Group 1 - The Hong Kong biotechnology sector experienced a rise on August 5, with notable increases in stock prices for several companies [1] - Gilead Sciences (歌礼制药) saw a surge of over 15% in its stock price [1] - Ascentage Pharma (亚盛医药) increased by more than 9% [1] - Other companies such as Jiahe Biopharma (嘉和生物) and Innovent Biologics (复宏汉霖) rose by over 8% [1] - CanSino Biologics (康希诺生物) and Zai Lab (再鼎医药) experienced increases of over 5% [1]

此外，复宏汉霖近日公布，公司自主研发的Prolia与Xgeva(地舒单抗)生物类似药HLX14获得欧洲药品管 理局(EMA)人用药品委员会(CHMP)的积极审评意见，推荐批准其上市许可申请。一旦获批，HLX14的 集中上市许可将在所有欧盟成员国及欧洲经济区(EEA)国家冰岛、列支敦士登和挪威生效。 消息面上，7月31日，复宏汉霖宣布，其自主研发的抗PD-1单抗H药(商品名：汉斯状，通用名：斯鲁利 单抗)已完成首批面向印度市场的发货。这意味着全球首个获批一线治疗广泛期小细胞肺癌(ES-SCLC)的 PD-1抑制剂正式登陆全球人口第一大国，而这距离其6月底获得印度中央药品标准控制组织批准，仅用 了30多天。至此，汉斯状已在近40个国家和地区获批。 复宏汉霖(02696)再涨超5%，截至发稿，涨5.28%，报70.8港元，成交额1515.65万港元。 ...

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]

Core Viewpoint - The industry is making substantial progress towards centralized procurement of biopharmaceuticals, with a focus on monoclonal antibodies, expected to be implemented around 2026, potentially reshaping a market worth nearly 30 billion yuan [1][2][3]. Group 1: Industry Developments - The Anhui Provincial Medical Procurement Platform has initiated the collection of information for eight monoclonal antibody biopharmaceuticals, indicating a move towards centralized procurement [1]. - The global market for biosimilars is projected to grow from $18 billion in 2020 to $75 billion by 2030, with a compound annual growth rate of 17.2% [2]. - The centralized procurement of biopharmaceuticals is still in the preliminary research phase, with companies required to report key information such as pricing and production capacity [2][3]. Group 2: Market Dynamics - The eight monoclonal antibodies included in the procurement process cover major therapeutic areas, with a total market size approaching 30 billion yuan [3]. - Bevacizumab, trastuzumab, and pertuzumab are highlighted as key drugs in oncology, with domestic market sizes of approximately 10.4 billion yuan, 6 billion yuan, and 4 billion yuan, respectively [5]. - The competition for bevacizumab is particularly intense, with 12 companies approved to market it, leading to potential price wars that could impact profit margins [6]. Group 3: Company Responses - Companies like Baiyoutai and Fuhong Hanlin are preparing for the centralized procurement, with Baiyoutai expressing confidence in its ability to manage price impacts due to its self-developed products and sufficient production capacity [10]. - Fuhong Hanlin is actively addressing potential challenges from biosimilar procurement by promoting the commercialization of innovative drugs and optimizing production processes [11]. - The sales of biosimilars, such as Baiyoutai's product, have shown growth, with revenue attributed to the increasing sales of its adalimumab biosimilar [8].

7月31日，复宏汉霖(2696.HK)宣布，其自主研发的抗PD-1单抗H药(商品名：汉斯状，通用名：斯鲁利 单抗)已完成首批面向印度市场的发货。这意味着全球首个获批一线治疗广泛期小细胞肺癌(ES-SCLC)的 PD-1抑制剂正式登陆全球人口第一大国，而这距离其6月底获得印度中央药品标准控制组织(CDSCO)批 准，仅用了30多天。至此，汉斯状已在近40个国家和地区获批，覆盖全球近半数人口，累计惠及患者逾 11万例。 H药闪电进入印度 据了解，H药于2025年6月底获得印度中央药品标准控制组织(CDSCO)批准，用于一线治疗广泛期小细 胞肺癌(ES-SCLC)，成为印度首个且唯一在该适应症获批的抗PD-1单抗。从获批到正式进入印度市场， H药展现出惊人的市场准入速度。 在印度，肺癌的防治形势严峻。数据显示，2022年印度肺癌新发病例超过8.1万例，死亡人数逾7.5万 人，肺癌在当地癌症发病率和死亡率中均位居前列。长期以来，广泛期小细胞肺癌治疗领域存在未被满 足的临床需求，H药的获批与商业化落地，为当地患者带来了一线创新免疫治疗选择。 作为全球首个获批一线治疗广泛期小细胞肺癌的抗PD-1单抗，H药自上市以来已在近 ...

本报讯 （记者金婉霞）日前，记者从上海复宏汉霖生物技术股份有限公司（以下简称"复宏汉霖"）获悉，由公司自主研发 的抗PD-1单抗汉斯状已在印度获批上市。7月31日，复宏汉霖在其徐汇生产基地完成了汉斯状的首批发货，正式启航印度市 场。 （编辑 郭之宸） 资料显示，汉斯状是全球首个获批用于一线治疗广泛期小细胞肺癌（ES-SCLC）的抗PD-1单抗，迄今已在中国、英国、德 国、印度、印度尼西亚、新加坡等近40个国家和地区获批上市。在印度，汉斯状于2025年6月份获印度中央药品标准控制组织 批准上市，用于一线治疗广泛期小细胞肺癌，成为印度首个在该适应症获批的抗PD-1单抗。复宏汉霖的合作伙伴Intas将负责汉 斯状在印度的商业化推广，帮助更多患者尽早受益。 复宏汉霖总裁黄玮表示："造福全球病患，是复宏汉霖始终坚守的战略愿景。此次汉斯状完成了对印度市场的首批发货， 不仅充分验证了我们全球供应体系的高效运营能力，更是中国原研创新药持续走向世界、造福全球的又一例证。自上市以来， 汉斯状已惠及全球逾11万名患者，持续拓展全球免疫治疗的可及边界。未来，我们将继续发挥全球一体化研产销优势，将更多 优质的创新药物带给全球更广泛的患 ...

格隆汇8月1日丨复宏汉霖(02696.HK)公布，谨定于2025年8月25日(星期一)举行公司董事会会议，以考 虑及通过公司及其附属公司截至2025年6月30日止的六个月中期业绩，及派发中期股息(如有)，以及处 理其他事项。 ...

代表董事會 上海復宏漢霖生物技術股份有限公司 主席 （股份代號：2696） 董事會會議召開日期 上海復宏漢霖生物技術股份有限公司（「本公司」）董事會（「董事會」）茲通告謹定 於二零二五年八月二十五日（星期一）舉行本公司董事會會議，以考慮及通過本公 司及其附屬公司截至二零二五年六月三十日止的六個月中期業績，及派發中期股 息（如有），以及處理其他事項。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） Wenjie Zhang 香港，二零二五年八月一日 於本公告日期，本公司董事會包括主席及非執行董事Wenjie Zhang先生，執行董 事朱俊博士，非執行董事陳啟宇先生、吳以芳先生、關曉暉女士、文德鏞先生及 Xingli Wang博士以及獨立非執行董事蘇德揚先生、陳力元博士、趙國屏博士及宋 瑞霖博士。 ...

Investment Rating - The report maintains a positive outlook on the pharmaceutical and biotechnology industry, emphasizing the transition from "Made in China" to "Created in China" for innovative drugs [10]. Core Insights - The report highlights that domestic innovative drugs are gaining global competitiveness and are currently in the first and second stages of international expansion, primarily through licensing agreements and partnerships [10][12]. - The report identifies key areas of focus for investment, including PD-(L)1 plus, ADCs, and GLP-1 drugs, which are expected to drive future growth and business development (BD) opportunities [10][51]. Summary by Sections Section 1: Transition from "Manufacturing" to "Innovation" - The policy reforms initiated in 2015 have stimulated a shift from generic to innovative drug development in China, with significant increases in R&D investment since 2018 [19][21]. - The number of First-in-Class (FIC) drugs developed in China has risen from 9 in 2015 to 120 in 2024, indicating a substantial increase in innovation [25][26]. Section 2: Continued BD Opportunities - PD-(L)1 plus is identified as a cornerstone for next-generation cancer treatments, with significant demand and potential for new products [51]. - The report notes that ADCs are transitioning towards more differentiated targets, focusing on unmet clinical needs, with promising candidates like PD-L1, DLL3, and EGFR [51]. - The GLP-1 market is experiencing rapid growth, with a focus on multi-target, oral, combination, and long-acting formulations [51]. Section 3: Investment Recommendations - For PD-(L)1 plus, companies such as Kangfang Biotech, Shansheng Pharmaceutical, and Junshi Biosciences are recommended for investment due to their strong pipelines [5]. - In the ADC space, companies like Fuhong Hanlin and Zai Lab are highlighted for their potential in addressing unmet clinical needs [5]. - In the GLP-1 sector, firms such as Borui Pharmaceutical and Zai Lab are noted for their promising developments [5].

复宏汉霖宣布，公司自主研发和生产的抗PD-1单抗H药(商品名：汉斯状 ，斯鲁利单抗，欧洲商品名： Hetronifly )完成首批面向印度市场的供货。据介绍，H药于2025年6月获印度中央药品标准控制组织 (CDSCO)批准，用于一线治疗广泛期小细胞肺癌，成为印度首个在该适应症获批的抗PD-1单抗。 ...