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)