复星医药公告称，其控股子公司复宏汉霖收到国家药监局关于同意注射用HLX43联合HLX07及斯鲁利 单抗注射液用于晚期实体瘤治疗开展临床试验的批准，拟于条件具备后在中国境内开展Ⅱ期临床研究。 截至2025年12月，该治疗方案累计研发投入约266万元。目前全球范围内尚无同类联合用药治疗方案获 批上市。所涉在研药品尚处临床试验阶段，药品研发存在风险。 ...

Investment Rating - The report does not explicitly state an investment rating for the industry or specific companies. Core Insights - The report highlights significant developments in the overseas pharmaceutical sector, including the collaboration between Insilico Medicine and Heng Tai Biopharma to develop a novel NLRP3 inhibitor for central nervous system diseases [2][6]. - The report notes that MicroPort Robotics expects a revenue growth of approximately 110%-120% year-on-year for 2025, with an adjusted net loss not exceeding 240 million yuan, representing a reduction of over 50% [5][6]. - GSK has reached a final agreement to acquire RAPT Therapeutics for approximately 2.2 billion USD, focusing on a long-acting monoclonal antibody currently in clinical trials [7][8]. Summary by Sections 1. Overseas Pharmaceuticals - Insilico Medicine and Heng Tai Biopharma have entered a partnership to develop ISM8969, a novel oral NLRP3 inhibitor, with both companies holding 50% global rights [2][6]. - The Hong Kong Stock Exchange has approved the full circulation of 182,645,856 H shares for Fuhong Hanlin, representing about 33.61% of the company's total issued shares as of January 19 [2][6]. - The new drug application for TLX591-CDx, a radiopharmaceutical for prostate cancer diagnosis, has been accepted by the NMPA [2][6]. 2. Company Updates - MicroPort Robotics has reported over 180 commercial orders and more than 120 installations globally as of January 21 [5][6]. - Legend Biotech, a joint venture of Genscript Biotech, reported a trade sales net of approximately 555 million USD for the quarter ending December 31, 2025 [5][6]. - GSK's acquisition of RAPT Therapeutics includes a payment of 58.00 USD per share, with an expected upfront investment of 1.9 billion USD after cash adjustments [7][8]. 3. Market Performance - The Hang Seng Healthcare Index fell by 4.35%, underperforming the Hang Seng Index by 3.26 percentage points [4]. - The report indicates a strong performance in the overseas education sector, with GMV for Dongfang Zhenxuan reaching approximately 310 million yuan, a 42.8% increase week-on-week [15][16]. 4. Recommendations - The report suggests focusing on innovative drugs and the ongoing clinical progress of key pipelines from companies such as BeiGene, Innovent Biologics, and others [12]. - It also recommends monitoring the performance of educational companies like Dongfang Zhenxuan and China Oriental Education, which are expected to benefit from improved operational strategies and increased enrollment [16].

Investment Rating - The report maintains a "Positive" outlook on the overseas pharmaceutical sector, highlighting significant developments and collaborations in the industry [1]. Core Insights - The collaboration between Insilico Medicine and Heng Tai Biologics to develop an innovative brain-penetrating NLRP3 inhibitor is a key highlight, with potential applications in treating central nervous system diseases [2][7]. - The approval of full circulation for Fuhong Hanlin's H shares is noted, which involves a significant number of shares and stakeholders [2][7]. - The report emphasizes the strong revenue growth projections for companies like MicroPort Robotics and King’s Ray Biotech, with expected revenue increases of approximately 110%-120% year-on-year for 2025 [6][10]. Summary by Sections 1. Overseas Pharmaceuticals - Insilico Medicine and Heng Tai Biologics have entered a partnership to develop ISM8969, a novel oral NLRP3 inhibitor, with a 50% global rights share and potential milestone payments exceeding HKD 500 million [2][7]. - Fuhong Hanlin's H shares have received approval for full circulation, involving 182,645,856 shares, which represents about 33.61% of the company's total issued shares [2][7]. 2. Company Performance Updates - MicroPort Robotics anticipates a revenue increase of 110%-120% for 2025, with adjusted net losses expected to narrow by over 50% [6][10]. - King’s Ray Biotech's joint venture, Legend Biotech, is projected to generate approximately USD 555 million in trade sales for the quarter ending December 31, 2025 [6][10]. 3. Recent Developments in Overseas Pharmaceutical Companies - GSK has reached an agreement to acquire RAPT Therapeutics for approximately USD 2.2 billion, focusing on a long-acting IgE monoclonal antibody currently in clinical trials [3][8]. - Corvus has reported positive results from a Phase I trial of its ITK inhibitor for moderate to severe atopic dermatitis, showing good safety and efficacy [3][9]. - Eli Lilly's FRα ADC has received breakthrough therapy designation from the FDA for treating platinum-resistant ovarian cancer [3][9]. 4. Recommendations - The report suggests monitoring innovative drug companies with active commercialization and business development opportunities, including companies like BeiGene, Innovent Biologics, and Fuhong Hanlin [13]. - It also highlights the importance of ongoing clinical progress in innovative pipelines for pharmaceutical companies transitioning towards innovation [13].

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for the treatment of advanced colorectal cancer [1] Group 1 - The approved drug, HLX701, is a recombinant human SIRPα-IgG4Fc fusion protein injection [1] - The clinical trials will be conducted in China once conditions are met [1]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1: Company Developments - The clinical trials for HLX701 will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan, once conditions are met [1] - HLX701 was introduced by Fuhong Hanlin in June 2025 and has exclusive licensing rights for development, production, and commercialization in specified regions including mainland China, Hong Kong, Macau, and certain Southeast Asian, Middle Eastern, and North African countries [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) for the clinical trial application of HLX701 in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer, indicating a significant step forward in its clinical development pipeline [1] Group 1: Product Development - HLX701 is a recombinant SIRPα-IgG4Fc fusion protein licensed from FBD Biologics Limited, intended for the treatment of various advanced solid tumors [1] - The company holds exclusive rights for the development, production, and commercialization of HLX701 in China (excluding Taiwan), Southeast Asia, the Middle East, and North Africa [1] Group 2: Mechanism of Action - HLX701 works by binding to CD47 on tumor cells, effectively blocking the inhibitory CD47 anti-phagocytic signal, which promotes macrophage phagocytosis of tumor cells and enhances anti-tumor activity [1] - Preclinical studies indicate that HLX701 can synergize with various drugs, including chemotherapy agents, immune checkpoint inhibitors, epidermal growth factor receptor inhibitors, and anti-angiogenic drugs, suggesting potential for enhanced immune responses when used in combination with standard treatment regimens [1]

Core Viewpoint - The approval of the IND application for HLX701 in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer marks a significant advancement for the company in its clinical development pipeline [1][2]. Group 1: Product Overview - HLX701 is a SIRPα-Fc fusion protein licensed from FBD Biologics Limited, intended for the treatment of various advanced solid tumors [2]. - The company holds exclusive rights for the development, production, and commercialization of HLX701 in China (excluding Taiwan), Southeast Asia, the Middle East, and North Africa [2]. Group 2: Mechanism of Action - HLX701 functions by binding to CD47 on tumor cells, effectively blocking the inhibitory CD47 anti-phagocytic signal, which promotes macrophage phagocytosis of tumor cells and enhances anti-tumor activity [2]. - Preclinical studies indicate that HLX701 can synergize with various drugs, including chemotherapy agents, immune checkpoint inhibitors, epidermal growth factor receptor inhibitors, and anti-angiogenic drugs, suggesting potential for enhanced innate and adaptive immune responses when used in combination with standard treatment regimens [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 HLX701（重組人SIRPα-IgG4 Fc融合蛋白注射液）聯合西妥昔單抗和化 療治療晚期結直腸癌的1b/2期臨床試驗申請獲國家藥品監督管理局批准 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。 HLX701是本公司自FBD Biologics Limited許可引進的SIRPα-Fc融合蛋白， 擬用於多種晚期實體瘤的治療，目前該產品的多項1/2期臨床試驗正於全球 範圍內開展中。根據許可安排，本公司獲得於中國（除中國台灣地區）及東南 亞、中東和北非的特定國家開發、生產及商業化HLX701的獨家許可權利。 HLX701是一種工程改構的人類SIRPα免疫球蛋 ...

Group 1 - The Hong Kong Stock Exchange has granted approval for the listing and trading of 183 million H-shares of Fuhong Hanlin on January 19, 2026 [1] - The approval involves converting unlisted shares into H-shares, with participating shareholders holding approximately 33.61% of the company's total shares [1] - Participating shareholders include Shanghai Fosun Pharmaceutical Research Co., Ltd. and Xiamen Health Hongtu Equity Investment Partnership, among a total of 17 shareholders [1] Group 2 - Following the conversion and listing, the company's share structure will change as follows: - Unlisted shares will decrease from 380,066,312 (69.93%) to 197,420,456 (36.32%) - H-shares will increase from 163,428,541 (30.07%) to 346,074,397 (63.68%) [2] - The total number of shares will remain the same at 543,494,853 [2]

Core Viewpoint - The company, Fuhong Hanlin (02696), has received approval from the Hong Kong Stock Exchange for the listing and trading of 182,645,856 H-shares, which are to be converted from unlisted shares, with the conversion involving 17 participating shareholders [1] Group 1 - The total number of H-shares to be listed and traded is 182,645,856 [1] - The conversion and listing will involve 17 participating shareholders [1] - The number of converted H-shares represents approximately 33.61% of the company's total issued shares as of the announcement date [1]