On July 19, TOT BIOPHARM (1875.HK) and BrightGene (688166.SH) jointly announced that the two companies will develop a strategic collaboration for Antibody-Drug Conjugates (ADC) CDMO services to facilitate the development and commercialization of innovative drugs.

According to the agreement, the two copmanies will jointly provide customers with pre-process development, intermediate scale-up and GMP manufacturing services of ADC. Based on the advantages of both parties, TOT BIOPHARM will focus on the manufacturing of monoclonal antibody and CMC process development, conjugates, and formulation filling of ADC, and provide GMP-compliant manufacturing services for pre-clinical studies, clinical studies and commercial scale; BrightGene can develop and provide intermediates such as linker and payload based on customer needs.

Both TOT BIOPHARM and BrightGene are located in Suzhou Industrial Park. The cooperation between two listed companies in the region realizes a seamless connection of the industrial chain, avoiding the risk caused by cross-regional regulation, as well as supporting association between strong enterprises through taking advantage of each other's technologies and resources. This strategic cooperation further upgrades and expands the ADC CDMO service platform, providing a “turnkey” one-stop solution for a wide array of innovative pharmaceutical companies, reducing R&D risks and improving commercialization efficiency.

Dr. Jun Liu, CEO of TOT BIOPHARM, said,

As a trailblazer of original new drugs and high-end generics in the domestic pharmaceutical industry, BrightGene has successfully developed a number of high-end generic products. We are pleased to enter into a strategic partnership with BrightGene. TOT BIOPHARM has a mature ADC R&D technology platform, professional team and rich experience in successful cases, we believe that this strategic agreement will further strengthen the CDMO service capability of TOT BIOPHARM and enable more and better innovative drugs to be successfully put into market and benefit patients finally.

Dr. Jiandong Yuan, Chairman of BrightGene, said,

TOT BIOPHARM is one of the earliest domestic enterprises engaged in ADC drugs, which has ADC drugs entering phase III clinical phase already. In addition to rich experience in development and manufacture of ADC drugs, it also has sound manufacture facilities and quality system to ensure compliance. BrightGene has provided linker and payload to TOT BIOPHARM at the early stage of its ADC drug development, and registered the drug master file (DMF). BrightGene has extensive experience in the development and global registration of complex small molecules, based on which it has developed a series of linkers and payloads for ADC. By drawing on each other’s strengths, TOT BIOPHARM and BrightGene can join hands to be the best partner for enterprises engaged in domestic ADC development, especially for those aspiring to reach global market in this regard.