Dandelion Bio·News | Weekly Highlights in Biopharma Industry (July 24–30, 2025)

Aug 03, 2025 18:30 CST Updated 18:30

Hrain Biotechnology

Developer of Tumor Immunotherapy Technology R&D

CSPC

Innovative Drug Research and Development, Manufacturer

yuan

Bio·News

Medicine

Supervision

Resources

News

1、CDE | Issued 4 Guidelines in a Row

2July 30, 2025，To guide sponsors in the effective application of quantitative methods during the research and development process of drugs for rare diseasesPharmacological Methods andReasonably Conduct Clinical Pharmacology Research,The Evaluation Center has releasedTechnical Guidelines for Clinical Pharmacology Studies of Drugs for Rare DiseasesAndTechnical Guidelines for Model-Informed Drug Development in Rare Diseases，Effective from the date of issuance.(Click here for related reading)

On the same day, the National Medical Products Administration (NMPA)CDE Release"Technical Guidelines for the Study of Drug Exposure-Effect Relationships"Guiding Principles for the Formulation of Impurity Limits in Fermentation or Semi-synthetic Chemical Generic Antibiotics, effective from the date of issuance.

(Source: ChinaMedicineSupervision and Administration BureauCenter for Drug Evaluation）

2. Hunan Drug Administration | ReleaseImplementation Requirements for the 2025 Edition of the Chinese Pharmacopoeia

2025Year JulyOn the 24th, the Hunan Drug Administration releasedNotice on the Implementation of the 2025 Edition of the Pharmacopoeia of the People's Republic of ChinaIf only the "Implementation Standard" section of the drug instruction and label is changed, there is no need to apply for record-filing with the Provincial Drug Administration.。(Click here for related reading)

(Source: Hunan Provincial Drug Administration）

Affected

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Affection

Situation

CDE Acceptance Status

July 24, 2025From January 1 to July 30, the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationA total of 357 drugs were acceptedIndividual, among whichBiological Products 54Individual（New Drug 2212 imported ones）。

Swipe up and down to view (click to enlarge)

(Source: Center for Drug Evaluation, National Medical Products Administration)

Enterprise

Industry

Move

State

1、Shanghai Hengrun Dasheng Biotechnology Co., Ltd | China-Produced CAR-T Therapy Approved for Marketing

2025On July 30, the National Medical Products Administration officially approved Shanghai Hengrun Dasheng Biotechnology Co., Ltd.
The declared Class 1 innovative biologic - Raniky Orencel Injection (Trade name: Hengkailai)^®, English Trade Name: HICARA^®) New Drug Marketing Application,As China's first completely self-developed product targetingRecurrent or RefractoryLarge B-cell Lymphoma（r/r LBCL）CD19 CAR-T Product`, which not only fills the gap in the field of domestically produced CAR-T in China, but also marks that China's immune cell treatment technology has entered a new stage of independent control.`Providing solutions for more unmet clinical needs。

(Source:Shanghai Hengrun Dasheng Biotechnology Co., LtdOfficial Weibo)

2. CSPC | Collaboration with MADRIGAL on SYH2086 Reached

2025JulyOn the 30th, CSPCAnnounce that this group has entered into an agreement with Madrigal Pharmaceuticals, Inc. (Madrigal）For the Group's orally administered small molecule activator of glucagon-like peptide-1 (GLP-1)Exclusive Licensing Agreement for the Development, Manufacturing, and Commercialization of Receptor Agonist SYH2086 Worldwide。

Pursuant to the terms of this Agreement, the Group agrees to grantMadrigalDevelopment, Production and Commercialization on a Global ScaleSYH2086 exclusive authorization, while retaining the group's development and sales rights for other oral small molecules in China.GLP-1 receptor agonist products. This group is entitled to receive a total consideration of up to 2.075 billion US dollars, including a prepayment of 120 million US dollars, potential development, regulatory and commercial milestone payments of up to 1.955 billion US dollars, as well as payments based onSYHDouble-digit sales growth in net sales for the year 2086.
(Source: CSPC)Official WeChat）

3. Alphamab| HER2 Bispecific Antibody Drug Granted FDA Orphan Drug Designation

2025Year7Month2On the 9th,Alphamab Oncology announced that its product JSKN003 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of gastric cancer and gastroesophageal junction cancer (“GC/GEJ”).(Click here for related reading)

(Source:蒲公英Ouryao）

4、Hengrui Medicine| Reached an agreement with GSK$12 Billion Collaboration

On July 28, 2025, Hengrui Medicine announced that it had reached a cooperation agreement with GlaxoSmithKline (GSK),The two parties will jointly develop up to12Innovative Drug, covering the fields of respiratory, autoimmune and inflammatory diseases, and oncology treatment, bringing breakthrough therapeutic solutions to patients worldwide and driving innovation in the pharmaceutical industry.Expand.(Click here for related reading)

(Source: Hengrui Medicine Official WeChat)）

5、BMS | Dual Immunotherapy Combination Approved for New Indication in China

2025On July 28, Bristol-Myers Squibb announced Opdivo(Nivolumab Injection)UnitedYiwo (Ipilimumab Injection)The program has been approved by China's NMPA and is applicable to PD-L1 tumor proportion score. (TPS) ≥1% EGFR Gene Mutation Negative andFirst-line Treatment for ALK-negative Metastatic Non-Small Cell Lung Cancer，BecomeChina's First Approved Dual Immunotherapy Combination for Lung Cancer。

(Source：Bristol-Myers Squibb China Official WeChat）

6. Akeso Bio | "Evolocumab" New Indication Submitted for Market Launch

July 2025On the 28th, the CDE official website showed that the PD-1/VEGF bispecific antibody Eadafang independently developed by Akeso Biopharma.^®(Ivonescimab Injection), a new drug marketing application for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) in combination with chemotherapy, has beenAccepted.

(Source: Akeso Biopharma)Official Weibo）

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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 reproduce it, please indicate the author and source:蒲公英Biopharma.

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