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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
- 78
- 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
【EXPERT Q&A】How should one apply for a medical device license (Class III)?

Drugdu.com expert’s response: For trading companies and distributors that sell Class III medical devices, it is the Class III Medical Device Business License that they need to apply for. For manufacturers, the required qualifications are the Medical Device Production License and the product-specific Medical Device Registration Certificate, and these two sets of qualifications must not be confused. The general application process for the Class III Medical Device Business License is as follows: Confirm that the product falls into the Class III category: Look up the medical device classification and corresponding classification coding of the target product first. Different products correspond to different business scope entries, and this step will directly affect the subsequent requirements for personnel, business premises and warehousing conditions. Prepare the required operating conditions: The enterprise needs to have a business premises that matches its operating scale, qualified quality management personnel, complete quality management rules and a computer ...
- Source: drugdu
- 79
- 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
- 118
- September 10, 2026
Health Asia

Organiser：Ecommerce Gateway Pakistan (Pvt.) Ltd Time：September 10th – 12th, 2026 Address：University Rd, Gulshan-e-Iqbal, Karachi, Pakistan Exhibition hall：Karachi Expo Center Product range: Medical Supplies‌: Medical diagnostic equipment & supplies, pharmaceuticals, electronic medical devices & instruments, ambulance equipment, medical reagent equipment, disposable medical devices ‌Hospital Supplies‌: Catheters, interventional materials, surgical hygiene products, disposable medical consumables, surgical medical instruments, medical uniforms & bedding, hospital furniture, first-aid equipment, maternal and infant care equipment, disinfection equipment, orthopedic prosthetics, air filtration devices, medical blood pressure diagnostic instruments, heart rate monitors, ultrasound equipment, X-ray medical diagnostic equipment, dialysis machines, physiotherapy equipment ‌Laboratory Equipment‌: Laboratory instruments and equipment, optical instruments and equipment, image analysis and processing systems, testing instruments and devices, quality inspection equipment, laboratory renovation and upgrading technologies, consumables and related software ‌Pharmaceuticals & Healthcare‌: Medical ophthalmic pharmaceuticals, orthopedic pharmaceuticals, traditional Chinese patent medicines, Western medicines, traditional Chinese healthcare medicines, nutritional foods, pharmaceutical chemical intermediates ‌Healthy ...
- 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
- 92
- 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
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- 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
- 87
- 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
- 78
- 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
- 79
- September 9, 2026

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