Gelonghui, May 6, 丨 Fosun Pharmaceutical (600196.SH) announced that its holding subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. and its holding subsidiary (hereinafter collectively referred to as “Fuhong Hanlin”) recently received a letter from the US FDA (i.e. the US Food and Drug Administration) agreeing to conduct clinical trials with HLX22 (i.e. anti-human epidermal growth factor receptor-2 (HER2) humanized monoclonal antibody injection) combined with trastuzumab and chemotherapy on the first-line treatment of advanced HER2 positive gastric cancer (hereinafter referred to as “this treatment plan”). Fu Hong Hanlin plans to conduct phase III clinical trials of this treatment plan in the US when conditions are met.
The HLX22 involved in this treatment plan is a novel monoclonal antibody targeting HER2 imported with permission from ABClon, Inc. from the Group (i.e. the Company and its holding subsidiaries/units, the same below) and subsequently independently developed. It is intended for the treatment of solid tumors such as stomach cancer and breast cancer. As of the date of this announcement, HLX22 monotherapy for treating advanced HER2 overexpressed solid tumors has completed phase I clinical studies in China (excluding Hong Kong, Macao and Taiwan; same below), first-line treatment of locally advanced/metastatic gastric cancer (GC) positive with HLX22 in combination with trastuzumab and chemotherapy is in phase II clinical trials in China, and HLX22 combined with HLX22 in combination with HLX22 (sululimab injection) standard treatment (i.e. trutuzumab combined chemotherapy) for locally advanced/metastatic gastric cancer (G) is the first-line treatment of locally advanced/metastatic gastric cancer (G) C) Approved for phase II clinical trials in China .