Production & Manufacturing
Manufacturing

WuXi STA, Antengene sign drug development and manufacturing deal

Published 20 July 2018

STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, and Antengene have entered into a partnership for the CMC development and manufacturing of innovative oncology drugs.

Under the terms of the collaboration, WuXi STA will provide Antengene an integrated solution in process R&D and manufacturing, using the MAH scheme to accelerate new drug development.

Antengene is a biopharmaceutical company focused on the development of new drugs in China and the Asia-Pacific region.

Through both internal research & development as well as external partnership, Antengene strives to bring cutting-edge innovative therapies to patients. 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 thanks to its industry leading "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.

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 such as solid tumor, hematological tumor and viral infection.

WuXi STA will provide process R&D and manufacturing from APIs to drug product. Beyond that, Antengene and WuXi STA will also explore expanding the collaboration to commercial stage assets as Antengene prepares for the commercialization of its late-stage pipeline agents.

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). Patient enrollment started in July 2018.

Antengene founder and CEO Jay Mei said: "We're delighted to partner with such a well-respected, world-class CDMO as WuXi STA.

"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."

WuXi STA CEO Minzhang Chen 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."

Source: Company Press Release