PharmaFocus Today – media

Five innovative drugs approved for marketing

Recently, the National Medical Products Administration (NMPA) approved the marketing of five innovative drugs: Deuterated Aitinib Mesylate Tablets, Icosine Hydrochloride Tablets, Varigratetinib Tartrate Tablets, Veritumab Injection, and Lyconchitatumab Injection (subcutaneous). All five drugs were approved through the priority review and approval process. The NMPA conditionally approved the marketing of Deuterated Aitinib Mesylate Tablets submitted by Zhejiang Tongyuankang Pharmaceutical, indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 substitution mutation, accompanied by central nervous system metastasis. The NMPA approved the marketing of Icosine Hydrochloride Tablets submitted by Janssen-Cilag, indicated for adult patients and children aged 12 years and above with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The NMPA conditionally approved the marketing of Varigratetinib Tartrate Tablets submitted by Hutchmed, indicated for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma with FGFR2 fusion or ...
- Source: drugdu
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- September 11, 2026
Subsidiary’s novel coronavirus mRNA vaccine receives drug registration certificate

On September 10, Walvax Bio (300142) announced that its wholly-owned subsidiary, Yuxi Walvax, recently received the “Drug Registration Certificate” for the novel coronavirus mRNA vaccine issued by the National Medical Products Administration (NMPA). This vaccine is the company’s third-generation COVID-19 mRNA vaccine, developed iteratively based on its mRNA platform technology strategy. The marketing authorization application was submitted and accepted earlier this year. The vaccine is designed based on the JN.1 strain and is indicated for individuals aged 18 years and above for the prevention of diseases caused by novel coronavirus infection. In the first half of 2026, Walvax Bio achieved revenue of 834 million yuan and net profit attributable to the parent company of 54.19 million yuan. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870738792.html
- Source: drugdu
- 47
- September 11, 2026
Lincomycin Hydrochloride Injection passes generic drug consistency evaluation

On September 10, Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., recently received the “Drug Supplementary Application Approval Notice” for Lincomycin Hydrochloride Injection issued by the National Medical Products Administration (NMPA). The drug has passed the generic drug quality and efficacy consistency evaluation. This drug is indicated for respiratory tract infections, skin and soft tissue infections, etc., caused by susceptible bacteria such as Streptococcus, Pneumococcus, and Staphylococcus aureus. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870825889.html
- Source: drugdu
- 44
- September 11, 2026
CSPC Pharmaceutical Group’s innovative chemical drug SYH2083 eye drops approved for clinical trials in China

On September 8, CSPC Pharmaceutical Group (1093.HK) announced that its Class 1 innovative chemical drug, SYH2083 eye drops, has been approved by the National Medical Products Administration (NMPA) of the People’s Republic of China to conduct clinical trials in China. This product is a small-molecule ophthalmic formulation with a novel mechanism of action. It treats ocular surface inflammation-related diseases by reducing T lymphocyte adhesion and activation, thereby lowering pro-inflammatory signals. Preclinical studies have shown that this product demonstrates significant pharmacodynamic activity in a mouse dry eye model, with a clear mechanism of action, indicating good clinical development potential. The approved clinical trial indication is dry eye syndrome, and the product also has the potential to be extended to other inflammatory ocular surface diseases such as allergic conjunctivitis. The approval of this product’s clinical trial will further enrich the Group’s innovative drug pipeline in the ophthalmology field. Source: WeChat Official Account ...
- Source: drugdu
- 43
- September 11, 2026
Novel influenza virus mRNA vaccine approved for clinical trials

Hualan Biological Vaccine Co., Ltd. announced that it recently received the “Drug Clinical Trial Approval Notice” for its novel influenza virus mRNA vaccine, issued and approved by the National Medical Products Administration (NMPA). Influenza is an acute respiratory infectious disease caused by the influenza virus, characterized by rapid transmission and seasonal epidemics. Influenza viruses are prone to mutation, and the general population is susceptible. Key populations such as the elderly, children, and patients with chronic underlying diseases have a higher risk of severe illness and complications after infection. Hualan Vaccine’s novel influenza virus mRNA vaccine utilizes mRNA technology, delivering mRNA encoding influenza virus-related antigens to express corresponding antigens in vivo and induce an immune response. mRNA vaccine technology features flexible antigen design and relatively short design and production cycles. As of now, no influenza virus mRNA vaccine product has been officially approved for marketing in China, and there is no ...
- Source: drugdu
- 44
- September 11, 2026
Yuanda and Weixin’s two adsorbed acellular pertussis-diphtheria-tetanus combination vaccines simultaneously approved for clinical trials

On September 7, 2026, two combination vaccines independently developed by Yuanda Weixin Life Sciences (Nanjing) Co., Ltd. and Yuanda Weixin Life Sciences (Hangzhou) Co., Ltd. simultaneously received clinical trial approval from the National Medical Products Administration (NMPA). The adsorbed component acellular pertussis-diphtheria-tetanus (reduced dose) combination vaccine is for individuals aged 6 years and above, while the adsorbed acellular pertussis-diphtheria-tetanus (component) combination vaccine is for individuals aged 2 months and above. Both vaccines employ component purification technology, aiming to provide safer and more effective prevention against pertussis, diphtheria, and tetanus. Source: WeChat Official Account | https://mp.weixin.qq.com/s?__biz=MzkzOTI1MDk5MA==&mid=2247571964&idx=1&sn=f1d26c6d22f66fb941eae3231fb9f78a
- Source: drugdu
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- September 11, 2026
Have You Booked Your Meetings Yet?

A practical 4-week guide to identifying the right contacts, sending meeting invitations, preparing for discussions, and following up after the show. CPHI Milan 2026 will take place from 6–8 October at Fiera Milano, Italy. With less than a month to go, flights, booth materials and product brochures may already be on your checklist. But there is another task worth starting now: Booking meetings with the people you actually want to meet. Trade shows are great for unexpected connections. But if you already have prospects who requested a quote, discussed a sample, showed interest in your products, or simply have a strong business fit, it makes sense to contact them before the exhibition. A simple “Welcome to visit our booth” may not be enough. Give people a reason to meet you, tell them what you would like to discuss, and make it easy to choose a time. 1. Start with what ...
- Source: drugdu
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- September 10, 2026
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
- 60
- 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
- 66
- 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
- 59
- September 9, 2026

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