Fosun Pharmaceutical (600196.SH): Application for registration of new indicated drugs for slulizumab injection accepted

Zhitong Finance App News, Fosun Pharmaceutical (600196.SH) announced that recently, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., the holding subsidiary of the company, and its holding subsidiary were accepted by the State Drug Administration (hereinafter referred to as the “State Drug Administration”) for new indications (i.e., new adjuvants with platinum-containing chemotherapy, adjuvant treatment after surgery, for patients with PD-L1 positive gastric cancer that can be surgically resected) by the State Drug Administration (hereinafter referred to as the “State Drug Administration”). Incorporate into the priority review process.

This drug is an innovative anti-PD-1 monoclonal antibody independently developed by the Group. As of the date of this announcement (i.e. December 12, 2025, same below), the drug has been approved for marketing in countries such as China, the European Union, the United Kingdom, Indonesia, Cambodia, Thailand, Malaysia, Singapore and India. Among them, the approved indications in China include first-line treatment of 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); in addition, the drug has been indicated for use in the United States, the European Union, Switzerland, and Drug regulatory authorities in South Korea and other countries/regions have granted orphan drug qualification, and the drug for the new adjuvant/adjuvant treatment of gastric cancer in combination with chemotherapy was included in the breakthrough treatment program by the National Drug Administration Drug Evaluation Center in November 2025; in addition, multiple combination therapies based on this drug are undergoing clinical trials in many countries and regions around the world, covering indications such as lung cancer, esophageal cancer, head and neck cancer, colorectal cancer, and stomach cancer.