2025.09.15
SPERA PHARMA, Inc. (headquarters: Osaka; President and Representative Director: Keitaro Iwaki; hereinafter “SPERA PHARMA”), today announced a strategic alliance with Mycenax Biotech Inc. (headquarters: Hsinchu, Taiwan; Chairman/CEO and President： Pei-Jiun Chen; hereinafter “Mycenax”), a leading biologics CDMO based in Taiwan. This collaboration brings together the complementary strengths of both companies to deliver a comprehensive, turnkey solution for antibody-drug conjugates (ADCs) and bioconjugates, covering linker/payload synthesis, drug substance production, formulation, and aseptic fill-finish.
The alliance aims to accelerate time-to-market for biopharmaceutical companies by offering an integrated and cost-effective ADC development and manufacturing platform. By leveraging Mycenax’s end-to-end biologics capabilities with Krisan Biotech and SPERA PHARMA’s CMC expertise —particularly in high-potent fill-finish services for ADCs, the partnership delivers a seamless, one-stop solution tailored to the needs of global clients.
Founded in 2017 as a spin-off from Takeda Pharmaceutical Company’s CMC Research Division, SPERA PHARMA is recognized for its deep experience in complex drug development, including process chemistry, formulation, analytical development, and GMP-compliant aseptic manufacturing. Building on Japan’s leading pharmaceutical heritage, SPERA PHARMA is considered one of the country’s top CDMOs, trusted by global partners for its technical excellence and integrated CMC solutions.
Mycenax is a global biologics CDMO audited by international regulatory agencies, including EMA, PMDA, and Health Canada. Its 2022 strategic partnership with KriSan Biotech further expanded its next-generation ADC technology platform, incorporating site-specific conjugation, multi-arm linkers, and novel linker designs.
Together, Mycenax and SPERA PHARMA offer a scalable, end-to-end development and manufacturing solution. This empowers global ADC developers with speed, flexibility, and technical excellence.
About SPERA PHARMA
“CMC Experts from Japan’s Leading Pharmaceutical Heritage”
SPERA PHARMA, founded in July 2017 in Osaka, Japan, is a contract development and manufacturing organization (CDMO) specializing in Chemistry, Manufacturing, and Controls (CMC). Its expertise spans process chemistry, formulation development, analytical sciences, and GMP-compliant manufacturing of investigational drugs. Backed by a team of highly experienced researchers with a strong track record, SPERA PHARMA provides flexible support across all phases of pharmaceutical development from early research to regulatory approval. As a one-stop provider of comprehensive CMC solutions, the company is committed to meeting the diverse needs of global clients. For further information, please visit spera-pharma.co.jp/en
About Mycenax
“Your Best CDMO Partner for Biologics”
Mycenax, a Taiwan-based CDMO, delivers integrated biologics solutions, from cell line development to manufacturing, analytical methods, and formulation. With two GMP-compliant manufacturing facilities and a strategic partnership with KriSan Biotech, Mycenax is committed to developing and manufacturing ADC therapeutics for the global market. In addition, Mycenax also serves as a partner to Alfresa Holdings Corporation, Kidswell Bio Corporation, and Chiome Bioscience Inc. in a joint application selected under the Ministry of Health, Labour and Welfare (MHLW)’s Medical Facility Development Subsidy Program (Subsidy Program for the Development of Domestic Manufacturing Facilities for Biosimilars). For details, please visit mycenax.com
Press Contact:
Ayako Tsuboi
SPERA PHARMA, Inc.
Email: mkouhou@spera-pharma.co.jp
Liru Yeh
Mycenax Biotech Inc.
Email: liru.yeh@mycenax.com
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