Dandelion Bio·News | Top Headlines in Biopharma Industry (July 31 – August 6)
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
CSPC
Innovative Drug Research and Development, Manufacturer
Neowise
Solid Tumor TCR-T Cell Therapy Drug Developer
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1、CDE | Release of 3 Drafts for Public Comment
2August 5, 2025，National Medical Products AdministrationCDEPublishCompletedGuiding Principles for Pharmaceutical Research and Evaluation of Recombinant Insulin Products (Revised Draft for Public Comment)》、"Guiding Principles on the Development of Appropriate Drug Packaging Specifications (Draft for Comments)》，The consultation period is one month from the date of publication.
(Source: ChinaPharmaceuticalsSupervision and Administration BureauCenter for Drug Evaluation）
2. Shanxi Drug Administration |Request for Comments:Management Measures for Innovative Services in Drug Registration
2025August 4, forStrengthen Full-process Communication on Drug Registration Management Matters, the Shanxi Medical Products Administration released"Measures for the Administration of Innovative Services for Drug Registration (Draft for Comments)", with comments due by September 1st.。(Click here for related reading)
(Source: Shanxi Provincial Drug Administration）
Recipient
Reason
Context
Situation
CDE Acceptance Status
July 31, 2025During the period from January to August 6, the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationA total of 393 drug applications were accepted.Individual, among whichBiological Products 54Individual（New Drug 277 domestic and 7 imported）。
Enterprise
Industry
Move
State
On August 6, 2025, Hengrui Pharma announced its ADC innovative drugRecombinant Trastuzumab Injection (Brand Name: Aivida)®) in combination with Adebrelimab (Brand name: Airui®) and chemotherapy for the treatment of gastric cancer or gastroesophageal junction adenocarcinomaGranted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). Recombinant trastuzumab isHengrui Pharma's self-developed antibody-drug conjugate targeting HER2。
(Source: Hengrui Pharma Official WeChat)）
2、CSPC | Semaglutide Submission for Market Approval
2025August 5,CSPC Announces that the Market Application of Semaglutide Injection Developed by CSPC Baik (Shandong) Biopharmaceutical Co., Ltd. Has Been Accepted by the National Medical Products Administration. The Indication Applied for in This Submission is for Blood Sugar Control in Adult Patients with Type 2 Diabetes.
(Source:CSPCOfficial Weibo)
(Source: Neowise BiotechnologyOfficial WeChat）
2025YearOn August 2, the CDE website showed that Novartis' Onasemnogene abeparvovec intrathecal injection (OAV101 injection,Zolgensma) Submit for market approval, this isA gene therapy drug based on an adeno-associated virus (AAV) vector, applicable for treating patients aged 6 months and above with 5q spinal muscular atrophy (SMA). This indication has previously been granted priority review by the CDE.
(Source: CDE official website)）
5. Mabwell | ADC Targeting CDH17 Submitted for Clinical Trials in China and the United States
2025July31st, Mabwell announced that its self-developedTargetedCDH17 Antibody-Drug Conjugate (ADC)(Research code: 7MW4911) has been accepted for clinical trial application by China's National Medical Products Administration (NMPA) and the U.S. FDA.
(Source: Mabwell Bio)Official WeChat）
Editor: Sesame Walnut
Statement:This article only represents the author's personal views and does not reflect the position of any organization or this official account. If there are any inaccuracies, please kindly point them out. For reprints, please indicate the author and source:蒲公英Biopharma.
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