Shanghai, China, March 5, 2019-- Shanghai HaiHe Biopharma Co., Ltd.  (hereinafter referred to as “HaiHe Biopharma”) announced today, that the company has has accomplished  first subject enrollment  of the pivotal phase II clinical trial (LP-X) for class 1 innovative drug Simmitecan.

Professor Liu Jie of Department of Gastroenterology of Huashan Hospital Fudan University will act as the principal investigator (PI) of the trial. LP-X is a single-arm, open-label phase II study designed for evaluating the efficacy, safety and tolerability in the patients with advanced colorectal cancer.

Simmitecan is a topoisomerase I inhibitor developed by HaiHe Biopharma and Shanghai Institute of Materia Medica, Chinese Academy of Sciences. It is a 2nd-generation camptothecin compound and is a chemotherapy drug with excellent safety and efficacy. The results of the phase I clinical trial showed that Simmitecan issafe, and had no serious reaction of diarrhea with the potential application for immunotherapy. It showed clinical effects in Irinotecan resistant patients.

Haihe Biopharma is an innovation-driven biotechnology company in China focusing on the discovery, development, production and commercialization of innovative anti-tumor drugs. Haihe brings life-saving therapies to cancer patients worldwide. It also has a research and management team with a global perspective, and is proactively mapping out the international development of innovative drugs. The Company currently has thirteen key drug candidates. As of today, Haihe Biopharma has received 21 IND or clinical trial approvals in four countries and regions.