#China #Hangzhou #Innovent Biologics #NMPA #Altruist Biologics

Altruist Biologics Achieves a Major Milestone

Altruist Biologics, a prominent subsidiary of Innovent Biologics, has made headlines by securing its first commercial manufacturing license, the Drug Product Manufacturing License (C Certificate), from the NMPA (National Medical Products Administration) in China. This achievement paves the way for the company's Hangzhou facility to operate at full capacity as a leading contract development and manufacturing organization (CDMO) in the biotech sector.

Setting New Standards in Biologics Manufacturing

The Hangzhou facility stands out with its four 20,000-liter stainless steel bioreactors, marking a significant step in China's biologics manufacturing landscape. This facility is the largest of its kind in the country, representing Altruist's commitment to advancing capabilities within the industry. The certification was granted only two months after the facility's qualification, demonstrating Altruist's dedication to adhering to stringent quality management systems and international standards.

Dr. Kaisong Zhou, the Chairman and CEO of Altruist Biologics, expressed his satisfaction with the achievement, stating, "This represents another remarkable milestone in our efforts to establish premier-quality operations and fully integrated services to support our clients' commercialization goals." This accomplishment shows the capability of the team to deliver life-saving treatments and positions Altruist as a key player in the global market.

A Proven Track Record of Quality

Altruist Biologics has a history of maintaining high-quality standards and has successfully assisted in the commercialization of eight different products to date. Several of these products have achieved regulatory submissions in key markets including the United States, Europe, and China. The organization has also successfully navigated through 30 regulatory inspections conducted by various global health authorities, including the FDA and EMA, and passed over 13 GMP (Good Manufacturing Practice) quality audits from international clients.

The Hangzhou facility, which began partial operations in 2024, aims to accommodate a total production capacity of 172,000 liters upon its full operational launch. Along with the bioreactors, the site includes specialized facilities for antibody-drug conjugates (ADCs), enhancing the breadth of services available for diverse biopharmaceutical developments.

Focus on Client Needs and Future Prospects

With the increasing demand for biologics and other advanced therapeutic interventions, Altruist Biologics is committed to expanding its service offerings to meet the evolving needs of the market. The company plans to leverage its accumulated expertise and advanced technologies to provide flexible, cost-effective manufacturing solutions. This proactive approach can help clients navigate challenges in production and bring important therapies to patients more quickly.

Altruist Biologics recognizes the importance of aligning its operational capabilities with market requirements, and they aim to continuously enhance their systems to fulfill clients’ needs effectively. For more information about the complete range of services offered by Altruist Biologics, interested parties can visit their official website at www.altruistbio.com.

Conclusion

The successful licensing of the Hangzhou facility marks a pivotal moment for Altruist Biologics as it seeks to support the global healthcare community with high-quality biopharmaceutical manufacturing. The advancements made by the organization not only symbolize a commitment to excellence in manufacturing practices but also reinforce the strategic direction of Altruist as a leading partner in drug development and production.

For media inquiries, please contact Courtney Garcia, Director of Global Marketing Communications.