Core Viewpoint - The company Fuhong Hanlin (02696) has announced the completion of the first patient dosing in a Phase II clinical trial for HLX79 injection combined with Hanlikang (Rituximab injection) for the treatment of active glomerulonephritis in China, excluding Hong Kong, Macau, and Taiwan [1] Group 1 - The study is a double-blind, randomized, controlled, multi-center Phase II clinical trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to placebo in patients with active glomerulonephritis, specifically lupus nephritis (LN) and membranous nephropathy (MN) [2] - The trial consists of two phases: the first phase is a dose-escalation period where eligible participants will receive weekly doses of HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with Hanlikang or Hanlikang placebo (375 mg/m²) [2] - The primary objective of the first phase is to assess the safety and tolerability of HLX79 combined with Hanlikang compared to placebo combined with Hanlikang in treating active glomerulonephritis [2] Group 2 - The second phase is an exploratory efficacy phase where eligible participants will receive weekly doses of HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo in a 2:2:1:1 ratio [2] - The primary objective of the second phase is to evaluate the clinical efficacy of HLX79 combined with Hanlikang, placebo combined with Hanlikang, and placebo treatment for active glomerulonephritis on top of standard treatment [2] - Secondary objectives include assessing other clinical efficacy, safety, tolerability, pharmacokinetic characteristics, and immunogenicity, while exploratory objectives aim to evaluate the dynamic changes of potential biomarkers [2] - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [2]

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]

Core Viewpoint - Fuhong Hanlin's stock has risen over 5% following the announcement of its PD-1 inhibitor H drug's first shipment to the Indian market, marking a significant milestone for the company and its product's global reach [1] Group 1: Product Developments - Fuhong Hanlin announced the completion of the first shipment of its self-developed PD-1 monoclonal antibody H drug (brand name: Hanshuang, generic name: Surulitinib) to the Indian market, making it 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: Regulatory Approvals - Fuhong Hanlin's biosimilar drugs Prolia and Xgeva (Dexamethasone) 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] - Once approved, 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 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].

Core Viewpoint - The rapid market entry of H drug (Hanshuanzhuang) in India marks a significant milestone for the company, being the first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in the country, enhancing treatment options for local patients [1][2]. Group 1: Product Approval and Market Entry - H drug received approval from the Central Drugs Standard Control Organization (CDSCO) in India at the end of June 2025 and completed its first shipment to the Indian market within 30 days [1][2]. - The drug is the first and only PD-1 monoclonal antibody approved for ES-SCLC in India, addressing a critical unmet clinical need in the treatment landscape [2]. Group 2: Market Context and Demand - In 2022, India reported over 81,000 new lung cancer cases and more than 75,000 deaths, with lung cancer being a leading cause of cancer incidence and mortality in the region [2]. - The approval and commercialization of H drug provide an innovative immunotherapy option for patients suffering from extensive-stage small cell lung cancer [2]. Group 3: Strategic Partnerships - The company has partnered with Intas, a leading local pharmaceutical firm, to facilitate the commercialization of H drug in India, leveraging Intas's extensive market insights and sales network [2][3]. Group 4: Global Operations and Supply Chain - The successful shipment of H drug to India demonstrates the company's efficient global supply chain operations and its commitment to bringing innovative Chinese-origin drugs to international markets [4]. - The company has established an integrated biopharmaceutical platform since its inception in 2010, with capabilities spanning research, production, and commercial operations, ensuring compliance with international standards [4]. Group 5: Financial Performance - The company reported a revenue of 5.724 billion yuan in 2024, reflecting a year-on-year growth of 6.1%, with global sales of H drug increasing by 17.2% [5]. - Analysts anticipate that the ongoing international promotion of H drug will further enhance the company's overseas revenue share, positioning it as a core growth driver for the future [5].