2、截至本公告日期，汉斯状于中国境内获批的适应症包括联合化疗一线治疗鳞状非小细胞肺癌(NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(NSCLC)。此外，该药品于欧盟的上市许可申请(MAA)也已于2023年3月获欧洲药品管理局(EMA)受理、并于2024年9月获欧洲药品管理局(EMA)人用医药产品委员会(CHMP)积极审评意见；另有以该药品为核心的多项联合疗法正在全球多个国家和地区开展临床试验。On January 10, Gelonghui reported that FOSUN PHARMA (02196.HK) announced that its holding subsidiary, HENLIUS, along with its holding subsidiaries (collectively referred to as "HENLIUS"), recently received the approval from the National Medical Products Administration (NMPA) regarding the clinical trial of HLX43 (a targeted PD-L1 antibody-new DNA topoisomerase I inhibitor conjugate, registered classification: Class 1 therapeutic Biological Product) in combination with Surufatinib injection (a product name in China: Hanshuang) for the treatment of patients with advanced/metastatic solid tumors (hereinafter referred to as "the treatment plan"). HENLIUS plans to conduct Phase Ib/II clinical trials for this treatment plan in China once conditions are met.
The HLX43 involved in this treatment plan is a targeted PD-L1 antibody conjugate (ADC) that the group (i.e., the company and its holding subsidiaries/units) will introduce from Suzhou Yilian Biomedical Co., Ltd., which is a new DNA topoisomerase I inhibitor small molecule toxin-peptide chain linker conjugated with the group's independently developed targeted PD-L1 antibody for the treatment of advanced/metastatic solid tumors; Hanshuang is an innovative anti-PD-1 monoclonal antibody independently developed by the group. As of the date of this announcement (January 10, 2025, hereinafter the same), the main clinical or registration progress of these Pharmaceuticals is as follows:
1. The Phase I clinical study of HLX43 for the treatment of advanced/metastatic solid tumors has been conducted in China; in December 2024, the application for the Phase Ib/II clinical trial of HLX43 as a monotherapy or combination therapy for advanced/metastatic solid tumors was approved by the NMPA; in November 2023, the Phase I clinical trial application for HLX43 for the treatment of advanced/metastatic solid tumors was also approved by the FDA.
2. As of the date of this announcement, the indications for Hanshuang approved in China include combination chemotherapy as the first-line treatment for squamous non-small cell lung cancer (NSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (NSCLC). In addition, the marketing authorization application (MAA) for this drug was also accepted by the European Medicines Agency (EMA) in March 2023, and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA in September 2024; furthermore, several combination therapies centered around this drug are currently undergoing clinical trials in various countries and regions worldwide.
