PharmaFocus Today – Page 2 – media

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
- 58
- 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
- 57
- 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
- 68
- 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
- 66
- 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
- 64
- 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
- 63
- September 8, 2026
The “King of Medicine” in Guangdong sold for 56.6 billion yuan.

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 ...
- Source: drugdu
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- September 8, 2026
The snoring of 1 billion people can finally be cured! The FDA has accepted the marketing application for a new oral drug for obstructive sleep apnea.

If all goes well, a new drug for snoring will be approved early next year, potentially becoming the world’s first landmark drug targeting the neuromuscular causes of snoring . In July, Phase III clinical data of AD109 , a new oral drug for obstructive sleep apnea ( OSA ), was published in the American Journal of Respiratory and Critical Care Medicine . The data showed that the apnea-hypopnea index (AHI) decreased by 44.1% after treatment , and the oxygen depletion index and blood oxygen saturation were improved, indicating a significant improvement in the severity of OSA. picture AD109, developed by the US biotechnology company Apnimed , consists of the marketed drug atomoxetine and a novel isomer, R -oxybutynin , derived from the older drug oxybutynin. It works by modulating nerve signals, allowing patients to maintain airway tone during sleep and reducing the occurrence of sleep apnea. Its new drug application ...
- Source: drugdu
- 83
- September 3, 2026
Biosimilar Export Accelerates! Jianyou’s Adalimumab Receives FDA Approval for Additional Manufacturing Site | Overseas Expansion News

On September 1, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (Jianyou, 603707.SH) announced that its subsidiary, Emerge Bioscience Pte. Ltd., recently received a letter from the U.S. Food and Drug Administration (FDA) approving an additional manufacturing site for adalimumab injection (40 mg/0.8 mL, single-dose) under BLA No. 761216. The approval authorizes production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility. Adalimumab injection, a biosimilar, was first approved by the U.S. FDA on December 17, 2021. Its indications cover multiple autoimmune diseases including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. The approval of the additional Nanjing manufacturing site further strengthens the product’s supply chain capabilities, providing more stable supply assurance for the U.S. market. Jianyou is an integrated pharmaceutical group focusing on R&D, production, and sales, with core business centered on heparin API and formulation supply. It has over 80 ...
- Source: drugdu
- 89
- September 3, 2026
Beyond Glycemic Control! Lilly’s Tirzepatide Receives FDA Approval for Cardiovascular Risk Reduction | Approval Alert

On September 1, Eli Lilly announced that the U.S. Food and Drug Administration (FDA) has officially approved tirzepatide (brand name: Mounjaro) for a new indication to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, in adults with type 2 diabetes at high risk for these events. With this approval, tirzepatide becomes the world’s first GIP/GLP-1 dual receptor agonist approved for this indication. Tirzepatide is an innovative dual-target metabolic drug that simultaneously activates GLP-1 and GIP receptors, offering multiple benefits including potent glycemic control, weight loss, and improvement of metabolic disorders. It was previously approved overseas for type 2 diabetes glycemic control and adult obesity or overweight management, with continuously expanding clinical applications. This cardiovascular protection indication approval is supported by data from the large-scale Phase 3 SURPASS-CVOT study involving over 13,000 participants, fully validating the drug’s cardiovascular benefit in diabetes ...
- Source: drugdu
- 91
- September 3, 2026

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