Core Viewpoint - The FDA has officially approved Braftovi, an oral cancer drug developed by Pfizer and Ono Pharmaceutical, for the treatment of colorectal cancer, based on Phase 3 BREAKWATER clinical trial data [1][2]. Group 1: FDA Approval and Clinical Data - Braftovi is approved as part of a combination therapy for previously untreated patients with metastatic colorectal cancer carrying the BRAF V600E mutation [1]. - The approval was granted through the accelerated approval pathway after achieving one of the dual primary endpoints related to overall response rate in the BREAKWATER study [1]. - The combination of Braftovi and the anti-cancer drug cetuximab resulted in a median progression-free survival of 12.8 months for newly diagnosed patients with BRAF V600E mutated metastatic colorectal cancer [1]. Group 2: Drug Composition and Patient Demographics - The active ingredient in Braftovi, encorafenib, is an oral small molecule BRAF inhibitor [2]. - BRAF mutations occur in up to 15% of metastatic colorectal cancer patients, who generally have a poor prognosis [2]. - Patients with BRAF V600E mutations have more than double the mortality rate compared to those with wild-type BRAF [2].

【国泰海通医药】春节期间创新药领域重点新闻梳理-海外公司 1）2/12 公司自2019年起任职的CEO PaulHudson不再续聘，前默沙东CEO BelénGarijo上任（#过去3年赛诺菲临床失 败多管线青黄不接）； 2）2/17 赛诺菲&TEVA更新了共同开发的TL1A单抗duvakitug IIb期更长期随访的数据，其中44周时接受900mg药物维 持治疗的UC患者临床缓解率达到58%（较安 【国泰海通医药】春节期间创新药领域重点新闻梳理-海外公司 赛诺菲： 1）2/12 公司自2019年起任职的CEO PaulHudson不再续聘，前默沙东CEO BelénGarijo上任（#过去3年赛诺菲临床失 败多管线青黄不接）； 2）2/17 赛诺菲&TEVA更新了共同开发的TL1A单抗duvakitug IIb期更长期随访的数据，其中44周时接受900mg药物维 持治疗的UC患者临床缓解率达到58%（较安慰剂提高27%），CD患者的内镜应答率达到55%（较安慰剂提高 35%），相比16周均有提高，数据亮眼； 阿斯利康： 1）2/20 FDA批准阿斯利康阿克替尼联合维奈托克全口服、固定疗程方案针对一线CLL ...

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 - 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 - The clinical trials for HLX701 will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - HLX701 is a recombinant human SIRPα-IgG4 Fc fusion protein injection, licensed from FBD Biologics Limited, with exclusive rights for development, production, and commercialization in specified regions [1] - As of the announcement date, there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [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 - HLX701 is a recombinant SIRPα-IgG4Fc fusion protein injection licensed from FBD Biologics Limited, with exclusive rights for development, production, and commercialization in China and certain regions [1] - The company plans to initiate clinical trials for HLX701 in mainland China, excluding Hong Kong, Macau, and Taiwan, once conditions are met [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, including licensing fees [1] Group 2 - As of the announcement date (January 20, 2026), there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [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: Clinical Trial Approval - The approval allows for the clinical trials of HLX701 to be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - HLX701 is a recombinant human SIRPα-IgG4 Fc fusion protein injection [1] Group 2: Licensing and Development - HLX701 was licensed from FBD Biologics Limited in June 2025, granting exclusive rights for development, production, and commercialization in specified regions including mainland China, Hong Kong, Macau, Southeast Asia, the Middle East, and North Africa [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, which includes licensing fees [1] Group 3: Market Context - As of the announcement date, there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [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].

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the National Medical Products Administration to conduct a Phase Ib/II clinical trial for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer in China [1] Group 1: Clinical Trial Approval - The approval allows for the initiation of clinical trials for HLX701, which is a targeted CD47 SIRPα-Fc fusion protein [1] - The clinical trials are set to take place within China [1] Group 2: Financial Investment - Fosun Pharma has invested approximately 76.09 million yuan in the research and development of HLX701 as of December 2025 [1] - The drug was licensed for introduction in June 2025 [1] Group 3: Market Context - There are currently no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]