Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance from the National Medical Products Administration for a new indication of the drug Surulitinib Injection, which is now included in the priority review process [1] Group 1 - The new indication is for the use of Surulitinib Injection in combination with platinum-based chemotherapy as neoadjuvant therapy and postoperative adjuvant treatment for PD-L1 positive, resectable gastric cancer patients [1] - Surulitinib is an innovative anti-PD-1 monoclonal antibody independently developed by the group [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received breakthrough therapy designation for its independently developed Sru Li Anti-Inflammatory Injection for use in combination chemotherapy for gastric cancer [1] Company Summary - The drug is an innovative anti-PD-1 monoclonal antibody developed by Fosun Pharma [1] - As of November 20, 2025, the drug has been approved for marketing in multiple countries, including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [1] - In China, the approved indications include first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - Multiple combination therapies involving this drug are currently undergoing clinical trials in various countries, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1]

Core Viewpoint - The announcement highlights the inclusion of Hanshuo (Sruilumab injection) in the National Medical Products Administration (NMPA) breakthrough therapy program for the neoadjuvant/adjuvant treatment of gastric cancer, indicating a significant advancement for the company in the oncology sector [1] Group 1: Product Development - Hanshuo is an innovative anti-PD-1 monoclonal antibody developed by the company, which has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The product has also received approvals in multiple countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [1] Group 2: Clinical Trials - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications such as lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]

Group 1 - The core point of the news is that the clinical trial for the company's self-developed drug, Hanshuai (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a mid-term analysis, supporting an early application for market approval [1] - The study is a randomized, double-blind, multi-center Phase 3 clinical trial comparing the efficacy and safety of Hanshuai combined with chemotherapy against placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) found that Hanshuai combined with chemotherapy showed a significant improvement in EFS compared to the control group, with a pathological complete response (pCR) rate more than three times that of the control group, and a significant reduction in recurrence risk, while safety was good with no new safety signals identified [1] Group 2 - Hanshuai is an innovative anti-PD-1 monoclonal antibody developed by the company, which has been approved for several indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also been approved in various countries/regions including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] Group 3 - The company is actively advancing multiple clinical trials for Hanshuai and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [3]

Core Insights - The company announced that its self-developed drug Hansizhuang® (sulizumab injection) has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1][2] Group 1: Clinical Trial Results - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hansizhuang® combined with chemotherapy to placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hansizhuang® group, achieving pre-set superiority standards [1] - The pathological complete response (pCR) rate for Hansizhuang® was over three times that of the control group, with a significant reduction in recurrence risk and no new safety signals reported [1] Group 2: Product Information and Approvals - Hansizhuang® is an innovative anti-PD-1 monoclonal antibody that has been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also received approvals in several countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation in the US, EU, Switzerland, and South Korea [2] - The company is actively advancing multiple clinical trials for Hansizhuang® and related combination therapies across various indications, including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]