September 4, 2019 ,Shanghai, China - HaiHe Biopharma, a biopharmaceutical company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the company has recently obtained the IND (Investigational New Drug) approval from FDA for HH2710, an extracellular regulated protein kinase (ERK) inhibitor developed by the company, which is intended to treat malignant tumors that have been confirmed to have abnormal MAPK signaling pathway genes by detection.

“HH2710 is HaiHe Biopharma’s first innovative drug to obtain the implied license of IND from FDA, demonstrating HaiHe Biopharma’s outstanding innovation and research capabilities worldwide and marking another important milestone in the international development of HaiHe Biopharma. In the future, we will submit IND in the United States for more cutting-edge innovative compounds in HaiHe Biopharma’s preclinical pipeline. We will also continue to leverage our unique, science-driven research and development advantages to advance clinical development of innovative drugs in the United States and around the world, and to provide more accurate and quality treatments for global patients,” said Dr Dong Ruiping, CEO of HaiHe Biopharma.

ERK is a key kinase in the MAPK signaling pathway. Targeted 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, bile duct cancer, 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 the efficacy and safety in clinical practice. 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 antitumor 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.

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

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