- GMP commercial manufacturing license authorized by the National Drug Regulatory Authority, demonstrating Chime Biologics' capabilities in large scale commercial production
- Only 18 months to help LEPU Biopharma to obtain the approval of Puyouheng ™ in a new drug application demonstrating "Chime Biologics Unprecedented Speed"
Wuhan /PRNewswire/ - On August 2, 2022 (Beijing time), Chime Biologics, a leading CDMO that enables its partners' success in biologics, announced that it has received the commercial manufacturing license from the National Medical Products Administration (NMPA), which represents Chime Biologics has achieved another remarkable milestone by having established sound quality operations on commercial scale.
After 18 months of intensive product development and manufacturing collaboration with publicly listed LEPU Biopharma (2157.HK), Chime Biologics successfully passed pre-approval inspection (PAI) including on-site inspection and GMP compliance inspection, which proved that Chime Biologics has been highly recognized not only on technical expertise for late stage biologics development, but also on data integrity and GMP compliance in the manufacturing and 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 the clients on every stage of biologics CMC work portfolio (CLD to commercial manufacturing) and with unprecedented speed.
Dr. Mary Hu, Co-General Manager of LEPU Biopharma, said, "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. 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."
Dr. John Zeng, Chief Executive Officer 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."
About LEPU BIOPHARMA (2157.HK)
LEPU BIOPHARMA is committed to innovation, focusing on the discovery, development and commercialization of first-in-class and best-in-class drug candidates in targeted anti-tumor therapy and immunotherapy drugs in China and the US. The company's mission is to develop the safest, most effective, and most accessible drugs for patients to improve their quality of life and fill the huge demand gap in the medical system. The company attaches great importance to the continuous construction of its commercialization capabilities, and strives to achieve a strong transformation from core technologies to finished drugs as well as the goal of industrialization. At present, the product pipeline of LEPU BIOPHARMA covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including 1 commercially marketing drug and 7 drug candidates at the clinical stage (5 of which are ADC drugs) and the combination therapies of multiple major drug candidates at the clinical stage. The company houses the leading ADC drug candidate pipeline in China.
About CHIME BIOLOGICS
Chime Biologics is a leading CDMO with the world's first modular biopharmaceutical factory, KuBio. It empowers the entire biologics processes - from cell line development to commercial manufacturing. Chime Biologics provides one-stop CMC solutions to worldwide biomedical customers, relying on cell line development and advanced technology development from its Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan campus. We share a common goal to make cutting-edge biologics affordable and accessible to all patients globally, fulfilling its commitment to human health.