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.

For more information, please call:

+86-28-85197385

Or visit:

www.hitgen.com

For business development: [email protected]
For investor inquiries: [email protected]
For media inquiries: [email protected]

Disclaimer

This press release has been prepared by HitGen Inc. (the �Company�). The information contained in this press release is intended for information purpose only and does not take your investment objectives, financial status, and special needs into consideration. This press release does not constitute legal, regulatory, accounting tax or investment advice to you, or any form of financial opinion or recommendation by the Company or any other party at any time. We recommend that you seek independent third party legal, regulatory, accounting, tax, investment and/or financial advice regarding the contents of this press.

This press release does not contain all relevant information relating to the Company or its securities, particularly with respect to the risks and special considerations involved with an investment in the securities of the Company. All relevant information relating to the Company should be subject to the information disclosed publicly by the Company. No securities of the Company may be sold in China without registration with China Securities Regulatory Commission (the �CSRC�) or an exemption from such registration. Any public offer of securities would be made pursuant to an effective registration statement and prospectus prepared by the Company that would contain material information not contained herein. Any offering of the securities of the Company to be made in China will be made solely on the basis of the information contained in the statutory prospectus included in a registration statement to be filed by the Company with the CSRC. If you invest in any securities of the Company, you should read such statutory prospectus and other documents that the Company may file with the CSRC.

In this press release, may be cited statistics from the history of public release of the data or information. The information herein is preliminary and subject to change and its accuracy is not guaranteed. The information included herein was obtained from various sources, including certain third parties, and has not been independently verified. No repress, warranty or undertaking, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness, timeliness, appropriateness or correctness of the information contained herein. None of the Company or any of its affiliates, shareholders, directors, employees, agents, advisors or representatives will be liable for any loss howsoever arising from any use of this press release or its contents or otherwise arising in connection with this press release or its contents (including but not limited to negligent repress or omission).

Contacts

Business Development

[email protected]