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STA will accelerate process R&D and manufacturing of late phase and commercial targets
March 21, 2019
By: Tim Wright
Editor-in-Chief, Contract Pharma
STA Pharmaceutical, a subsidiary of WuXi AppTec, and Beta Pharma, a biotech company focusing on innovative drug discovery and development in oncology, have formed a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred contract development and manufacturing organization (CDMO) partner of Beta Pharma, leveraging its platform to accelerate process R&D and manufacturing of later phase and commercial production, utilizing the Marketing Authorization Holder (MAH) scheme. Beta Pharma is an emerging specialty pharmaceutical company dedicated to the discovery, development, and commercialization of innovative late stage therapies targeting oncology. The company has a pedigree spanning some 20 years and its founder and chief executive officer, Xiaodong Zhang, even participated in the molecular invention, development and listing in China of the first small molecule targeted anticancer drug, Icotinib. Today, Beta Pharma continues to expand its pipeline to integrate anticancer drugs and therapies, such as biopharmaceuticals, into its long-term development planning. In February 2019, Beta Pharma officially launched the China registered Phase II clinical trial for the target BPI-7711, a third generation of EGFR TKI that has a highly selective inhibitory effect on T790M mutations and EGFR single mutant tumors after a generation of EGFR TKI resistance. The company also has another target, BPI-1178 undergoing preclinical research and it is expected to submit a clinical application in the first quarter of 2019. WuXi STA was chosen as the strategic partner due to its “end-to-end” CMC platform for new drug development from preclinical to commercial—for both API and finished dosage forms—as well as its expertise and track record for meeting global quality standards. “We’re delighted to partner with such a well-respected, world-class CDMO such as WuXi STA,” said Beta Pharma’s Dr. Zhang. “WuXi STA’s enabling end-to-end CMC platform and efficient, flexible solutions that meet the timeliness of our clinical and commercial use, will enable us to advance our pipeline more quickly worldwide.” Minzhang Chen, chief executive officer, WuXi STA, said, “Our mission is to empower and accelerate customers to develop innovative drugs from clinical to commercial—faster and more efficiently. We are delighted to become the strategic partner of Beta Pharma and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.
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