July 19, 2019, Shanghai, China -HaiHe Biopharma, a biopharmaceutical company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced today that the first subject has been dosed in the Phase II clinical trial of innovative drug Simmitecan and 5-FU/LV regimen combined with Toripalimab in the treatment of advanced recurrent or metastatic neuroendocrine carcinoma.

Neuroendocrine neoplasms (NENs) are highly heterogeneous tumors that originate in the neuroendocrine system of various organs of the body, with the most common sites being the gastrointestinal tract, pancreas and lungs. Among them, highly differentiated neuroendocrine neoplasms are named neuroendocrine tumor (NET), and poorly differentiated neuroendocrine neoplasms are named neuroendocrine carcinoma (NEC). NEC is an invasive, rapidly growing tumor that usually does not secrete hormones or produces hormone syndrome. It has a high degree of malignancy and a poor prognosis. The median survival time is about 10 months.  First-line chemotherapy in NEC patients is difficult to maintain for a long term. In patients with disease recurrence or progression within 1 year, untreated OS is only 2-3 months. There is no standard treatment for recurrence or progression after first-line treatment in NEC patients.

Glumetinib (code: SCC244) is a potent and selective small molecule MET kinase inhibitor with global proprietary intellectual property rights developed by HaiHe Biopharma Co., Ltd and the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences. Preclinical studies have shown that Glumetinib potently and specifically targets the inhibition of MET kinase in vitro activity. Preliminary clinical studies have shown that Glumetinib has better human pharmacokinetic characteristics than small molecule MET kinase inhibitors with the same selectivity, including longer metabolic half-life, good permeability through the blood-brain barrier, etc. It showed initial efficacy as well as good safety and tolerability in patients with MET-positive advanced non-small cell lung 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.