On September 5, 2024, China-based Hanx Biopharmaceuticals Co., Ltd announced that it has received approval from the National Medical Products Administration (NMPA) for the Phase II clinical trial of its investigational drug HX009 in combination therapy for biliary tract cancer (BTC). The application met the relevant requirements for drug registration, and the NMPA has given the green light for the conduct of this Phase II clinical trial.
HX009: A Clinical-Stage Bispecific Antibody for Cancer Immunotherapy
HX009 is a clinical-stage investigational new drug independently developed by Hanx Biopharmaceuticals, targeting both PD-1 and CD47 for cancer immunotherapy. The drug has been studied in Australia and China, where it has successfully completed two Phase I clinical trials for solid tumors as a monotherapy. The Phase I monotherapy data demonstrated good safety and tolerability, and antitumor efficacy was observed across various indications, including biliary tract cancer. The existing data supports the advancement to Phase II clinical trials and combination therapy studies. The company is currently planning to conduct multicenter Phase II clinical trials for a variety of clinical indications.
About Hanx Biopharmaceuticals
Hanx Biopharmaceuticals is a clinical-stage biopharmaceutical company focused on the independent research and development and manufacturing of precise oncology immunotherapy antibodies and small molecule drugs. The company’s main scientific and management team possesses extensive experience in the research and development, industrialization, and management of new drugs in multinational companies, with a focus on Western markets. Hanx Biopharmaceuticals has established management teams from drug discovery to clinical research in Wuhan, Shanghai, Hangzhou, Hong Kong, Australia, and San Diego, USA. The company has built an innovative technology platform with a global patent portfolio for high-affinity, long-half-life antibody screening and has established a pipeline of innovative drugs focusing on tumor immunology diseases and international cooperation projects, including several drugs that have entered Phase II clinical trials.-Fineline Info & Tech
