Chime Biologics, a contract development and manufacturing organization (CDMO), recently received its commercial manufacturing license from China’s National Medical Products Administration (NMPA).

After 18 months of an intensive product development and manufacturing collaboration with LEPU Biopharma, Chime Biologics passed pre-approval inspection (PAI) including on-site inspection and GMP compliance inspection. The company was recognized for its technical expertise for late stage biologics development, and also on data integrity and GMP compliance in manufacturing and its quality management system.

Under the partnership, LEPU Biopharma announced its first innovative biological drug, anti-PD-1 monoclonal antibody – Puyouheng  (pucotenlimab injection), has been conditionally approved for marketing by NMPA. The drug is approved for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors.

Chime Biologics serves as a long-term partner to biopharmaceutical clients with sound solutions for manufacturing and more recently moved into late stage and commercial manufacturing. Chime Biologics can support clients on every stage of biologics CMC work portfolio—CLD to commercial manufacturing.

“We are pleased to see the approval of the first indication of pucotenlimab in China, which is also the first marketed product of LEPU Biopharma and officially kicked off the commercialization of our company,” said Mary Hu, co-general manager of LEPU Biopharma. “During the process of collaborating with Chime Biologics, we recognize its world-class expertise in CMC development and manufacturing, as well as the ability to deliver projects in a timely manner. We appreciate the efforts of Chime Biologics, and look forward to the subsequent commercialization of the product to provide more options for oncology patients worldwide and improve their quality of life.”

John Zeng, CEO of Chime Biologics, said, “We are honored to work with LEPU Biopharma to move pucotenlimab from clinical phase II scale-up manufacturing to BLA approval on the Chime Biologics CMC platform. This also marks the official entry of Chime Biologics into the era of commercial production service. Chime Biologics will work with Lepu side by side to provide alternative medical solutions to cancer patients in China and the rest of the world. Chime Biologics also has a robust pipeline of late-stage customers and we are committed to bringing those biological products to the market as soon as possible.”