Shanghai, China, November 28, 2018 – Shanghai HaiHe Biopharma Co., Ltd. (hereinafter referred to as “HaiHe Biopharma”) announced today that the site initiation visit meeting of the pivotal phase II clinical trial (LP-X)of Simmitecan, an innovative drug developed by HaiHe Biopharma, was successfully convened in Huashan Hospital Shanghai Fudan University. Professor Liu Jie of Department of Gastroenterology of Huashan Hospital Fudan University will act as the principal investigator (PI) of the trial.

“We are very pleased to see the official initiation of the pivotal phase II clinical trial of Simmitecan. Simmitecan is a second-generation camptothecin compound with good safety and potential application in immunotherapy. Metronomic chemotherapy offers a new strategy for cancer treatment, which is good news to the patients with advanced colorectal cancer. The successful initiation of the LP-X project is a significant progress made by HaiHe Biopharma. We will work hard to accomplish the LP-X clinical trial as early as possible, so as to make Simmitecan available to the tumor patients both in China and around the world as soon as possible,” said Dr. Dong Ruiping, CEO of HaiHe Biopharma.

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.

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.

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.