The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters.
Innovent Biologics’ contract manufacturing business has secured a license for a production plant in China with four 20,000-liter-scale bioreactors.
The Hangzhou facility is the first 20,000-liter biologics production plant in China to gain a license to make drug products, Altruist Biologics, Innovent’s contract development and manufacturing organization (CDMO), said in a press release on Wednesday. China’s National Medical Products Administration (NMPA) granted the license after assessing the Hangzhou site’s compliance with good manufacturing practices (GMPs).
The assessment confirmed that the plant’s quality systems, GMP facilities and technologies meet the NMPA’s requirements for drug production quality management, according to Altruist. The company received the license two months after qualifying the facility.
Work on the Hangzhou site is continuing, with Altruist aiming to raise the facility’s capacity to 172,000 liters. The plan is a significant expansion of the company’s manufacturing footprint, which includes a 60,000-liter plant in Suzhou, a city west of Shanghai.
Across the plants, Altruist is establishing the capacity to develop modalities including antibodies, fusion proteins and antibody-drug conjugates (ADCs), and to make molecules for clinical and commercial supply. A standalone bioconjugation facility for ADCs, a focus modality for rival Chinese CDMO WuXi Biologics, is part of the plan for Hangzhou.
Altruist has invested in areas from cell line development to aseptic fill-finish to support clients at a time when companies are rethinking global supply chains. The Biosecure Act informed changes at companies such as Amicus Therapeutics, which worked with its supplier WuXi to establish a second facility outside China as lawmakers threatened to restrict business with the Asian country.
Pressures to return production to the U.S. have intensified since the Biosecure Act was proposed. Nevertheless, companies have shifted to regional supply models that could drive demand for Chinese capacity. Companies, including AstraZeneca, are building Chinese sites to serve Chinese patients.
The Hangzhou license is a milestone for a business that Innovent created in 2022. Innovent, a Chinese biopharma company, has established 140,000 liters of manufacturing capacity. The capabilities, which it claims give it “world-leading single-batch antibody production scale,” support approved products such as the anti-CTLA-4 antibody Tabosun and the Eli Lilly-partnered dual GLP-1/glucagon drug mazdutide.
