STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, will use the Marketing Authorization Holder (MAH) scheme to advance Beta Pharma’s late phase and commercial targets.
The MAH scheme, first piloted in 2017, enables drug license holders to use a third party manufacturer instead of building GMP manufacturing capabilities in-house, as was previously required in China.
Headquartered in Princeton, NJ, Beta Pharma is a biotech company focusing on oncology drug discovery and development.
Under the terms of the collaboration, the contract development and manufacturing organization (CDMO) WuXi STA will become the preferred partner for Beta Pharma, which in February 2019 launched a Phase II clinical trial in China for the target BPI-7711.
According to the company, BPI-7711 is a third generation of EGFR TKI and aims to treat mutation positive non-small cell lung cancer.
Beta Pharma also is in the preclinical research phase with another target, BPI-1178, for the treatment of metastatic breast cancer. It expects to submit a clinical application in the first quarter of 2019.