Core Insights - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, has received inclusion in the Breakthrough Therapy designation for its independently developed drug, Surulitinib Injection, for use in combination chemotherapy for gastric cancer [1] Group 1: Drug Development and Approvals - Surulitinib Injection, marketed as Hanshuan® in China, is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - 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] Group 2: Regulatory Designations and Clinical Trials - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - Multiple combination therapy clinical trials involving Surulitinib are ongoing globally, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1] - Inclusion in the Breakthrough Therapy program is expected to expedite the review and market launch process for the drug's related indications in China [1]