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Fosun Pharma’s FXS5626 Tablets Approved for Phase II/III Trial, TYK2/JAK1 Dual-Target Inhibitor for Vitiligo | Clinical Progress

On September 8, Fosun Pharma (600196.SH; 02196.HK) announced that its controlling subsidiary Fosun Pharma Industrial has received approval from China’s National Medical Products Administration (NMPA) to conduct a Phase II/III adaptive seamless design clinical trial of FXS5626 tablets for the treatment of non-segmental vitiligo. FXS5626 is an oral small molecule JAK inhibitor (TYK2/JAK1 dual-target inhibitor) licensed in by the Group, which holds exclusive rights for research, development, production, registration, and commercialization of the drug in mainland China, Hong Kong, and Macau. FXS5626 (original project code AC-201) is an oral small molecule TYK2/JAK1 dual-target inhibitor, primarily intended for the autoimmune disease field. Vitiligo is a common acquired pigmentary depigmentation skin disorder, with non-segmental vitiligo being the most common type, and its pathogenesis is closely related to autoimmune mechanisms. Currently, treatment options for vitiligo are limited. By inhibiting the JAK-STAT signaling pathway, JAK inhibitors can regulate immune responses and promote melanocyte function ...
- Source: drugdu
- 20
- September 9, 2026
InnoCare’s First Bispecific ADC ICP-B381 Approved for Clinical Trials, Targeting PSMA/STEAP1 for Prostate Cancer | Clinical Progress

On September 9, InnoCare (688428.SH; 09969.HK) announced that its self-developed bispecific ADC drug ICP-B381, targeting PSMA and STEAP1, has been approved by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to conduct clinical trials for the treatment of solid tumors including prostate cancer. This is the company’s first bispecific ADC approved for clinical trials and its third ADC innovative drug to enter the clinical stage. ICP-B381 is the first bispecific ADC developed by InnoCare based on its proprietary ADC platform, consisting of a humanized anti-PSMA/STEAP1 antibody, the company’s self-developed next-generation irreversible linker, and a potent payload. PSMA (prostate-specific membrane antigen) and STEAP1 (six-transmembrane epithelial antigen of prostate 1) are both highly expressed on the surface of prostate cancer cells. By simultaneously targeting these two antigens, ICP-B381 can effectively cover heterogeneous tumor cells, reduce tumor escape risk, and potentially benefit more patients. Preclinical studies have shown ...
- Source: drugdu
- 20
- September 9, 2026
another blockbuster imported drug approved for marketing in China

On September 3, 2026, according to the official website of the National Medical Products Administration (NMPA) of China, Tasultinib Succinate Tablets, submitted by SciSheng Pharmaceuticals (China) Co., Ltd., were approved for marketing. Public information shows that it was included in the priority review process on November 27, 2025, with the indication of treating unresectable biliary tract cancer patients who have failed prior chemotherapy and have been confirmed to have the FGFR2 fusion/rearrangement gene. China has one of the highest age-standardized incidence rates of biliary tract tumors (BTC). Intrahepatic cholangiocarcinoma (ICC) is a subtype of BTC that originates in the intrahepatic bile ducts and may affect approximately 60,000 people in China each year. Cholangiocarcinoma accounts for about 10%-15% of all primary liver malignancies, making it the second most common primary liver cancer after hepatocellular carcinoma. Tasurgratinib, developed by Eisai, is an oral selective tyrosine kinase inhibitor of fibroblast growth factor receptor ...
- Source: drugdu
- 20
- September 9, 2026
A New Battlefield for China’s Innovative Drugs

Recently, Reindeer Biotech announced that the Australian Therapeutic Goods Administration (TGA) has formally accepted its application for marketing authorization of its CAR-T cell product, Ikiorenzai Injection (FUCASO), for inclusion in the Australian Therapeutic Goods Register (ARTG) and entered the evaluation stage for the treatment of adult patients with relapsed/refractory multiple myeloma (r/r MM) who have progressed after at least three lines of prior therapy. This event is not only a milestone in the internationalization of a single company, but also reflects a profound shift in the strategic positioning of Chinese innovative drugs in Australia. For a long time, Australia has been a “hotbed” and “stepping stone” for Chinese pharmaceutical companies to conduct early clinical trials, but there are very few cases of commercialization and listing in Australia. As clinical benefits gradually reach their peak and market competition intensifies, Chinese pharmaceutical companies, represented by Reindeer Biotech, are attempting to bridge the ...
- Source: drugdu
- 20
- September 9, 2026
New lung cancer drug launched

Recently, Betta Pharmaceuticals’ ensartinib hydrochloride capsules were approved by the National Medical Products Administration for adjuvant therapy after surgery in patients with anaplastic lymphoma kinase (ALK)-positive stage IB to IIIB non-small cell lung cancer (NSCLC) . According to the approved indication, patients must have previously undergone surgical resection, and their choice to receive adjuvant chemotherapy can be determined by their physician. the third indication approved for ensartinib , making it the first domestically produced ALK inhibitor to be approved for this indication. Previously, the only drug approved for this indication globally was Roche’s alectinib. The approval of this indication targets a long-standing unmet clinical need. Lung cancer is a malignant tumor with high incidence and mortality rates globally and in China . According to the “Analysis of the Epidemiology of Malignant Tumors in China in 2022” released by the National Cancer Center, there were 1.06 million new cases of lung ...
- Source: drugdu
- 20
- September 9, 2026
【EXPERT Q&A】If the buyer only says “Send me your catalog”, should the entire catalog be sent directly?

Drugdu.com expert’s response: When engaging in pharmaceutical foreign trade, you often receive very short inquiries that simply say: “Send me your catalog.” Some buyers only leave their country and email address, with no mention of specific products, purchase quantities, or whether they are importers, distributors or end users. Many suppliers’ first reaction is to send over the company catalog directly. It is a dozens-of-page PDF covering a full product line, complete with images, parameters and company introduction. After sending it, they just wait for the buyer’s reply. But more often than not, there is no follow-up response. It is not that the catalog is completely useless. The problem is that when you send the entire catalog directly, the buyer may not bother to read it carefully. Especially for products like APIs, excipients, medical devices and consumables, buyers rarely go through a catalog “just browsing casually”. They probably already have a ...
- Source: drugdu
- 29
- September 9, 2026
New At-Home Option for Alzheimer’s! Lecanemab Subcutaneous Auto-Injector Pen Approved in China | Approval Alert

Recently, China’s National Medical Products Administration (NMPA) approved the marketing of the anti-amyloid beta antibody drug lecanemab subcutaneous auto-injector pen for the treatment of early Alzheimer’s disease. This is the first and currently only anti-amyloid therapy in China that can be administered at home, making China the second country globally to approve this subcutaneous formulation. The at-home injection product is expected to be officially launched by the end of 2026 or early 2027. Lecanemab, jointly developed by Eisai and Biogen, is an anti-amyloid beta protofibril antibody that slows the progression of Alzheimer’s disease by clearing beta-amyloid deposits in the brain. Previously, the intravenous infusion formulation of lecanemab was already approved in China, requiring patients to regularly visit hospitals for infusion treatment. The newly approved subcutaneous auto-injector pen allows patients to self-inject at home, significantly improving medication convenience and patient adherence. Patients now have two administration route options: they can choose ...
- Source: drugdu
- 42
- September 8, 2026
Sinopharm Group and Hansoh Pharmaceutical Reach Strategic Cooperation, Launch Four Special Projects Including Broad Market, Medical Access, Retail, and DTP | Market News

On September 8, according to Sinopharm Group (01099.HK), Sinopharm Group and Hansoh Pharmaceutical (03692.HK) recently reached a strategic cooperation. Based on years of in-depth cooperation, and centered on the goals of deepening industry-commerce collaboration and empowering high-quality industrial development, the two parties signed a strategic cooperation agreement and simultaneously launched four special cooperation agreements covering broad market, medical access, retail, and DTP, promoting the upgrade of industry-commerce cooperation from traditional business docking to a full-chain, full-cycle strategic collaboration. This strategic cooperation covers four key directions: in the broad market, the two parties will jointly promote the penetration of Hansoh Pharmaceutical’s products to grassroots medical markets to improve drug accessibility; in medical access, they will collaborate to advance product access and clinical application in hospitals at all levels; in retail, they will strengthen cooperation in retail pharmacy channels to expand the out-of-hospital market; in DTP (Direct to Patient), they will establish ...
- Source: drugdu
- 43
- September 8, 2026
Hybio Pharmaceutical’s Subsidiary Obtains Registration Certificate for Carboprost Tromethamine Injection, Deemed Passed Consistency Evaluation | Approval Alert

On September 7, Hybio Pharmaceutical (300199.SZ) announced that its wholly-owned subsidiary Gansu Chengji Biopharmaceutical Co., Ltd. has recently received the “Drug Registration Certificate” for Carboprost Tromethamine Injection (Certificate No.: 2026S03186) issued by China’s National Medical Products Administration (NMPA), with the drug approval number Guo Yao Zhun Zi H20265776 and specification of 1ml:250μg (calculated as C₂₁H₃₆O₅). Carboprost Tromethamine Injection is a prostaglandin prescription drug, classified as chemical drug Class 4, mainly used for the treatment of postpartum hemorrhage caused by uterine atony. According to relevant review principles, the drug is deemed to have passed the generic drug quality and efficacy consistency evaluation upon market approval. Postpartum hemorrhage is the leading cause of maternal death worldwide, and carboprost tromethamine, as a first-line drug for treating atonic postpartum hemorrhage, has stable clinical demand. Hybio Pharmaceutical stated that this certificate enriches the company’s product pipeline in the obstetrics and gynecology field, will enhance the ...
- Source: drugdu
- 37
- September 8, 2026
First in China! Hualan Vaccine’s Novel Influenza mRNA Vaccine Approved for Clinical Trials | Clinical Progress

On September 7, Hualan Vaccine (301207.SZ) announced that it has received the “Drug Clinical Trial Approval Notice” for its novel influenza virus mRNA vaccine from China’s National Medical Products Administration (NMPA). The vaccine is classified as a preventive biological product Class 1.2, and is approved for clinical trials to prevent influenza caused by vaccine-related influenza virus strains. Hualan Vaccine becomes the first company in China to obtain implied clinical trial approval for a novel influenza mRNA vaccine. The vaccine adopts the mRNA technology route, delivering mRNA encoding influenza virus-related antigens to express corresponding antigens in vivo and induce immune responses. From CDE acceptance on June 22 to clinical approval, it took only two and a half months, significantly faster than traditional vaccines. There are currently no influenza mRNA vaccine products on the market in China. As a leading enterprise in China’s influenza vaccine sector, Hualan Vaccine’s quadrivalent influenza vaccine consistently ...
- Source: drugdu
- 41
- September 8, 2026

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