Henlius gets NMPA approval for HER2-positive breast cancer trials

Shanghai Henlius Biotech, Inc. has received National Medical Products Administration (NMPA) approval for its applications for phase 2/3 clinical trials of HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) in combination with HLX87 for injection (antibody-drug conjugate targeting HER2). These trials target first-line treatment of HER2-positive breast cancer and neoadjuvant treatment for HER2-positive breast cancer. The company plans to initiate relevant clinical trials in mainland China.

HLX22 is a licensed-in anti-HER2 monoclonal antibody, which the company subsequently self-developed, with potential indications including gastric cancer and other solid tumors. It has received Orphan-drug Designation for gastric cancer from the United States FDA and the European Commission. HLX87, an innovative HER2-targeted antibody-drug conjugate (ADC), is currently in phase 3 clinical development for various indications, including HER2-positive breast cancer.

A phase 3 clinical trial of HLX87 for second-line HER2-positive breast cancer is already underway in mainland China. As of the announcement date, no similar combination has been globally approved for marketing. The company advises shareholders and potential investors to exercise caution, noting that successful development and commercialization of HLX22 and HLX87 cannot be guaranteed.