WuXi STA and Antengene partner under MAH scheme
According to the terms, Chinese contract development and manufacturing organisation (CDMO) STA Pharmaceutical (WuXi STA) – a subsidiary of WuXi AppTec – will provide process R&D and manufacturing services for Antengene’s oncology drugs.
The collaboration will focus on Antengene’s Phase II/III mTOR inhibitor candidate ATG-008, designed for the treatment of hepatitis B virus positive advanced hepatocellular carcinoma (HCC) patients, and extend to commercial-stage assets.
Antengene’s pipeline focuses on relapsed/refractory multiple myeloma, lymphomas and solid tumours, as well as colorectal and prostate cancers. Early-phase ATG-527 is being explored for anti-viral indications such as influenza, RSV (respiratory syncytial virus infection), and EB (Epstein Barr) viral-related diseases.
The partnership marks the first time the companies have collaborated, and will target Chinese and Asia-Pacific regions, a WuXi STA spokesperson told us.
According to Antengene CEO Jay Mei, “WuXi STA’s end-to-end CMC [chemistry, manufacturing, and controls] platform enables us to focus on our research and development, and to move our drug candidates from clinical-stage to commercialisation more efficiently. We look forward to a much broader collaboration in the near future.”
The agreement follows on from China’s 2016 Marketing Authorisation Holder (MAH) pilot programme, which enables good manufacturing practice (GMP)-compliant third party manufacturers, in some provinces, to make pharmaceutical drug products for customers.
Last month, China approved its first CMO-made new drug since the implementation of the MAH scheme – Ascletis’ viral hepatitis C treatment Ganovo – which had been made by WuXi STA.