Altruist receives first GMP license for 20,000L-scale biologics facility in China

Altruist Biologics, a contract development and manufacturing organization (CDMO) and subsidiary of Innovent Biologics, has received a Drug Product Manufacturing License from China’s National Medical Products Administration (NMPA) for its Hangzhou facility. It is the first such Good Manufacturing Practice (GMP) license granted to a biologics manufacturing facility operating at 20,000-liter scale in China, according to the company.

The facility commenced partial operations in 2024 with four 20,000-liter stainless steel bioreactors, which the company said are the first and largest of their kind in China. The license was granted two months after facility qualification, according to the announcement. The site will hold a total capacity of 172,000 liters upon completion and includes a standalone antibody-drug conjugate (ADC) and bioconjugation facility to support clinical and commercial supply of high-potency ADCs, the company said.

Altruist said it has supported the successful commercialization of eight products to date, with several achieving regulatory submissions in the U.S., Europe, and China, and has passed 30 regulatory inspections, including inspections conducted by the FDA and the European Medicines Agency (EMA).

The announcement follows developments at parent company Innovent Biologics. In January 2025, Innovent entered an exclusive global license agreement with Roche for IBI3009, a DLL3-targeted ADC for small cell lung cancer, under a deal that includes an $80 million upfront payment and up to $1 billion in milestone payments, along with royalties on future sales.