Weekly Pharmaceutical Highlights (March 30 – April 5, 2026): Regulatory Updates, Product Approvals, and Strategic Collaborations

(Source: China Food and Drug Administration Network)

NMPA Releases the 103rd Batch of Reference Listed Drug Catalog for Generic Drugs, Including Sodium Zelucure Injection and Other Varieties; Insilico Medicine Reaches Out-License and Global R&D Cooperation with Eli Lilly……From March 30 to April 5, These Dynamics in the Pharmaceutical Industry Are Worth Noting.

Industry Policies and Drug Supervision Dynamics

1. NMPA Releases the "List of Reference Preparations for Generic Drugs (103rd Batch)," Including Sodium Zelucure Injection and Other Varieties.

2. The General Office of the National Medical Products Administration released the "2026 Drug Regulatory Information Standards Project Plan," approving nine standard development and revision projects, including the "Basic Technical Requirements for Drug Traceability Systems," to further improve the drug regulatory information standards system, enhance the level of regulatory informatization and intelligence, and serve the needs of drug safety and high-quality development.

3. The General Office of the National Medical Products Administration issued the "Notice on Doing a Good Job in the Relevant Work of Segmented Production of Biological Products," clarifying the requirements for production licensing, technical review, cross-border segmented production, and other related work for the segmented production of biological products.

4. The Center for Food and Drug Inspection of the National Medical Products Administration released the "Guidelines for the Inspection of Pharmaceutical Water," aiming to help inspectors identify risk control points in pharmaceutical water and guide inspectors in conducting on-site inspections. These guidelines apply to on-site inspections of the preparation/distribution systems for drinking water, purified water, water for injection, and pure steam used by pharmaceutical manufacturing enterprises.

5. The CDE website announced one generic drug quality and efficacy consistency evaluation task (see table for details), involving the drug Nicorandil Tablets.

Product Development and Market Launch Information

1. The National Medical Products Administration released the delivery information of four batches of drug approval certificates, covering a total of 315 application numbers, involving companies such as Chongqing Shenghuaxi Pharmaceutical Co., Ltd.

2. CDE accepted 53 new drug marketing applications, including Tuber Gel, etc.

3. Grail Bio announced that its self-developed membrane-bound IL-15 complex-edited tumor-infiltrating lymphocyte therapy, GT201, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.

4. Abbisko announced that its self-developed highly selective small molecule FGFR4 inhibitor, Erapogatinib, has been granted orphan drug designation by the European Medicines Agency for the treatment of hepatocellular carcinoma.

Pharmaceutical Enterprise Observation

1. Insilico Medicine Announces Out-Licensing and Global R&D Collaboration with Eli Lilly. According to the collaboration agreement, Eli Lilly will obtain a global exclusive license for the development, manufacturing, and commercialization of novel oral therapeutic drugs targeting specific indications. Both parties will also collaborate on multiple R&D projects centered around targets selected by Eli Lilly. Insilico Medicine is eligible to receive an upfront payment of $115 million and additional payments upon achieving development, regulatory, and commercial milestones, with the total value of the deal reaching up to approximately $2.75 billion. Moreover, Insilico Medicine will also receive tiered royalties based on future sales.

2. Biocytogen Announces Strategic Cooperation with SihuanPharm. According to the cooperation agreement, both parties will rely on Biocytogen's fully human antibody development platform and combine SihuanPharm’s experience in drug development, production, and commercialization to carry out cooperation and exchanges on innovative drug research and development in multiple fields such as weight loss.

3. Zai Lab announced a global clinical research collaboration with Amgen. This collaboration aims to evaluate the safety and efficacy of Zai Lab's delta-like ligand 3 (DLL3)-targeted antibody-drug conjugate zocilurtatug pelitecan in combination with Amgen's DLL3-targeted bispecific T-cell engager therapy tarlatamab for the treatment of extensive-stage small cell lung cancer. Under the agreement, Amgen will sponsor a global Phase Ib clinical study; Zai Lab will retain full ownership of zocilurtatug pelitecan and will supply the clinical study medication to Amgen.

4. Medici announces a strategic cooperation with Hailu Bio, a wholly-owned subsidiary of Yangtze River Pharmaceutical. Both parties will conduct in-depth collaboration in the fields of preclinical research and development of new drugs, project export and import, etc., jointly building an efficient, open, and international R&D new ecosystem from original innovation to new drug clinical trial applications.

5. Sinopharm announced a strategic partnership with Luye Pharma. This collaboration will focus on Luye Pharma's oxycodone/naloxone sustained-release tablets and other products, conducting comprehensive cooperation in channel layout, market access, and resource synergy to jointly promote the efficient reach of pharmaceutical products across the Chinese market.

Centralized Drug Procurement

Sichuan Provincial Pharmaceutical and Medical Device Bidding and Procurement Service Center Releases "Notice on the Signing of Tripartite Contracts for Volume-based Inter-Provincial Alliance Procurement of Large-Volume Injectables Such as Sodium Chloride." The notice specifies that, starting from March 31, 2026, relevant medical institutions, selected enterprises from centralized procurement, and distribution enterprises must complete the signing of tripartite contracts within one month. (Compiled by Liu He)

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(Editor: Liu Sihui)