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HitGen's Small Molecule IND Receives Approval by CFDA for Clinical Trials Release Time:2018-05-07

Chengdu, China, May 7, 2018– HitGen Ltd. announced that its novel small molecule Class I/IIb HDAC inhibitor HG146 (Category 1 of new chemical drug) received approval by Chinese Food and Drug Administration (CFDA) to begin the clinical trialsforMultiple Myeloma.


HG146 is a self-developed Class I/IIb HDAC inhibitor with novel chemical scaffold developed from HitGen’s proprietary DNA Encoded Library technology. Comparing with the current listed HDAC inhibitors for multiple myeloma, its preclinical studies showed better efficacy and safety profile with potential application in immuno-oncology.


“With this CFDA approval, we aim to start the clinical trials of HG146 as soon as possible. Meanwhile, we will continue to innovate and improve our core platform of DNA Encoded Libraries, in order to bring more new medicines to patients while collaborating with our partners and satisfying unmet clinical needs.” said Dr. Jin Li, Chairman and Chief Executive Officer of HitGen.



About HG146


In preclinical studies, HG146 has been shown to upregulate the acetylation level of histone and tubulin, modulating the expression of tumor-suppressing genes and disrupting the protein homeostasis in cancer cells to induce apoptosis. By selectively inhibiting Class I/IIb HDAC, HG146 can inhibit the critical signaling pathways related to the prognosis of multiple myeloma and realize its antitumor biological effects while reducing potential side effects.



About Multiple Myeloma


Multiple Myeloma (MM) is a type of neoplasm formed by malignant plasma cells, which still remains an unmet medical need.Through a complex, multi-step process, healthy plasma cells transform into malignant myeloma cells developing in the soft, spongy tissue within bone marrow or two sides of bones to form multiple tumor lesions. MM will cause osteocyte activation, damage os osseum to further trigger osteodynia, hypercalcemia, anaemia, kidney damage, etc. The average age of patients suffering from MM is above 50 with the ratio of male to female 1.6:1. There are about 488,000 patients annually worldwide and about 100,000 of them will lose their lives. According to China’s 2017 statistics, the incidence of MM in China is about 2-3 out of 100,000 people with 20,000 new cases annually. Meanwhile, the incidence of MM in US is about 6.5 out of 100,000 people accounting for 1.8% of all cancer cases in 2017, with 30,280 new cases and 12,590 death.



About HitGen Ltd.


HitGen is a biotech company with headquarters and main research facilities based in Chengdu, China and with a subsidiary in the USA. HitGen has established a platform for small molecular discovery centred around DNA encoded chemical libraries (DELs). HitGen’s DELs contain more than 100 billion novel, diverse, drug-like small molecule and macrocyclic compounds. These compounds are members of DELs synthesised from many hundreds of distinct chemical scaffolds, designed with tractable chemistry, and yielding proven results for the discovery of small molecule leads against precedented and unprecedented classes of biological targets. HitGen is collaborating with over 50 pharmaceutical, biotech, and chemical companies and research institutes in Asia, North America and Europe to discover and develop approaches for novel medicines.


For more information, you may visitwww.hitgen.com OR contact

Dr. Jin Li, Chairman & CEO, HitGen Ltd., Tel: +86 28 85197385 (Ext: 8001)


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