STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, and Antengene Corp., have entered a strategic partnership for the CMC development and manufacturing of innovative oncology drugs. WuXi STA will provide in process R&D and manufacturing services using the MAH scheme to help accelerate new drug development.
 
Antengene is focused on the development of new drugs in China and the Asia-Pacific region through internal R&D as well as external partnerships. The company’s pipeline includes several clinical-stage drug candidates covering therapeutic areas from solid tumors, hematologic malignancies to viral infections. WuXi STA was chosen as the strategic partner to leverage its CMC platform for new drug development from preclinical to commercial, for both API and finished dosage forms.
 
The collaboration will include both clinical stage and commercial projects, starting with Phase II/III candidate ATG-008 and then further expand into three dominant areas of solid tumor, hematological tumor and viral infection. Antengene and WuXi STA will also explore expanding the collaboration to commercial stage assets as Antengene prepares for the commercialization of its late-stage candidates.
 
ATG-008 is currently in multi-regional clinical trial (MRCT) for the treatment of hepatitis B virus positive (HBV+) advanced hepatocellular carcinoma (HCC) patients (TORCH study).
 
“We’re delighted to partner with such a well-respected, world-class CDMO as WuXi STA,” said Dr. Jay Mei, founder and chief executive officer of Antengene, “WuXi STA’s end-to-end CMC platform enables us to focus on our research and development, and to move our drug candidates from clinical-stage to commercialization more efficiently. We look forward to a much broader collaboration in the near future.”
 
Dr. Minzhang Chen, chief executive officer of 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 Antengene and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.”