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2020

First patient dosed in the United States with HaiHe Biopharma’s innovative drug ERK inhibitor

January 24, 2020, Shanghai, China - HaiHe Biopharma, a company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the Phase I clinical trial of HH2710, an extracellular regulated protein kinase (ERK) inhibitor developed by the company, has recently completed the dosing of the first patient in the United States.

Dr. Ruiping Dong, CEO of Haihe Biopharma, commented:
“With an efficient and excellent team, HaiHe Biopharma’s HH2710 successfully reached the milestone of first patient dosed in the United States shortly after obtaining the IDN Implied License from the US FDA. Meanwhile, HaiHe Biopharma has submitted the IND application for HH2710 in China. In the future, we will accelerate the Company’s internationalization process and expand the global market along with the launch of the overseas clinical trials of more cutting-edge new drug programs.”
 
About HH2710

ERK is a key kinase in the MAPK signaling pathway. Targeting ERK can be used for the treatment of a variety of tumors caused by the prevalent mutations in the MAPK signaling pathway, such as non-small cell lung cancer, melanoma, thyroid cancer, pancreatic cancer, cholangiocarcinoma, head and neck cancer, prostate cancer, ovarian cancer, cervical cancer, endometrial cancer and other advanced tumors. At present, no ERK kinase inhibitor has been approved for marketing in the world. MAPK signaling pathway is a pathway with the highest mutation frequency in human malignant tumors, and its mutation rate reaches more than 80% in non-small cell lung cancer, melanoma and pancreatic cancer. Therefore, targeting MAPK signaling pathway has become an important tumor treatment strategy, which has been widely and deeply studied. The marketed inhibitors targeting upstream kinases of the MAPK signaling pathway, such as Vemurafenib, Dabrafenib, Trametinib and Cobimetinib, have demonstrated that inhibitors of this signaling pathway are efficacious and safe in clinical practice for tumor treatment. They are used as the first-line and the second-line standard treatment for the patients with melanoma and non-small cell lung cancer. Although these approved upstream kinase inhibitors bring exciting anti-tumor activity and survival benefits, most patients inevitably develop acquired drug resistance within a year. As the only key downstream kinase in the MAPK signaling pathway, ERK is expected to overcome the acquired drug resistance or non-druggability of upstream kinase and provide possible treatment for the majority of patients.  HH2710 is an innovative, potent and specific small molecule ERK kinase inhibitor, which was developed jointly by HaiHe Biopharma and Shanghai Institute of Materia Medica, Chinese Academy of Science.

About Haihe Biopharma

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. 

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