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HitGen’s New Generation of NTRK/ROS1 Inhibitor HG030 Approved for Clinical Trial Release Time:2020-03-30

On 30th March 2020, HitGen Inc announces that its small-molecule tyrosine kinase inhibitor HG030 has obtained IND approval from the CDE (Center For Drug Evaluation), NMPA, China’s Regulatory Authority for clinical trials and new products approval. The potential indications for HG030 are against the solid tumors harboring NTRK1/2/3/ROS1 fusion genes.

NameHG030 TabletHG030 Tablet
Dosage FormTabletTablet
Strenth20 mg50 mg
ApplicantHitGen Inc.
Application ItemTo initiate clinical trials of HG030 tablet in patients with NTRK gene fusion-positive solid tumors or ROS1 gene fusion-positive solid tumors
Application No.CXHL2000003,CXHL2000004
Review DecisionHG030 was approved for clinical trials in patients with NTRK gene fusion-positive solid tumors or ROS1 gene fusion-positive solid tumors

Tropomyosin receptor kinase (Trk) is a family of receptor tyrosine kinases, including the TrkA, TrkB, and TrkC receptors encoded by the NTRK1, NTRK2, and NTRK3 genes, respectively. The aberrant constitutive activation of the Trk signaling pathway is linked with the onset of a wide range of cancers. So far, the FDA has approved two small-molecule Trk inhibitors, Larotrectinib (trade name "Vitrakvi") on Nov 26, 2018 and Entrectinib (trade name "Rozlytrek") on Aug 15, 2019, used for the treatment of cancers harboring NTRK1/2/3/ROS1 fusion genes, regardless of tissues and tumor types. However, the acquired resistance is emerging along with the clinical use of the first generation of Trk inhibitors. Thus, there still exists high unmet medical needs for new medicines to overcome the resistance.     

HG030 is a new generation of Trk inhibitor against various mutated Trk proteins and ROS1 as well. Preclinical data of HG030 demonstrated good drug-like properties and excellent antitumor activity in a variety of tumor models. HG030 is intended for the treatment of patients with locally advanced or metastatic solid tumors harboring NTRK and ROS1 fusion genes. HitGen will advance the clinical research of HG030 according to the regulatory requirements and processes, and expect to bring a new treatment option for cancer patients in near future. HG030 is HitGen’s second IND programme won approval from NMPA.

WARNING: the research and development process of pharmaceutical products involve major financial investment, long period of time, significant risks and many uncertainties. IND approval is an important but only the first step of a long process of clinical development which has no guaranteed success. HitGen will actively  prepare the clinical development work for HG030 in compliance with the relevant regulations, and make timely update on the progress of the programme.

HitGen is a rapidly growing biotech company with headquarters based in Chengdu, China, with a subsidiary in the USA. HitGen has established an industry-leading platform for early-stage drug discovery research centred on DNA encoded chemical libraries (DELs). HitGen’s DELs include encoded syntheses for hundreds of billions of novel, diverse, drug-like small molecule and macrocycle compounds. These compounds are members of DELs synthesised from many hundreds of distinct chemical scaffolds, designed and assembled with tractable chemistry based on proven results for identifying drug-like leads against biological targets from known and novel classes. HitGen is working with multiple pharmaceutical and biotech companies, foundations and research institutes in North America, Europe and Asia to discover and develop novel therapeutics of the future.

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