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Haihe Biopharma obtains the IND Approval from FDA for its innovative PI3Ka inhibitor

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.

Dr. Ruiping Dong, CEO of Haihe Biopharma, commented:
“CYH33 has significant in vivo and in vitro anti-tumor activity and high selectivity to PI3Kα. It has a distinct competitive advantage in avoiding potential toxicity caused by multi-target inhibition, selection of sensitive populations, and rational design of combination therapies. Haihe has already obtained IND approvals for five compounds in the US. We look forward to bringing safer and more effective treatment options to cancer patients worldwide.”
About CYH33

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.

About Haihe Biopharma

Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, “Inclusive and open to diversity, innovation oriented to win together and benefit the mankind”, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and validation, medical strategy and clinical study, etc. The company has established a globally competitive innovative drug R&D system and robust product pipeline. There are 7 compounds in clinical and 3 compounds in preclinical studies, among which 7 compounds are discovered in-house.

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