PuGongYing Bio·News | Top Headlines in Biopharma Industry (Nov 21–27, 2024)
Imunopharm
Developer of Gene and Cell Therapy Technologies
CSPC
Innovative Drug Research and Development, Manufacturer
Bio·News
Medicine
Supervision
Resources
News
1. National Medical Products Administration | Draft 2025 Edition of the Chinese Pharmacopoeia Approved
2024On November 27, the plenary session of the Executive Committee of the 12th Pharmacopoeia Commission was held in Beijing, where the draft of the 2025 edition of the "Pharmacopoeia of the People's Republic of China" was reviewed and approved, and plans for the promulgation and implementation of the new edition were discussed and arranged.。(View related readings by clicking)
(Source：National Medical Products Administration）
2. National Medical Products Administration (NMPA) | Pilot Reform of Drug Review and Approval in Ten Provinces and Municipalities
2024November 22,The National Medical Products Administration has issued the "Approval on Agreeing to the Pilot Reform of Optimizing the Review and Approval Process for Drug Supplemental Applications in Beijing and Other Ten Provinces (Municipalities)."Pilot Ten Provinces (Municipalities):Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Shandong, Guangdong, Chongqing, Sichuan.(View related readings by clicking)
(Source：National Medical Products Administration）
3. Heilongjiang Provincial Drug Administration | Pharmaceutical Companies Grading Supervision Measures Released
2024On November 20, the Heilongjiang Drug Administration released the "Quantitative Grading Supervision and Management Measures for Pharmaceutical Marketing Authorization Holders and Pharmaceutical Manufacturing Enterprises in Heilongjiang Province."This Measures shall come into force on December 1, 2024, and remain valid for five years.。(Click to view related reading)
(Source: Heilongjiang ProvinceNational Medical Products Administration）
Affected
Reason
Feelings
Situation
CDE Acceptance Status
November 21, 2024From November 27, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA)A total of 412 drugs were acceptedIndividual, among which56 Biological Products（18 new drugs and 7 imported）。
(Source: Center for Drug Evaluation, National Medical Products Administration)
Enterprise
Industry
Move
State
2024NovemberOn the 27th,Beijing Yimiao Shenzhou Medical Technology Co., Ltd. announced that the New Drug Application (NDA) for its first self-developed autologous CAR-T cell candidate product, IM19 Chimeric Antigen Receptor T-cell Injection (referred to as “IM19”), which targets CD19 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), has been officially accepted by the National Medical Products Administration (NMPA).
（Source: Official WeChat account of Beijing Yimiaoshenzhou Medical Techology Co., Ltd.)
2024NovemberOn the 26th,CSPC announced that the biologics license application for ustekinumab injection ("the product") developed by the group has been formally accepted by the National Medical Products Administration of the People's Republic of China.
（Source: CSPC Official WeChat)
2024NovemberOn the 21st, Merck announced that its HIF-2α inhibitor Verilumi®(Belzutifan) has been approved by the NMPA for the treatment of adult patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) who do not require immediate surgical intervention. According to reports,Veliri®As the first and only HIF-2α inhibitor approved in China, which will bring a new mechanism of treatment options to patients in this rare disease field.
（Source: MSD China Official WeChat)
2024Year 11Day 21Day，Mabwell Announces Two Denosumab Injection Products 9MW0311 (Prolia)®Biosimilar, Trade Name in China: Milexus®）and 9MW0321 (Xgeva®Biosimilar, Trade Name in China: Maiweijian®) Sign exclusive licensing and commercialization agreements with strategic partners in the Peruvian market. According to the agreement, the partner has exclusive sales rights for two products in the Peruvian market, while Maiwei Biotech is responsible for the development, production, and commercial supply of the products.
(Source: MW BIO Official WeChat)）
5、CStone Pharmaceuticals | Pharmalink Enter into Strategic Collaboration for Sugemalimab in Middle East and Africa
22024November 21CStone Pharmaceuticals announced a commercial strategic partnership with Pharmalink Store. Pharmalink is a renowned pharmaceutical company headquartered in the United Arab Emirates. Under the licensing and commercialization agreement, Pharmalink will obtain the commercial rights for Sugemalimab in the Middle East and North Africa regions, including Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Oman, Bahrain, Algeria, Tunisia, Egypt, Morocco, Libya, as well as South Africa.Sugrelimab is the first PD-L1 monoclonal antibody developed by a Chinese biopharmaceutical company to successfully enter the world's second-largest pharmaceutical market – the EU and the UK.
(Source: CStone Pharmaceuticals Official WeChat)）
Editor: Sesame Walnut
Statement:This article only represents the author's personal views and does not represent the position of any organization or this official account. If there are any inappropriate points, please correct them. If you need to reprint, please indicate the author and source:蒲公英Biopharma.
Dandelion BioIt belongs to one of the ten major sectors of Dandelion, specifically the media sector, and is a professional module focusing on media market cooperation for biopharmaceutical manufacturing and supply chain enterprises. Since 2022, it has been independently operated by Dandelion Shanghai Yaozhi Technology Co., Ltd., with its headquarters located in Zhangjiang Science City, Shanghai.
Service Content:Based on蒲公英Ouryao and its media matrix (1.2M+Pharmaceutical vertical users), includingMarket Planning, Media Promotion, Online Live Streaming, Essay Contests & Research, Writing & Interviewing, Brand SummitSix major businesses, andUndertake Customized Online and Offline Activities。
Team Composition:The management team is composed of biopharmaceutical professionals with over 15 years of industry experience. All team members hold at least a full-time bachelor’s degree or higher, with expertise spanning biology, pharmaceuticals, advertising, journalism, and English. Skilled in creating tailored and precise market strategies for enterprises, they effectively support brand promotion and market conversion.
Dandelion Bio, Empowering 100 Biomedical Supply Chain Enterprises to Excel in the Market!
Contact Us:
Teacher Zhang, 13062776509(WeChat remarks:Dandelion Bio)
Email: bio@ouryao.com