晚期实体瘤治疗
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复宏汉霖(02696):注射用HLX43联合HLX07及汉斯状 用于晚期实体瘤治疗的临床试验申请获国家药品监督管理局批准
智通财经网· 2026-01-27 10:06
Group 1 - The company Fuhong Hanlin (02696) has received approval from the National Medical Products Administration (NMPA) for a clinical trial application involving HLX43, a PD-L1 targeted antibody-drug conjugate, in combination with HLX07 and Hanshuan® for the treatment of advanced solid tumors [1] - HLX43's phase 1 clinical data is set to be presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and the 2025 World Lung Cancer Conference (WCLC), showing promising safety and preliminary efficacy in non-small cell lung cancer (NSCLC) and other solid tumors [2] - HLX07, an innovative biopharmaceutical developed by the company targeting the EGFR pathway, has demonstrated good safety and tolerability in a phase 1b/2 clinical study for advanced solid tumors [2] - Hanshuan® (sruvalizumab) has been approved for multiple indications in mainland China, including first-line treatment for squamous NSCLC, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC [2] - The New Drug Application (NDA) for Hanshuan® in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer has been accepted by the NMPA and is included in the priority review process [2]
复星医药:控股子公司药品获晚期实体瘤治疗临床试验批准
Xin Lang Cai Jing· 2026-01-27 09:07
Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the National Medical Products Administration for clinical trials of HLX43 in combination with HLX07 and Sruvelizumab for the treatment of advanced solid tumors, with plans to conduct Phase II clinical research in China once conditions are met [1] Group 1: Clinical Development - The approved treatment regimen involves a combination of HLX43, HLX07, and Sruvelizumab, which is currently not available in any similar combination therapy approved globally [1] - The total research and development investment for this treatment plan is approximately 2.66 million yuan, expected to be accumulated by December 2025 [1] Group 2: Market Context - The involved investigational drugs are still in the clinical trial phase, indicating that there are inherent risks associated with drug development [1]
恒瑞医药:拟用于治疗晚期实体瘤的SHR-4298 注射液获批开展临床试验
Zhi Tong Cai Jing· 2025-09-30 10:22
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-4298 injection, a novel anti-tumor drug [1] Group 1: Product Development - SHR-4298 injection is a first-class therapeutic biological product developed independently by the company [1] - The drug has shown good anti-tumor activity in preclinical animal models and is intended for the treatment of advanced solid tumors [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-4298 injection project has reached approximately 28.79 million yuan [1]