PharmaFocus Today – Page 10 – media

Nine drugs, including HRS-4642 injection, received approval notices for clinical trials.

　　Nanfang Finance News, November 17th – Jiangsu Hengrui Medicine Co., Ltd. ( 01276.HK) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd., recently received approvals from the National Medical Products Administration for HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, adebecilimab injection, bevacizumab injection, SHR-A2102 for injection, and apple .The Clinical Trial Approval Notices for Famitinib Malate Capsules and Dalcilide Ethylhex … https://finance.eastmoney.com/a/202511173566406150.html
- Source: drugdu
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- November 18, 2025
China’s First FRα-ADC Drug Receives Routine Approval

　　On the evening of November 17th, Huadong Medicine(000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its supplemental application to change from conditional approval to regular approval for somituximab injection (ELAHERE®). 　　The announcement indicates that somituximab is the first and currently only FRα-targeting ADC drug approved in China, the United States, and the European Union for the treatment of platinum-resistant ovarian cancer (PROC). Hangzhou Sino-American East China Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, holds exclusive clinical development and commercialization rights for this product in Greater China. 　　It is understood that somituximab is an innovative ADC drug targeting folate receptor α (FRα, a cell surface protein highly expressed in ovarian cancer), developed in collaboration between Sino-American Huadong and Immuno Gen, Inc. (now acquired by AbbVie).It consists of an FRα-binding antibody, a cleavable linker, ...
- Source: drugdu
- 75
- November 18, 2025
Former Hengrui Medicine executive Shen Yaping joins Hanyu Pharmaceutical, marking the beginning of a new journey for the company’s international development.

　　On November 17th, Hanyu Pharmaceutical, a leading company in peptide drugs…(300199.SZ) announced a major personnel appointment: former Hengrui MedicineMr. Shen Yaping, Vice President and Head of International Business, has officially assumed the position of Executive President of Hanyu Pharmaceutical . 　　The announcement states that Dr. Shen Yaping graduated from the University of Ottawa, Canada, and previously worked for several well-known overseas pharmaceutical companies, including Inflazyme (Canada), Lipont (USA), and Chemwerth (USA). He joined Hengrui Medicine in 2012 , serving successively as Assistant to the Chairman and Vice President, overseeing Hengrui Medicine’s International Business Department, International Generic Drug Research Institute, eVenus (USA), Hengrui (Japan), and Hengrui (Singapore), responsible for APIs, generic drugs, and some innovative drugs.Market development, registration, sales, and maintenance of products in overseas markets. 　　His joining not only signifies a proactive choice regarding the development of Hanyu Pharmaceutical’s peptide field and its international commercial prospects after in-depth analysis of ...
- Source: drugdu
- 71
- November 18, 2025
Iza-bren met its primary endpoint in interim analysis of a phase III clinical trial for recurrent or metastatic esophageal squamous cell carcinoma.

　　Baili Tianheng(688506) announced on the morning of November 18th that its independently developed, world’s first, novel, and only EGFR×HER3 bispecific antibody ADC (iza-bren) to enter Phase III clinical trials for esophageal squamous cell carcinoma has met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in the pre-specified interim analysis, as determined by the independent data monitoring committee. The indication is recurrent or metastatic esophageal squamous cell carcinoma that has failed prior treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. This is the world’s first Phase III clinical study of an ADC drug to achieve double positive results for PFS/OS in the treatment of esophageal cancer. https://finance.eastmoney.com/a/202511183566910923.html
- Source: drugdu
- 68
- November 18, 2025
Voluntary Information Disclosure Announcement Regarding the Company Obtaining Approval Notice for Drug Clinical Trials

　　SecuritiesDaily News reported on the evening of November 12th that Panlong Pharmaceutical…The company announced that it recently received a “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, approving the clinical trial of Panlongqi Gel Patch for knee osteoarthritis. https://finance.eastmoney.com/a/202511123562395262.html
- Source: drugdu
- 79
- November 15, 2025
Quanxin Bio-B Long-Acting Bispecific Antibody QX027N Injection Receives Approval for Two Clinical Trials

　　On November 13, Quanxin Bio-B (02509) issued an announcement stating that its independently developed long-acting bispecific antibody QX027N injection has obtained implied approval for clinical trials from the Center for Drug Evaluation of the National Medical Products Administration, with acceptance numbers CXSL2500757 and CXSL2500758. 　　This drug is intended for the treatment of asthma and atopic dermatitis, marking the official entry of the company’s innovative dual-antibody matrix in the field of autoimmune and allergic diseases into the clinical stage. https://finance.eastmoney.com/a/202511143564486287.html
- Source: drugdu
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- November 15, 2025
Receives Approval Notice for New Clinical Trial of Innovative Drug HSK39297 Tablets

　　Haisco On November 13, the company announced that its HSK39297 tablets had received a “Drug Clinical Trial Approval Notice” from the National Medical Products Administration, approving the company to conduct clinical trials. The indication is age-related macular degeneration. https://finance.eastmoney.com/a/202511133563521296.html
- Source: drugdu
- 77
- November 15, 2025
Subsidiary’s GenSci143 for Injection Receives FDA Clinical Trial Approval

　　China Securities Intelligent Finance Changchun High & New Technology Industries Group(000661) announced on November 14 that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., recently received written notification from the U.S. Food and Drug Administration (FDA) that its clinical trial application for its independently developed injectable GenSci143 has been approved. GenSci143 is a bispecific antibody-drug conjugate targeting B7-H3 and PSMA, with dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy, and is intended for the treatment of various advanced solid tumors such as prostate cancer and lung cancer. 　　According to the announcement, the drug binds to B7-H3 or PSMA, internalizes into lysosomes to release TOPO-I inhibitor toxins, and kills tumor cells. Its dual-target synergistic effect can overcome tumor heterogeneity and drug resistance, cover more patients and produce a more durable anti-tumor effect. 　　Previously, GenSci143 had been approved in China to conduct clinical trials for advanced solid tumors. 　　The announcement stated ...
- Source: drugdu
- 90
- November 14, 2025
Plans to acquire 70% stake in Sinopharm for 1.733 billion yuan to quickly enter the biopharmaceutical industry

　　According to NBD AI News, on November 13th, Leadman…(300289.SZ) disclosed a draft report on a major asset purchase, proposing to acquire 70% of the shares of Xiansheng Xiangrui from Shanghai Baijiahui Investment Management Co., Ltd., Nanjing Baijiarui Enterprise Management Consulting Partnership (Limited Partnership), and Hainan Xiansheng Baijiahui Technology Development Co., Ltd. for RMB 1.733 billion in cash. The target company is mainly engaged in biological products.(In vivo diagnostic reagents, vaccines) and in vitro diagnosticsThe company focuses on the research, development, production, and sales of reagents, with its core products being TB-PPD, BCG-PPD, and IGRA, all concentrated in the field of tuberculosis screening and diagnosis. On the other hand, Simcere is one of the few companies in China holding a vaccine production license, focusing on innovative human vaccines that do not yet meet clinical needs. Simcere’s Xs03 project, applied to the field of meningitis, has submitted a pre-IND application, and several ...
- Source: drugdu
- 83
- November 14, 2025
ZG006 for injection, in combination with etoposide and cisplatin, received approval for clinical trials

　　Southern Finance reported on November 13th that the company recently received a “Drug Clinical Trial Approval Notice” from the National Medical Products Administration, approving a clinical trial of ZG006 for injection in combination with etoposide and cisplatin for advanced neuroendocrine carcinoma. This clinical trial approval will not have a significant impact on the company’s recent performance. However, given the long development cycle, numerous approval processes, and substantial R&D investment required for pharmaceuticals, they are susceptible to uncertainties. Investors are advised to exercise caution and be aware of investment risks. https://finance.eastmoney.com/a/202511133563656229.html
- Source: drugdu
- 71
- November 14, 2025

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