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港股异动 | 复宏汉霖(02696)再涨超5% H药汉斯状进入印度市场 HLX14此前获EMA积极审评意见
智通财经网· 2025-08-05 03:25
Core Viewpoint - The stock of Fuhong Hanlin (02696) has risen over 5%, reaching HKD 70.8, following significant regulatory approvals for its products in key markets [1] Group 1: Product Approvals - Fuhong Hanlin announced the completion of the first shipment of its self-developed anti-PD-1 monoclonal antibody, H drug (brand name: Hanshuang, generic name: Surulitinib), to the Indian market, marking the first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in India [1] - The approval from the Central Drugs Standard Control Organization of India was obtained in late June, and the shipment occurred within 30 days, indicating rapid market entry [1] - The H drug has now been approved in nearly 40 countries and regions globally [1] Group 2: European Market Developments - Fuhong Hanlin's biosimilar drugs, Prolia and Xgeva (Denosumab), have received positive review opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending approval for their marketing authorization applications [1] - Upon approval, the marketing authorization for HLX14 will be effective across all EU member states and in the European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway [1]
招银国际一举升复宏汉霖目标价至61.98港元 料创新药研发有庞大潜力
news flash· 2025-06-25 04:26
Core Viewpoint - 招银国际 has raised the target price for复宏汉霖 from HKD 20.33 to HKD 61.98, indicating strong potential for growth in the innovative drug development sector [1] Company Summary - 复宏汉霖 is transitioning from a profitable biosimilar company to a leading player in the biopharmaceutical field, with several innovative drugs such as HLX43, HLX22, and Serplulimab showing promising clinical data [1] - The company is actively expanding its global biosimilar business through partnerships with pharmaceutical companies, with strong commercialization performance from 汉曲优 (Trastuzumab) and Serplulimab [1] - The FDA is currently reviewing the market approval applications for HLX14 and HLX11, which are expected to contribute to overseas revenue sources [1]