- Mycenax and three Japanese partners have established Alfenax Biologics, a new CDMO joint venture focused on biosimilar manufacturing in Japan.
- The venture supports Japan’s national strategy to expand domestic biosimilar production under an MHLW subsidy programme.
Mycenax, together with Alfresa Holdings, Kidswell Bio and Chiome Bioscience, has established Alfenax Biologics, a joint venture designed to build a biologics manufacturing base in Japan with end-to-end CDMO and contract manufacturing capabilities. The agreement follows approval of an MHLW subsidy in May and the signing of an investment framework in October. Mycenax and Alfresa will each hold 45 per cent ownership.
The joint venture will manufacture active pharmaceutical ingredients and drug products for biosimilars, supporting Japan’s efforts to strengthen domestic supply capacity. The Ministry of Health, Labour and Welfare has set a target for biosimilars to represent more than 80 per cent of prescriptions for at least 60 per cent of eligible ingredients by the end of fiscal year 2029. The companies stated that demand for local manufacturing has grown under national economic-security measures and the introduction of subsidies for facility development.
The initiative builds on earlier collaboration between the partners, including agreements covering joint biosimilar development and product-specific programmes. Alfenax Biologics will operate on the basis of Alfresa Fine Chemical Corporation’s infrastructure, with plans to develop manufacturing capabilities under the Subsidy Program and offer CDMO services across the biosimilar value chain.
The consortium aims to integrate manufacturing, development and distribution strengths to improve Japan’s self-sufficiency in biosimilars and establish a stable domestic supply. The partners also intend to support export opportunities and contribute to workforce development in biopharmaceutical manufacturing.
