On May 19, Mycenax Biotech announced a significant milestone: its first internationally marketed biopharmaceutical product has officially entered commercial-scale production. Earlier this year in February, the company passed an on-site inspection by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Recently, Mycenax received notification from its client that the PMDA has granted final approval for the product’s technology transfer and production at Mycenax’s facility in Taiwan.

Mycenax stated that this approval marks a major step forward in its expansion into international markets. With this milestone, Mycenax has officially become a commercial-scale manufacturer of an approved biopharmaceutical product. In addition, the company has signed a long-term supply agreement with its Japanese client, laying a solid foundation for sustained revenue growth.

The on-site inspection by the PMDA took place at Mycenax’s Zhunan facility in November 2024. The review covered compliance with GMP standards, process validation, and the overall quality management system. Following several days of rigorous assessment, Mycenax received formal notification in February that it had passed the inspection, confirming that its GMP facility meets Japan’s pharmaceutical regulatory standards.

The approval follows a successful technology transfer from the client to Mycenax. The company completed all required process validations and consecutive GMP manufacturing batches in line with regulatory standards. It also passed a comprehensive quality system audit, ultimately earning PMDA’s official approval for the production transfer.

Mycenax emphasized that this achievement strengthens its presence in Japan’s CDMO (Contract Development and Manufacturing Organization) market and represents a critical milestone in its entry into the Japanese biopharmaceutical sector.

Since its transformation in 2019 into a company focused exclusively on CDMO services, Mycenax has built advanced biopharmaceutical capabilities and a robust quality management system. Starting in 2024, the company has undergone on-site inspections by multiple global regulatory authorities. It has successfully passed inspections by both Japan’s PMDA and the European Medicines Agency (EMA), further validating its world-class manufacturing and quality standards.

Mycenax reaffirmed its commitment to becoming a leading global CDMO by continuing to drive innovation and expand its international presence, aiming to provide comprehensive, high-quality one-stop services for the global biopharmaceutical industry.

Resource: 永昕第一項國際上市生物藥品 商業化量產正式啟動