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HaiHe Biopharma Obtains the IND Implied License from FDA for its Innovative Drug EZH1/2 Dual Inhibitor

March 17, 2020, Shanghai, China - HaiHe Biopharma, a company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that HH2853, a EZH1/2 dual inhibitor developed by the company, has recently obtained the IND approval from the US Food and Drug Administration (FDA). HH2853 is intended to treat patients with recurrent/refractory non-Hodgkin's lymphoma and advanced solid tumors.


“By keeping driven by science and focusing on innovation, HaiHe has successfully obtained the IND implied license for its another cutting-edge new drug in the United States. HH2853 has development prospects and druggability in terms of compound properties, in vivo and in vitro activity and DMPK characteristics. At the same time, we are working on the IND and NDA of several other compounds in both China and the United States. In the future, more candidate compounds developed by HaiHe will be brought to the global market,” said Dr. Dong Ruiping, CEO of HaiHe Biopharma.

About HH2853

EZH1 or EZH2 is the catalytic subunit of epigenetic regulators PRC2 complex, responsible for the methylation of H3K27, causing the loss of expression of the related genes. Some tumors and immune cells use EZH2 to promote the development and progression of tumors, and to inhibit the response to anti-tumor drugs. For instance, EZH2 often has gain-of-function mutation in follicular lymphoma, diffuse large B-cell lymphoma, multiple myeloma, etc., which is the driver of tumorigenesis. The overexpression of EZH2 in breast cancer, ovarian cancer, lung cancer, prostate cancer, liver cancer and other solid tumors is highly correlated with the development, invasion, metastasis and poor prognosis of tumor. Tumors with loss-of-function mutation in the chromatin remodeling complex SWI/SNF or histone deubiquitinase BAP1 also rely overly on PRC2 activity, and are sensitive to EZH2 inhibitors. Moreover, the high-level expression of EZH2 by immune cells in tumor immune microenvironment is an important mechanism of tumor immune escape. There is increasing evidence showing that EZH1 and EZH2 compensate each other in various tumors. Therefore, simultaneous targeting EZH1/2 has the potential to treat various malignant tumors. There are few micromolecules targeting PRC2 complexes worldwide, and most are EZH2 selective inhibitors. Usually these molecules have poor pharmacokinetics properties.


HH2853 refers to a new, potent, and specific EZH1/2 dual inhibitor jointly developed by HaiHe Biopharma Co., Ltd. and Shanghai Institute of Materia Medica. The systematic non-clinical studies have shown that HH2853 has excellent anti-tumor activity in vitro and in vivo, has good pharmacokinetics properties and outstanding safety in all tested species and shows good prospects for clinical application and development. 

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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