On May 19, 2023, TOT BIOPHARM (stock code: 1875.HK) announced a strategic cooperation was established with BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as BioRay). Dr. Haibin Wang, CEO of BioRay, and Dr. Jun Liu, CEO of TOT BIOPHARM attended the signing ceremony. With a one-stop, end-to-end CDMO service platform, TOT BIOPHARM will provide comprehensive support to BioRay for its multiple R&D projects, helping BioRay to develop antibody-drug conjugate (ADC) pipeline from R&D to IND, and future clinical approval and commercial production.

According to the agreement, TOT BIOPHARM will provide one-stop CDMO services for multiple ADC development projects as CDMO partner, covering ADC drug development, process development, analytical method development, conjugated drug development, as well as clinical and commercial production.

Dr. Haibin Wang, CEO of BioRay, said:“We are very glad to enter into a strategic collaboration with TOT BIOPHARM. Focusing on the two therapeutic areas of autoimmunity and tumor immunity, Bioray has built a comprehensive and in-depth innovation pipeline and is committed to providing an entire and diverse product portfolio. This strategic collaboration with TOT BIOPHARM will further leverage the synergies between the two companies in the field of antibody drug conjugates. The one-stop ADC development platform of TOT BIOPHARM will not only reduce the risk of resource crossover and regulatory risks associated with segmented manufacturing, accelerate the launch of ADC drugs, but will also help Bioray to build multiple immune pipelines in a comprehensive manner, thus avoiding homogeneous competition and bringing benefit to more patients.”

Dr. Jun Liu, CEO of TOT BIOPHARM, said:"We are very glad to establish strategic collaboration with Bioray, a first-class innovative drug company. Bioray is an innovative biopharmaceutical company focusing on autoimmunity and oncology, with expertise and innovation in all aspects of R&D. It has launched multiple drugs and pipelines under development which are also highly anticipated by the industry. TOT BIOPHARM is one of the few companies that have several complete commercial production lines of antibodies and ADC, and also one of the leading one-stop ADC CDMO service companies in the world that integrates antibody intermediate, ADC DS and ADC DP. On the other hand, TOT BIOPHARM has accumulated comprehensive experience in drug process development, clinical research, product launch and commercialization over more than 10 years’ development, and currently has two drugs in commercial production in our Suzhou plant. The quality system is continuously regulated by national regulations and passed the EU QP audit with zero defects last year. These may increase the quality and speed of several ADC drug development projects by Bioray. In the future, both parties will work together to deepen the cooperation from R&D, to clinical and commercial production of ADC drugs to promote the rapid development of the ADC industry.”