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） （股份代號：2696） 自願公告 HLX79注射液（人唾液酸酶融合蛋白） 聯合漢利康® （利妥昔單抗注射液） 治療活動期腎小球腎炎的 2期臨床研究於中國境內完成首例患者給藥 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣布，近日，一項HLX79注射液（人唾液酸酶 融合蛋白）（「HLX79」）聯合漢利康® （利妥昔單抗注射液）（「漢利康®」）治療活 動期腎小球腎炎的2期臨床研究於中國境內（不包括中國港澳台地區，下同） 完成首例患者給藥。 B. 臨床試驗設計及目的 本研究為一項雙盲、隨機對照、多中心的2期臨床試驗，旨在評估HLX79 聯合漢利康®對比安慰劑在活 ...

Core Insights - Adidas reported a 7% year-on-year revenue growth for FY2025H1, reaching €12.105 billion, with a net profit increase of 121% to €798 million [4] - The brand's revenue growth was 14% on a currency-neutral basis, with all regional markets achieving double-digit growth [4] - The company maintains its full-year guidance, expecting high single-digit revenue growth on a currency-neutral basis for FY2025, with double-digit growth for the Adidas brand [4] Market Trends - The domestic market indices showed positive performance, with the Shanghai Composite Index closing at 3,617.60, up 0.96% [3] - The textile and apparel sector experienced a decline of 2.14% this week, underperforming the broader market [5] - Retail sales of sports and entertainment products grew significantly, with a 22.2% year-on-year increase in the first half of 2025 [5] Industry Dynamics - The Chinese gold consumption in the first half of 2025 was 505.205 tons, a decrease of 3.54% year-on-year, with jewelry consumption dropping by 26% [5] - The pharmaceutical industry is seeing advancements in innovative drugs, particularly in obesity treatments with GLP-1 and Amylin therapies showing promising results in clinical trials [8][11] - In the biopharmaceutical sector, ADC drugs for lung cancer are demonstrating significant efficacy, with several products showing improved outcomes in clinical trials [10][12]

Core Viewpoint - The stock price of Fuhong Hanlin (2696.HK) surged over 11% to reach a new high of 75 HKD, with a market capitalization exceeding 40 billion HKD, reflecting a reassessment of its long-term growth value in the innovative drug sector [1] Group 1: Stock Performance - The company's stock has been rising for multiple trading days since last week, driven by a strong performance in the innovative drug sector [1] - The market capitalization surpassing 40 billion HKD indicates recognition of the company's global strategy and continuous innovation capabilities [1] Group 2: Recent Developments - The company announced several innovative drug research results selected for the World Lung Cancer Conference (WCLC), including PD-L1 ADC and the combination therapy with Surulitinib [1] - The self-developed biosimilar HLX14 received a positive opinion from the European Medicines Agency (CHMP), marking a significant step towards European market entry [1] - Surulitinib's lung cancer indication has been approved in the UK and India, with commercial shipments initiated in India, the world's most populous country [1] Group 3: Product Pipeline - The company has multiple products approved for sale globally, with ongoing clinical and registration efforts in overseas markets [1]

Group 1 - The Hong Kong biotechnology stocks collectively rose, with notable increases in several companies' stock prices [1][2] - Beihai Kangcheng-B saw a rise of nearly 19%, while other companies like Gilead Sciences-B and Ascentage Pharma-B also experienced significant gains of over 15% and 9% respectively [1][2] - The overall trend indicates a positive sentiment in the biotechnology sector, with multiple companies achieving gains of over 5% [1][2] Group 2 - Specific stock performance includes: Beihai Kangcheng-B at 18.99% increase, Gilead Sciences-B at 15.30%, and Ascentage Pharma-B at 9.48% [2] - The market capitalization of these companies varies significantly, with Gilead Sciences-B at approximately 11.477 billion and Ascentage Pharma-B at about 29.86 billion [2] - Other notable performers include Jiahua Bio-B and Beikang Medical-B, both showing increases of over 7% [1][2]

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 ...