HANGZHOU, China, October 29, 2026
Altruist Biologics, a contract development and manufacturing organization (CDMO) and wholly owned subsidiary of Innovent Biologics, has announced that China’s National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) and granted priority review for the localized manufacturing of a biologic medicine developed by a multinational pharmaceutical company. The regulatory milestone supports the client’s transition from overseas manufacturing to domestic production in China and demonstrates the role of Altruist’s integrated Chemistry, Manufacturing and Controls (CMC) platform in supporting regulatory submissions and manufacturing technology transfer. The multinational client and the specific biologic have not been identified. The NMPA’s decision is expected to support a faster regulatory review pathway, although final authorization for localized production remains subject to the authority’s assessment. The development also highlights China’s efforts to strengthen domestic pharmaceutical manufacturing capabilities and improve supply-chain resilience for innovative biologic medicines.
NMPA Acceptance Highlights China’s Biologics Localization Framework
The NDA acceptance and priority review represent an important step in implementing China’s 2024 regulatory framework for pharmaceutical manufacturing localization. This framework provides a pathway for eligible medicines previously manufactured overseas to transition to domestic production through qualified local manufacturing arrangements. For multinational pharmaceutical companies, localizing production can help strengthen supply-chain resilience, improve manufacturing flexibility and support access to medicines in the Chinese market. Altruist worked with the unnamed multinational partner to establish a localized manufacturing pathway that incorporates its technical capabilities and understanding of NMPA regulatory requirements. CMC expertise is essential to this process, as transferring biologic manufacturing involves demonstrating that the production process and quality controls can consistently deliver a medicine meeting the required specifications. The work can involve process development, analytical testing, technology transfer, manufacturing documentation and quality-system preparation. Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, said the regulatory achievement reflects close collaboration between the two organizations. He also highlighted the opportunity for localized manufacturing to strengthen supply chains while supporting access to innovative medicines in China. Importantly, NDA acceptance and priority review do not constitute final product approval; the application must still undergo regulatory assessment.
Hangzhou Facility Expands Large-Scale Antibody Manufacturing Capabilities
Altruist’s Hangzhou manufacturing site is designed to support large-scale biologics production, with a planned total antibody manufacturing capacity of 172,000 litres. Currently, 80,000 litres are operational, distributed across four 20,000-litre stainless-steel bioreactors. This infrastructure provides substantial capacity for antibody manufacturing and supports the company’s ambition to serve pharmaceutical partners requiring clinical and commercial production. The facility also includes a dedicated antibody-drug conjugate (ADC) and AXC bioconjugation operation, supporting the production of different bioconjugates, including high-potency ADCs. These capabilities are intended to accommodate manufacturing requirements at both small and large scales. In addition, a 2,000-litre single-use production line is under construction and is expected to become operational by mid-2027. Single-use manufacturing systems can provide flexibility for selected biologics production processes and may help accommodate different customer requirements. The company states that its Hangzhou site is designed to meet GMP requirements across major regulatory authorities. Its combination of stainless-steel bioreactors, bioconjugation infrastructure and planned single-use capacity strengthens its position as a manufacturing partner for complex biologic products.
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Altruist Strengthens Its Integrated CMC and CDMO Services
Altruist Biologics provides development and manufacturing services covering antibodies, fusion proteins, recombinant proteins, antibody-drug conjugates and other biologic medicines. Its operations in Suzhou and Hangzhou, China, provide a combined reported production capacity of approximately 232,000 litres. The company says it has supported the commercialization of 20 medicines and completed more than 2,000 commercial manufacturing batches, with a reported batch success rate exceeding 99.8%. It also reports more than 100 global regulatory filings involving authorities including the FDA, EMA, NMPA, PMDA and TGA, alongside more than 80 successful regulatory authority inspections. These figures reflect the company’s reported manufacturing and regulatory experience. As a wholly owned subsidiary of Innovent Biologics, Altruist is positioned to serve customers seeking integrated development, regulatory and commercial manufacturing support.
The latest NMPA milestone demonstrates how integrated CMC capabilities can support the localization of biologic manufacturing for multinational pharmaceutical companies. The next important stage will be completion of the regulatory review and the subsequent implementation of the approved manufacturing pathway. While the client and medicine remain undisclosed, the development highlights the growing importance of qualified CDMOs in supporting biologics production, regulatory compliance and pharmaceutical supply-chain development in China.
Source: Altruist Biologics press release
