HitGen Licenses Its Trk/ROS1 Inhibitor HG030 to Baiyunshan for Development and Commercialisation in China

CHENGDU, China--(BUSINESS WIRE)--HitGen Inc. (HitGen, 688222.SH) announces it has entered into a collaboration and licensing agreement with Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd (Baiyunshan, 600332.SH/00874.HK) to develop and commercialise its HG030 programme in mainland China. Baiyunshan is a publically listed company in Shanghai and Hong Kong engaged in the pharmaceutical and healthcare industry. HG030 is a novel inhibitor for Trk/ROS1 discovered by HitGen, which received IND approval from China’s National Medical Products Administration (NMPA) in March 2020, and is entering Phase I clinical trial in China for patients with NTRK/ ROS1 gene fusion-positive cancers.

Under the terms of the agreement, Baiyunshan will receive exclusive rights for the development and commercialisation of HG030 in the mainland China, and will pay HitGen an upfront licensing fee of RMB 38M, followed by a series of milestones and royalty of sales as the product progresses through clinical trials and product launches in the mainland China. HitGen retains all rights of the product in all territories outside the mainland China.

HG030 is a second-generation small molecule Trk inhibitor designed to treat patients with NTRK gene fusion-positive cancers, regardless of cancer type. Most patients with NTRK-rearranged advanced cancer are sensitive to tyrosine kinase inhibitor (TKI) therapy. These TKIs have dramatically improved outcomes for patients with advanced Trk-positive cancer, yet these cancers remain incurable. Resistance invariably develops, such as acquired mutations G595R and G667C. HG030 is a novel, highly potent, selective, second-generation Trk inhibitor with clear activities in preclinical models against most known resistance mutations in patients with advanced Trk-positive cancer. Therefore, HG030 might be an effective therapeutic strategy for patients with Trk-positive advanced cancer who were naive or had become resistant to currently available TKIs.

“We are very pleased to enter this licensing agreement with Baiyunshan. Over the past few years, HitGen has been developing an innovative drug discovery technology platform centred on DNA-encoded libraries (DELs), and has entered into a number of research collaborations with leading pharmaceutical and biotechnology companies worldwide utilising this technology. In addition to the development and applications of DELs technology, we have also been applying our discovery research capabilities to build a portfolio of innovative drug discovery projects for collaboration and licensing. HG030 is the first out-licensing result of such an effort. This collaboration and licensing demonstrates HitGen’s capability in progressing discovery projects from target nomination to early clinical trials, as well as the quality of the programme. We hope our effort of this type will contribute to the discovery and development of innovative medicines for patients. With their tremendous clinical development, manufacturing and commercialisation capabilities and track record, I look forward to seeing further progress of HG030 in clinical development and ultimate successful product launch by Baiyunshan”, said Dr Jin Li, Chairman and CEO of HitGen Inc.

About HitGen Inc.

HitGen is a rapidly growing biotech company with headquarters in Chengdu, China, and 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 synthesized 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, Australia and Asia to discover and develop novel therapeutics of the future.

About Guangzhou Baiyunshan Pharmaceutical Co., Ltd

Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (600332.SH/00874.HK) is engaged in the pharmaceutical and healthcare industry. The Company's segments are Great Southern TCM, Great Commerce, Great Health and Great Medical Care. The Company's Great South TCM includes research, development, manufacturing and sales for Chinese and western medicine, chemical raw medicine, natural drug, biological medicine and intermediates of chemical raw medicine. The Company's Great Health segment includes research, development, manufacturing and sales for the products of Great Health. The Company's Great Commerce segment includes wholesale, retail, import and export for western medicine, Chinese medicine and medical apparatus and instruments. The Company has an antibiotic production chain ranging from raw material medicine to preparation, with products covering commonly used antibiotics. It is engaged in the research and development (R&D), and manufacturing of beverage and food, among others.

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