Altruist Biologics' Suzhou Site Receives EMA GMP Certification, Enabling Product Commercialization for the European Market

SUZHOU, China, Sept. 22, 2026 /PRNewswire/ -- Altruist Biologics, a world-class contract development and manufacturing organization (CDMO) and wholly owned subsidiary of Innovent Biologics (1801.HK), announced that its Suzhou commercial manufacturing facility has successfully passed a Good Manufacturing Practice (GMP) inspection by the European Medicines Agency (EMA) with zero critical findings. This marks the first time the facility has successfully received EMA GMP certification.

The inspection supported the European Union marketing authorization application for a biologics product from a top biopharmaceutical client. The EMA inspection involved a comprehensive assessment covering the full biologics manufacturing lifecycle and a rigorous review of the facility's quality systems and operational performance. The Suzhou facility's quality management system, infrastructure, technical capabilities, data integrity controls and organizational management were highly recognized by the EMA. The company's robust Quality Risk Management (QRM) framework has enabled proactive identification of compliance risks, reduced uncertainties associated with cross-regional technology transfer, and provided greater predictability as innovative therapies advance toward global regulatory submission and commercialization.

Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, commented: "Quality spans the entire biologics lifecycle, ensuring compliance with rigorous regulatory requirements from development through commercialization. As innovative drug companies face complex cross-border requirements, uncertainties with technology transfer, and increasing capacity needs, Altruist is committed to providing a path forward for every innovative medicine at the highest global standards. The recent EMA GMP certification exemplifies that our robust manufacturing processes, quality systems, talent and world-class facility meet regulatory requirements, and we have the agency's trust to manufacture and deliver products on behalf of our global partners and the patients they serve."

Altruist's Suzhou and Hangzhou sites are designed and operated to meet GMP requirements across multiple major regulatory authorities, including the EMA, U.S. Food and Drug Administration (FDA), the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and the National Medical Products Administration (NMPA) of China. Equipped with 60,000 liters of antibody manufacturing capacity and an ADC clinical manufacturing line, the Suzhou facility provides end-to-end services for antibodies, fusion proteins and antibody drug conjugates. The 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 antibody production line is currently under construction and is expected to be operational by mid-2027.

Altruist collectively has 140,000 liters of operational CDMO manufacturing capacity, representing approximately 20% of China's total capacity. As additional planned capacity comes online, Altruist's total manufacturing capacity is expected to reach 232,000 liters, positioning the company among the top 10 biologics CDMOs globally by manufacturing capacity.

In addition to the EMA, the Suzhou site has received multiple recognitions from other global regulatory authorities. It has successfully completed remote interactive evaluation by the FDA, and has passed inspections by the NMPA and the Federal Committee for Protection from Sanitary Risks (COFEPRIS) of Mexico, as well as more than 40 quality audits conducted by global clients.

Building on this milestone, Altruist Biologics is committed to providing global biotech and pharmaceutical companies with high-quality, reliable CDMO services, supporting more innovative therapies from around the world to overcome geographic and regulatory barriers to reach patients faster.

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