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]

H药目前已在欧洲、东南亚和中国等30多个国家获批上市。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，复宏汉霖（2696.HK）于近日公布了产品最新进展。2月5日，公司宣布，H药汉 斯状（斯鲁利单抗，欧洲商品名：Hetronifly）获欧盟委员会（EC）批准上市，用于联合卡铂和依 托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，H药成为了首个且唯一在欧盟获 批上市用于ES-SCLC治疗的抗PD-1单抗。截至目前，H药已在欧洲、东南亚和中国等30多个国家 获批上市，惠及超过90,000位患者。 此外，公司在研的Perjeta（帕妥珠单抗）生物类似药HLX11的生物制品许可申请（BLA）也于近日 获FDA受理。目前Perjeta已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2 阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及部分HER2阳性早期乳腺癌患者的辅助 治疗等。 迄今为止，复宏汉霖已有已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别 获中国药监局、美国FDA和欧盟EMA受理。 突破差异化临床需求，H ...