Altruist Biologics 一体化 CMC 平台支持跨国客户生物药本地化生产 NDA 获 NMPA 受理并纳入优先审评

, /PRNewswire/ -- Altruist Biologics, a world-class contract development and manufacturing organization (CDMO) and wholly owned subsidiary of Innovent Biologics (1801.HK), announced that China's National Medical Products Administration (NMPA) has accepted the new drug application (NDA) and granted priority review for the localized manufacturing of a biologic drug developed by a leading multinational pharmaceutical company. This designation will significantly shorten the regulatory review timeline and support an accelerated pathway toward approval of the client's drug.

This achievement demonstrates the practical implementation of NMPA's regulatory framework for the localization of manufacturing, introduced in 2024, and marks an important milestone in the client's transition from overseas manufacturing to domestic manufacturing in China. Through its partnership with Altruist, the multinational client established a localized manufacturing pathway that leverages Altruist's end-to-end capabilities and expertise in NMPA regulatory requirements, supporting a streamlined route to market.

Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, commented: "The successful NDA acceptance and priority review are the result of close team collaboration between Altruist and our valued partner. Localizing manufacturing offers global companies an opportunity to strengthen supply chain resilience, while expanding access to innovative medicines for patients in China. We will continue to leverage our industry-leading technical capabilities and end-to-end CMC platform to empower our partners to accelerate their pathway to market for the benefit of patients worldwide."

Meeting GMP requirements across major regulatory authorities, Altruist's Hangzhou site is designed with a total antibody manufacturing capacity of 172,000 liters, with 80,000 liters currently operational across four 20,000-liter stainless-steel bioreactors. A 2,000-liter single-use production line is currently under construction and is expected to be operational by mid-2027. The site also offers a standalone ADC and AXC bioconjugation facility to support the manufacture of various bioconjugates, including high-potency ADCs for clinical and commercial supply at both small and large scales.

For more information about Altruist Biologics' end-to-end service capabilities, please visit: www.altruistbio.com.

About Altruist Biologics

Altruist Biologics is a reliable CDMO service provider and wholly owned subsidiary of Innovent Biologics, Inc. (1801.HK), focusing on the development, clinical, and commercial manufacturing of antibodies, fusion proteins, recombinant proteins, antibody drug conjugates, and other drugs. The company operates advanced cGMP facilities in Suzhou and Hangzhou, China, with a total production capacity of 232,000 liters, and continues to invest in new capabilities to maximize operational and quality excellence, ensuring flexibility, safety and agility for clients. With over a decade of bioprocessing expertise, the company has supported the commercialization of 20 drugs and completed more than 2,000 commercial batches with a >99.8% success rate. Its track record includes 100 global regulatory filings with the FDA, EMA, NMPA, PMDA, and TGA as well as over 80 successful regulatory authority inspections across global markets. With over 1,400 employees, including leading experts and scientists spanning all areas of biologics production and innovation, Altruist is committed to supporting clients in developing affordable and high-quality biopharmaceuticals for the benefit of patients worldwide.

SOURCE Altruist Biologics