Innovent Biologics’ contract development and manufacturing organization, Altruist Biologics, announced on Apr. 9 that it has received a license from China's National Medical Products Administration to operate a large-scale biologics production plant in Hangzhou. The facility is equipped with four 20,000-liter bioreactors and is the first of its size in China to obtain such a license for drug product manufacturing.
The licensing of the Hangzhou site marks an important step for Innovent as it expands its capacity to meet growing demand for biologic medicines. The approval followed an assessment by regulators that confirmed the facility meets good manufacturing practices and quality management standards required by Chinese authorities.
Altruist said it plans to further increase the Hangzhou plant's capacity to 172,000 liters. This expansion will add to Innovent’s existing manufacturing network, which already includes a 60,000-liter facility in Suzhou. Across these sites, Altruist aims to develop and manufacture various modalities such as antibodies, fusion proteins, and antibody-drug conjugates (ADCs) for both clinical trials and commercial supply. Plans also include building a standalone bioconjugation facility dedicated to ADCs at Hangzhou.
The company has invested in multiple areas including cell line development and aseptic fill-finish processes to support clients amid shifts in global supply chains. These changes have been influenced by regulatory proposals like the Biosecure Act, which prompted some pharmaceutical companies—such as Amicus Therapeutics—to diversify their supplier base outside China due to potential restrictions on business operations with Chinese firms.
Despite pressures encouraging companies to bring production back to the United States since the introduction of the Biosecure Act, there has been continued movement toward regional supply models that may boost demand for Chinese manufacturing capacity. Companies like AstraZeneca are reportedly constructing facilities within China specifically aimed at serving local patients.
According to Innovent, achieving this milestone supports its portfolio of approved products—including Tabosun (an anti-CTLA-4 antibody) and mazdutide (a dual GLP-1/glucagon drug developed with Eli Lilly)—and strengthens what it describes as “world-leading single-batch antibody production scale.”
