Policy Developments - The National Healthcare Security Administration has issued a guideline for the pricing of surgical and treatment auxiliary operations, focusing on medical technology innovations such as robotic surgery and 3D printing, establishing 37 pricing items and guiding the transition from traditional to precision medicine [2] Drug and Device Approvals - Bailitianheng's drug application for iza-bren, a first-in-class EGFR×HER3 dual antibody ADC for treating recurrent or metastatic esophageal squamous cell carcinoma, has been accepted and prioritized for review by the National Medical Products Administration [4] - Heng Rui Medicine has received clinical trial approval for SHR-9839, a humanized antibody for advanced solid tumors, and HRS-4642, a KRAS G12D inhibitor [5] - Fosun Pharma's subsidiary has been approved to conduct clinical trials for HLX701 in combination with chemotherapy for advanced colorectal cancer [6] Capital Market Activities - InnoCare Pharma has entered a collaboration agreement with Shenzhen Hengtai Biotechnology for the ISM8969 project, a new NLRP3 inhibitor for CNS diseases, with a potential total payment of up to $66 million [8][9] - Zhejiang Dejin Bio completed a multi-million A round financing to advance its core product, a recombinant botulinum toxin, and for international expansion [10] Industry Developments - Ant Group's Antifor has launched a DeepSearch feature on its PC platform to assist medical professionals with literature searches and clinical diagnosis [12] - Guangzhou's political advisor has proposed a plan to develop the brain-computer interface industry, aligning with national strategies and leveraging local resources [13] Shareholder Actions - Meihua Medical announced that shareholders plan to reduce their holdings by up to 2.51% of total shares due to personal financial needs [15] - Kain Technology has voluntarily withdrawn its drug registration application for a new hepatitis B indication, which will impact its 2025 profits [16]

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: 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]