年表作成・共有サービス - pastport

SHANGHAI, CHINA, WuXi STA – a subsidiary of WuXi AppTec– and Xynomic Pharmaceuticals (Nanjing) Co., Ltd. (“Xynomic”) announced the signing of a strategic partnership agreement.

According to the agreement, WuXi STA becomes the preferred CDMO partner providing Xynomic integrated CMC services to accelerate its present and future drug candidates (small molecule, peptide, oligonucleotide and complex chemical conjugate, etc.), from API to drug product, including but not limited to the process development, manufacturing, analytical and regulatory filing support.

Xynomic Pharmaceuticals (Nanjing) Co., Ltd. is a global biopharmaceutical company that is committed to developing and commercializing innovative medicines for oncology. Their pipeline is built on both internal R&D and license-in programs, including three clinical-stage and two preclinical-stage small-molecule drug candidates. Xynomic owns global exclusive right for development and manufacturing of their entire pipeline. The lead drug candidate abexinostat has successfully completed the dosing of the first-phase patients in its on-going China phase 2 clinical trial, as a third-line therapy against relapsed or refractory follicular lymphoma. The preliminary data shows excellent result and now the team is preparing NDA filing documents to China NMPA. The collaboration with WuXi STA will speed up the global commercialization of Xynomic.

Currently, WuXi STA is the CDMO partner of Xynomic for the API and tablet R&D, manufacturing and packaging of abexinostat. With the agreement signed, WuXi STA will further support the New Drug Application (NDA) filing in both the US and China and global commercial manufacturing for this product. The signing of this strategic partnership agreement proved the enhanced collaboration between the two companies.

Deeply involved in the CDMO industry for twenty years, WuXi STA has established an integrated CMC platform with global standard quality systems. It has supported 33 new drugs approved globally and products manufactured by WuXi STA have been launched in 105 countries around the world. With industry-leading capabilities and expertise, WuXi STA has the quality and technical advantages through many years of successful experience in the in-licensing programs, which will accelerate technical transfer, global NDA approval and commercial manufacturing.

Mr. Y. Mark Xu, Chairman and CEO of Xynomic, commented, “We are delighted to form a comprehensive strategic cooperation with WuXi STA. Xynomic is currently simultaneously advancing multiple new drugs, and we are very happy to expand the collaboration scope with WuXi STA at such an important stage. WuXi STA has world-class scientific and technical strengths and industry leading capability and capacity, and I believe that this strong alliance will further accelerate the development of our innovative drugs, especially abexinostat, to benefit patients around the world.”

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “We are pleased to enhance our partnership with Xynomic for all the drug candidates in its pipeline, which once again demonstrates how WuXi STA’s end-to-end CMC platform empowered our partner. We look forward to leveraging our proven integrated CMC platform, along with our global standard quality systems, to accelerate the development and commercialization of Xynomic’s pipeline drugs for the benefit of global patients.”

1. Formulation development#