News Center

9/4

2019

HaiHe Biopharma obtains the IND approval from FDA for its innovative drug ERK inhibitor

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.

About HH2710

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.

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.

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

 

References:

Roskoski, R., Jr., ERK1/2 MAP kinases:structure, function, and regulation. Pharmacol Res, 2012. 66(2): p. 105-43.

Maik-Rachline, G. and R. Seger,The ERK cascade inhibitors: Towards overcoming resistance. Drug Resist Updat,2016. 25: p. 1-12.

Liu F, Yang X, Geng M, Huang M.Targeting ERK, an Achilles' Heel ofthe MAPK pathway, in cancer therapy. Acta Pharm Sin B. 2018 Jul, 8(4):552-562.

Dhillon, A. S., Hagan, S., Rath, O. & Kolch, W. MAP kinasesignalling pathways in cancer. Oncogene, 2017, 26: 3279-3290

Balmanno, K. & Cook, S. J. Tumour cell survival signalling bythe ERK1/2 pathway. Cell death and differentiation, 2009, 16: 368-377

Holderfield, M., Deuker, M. M., McCormick, F. & McMahon, M.Targeting RAF kinases for cancer therapy: BRAF-mutated melanoma and beyond.Nature reviews Cancer, 2014, 14: 455-467.

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