Core Insights - Recently, Fuhong Hanlin announced key updates on its PD-L1 ADC (antibody-drug conjugate) HLX43 for treating non-small cell lung cancer (NSCLC), integrating results from an international multi-center Phase II clinical study, further validating its global clinical value [1] - The company also released follow-up data on its self-developed recombinant anti-EGFR monoclonal antibody HLX07, in combination with the anti-PD-1 monoclonal antibody H drug Hanshuozhuang, for first-line treatment of EGFR high-expressing advanced or metastatic squamous NSCLC [1] Group 1: Product Development - HLX43 aims to combine broad anti-tumor activity with immune function, distinguishing itself from other ADCs targeting driver gene mutations by focusing on the PD-L1 pan-tumor target [2] - HLX43 is the second PD-L1 ADC globally and the first in China to enter clinical development, utilizing a proprietary antibody framework and an innovative linker-toxin combination [2] - The company has received clinical trial approvals from both the NMPA and FDA for HLX43, with over 400 patients enrolled globally, including more than 170 NSCLC patients [2] Group 2: Clinical Trials and Future Plans - The company is confident in HLX43's Phase III clinical study, with plans to initiate at least eight Phase III projects focused on lung cancer treatment [3] - Fuhong Hanlin is enhancing its global competitive innovation platform, which includes proprietary ADC technology and early-stage drug development platforms, improving the efficiency and success rate of its R&D projects [3] Group 3: Global Expansion and Financial Performance - The trend of "license-out" transactions for Chinese innovative drugs is increasing, with 103 deals recorded in the first three quarters of 2025, surpassing the total for 2024, amounting to $92.03 billion [4] - The company reported a revenue of 2.82 billion yuan in the first half of 2025, a 2.7% year-on-year increase, with overseas product profits growing over 200% [5] - Fuhong Hanlin has successfully launched nine products globally and has six self-developed products that have "gone abroad," including the anti-PD-1 monoclonal antibody H drug Hanshuozhuang [5] Group 4: Clinical Trial Updates - The ASTRIDE study for H drug Hanshuozhuang has completed the enrollment of 200 patients in the U.S., comparing its efficacy and safety against the standard treatment drug Atezolizumab [5][6] - The company aims to expedite the trial process and plans to submit a Biologics License Application (BLA) to the FDA as soon as possible [6] Group 5: Strategic Vision - The company emphasizes a long-term development strategy of "innovation + internationalization," aiming to strengthen its competitive advantage through innovative R&D and partnerships with global collaborators [6]

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 ...