May 22, 2020 ,Shanghai, China - Haihe Biopharma, a company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the company has recently obtained the IND approval from the US Food and Drug Administration (FDA) for its phosphoinositide 3-kinase (PI3K) αinhibitor CYH33 developed by the company. It is intended to be used to treat advanced solid tumors.

The dysregulation of the PI3K signaling pathway involves most human cancers. PIK3CA (encoding PI3K catalytic subunit α) is one of the common mutated oncogenes in human tumors. About 2-5% of human solid tumors have mutations in the oncogene PIK3CA, involving tumor types such as breast cancer, ovarian cancer, colon cancer, glioblastoma, lung cancer, and esophageal cancer.

CYH33 refers to a new, potent and selective PI3Kα inhibitor co-developed by Haihe Biopharma and the Shanghai Institute of Materia Medica (SIMM). By inhibiting PI3K-mediated signaling pathways, cells are blocked in G1 phase, thereby inhibiting tumor cell proliferation. The clinical studies showed that the compound has good safety and preliminary clinical efficacy. At present, no selective PI3Kα inhibitors have been approved for marketing in China.

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.

Please visit the company website for more information: http://www.haihepharma.com