Mycenax and SPERA PHARMA Forge Strategic Alliance to Streamline ADC Drug Substance and Drug Product Manufacturing Services

TAIPEI, Sept. 15, 2025 /PRNewswire/ -- Mycenax Biotech Inc. (TWO:4726), a leading biologics CDMO based in Taiwan, today announced strategic alliance with SPERA PHARMA Inc., a Japan-based expert in pharmaceutical Chemistry, Manufacturing, and Controls (CMC). This collaboration brings together the complementary strengths of both companies to deliver a comprehensive 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 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.

Together, Mycenax and SPERA PHARMA offer an end-to-end development and manufacturing solution. This empowers global ADC developers with speed, flexibility, and technical excellence.

About SPERA PHARMA

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

Mycenax, a Taiwan-based CDMO, delivers integrated biologics solutions from process development to cGMP-compliant manufacturing. 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. For further information, please visit https://www.mycenax.com/