Dandelion Bio·News | Biopharmaceutical Industry Weekly Highlights (April 10–16, 2025)
Gritgen
Gene Therapy Drug Developer
Johnson & Johnson
Medical Device R&D and Manufacturer
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Bio·News
Medicine
Supervision
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News
1. Central Military Commission | Implementation of the "Pharmaceutical Administration Law of the People's Republic of China"
22025April12Day, ChinaCentral ArmyThe issuance of the "Implementation Measures of the People's Liberation Army for the 'Pharmaceutical Administration Law'" will take effect from June 1st, regulating the research, production, reserve, supply, and supervision of pharmaceuticals within the military. Military medical institutions must procure medicines from legitimate enterprises (excluding unapproved Chinese herbal medicines), with vaccines being procured by military disease control institutions through national channels or as per military regulations. Special military pharmaceuticals require registration and approval from the Logistics Support Department of the Central Military Commission; production units must obtain a license (local enterprises need to register with provincial pharmaceutical regulatory authorities). Contract manufacturing requires an agreement and oversight of product quality.
(Source: Official Website of the Central People's Government of China）
Affected
Li
Context
Situation
CDE Acceptance Status
April 10, 2025During the period from January to April 16, the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationA total of 347 drugs were acceptedIndividual, among whichBiological Products: 53（30 New Drugs andInOral 5）。
Enterprise
Industry
Move
State
1、Gritgen | Hemophilia Gene Therapy Proposed for Inclusion in Breakthrough Treatment Category
2025On April 16, the CDE official website announced,GritgenGritgen Therapeutics Co., Ltd.'s novel Class 1 drug GS1191-0445 injection is proposed to be included in the breakthrough therapy designation for the treatment of Hemophilia A caused by congenital Factor VII deficiency. Public data shows that GS1191-0445 injection is an investigational adeno-associated virus (AAV) gene therapy for Hemophilia A. The product officially entered Phase 3 clinical research in February this year.
(Source: CDE Official WeChat, Pharmaceutical Observer)）
2、Merck | Nine-valent Human Papillomavirus Vaccine (Saccharomyces cerevisiae) Approved for Male Indications in China
2025April 14，Merck (known as Merck & Co., Inc., Rahway, NJ, USA) announced that Gardasil®91[9-Valent Human Papillomavirus Vaccine (Saccharomyces cerevisiae)] (hereinafter referred to as "9-valent HPV vaccine") has received marketing approval from the National Medical Products Administration for multiple new indications, applicable for males aged 16 to 26.This approval makes Gardasil®9 the first and currently the only nine-valent HPV vaccine approved in China for use in both eligible males and females, marking a new phase where China officially enters into "joint prevention of HPV-related cancers and diseases" for both men and women.
(Source: MSD China Official WeChat）
3, Johnson & Johnson | Carestream®(Evantumab Injection) Launched in China
2025On April 12, Johnson & Johnson announced that its innovative lung cancer treatment drug, Rikoe®(Amivantamab Injection) Officially Launched in China. It is used for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations, bringing an innovative breakthrough for patients with previously poor prognosis and limited treatment options.
(Source: Johnson & Johnson Innovative Pharmaceuticals)）
2025On April 10, the National Medical Products Administration approved Boparadacog Alfa Injection (trade name: Xunjuning).®) has been launched in China for the treatment of adult patients with moderate to severe hemophilia B (congenital factor IX deficiency).This is the first gene therapy drug for hemophilia B, and also the first gene therapy drug approved in China.Marks a major breakthrough in China's gene therapy field. In addition, the drugIt is also the third domestically produced Class 1 innovative drug approved for marketing in Shanghai this year.（Click to view related readings)
(Source: NMPA official website, Belief Biomed official WeChat)）
5、Tasly | CAR-T Therapy New Drug Approved for Clinical Trials
2025AprilOn the 10th, the CDE website announced that Tasly's Class 1 new drug, P134 Cell Injection, has been approved for clinical trials, intended for the development of treatment for recurrent glioblastoma. According to publicly available information, this is an innovative biologic jointly developed by Tasly and the Beijing Neurosurgical Institute. It is an autologous CAR-T product targeting CD44 and/or CD133. This marks the first time the product has received IND approval in China.
(Source: CDE)OfficialNetwork, Pharmaceutical Viewpoint）
Editor: Sesame Walnut
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