Domestically developed blockbuster ADC approved for new indication

On February 6, the NMPA website showed that Kelun Biotech’s TROP2 ADC, sasugamucil ( sac-TMT), has been approved for a new indication: the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) who have previously received endocrine therapy and other systemic therapies at an advanced or metastatic stage . This indication had previously been included in the priority review and approval process by the CDE (Center for Drug Evaluation). Screenshot source: NMPA official website Sacubituzumab is an ADC drug targeting TROP2 developed by Kelun Biotech. It is composed of a humanized monoclonal antibody, Sacituzumab, an enzymatically cleavable linker, and a novel topoisomerase I inhibitor, T030, with an average drug-to-antibody ratio (DAR) as high as 7.4. In May 2022, Kelun Biotech and Merck signed a collaboration agreement, granting the latter exclusive rights to develop, use, manufacture, ...

• Source: drugdu
• 39
• February 10, 2026

Novartis’s first-ever autoimmune drug has been submitted for marketing approval in China.

On February 6, the CDE website showed that Novartis’ ianalumab had applied for marketing approval in China. Ilimumab, acquired by Novartis (from MorphoSys) , is a fully human monoclonal antibody targeting B-lymphocyte activating factor receptor ( BAFF-R ). It possesses a dual mechanism of action: depleting B cells and inhibiting BAFF-R. It can be used to treat various autoimmune diseases, including Sjögren’s syndrome, immune thrombocytopenic purpura (ITP), and systemic lupus erythematosus (SLE) . This drug is the first anti- BAFF-R antibody to complete Phase III trials.In the phase III NEPTUNUS-1 study , after 48 weeks of illuminumab treatment, patients with Sjögren’s syndrome had a 6.4-point reduction in the EULAR Sjögren’s Disease Activity Index (ESSDAI) score, compared to a 5.1-point reduction in the placebo group. In the phase III NEPTUNUS-2 study, patients with Sjögren’s syndrome who received irinumab treatment for 48 weeks experienced a 6.5-point reduction in their ESSDAI score, compared ...

• Source: drugdu
• 34
• February 10, 2026

InnoCare Receives First-in-China Clinical Approval for VAV1 Molecular Glue Degrader

Today (February 9), InnoCare announced that ICP-538, its internally discovered VAV1-targeted molecular glue degrader, has been officially approved by the National Medical Products Administration (NMPA) to initiate clinical trials. It is the first VAV1 molecular glue degrader to enter clinical development in China, and the second worldwide. ICP-538 is a novel, oral, potent and highly selective VAV1-targeted molecular glue degrader. Its mechanism of action is highly innovative: it selectively mediates the formation of a ternary complex between CRBN E3 ubiquitin ligase and VAV1 protein, thereby inducing rapid, dose-dependent degradation of VAV1. ICP-538 drug list Picture source: Yaozhi Data-Global Drugs Analysis System As a key protein in the downstream signaling pathways of T-cell and B-cell receptors, VAV1 plays a central role in immune cell activation, proliferation and cytokine release. By degrading VAV1, ICP-538 effectively inhibits T-cell proliferation, differentiation and activation, while suppressing B-cell activation and inflammatory cytokine secretion. These actions confer ...

• Source: drugdu
• 45
• February 10, 2026

End of Overseas Partnership for Compound Danshen Dripping Pills Deals, Another Blow to Tasly’s “American Dream”

On February 6, Tasly issued an announcement stating that the company had terminated its cooperation with US-based Arbor Pharmaceuticals and regained the exclusive US marketing and distribution rights for Compound Danshen Dripping Pills. This marks a potential setback for more than 20 years of efforts by Chinese patent medicines to break into the mainstream US pharmaceutical market. Compound Danshen Dripping Pills, developed by Tasly, is one of the earliest Chinese patent medicines seeking to enter the US market through formal drug registration. It first filed for FDA clinical trials in 1997, a process that has now stretched nearly 30 years — far longer than the typical approval cycle for a new drug. Following the termination of the partnership, the prospects for the product’s eventual US launch have become even more uncertain. Under the agreement, Tasly will receive a total payment of $7.5 million. Tasly told Jianshiju, a leading Chinese pharmaceutical ...

• Source: drugdu
• 40
• February 10, 2026

Phase III clinical trial of vetcotozumab completes patient enrollment

On the morning of February 9th, China Biopharmaceutical announced on the Hong Kong Stock Exchange that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., had independently developed a Class 1 innovative drug.Vitectumomarab (development code: LM-302, abbreviated as “CLDN18.2 ADC”) is undergoing a Phase III registration clinical trial (LM302-03-101) for the treatment of third-line or higher CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, and patient enrollment has been successfully completed. LM302 is the world’s first CLDN18.2 ADC drug to complete enrollment in a Phase III registration clinical trial. https://finance.eastmoney.com/a/202602093644922352.html

• Source: drugdu
• 44
• February 9, 2026

The first long-acting coagulation factor VIII, has officially entered the Chinese mainland market.

Recently, Novo Nordisk, a leading global biopharmaceutical company…We announce the official launch of Pertrol Alpha for Injection (trade name: Noyt®) in mainland China. Noyt® is the first and currently the only* approved long-acting recombinant coagulation factor VIII in my country, and has been successfully added to the new version of the National Reimbursement Drug List. The full launch of Noyt® in the mainland China market fills the gap in long-acting treatment for hemophilia A, further improves patient accessibility, and brings Chinese hemophilia A patients into a new stage of treatment. Hemophilia is an X-linked recessive inherited bleeding disorder, which can be divided into hemophilia A and hemophilia B. Hemophilia A is characterized by a deficiency of clotting factor VIII (FVIII), and patients with this condition account for approximately 80%-85% of all hemophilia cases. It requires lifelong medication, and without timely treatment, it can lead to disability and, in severe cases, ...

• Source: drugdu
• 44
• February 9, 2026

17.9 billion yuan! A top-selling topical medication emerges.

According to data from Yaozhi, from 2016 to the first three quarters of 2025, flurbiprofen gel patch (by product category) ranked among the top-selling topical preparations in domestic public medical institutions, with a cumulative sales volume of 17.859 billion yuan , becoming the ” top seller ” in the field of topical preparations for nearly ten years , and the only product with a cumulative sales volume exceeding 10 billion yuan. Note: The scope of topical preparations in this statistic covers all chemical drugs and traditional Chinese medicines approved in the Chinese market; the statistical scope is based on the product category, not the brand dimension. 01 The Growth Secret of Top Sales Performers Flurbiprofen gel patch is a prescription topical analgesic drug. Its active ingredient is flurbiprofen, which belongs to the nonsteroidal antipyretic, analgesic, and anti-inflammatory class of drugs. It exerts its analgesic, anti-inflammatory, and antipyretic effects by inhibiting ...

• Source: drugdu
• 39
• February 9, 2026

Turnaround! Generic drug giant successfully “revived”

Recently, Teva Pharmaceuticals, an Israeli multinational pharmaceutical company, released its 2025 financial report. The company achieved total revenue of $17.3 billion, a 4% year-on-year increase in US dollar terms; net profit of $1.42 billion, successfully reversing the losses of the same period in 2024; and free cash flow of $2.4 billion, a 16% year-on-year increase. Notably, Teva has achieved revenue growth for three consecutive years . Revenue from its innovative drug portfolio exceeded $3.1 billion, representing a year-on-year increase of approximately 35%, becoming the core engine driving the company’s transformation. 01 Three new drugs continue to see increased sales volume In recent years, Teva’s revenue from innovative drugs has continued to increase, from 9% in 2022 to about 18% in 2025. Image source: Teva official website Austedo (deuterated benzidine) is its most important innovative drug to date. Approved for marketing in 2017, it was the world’s first approved deuterated drug ...

• Source: drugdu
• 40
• February 9, 2026

Novartis’s first-ever autoimmune drug has been submitted for marketing approval in China.

On February 6, the CDE website showed that Novartis’ ianalumab had applied for marketing approval in China. Ilimumab, acquired by Novartis (from MorphoSys) , is a fully human monoclonal antibody targeting B-lymphocyte activating factor receptor ( BAFF-R ). It possesses a dual mechanism of action: depleting B cells and inhibiting BAFF-R. It can be used to treat various autoimmune diseases, including Sjögren’s syndrome, immune thrombocytopenic purpura (ITP), and systemic lupus erythematosus (SLE) . This drug is the first anti- BAFF-R antibody to complete Phase III trials.In the phase III NEPTUNUS-1 study , after 48 weeks of illuminumab treatment, patients with Sjögren’s syndrome had a 6.4-point reduction in the EULAR Sjögren’s Disease Activity Index (ESSDAI) score, compared to a 5.1-point reduction in the placebo group. In the phase III NEPTUNUS-2 study, patients with Sjögren’s syndrome who received irinumab treatment for 48 weeks experienced a 6.5-point reduction in their ESSDAI score, compared ...

• Source: drugdu
• 38
• February 9, 2026

A world first! A serum-free rabies vaccine is about to be launched, marking a major breakthrough in safety.

• Source: drugdu
• 39
• February 9, 2026