Shanghai, China, July 12, 2023 - Haihe Biopharma (Haihe), a company focused on the discovery, development, and commercialization of innovative oncology drugs, first patient dosed in China in a phase III global multi-center clinical trial (SCC244-G303) of Gumarontinib (SCC244), Haihe Biopharma’s de novo developed innovative drug with global rights.
SCC244-G303 is an open-label, multicenter, randomized controlled, Phase III clinical trial to evaluate the efficacy and safety of Gumarontinib versus docetaxel in locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have experienced disease progression after receiving prior immunotherapy (anti-PD-1/PD-L1 antibodies) and platinum-based doublet chemotherapy (concurrent or sequential therapy), and who have MET overexpression and driver gene-negative status. This trial will be global across China, Japan, the United States, and other countries.
Gumarontinib (code: SCC244) is an oral, potent and highly selective small molecule MET inhibitor. Gumarontinib has shown excellent pharmacokinetic characteristics, highly effective and durable efficacy and favorable safety profile in NSCLC patients with MET alterations. as of today, Compared with its competitors, Gumarontinib has long half-life to achieve sustained target inhibition, low DDI potential to enable less co-medication restrictions, convenient QD regimen. Gumarontinib has been approved by the NMPA in china with breakthrough designation for the treatment of non-small cell lung cancer (NSCLC) with MET genomic aberration.
Haihe Biopharma Co., Ltd is a global, values-based, R&D driven biopharmaceutical leader headquartered in China with operation centers in the US and Japan, and mainly focuses on innovative anti-tumor therapies. The company has the fully capability of drug discovery, development, manufacture and commercialization and delivers life-saving therapies to cancer patients in China, even the world widely. As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed in-house innovator with global perspective management and R&D team. Currently Haihe Biopharma has one approved product (Gumarontinib, Haiyitan®) in China and nine drug candidates.