On April 25, 2023, TOT BIOPHARM (1875.HK) and Shanghai Escugen BiotechnologyCo., Ltd. ("Escugen Biotechnology  ") achieved an in-depth strategic collaboration for the development and production of antibody-drug conjugate (ADC) from late clinical stage to commercialization.

According to this cooperation agreement, TOT BIOPHARM will provide full support to Escugen Biotechnology in the production of key clinical batches, process characterization and validation (PC/PV), new drug application and commercialization of ADC projects in China/US/Europe with its extensive experience in the whole value chain of drug development, the commercial advantage of integrating ADC antibody, drug substance and formulation in one location, and the quality system validated by regulatory units. Both parties have entered into a long-term strategic cooperation and will fully utilize their respective advantages and resources to achieve win-win cooperation in the ADC field.

Dr. Jun Liu, CEO of TOT BIOPHARM, said:
"We are very pleased to enter into a strategic collaboration with Escugen Biotechnology to jointly drive the development and commercialization of ADC drugs. Escugen Biotechnology is a global Best/First-in-Class company with a pipeline of products that have both druggability and market potential. TOT BIOPHARM has been engaged in ADC drug development for more than 10 years and has rich experience in ADC development and production; as one of the few companies that have commercial production lines integrating   antibody intermediate, ADC DS and ADC DP, and also one of the leading CDMO service companies in the world that have complete ADC industry line, it has a capacity of 20,000 liters of antibody, several 500 liters of ADC drug substance and 50,000 pcs of formulation per batch. With a proven quality system, it may effectively support the development and large-scale commercialization of Escugen Biotechnology's new drugs. With our one-stop service advantage, we look forward to serving more ADC drug development companies to accelerate drug development and production, and fulfill the unmet clinical needs for the benefit of patients.”

Dr. Qing Zhou, founder and CEO of Escugen Biotechnology, said:
"ADC drugs have become an industry hotspot, and our product pipeline has entered the late clinical stage. In the ADC field, TOT BIOPHARM is one of the few CDMO companies that can meet the requirement of one-site production from antibody to ADC drug substance and formulation. In addition, TOT BIOPHARM has a complete ADC analysis technology platform and can perform independent analysis for key quality attributes. It is believed that this in-depth strategic cooperation will provide production guarantee for Escugen Biotechnology. With the help of strategic CDMO partners, Escugen Biotechnology will continue to focus on innovative new ADC drug development with unmet clinical needs as the guide. Through integrating antibody and ADC platform technology innovation, target innovation and clinical development pathway differentiation, Escugen Biotechnology will continue to create innovative ADC products for the benefit of patients worldwide.