#China #Hangzhou #CDMO #Altruist Biologics

Altruist Biologics Secures First GMP Manufacturing License in China

In a significant development for biomanufacturing in China, Altruist Biologics, a subsidiary of Innovent Biologics, has announced that its facility in Hangzhou has been awarded a Drug Product Manufacturing License (C Certificate) by the Chinese National Medical Products Administration (NMPA). This momentous achievement marks the facility as the first 20,000-liter scale biologics manufacturing site in China to receive such certification.

The transition from facility qualification to obtaining this license took only two months, showcasing Altruist's commitment to maintaining exemplary technical standards and a robust quality management system that aligns with international regulatory requirements. The facility’s successful licensure highlights its ability to uphold rigorous standards for drug production quality management.

Dr. Kaisong Zhou, the Chairman and CEO of Altruist Biologics, expressed his satisfaction with this milestone, stating, "We’re pleased that our Hangzhou facility successfully achieved the C Certificate for biologics commercial manufacturing. This represents another remarkable milestone in our efforts to establish premier-quality operations and fully integrated services to support our clients’ commercialization goals. We look forward to supporting the development and manufacture of more life-saving treatments for our global clients to benefit patients worldwide."

Altruist Biologics has established itself as one of China’s leading contract development and manufacturing organizations (CDMOs) specializing in commercial-scale manufacturing. The company has a proven track record, having supported the successful commercialization of eight products, with several gaining regulatory approvals across the United States, Europe, and China. Notably, Altruist has successfully navigated 30 regulatory inspections, including assessments by the FDA and EMA, and has undergone numerous GMP quality audits by global clients.

The Hangzhou facility began partial operations in 2024, which included the commissioning of four 20,000-liter stainless steel bioreactors—the largest of their kind in the country. The facility is designed to accommodate a total capacity of 172,000 liters upon full completion. Furthermore, it contains a dedicated facility for the manufacture of antibody-drug conjugates (ADCs) and antibody-extracellular vesicles (AXCs), targeted at producing various bioconjugates for both clinical and commercial use.

As Altruist Biologics continues to expand, the company is focused on enhancing its manufacturing capabilities and quality systems. This approach ensures that it remains responsive to anticipated market demands and can deliver flexible and economical services that aid clients in overcoming manufacturing challenges. Altruist aims to expedite the delivery of therapeutic solutions to patients worldwide, reinforcing its commitment to advancing biopharmaceutical development.

For more detailed information about Altruist Biologics’ comprehensive service offerings, visit www.altruistbio.com.

About Altruist Biologics

Altruist Biologics is a reliable contract development and manufacturing organization (CDMO) that is entirely owned by Innovent Biologics. It focuses on the development and manufacturing of biopharmaceuticals, including antibodies, fusion proteins, and antibody-drug conjugates. The company offers a wide array of services ranging from cell line development to aseptic fill-finish. Altruist is dedicated to collaborating with clients to create cost-effective and high-quality biopharmaceuticals for patients around the world. With CGMP-compliant facilities located in China, Altruist has a total capacity of 60,000 liters at its Suzhou site and has recently commenced operations with four 20,000-liter bioreactors at its Hangzhou facility, reinforcing its status as a pivotal player in the global biopharmaceutical industry.

Follow them for updates as they continue their mission of providing comprehensive support for life-saving therapeutic technologies.