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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
The period from 2016 to 2025 marks a decade of continuous reform in China’s pharmaceutical industry. Centralized procurement policies are reshaping the industry’s logic, and a wave of innovative drugs is surging forward. In this profound industrial transformation, Guangdong’s pharmaceutical companies have delivered a remarkable performance . the rise of Guangdong’s “King of Medicines” from the perspectives of enterprise and brand dimensions, based on the terminal sales data of Guangdong pharmaceutical companies and drug brands from 2016 to 2025, using data from Yaozhi Data . Note: The drugs mentioned in this article cover various types of drugs, including innovative drugs, generic drugs, and traditional Chinese medicines; sales data comes from Yaozhi Data; the sales figures are based on the sales performance of pharmaceutical companies registered in Guangdong (including 21 prefecture-level cities) across the country in terms of terminal sales (hospitals + retail + e-commerce channels). 01 The King of Pharmaceutical ...
Organiser:Messe München International Time:September 10th – 12th, 2026 Address:HITEX Exhibition Centre Izzat Nagar Hyderabad 500 032, A.P. Exhibition hall:Hyderabad International Trade Exposition Centre Product range: Analytical Technology: Analytical instruments and equipment, microscopes and optical imaging processing, spectroscopy and chromatography products Testing, Measurement and Quality Control: Industrial quality control, material property identification technology, material testing, pharmaceutical and industrial quality control Laboratory Equipment: Laboratory apparatus and equipment, laboratory data and archiving management equipment, chemicals, reagents and consumables Life Sciences and Testing & Measurement Technology: Bioanalysis, biochemical reagents and bioinformatics technology, laboratory testing and measurement supplies About Analytica Anacon India: Analytica Anacon India is the most influential exhibition for laboratory, analytical and biochemical technologies in India and South Asia. This initiative will make the Indian Laboratory and Biotechnology Exhibition the largest and most influential professional exhibition for the laboratory, analytical and biochemical technology industry in India and even the entire South ...
Drugdu.com expert’s response: Many new suppliers on the platform get stuck on one question when completing their company profile page: “We don’t have many mature export cases yet, so is there nothing substantial to write in our company introduction?” This is especially true for enterprises in the API, excipient, pharmaceutical intermediate and medical device sectors. If they do not yet have stable overseas orders or representative clients, they can easily end up with a very empty and generic company page. Common generic lines include: “We are a professional supplier.” “We provide high quality products.” “We have competitive prices and good service.” These statements are not technically wrong, but overseas buyers can hardly tell exactly what the enterprise is capable of delivering after reading them. Not having mature export cases does not mean your company page has to be empty. When buyers visit a company page, they do not only look ...
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