Alumni News | Pregene Licenses Rights to PRG1801 CAR-T Cell Drugs in India to Dr. Reddy’s Laboratories, a leading Indian pharmaceutical company

*Pregene Biotech announces licensing agreement with leading Indian multinational pharmaceutical, Dr. Reddy’s

Shenzhen Pregene Biotechnology Co. Ltd. (Pregene) announced that it has entered into a licensing agreement with the Indian multinational pharmaceutical company Dr. Reddy's Laboratories (Dr. Reddy’s). Dr. Reddy will obtain the exclusive rights and interests to the nanobody-based chimeric antigen receptor T (CAR-T) cell injection product developed by Pregene and will be responsible for its clinical development and commercialization of the product in India. Pregene will retain its exclusive right to supply the core APIs for viral vector production in India.

*License agreement

Under the terms of the agreement, Pregene will receive an upfront payment of US$5 million for the development and commercialization of the product for its primary disease indication. Pregene will also receive subsequent contingent milestone payments of no more than US$7.5 million for other associated indications, along with no more than US$150 million in royalties on commercial sales. In addition, Pregene will continue to exclusively supply the core APIs to Dr. Reddy for virus vector production for an undisclosed fee.

PRG1801 is a globally patented, targeted BCMA CAR-T cell injection independently developed by Pregene. Of great significance is the fact that having completed a course of clinical treatment on 34 patients with relapsed and refractory multiple myeloma in China, the medication has proven to be highly efficacious with adequate safety. The medication was also green-lit and approved by the National Medical Products Administration in 2020 for further phase 1 clinical trials, which has since commenced.

This licensing arrangement marks its third in quick succession over the past few months by Pregene with a large pharmaceutical company, after similar agreements were entered into with Simcere Pharmaceutical Group (2096.HK) and South Korea's Biocast. It marks another important milestone for the global commercialization of Pregene’s core products. These agreements, along with the subsequent collaboration with renowned global pharmaceutical companies, highlights Pregene’s being constantly innovative, striving for R&D excellence and adopting a flexible mindset towards commercialization of its products.

Pregene Biotechnology Co. Ltd.

Shenzhen Pregene Biotechnology Co. Ltd. is positioned as a leader in cell and gene therapy drugs with core technologies being developed for commercialization in the near future. Company shareholders include the National Small and Medium Enterprise Development Fund, Guokejiahe (国科嘉和) Fund, Haier Medical, Winbond Health, Hunan Health and Elderly Industry Investment Fund, etc. The company’s core team has extensive commercialization experience, along with deep R&D expertise backed by years of academic and practical excellence.

Pregene participated in the drafting of the "CAR-T Cell Quality Control Testing Research and Non-clinical Evaluation Considerations" initiative, issued by China’s National Inspection Institute in June 2018, and has since also participated in the revision of relevant regulations as a member of an expert panel. The company's product pipeline includes CAR-T, TCR-T, CAR-NK, stem cell drugs, etc. Disease indications cover multiple therapeutic areas such as hematological tumors, solid tumors, and orthopedics.

Pregene stands as a leading drug company driven by innovation, with an extensive pipeline of immune and stem cell drug that will likely cover a wide range of market needs. As its forward mission, Pregene looks to strengthen its advanced core R&D, apply for multiple global patents that will secure its development of several high-value novel drugs and look to extend its edge in this highly competitive industry.

Bio Innovators Academy was officially established in 2017 by Bioclub, in collaboration with BGI, Lepu Medical, AstraZeneca, Tigermed and a dozen other listed companies, medical institutions, and industry associations in the healthtech sector. Professor Zhu Xun serves as the current honorary Chair. Current board members of the academy comprise of eminent healthtech sector academicians, entrepreneurs and clinical experts, including: Li Xiaokun, Zhou Caicun, Cai Jiangnan, He Ruyi, Yu Rong, Yu Guoliang, Cao Xiaochun, Wang Jian, Wang Lei, Pu Zhongjie and Wang Donghui. Bio Innovators Academy provides healthtech sector C-suite executives with entrepreneurial training that combines theoretical value with industry-wide application, in addition to resource integration, sector empowerment and investment and financing services. Bio Innovators Academy aims to be the leading platform for entrepreneurs in the healthtech sector.