Shanghai, China, July 26, 2018/ Shanghai HaiHe Biopharma Co., Ltd. (“HaiHe Biopharma”) announced today its Class 1 innovative drug CYH33 recently completed dosing of the first cancer patient.

“We are very pleased that CYH33 project has completed dosing of the first cancer patient. This is a good start. We will do our best to advance the clinical development guided by unique biomarkers, and strive for early launch of this new drug after various stages of clinical studies to benefit Chinese and global cancer patients."

CYH33, a highly selective PI3Kα inhibitor with a new structure is co-developed by HaiHe Biopharma and the Shanghai Institute of Materia Medica (SIMM), with globally independent intellectual property and rights. The existing data showed that CYH33 has the potential to become a highly effective innovative anti-tumor drug, and it is expected to be clinically used for the treatment of various tumors with PI3Kα mutation.

The phosphoinositide 3-kinase (PI3K) signaling pathway plays an important role in the growth, survival, proliferation and metabolism of cells by acting on the receptor tyrosine protein kinase and downstream G protein-coupled receptors. PI3K has 3 classes, among which Class I is extensively studied. Class I PI3K is divided into four subtypes (α, β, δ, and γ), of which PI3Kα plays a major role in the signaling pathway induced by growth factor stimulation, and only this subtype activates mutations at high frequency in tumor tissues. PI3Kα inhibitors could selectively inhibit tumor cells in which PI3Kα has been highly activated, thereby reducing toxicities. Currently, no selective PI3Kα inhibitors have been approved for marketing worldwide.

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.