PharmaFocus Today – media

The first subject has been dosed in the Phase I clinical trial of Yuandong Bio’s EP-0210 monoclonal antibody injection.

On the evening of February 9, Yuandong Bio issued an announcement stating that its wholly-owned subsidiary, Chengdu Youluo Biotechnology Co., Ltd., is conducting a Phase I clinical trial of its independently developed Class 1 biological drug EP-0210 monoclonal antibody injection for the treatment of inflammatory bowel disease, and recently completed the dosing of the first subject. The announcement shows that EP-0210 monoclonal antibody injection is a humanized IgG1 monoclonal antibody drug that targets human tumor necrosis factor-like ligand 1A (TL1A). Its proposed indication is inflammatory bowel disease. Its mechanism of action is to bind to human TL1A efficiently and block the TL1A-mediated pro-inflammatory signaling pathway, thereby playing a role in the treatment of inflammatory bowel disease. Yuandong Bio stated that TL1A antibody drug development is one of the most promising emerging targets in the field of inflammatory bowel disease research, and currently there are no drugs targeting the same target ...
- Source: drugdu
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- February 10, 2026
Clinical trial of recombinant herpes zoster ZFA01 adjuvant vaccine (CHO cells) approved

On February 9, Zhifei Biological Products Co., Ltd. announced that it had recently learned that the recombinant herpes zoster ZFA01 adjuvant vaccine (CHO cell) developed by its wholly-owned subsidiary Zhifei Longcom has received a drug clinical trial approval notice from the National Medical Products Administration, agreeing to conduct clinical trials for the prevention of herpes zoster in people aged 40 and above. If the project progresses smoothly, it will further enrich Zhifei Biological’s adult vaccine portfolio and improve its product portfolio. However, it should be noted that drug development is characterized by large investments, long cycles, and high risks, and there are uncertainties regarding the progress, results, and market launch of subsequent clinical trials. This vaccine uses a novel, independently developed adjuvant that can simultaneously stimulate both cellular and humoral immune responses, potentially enhancing its protective efficacy. However, the shingles vaccine market is highly competitive, and its commercial performance remains ...
- Source: drugdu
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- February 10, 2026
Heyu Pharmaceuticals’ FGFR4 inhibitor ipagoglottinib has received Fast Track designation from the FDA for the treatment of advanced HCC patients with FGF19 overexpression who have been treated with ICIs and mTKIs.

On February 10, 2026, Shanghai Heyu Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “Heyu Biopharmaceutical”, HKEX code: 02256) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Heyu Biopharmaceutical’s independently developed highly selective small molecule FGFR4 inhibitor, ipraginib (Irpagratinib/ABSK-011) , for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received immune checkpoint inhibitor (ICI) and multi-target kinase inhibitor (mTKI) therapy and have FGF19 overexpression. Currently, there is a lack of effective follow-up treatment options for patients with advanced or unresectable HCC after ICI and mTKI therapy. Studies show that approximately 30% of HCC patients overexpress FGF19, and these patients have a relatively poor prognosis after first-line targeted immunotherapy. Therefore, precise targeted therapy against the FGF19/FGFR4 signaling pathway holds promise for providing new and effective options for these patients. Ipatoloteinib is a highly selective FGFR4 inhibitor independently developed by Heyu ...
- Source: drugdu
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- February 10, 2026
Sanofi’s “Rilzabrutinib” has been recognized as a Breakthrough Therapy in the United States and an Orphan Drug in Japan, and has applied for marketing approval in China.

Today, Sanofi announced that its investigational oral BTK inhibitor, Rilzabrutinib, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug designation by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of warm autoimmune hemolytic anemia (wAIHA).According to Sanofi’s announcement, both recognitions are based on clinical data from the ongoing LUMINA Phase 2b study (Clinical Study No.: NCT05002777), which aims to evaluate the efficacy and safety of rizabutinib in patients with wAIHA. In addition, the newly initiated LUMINA Phase 3 study (Clinical Study No.: NCT07086976) is evaluating the efficacy of rizabutinib versus placebo in patients with wAIHA.In addition, the drug has been approved for marketing in the United States, the European Union and the United Arab Emirates (UAE) under the brand name Wayrilz for the treatment of immune thrombocytopenic purpura (ITP) in adults. (Image source: Sanofi official website) Follow NewDrugs.com ...
- Source: drugdu
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- February 10, 2026
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
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- 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
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- 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
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- 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
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- 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
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- 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
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- February 9, 2026

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