WuXi STA Forms Strategic Partnership with BioNova

(2023年)

STA Pharmaceutical Co., Ltd., a WuXi AppTec Company (WuXi STA)–and BioNova Pharmaceuticals (Shanghai) Ltd. ("BioNova") recently announced the signing of a collaboration agreement to jointly accelerate the development and manufacture processes for BioNova's innovative oncology medicines. Ye Hua, M.D. MPH, Founder, Chairman & CEO of BioNova, Steve Yang, Ph.D., Co-CEO of WuXi AppTec and Xiaoyong Fu, Ph.D., WuXi Chemistry CTO (Chief Technical Officer), and Head of API business attended the signing ceremony.

BioNova is a fast-growing biopharmaceutical company that is committed to developing and commercializing innovative medicines for cancer and other life-threatening diseases. The company pipeline is built on internal R&D programs, collaborations with, and acquisitions from partners of cutting-edge technology. BN101 (KD025) is one asset, originated by Kadmon Holdings (NYSE: KDMN) for which the two companies entered into a strategic partnership in 2019 to develop and commercialize for graft-versus-host disease (GVHD) in China. Currently, BioNova is conducting a Phase 2 BN101 clinical trial in China.

This strategic partnership between BioNova and WuXi STA is to broaden the collaboration beyond BN101. According to the agreement, WuXi STA will become the preferred CDMO partner and provide BioNova with integrated CMC services to accelerate its present and future drug candidates (small molecule, peptide, oligonucleotide and complex chemical conjugate, etc.), from drug substances to drug products, including but not limited to the process development, manufacturing, analytical and regulatory filing support.

Risk assessment, partner selection, and reliable and efficient CMC work are the key factors to the success of these in-licensing programs. With industry-leading capabilities and expertise, WuXi STA, through many years of successful experience in the in-licensing programs, has unique quality and technical advantages. WuXi STA's platform will enable BioNova to accelerate new drug innovation as well as localization for licensed-in products towards commercialization.

"We are delighted to establish this strategic collaboration with WuXi STA. As a leading CDMO company, WuXi STA is well known for its world-class scientific and technical strengths and expertise in the industry. With the support of industrial leading end-to-end service from WuXi STA, we look forward to expeditiously driving our development stage innovative drugs towards the clinic to fill the gap of unmet medical needs worldwide." said Ye Hua, M.D., Founder, Chairman & CEO of BioNova.

"It's an honor to become a strategic partner of BioNova. This collaboration once again demonstrates that our integrated CMC platform is highly trusted by the customers. We are looking forward to accelerating BioNova's innovative drug development and ultimately benefit global patients." said Dr. Minzhang Chen, Co-CEO of WuXi AppTec.