with rare diseases, with more than 200,000 new cases each year. The first batch of treatment guidelines was published in 2019 and covered 121 rare diseases.

The Peking Union Medical College Hospital said Thursday that the new guidelines were jointly compiled by the hospital and the China Alliance for Rare Disease at the commission's request. "These guidelines have comprehensively outlined the clinical features, diagnostic standards, treatment approaches and long-term management strategies for 86 rare diseases, serving as a valuable reference for medical workers," the hospital said in a statement. "Their implementation is expected to minimize diagnostic errors, optimize care and improve patient outcomes," it said. (Source: China Daily)

July: Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount

China’s first domestically made nine-valent HPV vaccine, a direct competitor to Merck’s Gardasil 9, is being priced at 499 yuan ($70) per dose, the state-owned Xinhua News Agency reports. The shot’s developer, Wantai BioPharm’s Xiamen Innovax Biotech, has set the sticker at an approximately 60% discount compared with the roughly 1,300 yuan-per-dose price for Gardasil 9 in China.

A lower price from a local competitor, while expected, marks another blow to Merck’s under-pressure Gardasil franchise. Thanks to its performance in China, Gardasil had been a top growth driver for the New Jersey pharma giant up until the second quarter of 2024. At that time, declining China sales slowed Gardasil’s year-over-year quarterly growth to merely 1%, compared with 14% during the three months before. As Gardasil represents Merck’s second-largest product behind cancer blockbuster Keytruda, news of the slowdown triggered a rare 9% share price drop for the company.

The situation has not improved since then. In the first quarter of 2025, Gardasil sales declined 41% to $1.3 billion, as its sales in China plummeted by about $1.1 billion. Excluding China, the shot’s sales grew 14%. Merck has a multifold explanation for Gardasil’s dramatic downturn in China. Besides a chilling effect from the Chinese government’s anti-corruption drive targeting the entire healthcare field, Merck CEO Rob Davis has cited a slowdown in “discretionary consumer spending” as one reason for a cooling across China’s vaccine space. Because HPV vaccines are not included in China’s national immunization program, people must pay out of pocket to get vaccinated.

Merck apparently has been trying to offset its price disadvantage. Media reports suggest that the company, through its local partner Chongqing Zhifei Biological Products, has been offering three-dose courses of Gardasil 9 at the price of two doses in some areas. The U.S. drugmaker has also ramped up its marketing push for Gardasil in the country.

Despite the headwinds, the Chinese HPV market still has great potential. Only 27% of Chinese women who were eligible had received at least one dose of an HPV vaccine, Wantai noted in an investor communication Tuesday, citing Chinese CDC data. Compared with the roughly 67% penetration rate in Western countries, HPV vaccines still have much room to grow in China, the Chinese company said. Wantai said it’s currently working to get Cecolin 9 onto the World Health Organization prequalification list to pave the way for its introduction outside China. The company is also testing the nine-valent shot in men in a phase 3 study and is developing a 21-valent version, as well. (Source: Fierce Pharma)

July: Crackdown on illicit Botox courses widens

China's health authorities have vowed to crack down on malpractice in the medical aesthetics industry and step up supervision of botulinum toxin — an anti-wrinkle injection better known as Botox — following media reports that exposed illicit crash courses claiming to teach cosmetic procedures in just days.

Reports about questionable training courses that enroll people with no medical background emerged about a week ago. These programs claim students can master non-surgical cosmetic procedures such as injectables and thread lifts, and even some surgical treatments, within a period of three to four days. The programs have been rolled out in at least 20 cities, including Beijing and Shanghai, as well as Shenzhen and Guangzhou in Guangdong province, China Central Television reported. During a recent training session in Fuzhou, Fujian province, a girl who was receiving Botox injections from program participants in a hotel room suddenly passed out and was sent to emergency care. She regained consciousness and was discharged from the hospital two days later.

The National Health Commission said on Thursday that it has instructed local authorities to verify and investigate the reports and strictly punish those involved in any illegal activities. "The commission will also collaborate with relevant departments to further strengthen regulation over misconduct in the medical aesthetics industry, promote cross-agency coordination in handling violations, and continue to crack down on illegal practices to effectively safeguard public health rights and interests," the commission said. The commission stressed that no institution may provide medical aesthetic services without obtaining a medical institution practice license or clinic registration certificate. Physicians providing such services must possess a physician qualification certificate and physician practice license — which typically requires nearly a decade of formal education — as well as a medical aesthetic physician qualification.

The National Medical Products Administration said on Thursday that it has established a national drug traceability and supervision system to monitor the distribution of Botox products and prevent illegal use. The administration said it will continue to enhance supervision over drug quality and safety and will work with public security authorities to combat criminal activities.

China's medical aesthetics market is estimated to have surged from about 64 million yuan ($8.9 million) in 2015 to more than 300 billion yuan last year. The boom has also fueled problems such as inadequate practitioner training, unsafe practices, disorderly pricing and exaggerated advertising claims.

Wang Yongqian, chief physician at the Chinese Academy of Medical Sciences' Plastic Surgery Hospital, said harmful reactions to cosmetic injections at unlicensed facilities can include infections due to violations of strict aseptic protocols, allergies and complications caused by fake products. "Non-medical professionals might accidentally inject fillers into blood vessels, which can lead to skin necrosis, blindness and even stroke," he said. "Non-medical institutions also lack effective emergency care and will not be able to provide prompt first aid in cases of severe allergic reactions or embolism." "Cosmetic treatments are in essence medical procedures," he said. "Consumers are advised against undergoing surgeries, laser or injectable treatments at beauty salons, nail studios and other non-medical facilities, or self-administer anti-wrinkle injections at home." With the start of summer vacation for students, he also advised against minors undergoing cosmetic procedures because their physiological development is incomplete and their aesthetic perceptions are still evolving. (Source: China Daily)

June: China confronts senior cancer surge with early detection and TCM

With a rapidly aging population, China is facing a pressing new public health challenge: cancer among the elderly. According to the latest data, people over the age of 60 now account for 60.7% of all new cancer diagnoses in the country, making senior cancer care one of the most urgent priorities in China's efforts to deliver health for all. China's demographic shift is accelerating: those aged 60 and above now make up more than 20% of the population. By 2035, that figure is expected to reach 30%, with the elderly population surpassing 400 million.

A report by the Chinese Anti-Cancer Association shows that lung and gastrointestinal cancers are the most prevalent among older adults, accounting for roughly 65 percent of malignant tumors in this age group. Other commonly diagnosed cancers include liver, lymphoma, prostate, and various blood cancers. "Cancer among seniors is not uncommon, and it's closely tied to the accumulation of genetic mutations over time," said Xue Dong, a specialist in senior oncology at Peking University Cancer Hospital. Xue explained that aging cells, a declining immune system, and long-term exposure to carcinogens significantly increase vulnerability. Early detection remains the most powerful tool in fighting cancer, experts say.

In response, China's National Health Commission has called for enhanced public health services, including nationwide health checkups for adults aged 65 and older, with more frequent screenings for high-risk groups.

Local initiatives are also underway. In Yancheng, East China's Jiangsu province, residents aged 60 to 69 now receive free testing for 12 common tumor markers. In Daqing, the northeastern province of Heilongjiang, authorities offer free screening for five major cancers -- lung, breast, liver, upper gastrointestinal, and colorectal -- to citizens aged between 45 and 74.

Beyond cancer screenings, physicians also promote healthier daily routines. Zhang Tong, a cancer specialist at Xiyuan Hospital of the China Academy of Chinese Medical Sciences, encourages seniors to maintain a balanced diet and practice traditional Chinese fitness exercises, such as Tai Chi and Baduanjin, which are known to enhance energy and immune function.

Doctors also emphasize that traditional Chinese medicine can play a supportive role in conjunction with Western medical treatments. During chemotherapy, therapies like acupuncture and acupoint patches help relieve side effects such as nausea, appetite loss, and constipation. For radiation-related symptoms like skin damage and mouth ulcers, herbal baths and steam therapy offer relief. Li Yuanqing, a colleague of Xue at the same hospital, noted that clinical experience shows these approaches can ease patient discomfort during chemotherapy and radiotherapy.

Additionally, experts warn of deep-rooted misperceptions. Many older patients place faith in miracle cures or folk remedies, while others fear that conventional treatments like surgery or chemotherapy will only accelerate their decline. "Treating elderly cancer patients requires balance," said Xue. "We can't simply apply treatments designed for younger people, nor should we dismiss care due to age. The key lies in personalized treatment, guided by both medical need and the patient's physical and emotional readiness." "With science and compassion as our prescription, more elderly cancer patients can look forward to a dignified late life," Xue said. (Source: Xinhua)

June: Diabetes affects 233 million Chinese, study says

China has an estimated 233 million diabetic patients by the year 2023, up 163% over 2005, latest study by Chinese public health experts has found. The study led by researcher Zhou Maigeng with the National Center for Chronic Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, was published in the June issue of the journal Military Medical Research.

Previously, the International Diabetes Federation estimated that China has 140 million diabetes patients. Compared to 2005, the diabetes prevalence has increased by nearly 50%, from 7.53% to 13.7% in 2023, according to the latest study. If the trend continues, the national prevalence is projected to reach 29.1% by 2050. The study also found that males had higher prevalence than females in general and the cities with the highest diabetes prevalence and disease burden were Beijing, Tianjin, and Shanghai.

The surge in diabetes prevalence was closely tied to the rapid increase in obesity rates. The prevalence of obesity among adults increased from 7.1% in 2002 to 16.4% during 2015–2019, it showed. Notably, with effective policies implemented to halt the rising obesity epidemic, researchers projected that the prevalence will gradually flatten and remain below 15% nationally in 2050.

Diabetes affects multiple organ systems and causes a variety of vascular and non-vascular complications, such as diabetic retinopathy and diabetic nephropathy, cardiovascular diseases, as well as liver and kidney conditions, experts warned. In 2021, 6.47% of total years lived with disability in China were attributed to diabetes and high fasting plasma glucose in general, ranking it the fourth highest risk factor for disease burden. The economic costs associated with diabetes were equally staggering. A recent study estimated that without immediate intervention, the total cost associated with diabetes in the country will reach $460 billion in 2030. (Source: China Daily)

June: China's child health improves

China's child health status has continued to improve in recent years, said a health official on Friday. In 2024, the national infant mortality rate and under-5 mortality rate dropped to 4 per 1,000 and 5.6 per 1,000 respectively, hitting record lows and ranking among the top in upper-middle-income countries globally, Shen Haiping, a senior official with the National Health Commission, told a press conference. Examining global trends over the past decade, China's average annual rate of decline in infant mortality and under-5 mortality ranked third and fourth, respectively, among 53 upper-middle-income countries globally, Shen said. Between 2010 and 2023, China's average life expectancy increased by 3.8 years, with 21.7% of this increase attributable to the decline in the under-5 mortality rate, she added. (Source: Xinhua)

May: Smoking rate falls amid bans and awareness

The smoking rate among people age 15 and older in China fell to 23.2% last year, down nearly 5% from 2010 and almost 1% from 2022, according to a national study released on Thursday. Health officials attributed the continued decline to stronger public education campaigns and stricter enforcement of smoking bans in public spaces.

The smoking rate in rural areas stood at 24.9% last year, compared with 20.9% in urban areas, according to the study, which was led by the Chinese Center for Disease Control and Prevention and surveyed nearly 200,000 people. Meanwhile, 46.5% of nonsmokers were exposed to secondhand smoke last year, down from 52.4% in 2022. Restaurants, homes and indoor workplaces were the most common places for such exposure.

Guo Yanhong, vice-minister of the National Health Commission, said tobacco control is a key part of China's broader effort to improve public health by 2030. "There is still a long way ahead to reach the goal of lowering the smoking rate among those age 15 and above to 20% by 2030," Guo said during an event in Beijing ahead of World No Tobacco Day, which is observed each year on May 31. Guo emphasized the importance of educating children and adolescents about the dangers of tobacco to help foster healthy lifestyles and reduce the number of future smokers.

According to the study, 40.1% of participants said they had seen tobacco control messages online in the past 30 days, an increase of 5.1% points from 2022. "Public awareness of the health risks of smoking has risen significantly, with 23.8% of respondents recognizing that tobacco use is linked to lung cancer, heart disease, stroke and erectile dysfunction — up 8.2% from 2022," said Shi Xiaoming, deputy director of the China CDC. Shi said understanding of the dangers of secondhand smoke has also improved, with 44.2% of respondents saying they were aware that it can cause lung cancer, pediatric respiratory illnesses and heart disease — an increase of 7.1% from 2022. Notably, 36.4% of respondents said they had seen smoking depicted in television shows, videos or movies in the past 30 days — a drop of more than 9 percentage points from 2022.

In Beijing, the smoking rate among those age 15 and older dropped from 23.4% in 2014 to 19.2% last year, following the 2015 implementation of a citywide smoking ban in restaurants, offices and on public transportation. Xu Xinchao, deputy secretary-general of the Beijing municipal government, said the number of smokers in the capital has fallen by nearly 700,000, and smoking in public places has become significantly less common. (Source: China Daily)

May: Guideline instructs major hospitals to open targeted weight management facilities

All major hospitals in China will establish weight management clinics by the end of next month, according to a guideline released last month by the National Health Commission and National Administration of Traditional Chinese Medicine. The requirement applies to all general hospitals, pediatric and traditional Chinese medicine hospitals under direct administration by the commission, the administration and provincial-level authorities. Other tertiary hospitals at the top of the nation's three-tier hospital system are also encouraged to establish weight management clinics.

The guideline clarifies 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.

Official data shows that more than half of Chinese adults are either overweight or obese. From 2018 to 2022, the number of overweight adults rose from 22.8% to 34.3%, and those classified as obese more than doubled from 7.1% to 16.4%. Among children and teenagers aged 6 to 17, more than 11.1% are overweight and nearly 8% are obese. (Source: China Daily)

April: MSD's nine-valent HPV vaccine approved for use in males in China

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)

April: New gene therapy drug approved for use in China

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)

April: Health authorities ask all major hospitals to set up weight management clinics

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)

March: Measures facilitate approval of 48 first-in-class innovative drugs

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)

March: Shanghai's first wholly foreign-owned hospital granted license

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)

March: China's average life expectancy reaches 79 years in 2024

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)

February: China's first wholly foreign-owned tertiary general hospital starts service in Tianjin

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)

February: Domestic ultra-long-acting GLP-1 injection approved for treatment of type 2 diabetes in adults

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)

January: HPV vaccine for males approved in China

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)

January: China to expand pediatric, mental health services

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)

January: New Imported Drug Approvals by the NMPA - December 2024
  • □ 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)
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