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Haihe Biopharma obtains the IND Approval from FDA for its innovative IDH1 inhibitor???????

May 7, 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 isocitrate dehydrogenase-1 (IDH1) inhibitor HH2301 developed by the company. It is intended to be used to treat solid tumors with IDH1 mutations including Advanced cholangiocarcinoma, chondrosarcoma and glioma.

Dr. Ruiping Dong, CEO of Haihe Biopharma, commented:
“Obtaining IND approval for HH2301 in the US is another breakthrough in Haihe's global R&D layout. HH2301 has showed great potential for clinical development and application in terms of in vivo and in vitro activity, DMPK and toxicological characteristics. Haihe will continue to promote the company's internationalization process based on China and focusing on the world.”
About HH2301

Abnormal metabolism is one of the ten major characteristics of malignant tumors. Targeting tumor metabolism has become a new anti-tumor strategy with great potential. Isocitrate dehydrogenase (IDH) is a rate-limiting enzyme in the tricarboxylic acid cycle (TCA), and one of the most common metabolic enzymes mutated in human tumors. Mutant isocitrate dehydrogenase 1 (mIDH1) can catalyze α-ketoglutarate (α-KG) to produce (R)-2-hydroxyglutarate (2-HG). As a recognized cancer metabolite, 2-HG can participate in the regulation of many important cell processes through different mechanisms and promote tumor occurrence and malignancy. IDH1 mutations occur widely in many tumors such as cholangiocarcinoma, chondrosarcoma, glioma, and acute myeloid leukemia (AML). More and more studies have confirmed that mIDH1 inhibitors have good therapeutic prospects and safety for the aforementioned tumors. Currently, two IDH inhibitors have been approved by the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia with IDH1 or IDH2 mutations, but no such target inhibitor has been approved for the treatment of solid tumors with IDH1 mutations.


HH2301 refers to a new, potent and selective mIDH1 inhibitor jointly developed by Haihe Biopharma and Shanghai Institute of Meteria Medica. Systematic non-clinical studies have shown that the compound has excellent anti-tumor activity in vivo and in vitro, has good pharmacokinetic properties and safety in all tested species. In a variety of solid tumor xenograft models (PDX models) derived from patients with IDH1 mutations, HH2301 exhibits significant anti-tumor activity and has a 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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