TEDA TIANJIN, P.R. China, and SINGAPORE, Oct. 20, 2022 – Asymchem (stock code: 002821.SZ), a leading global contract development and manufacturing service provider, and AUM Biosciences, a clinical-stage biotech company focused on developing targeted oncology therapeutics, have announced the successful completion of their first GMP production campaign for AUM601.
Earlier this year, the two companies initiated a collaboration to work on the process development and both clinical and commercial production of AUM601, a selective oral small molecule inhibitor targeting the tropomyosin receptor kinase (TRK) aimed at treating rare cancers.

The partnership successfully produced 10 kg of GMP bulk drug substance of AUM601, which will be utilized for Phase II clinical trials. AUM601 has demonstrated significant in vitro and in vivo anti-tumor efficacy against tumors with NTRK fusion.

“Collaborating with Asymchem allowed us to refine our manufacturing process for AUM601 by leveraging cost-effective and safe reagents, enhancing both yield and quality. The encouraging results validate our progress as we move into Phase II clinical trials,” stated Vishal Doshi, CEO of AUM Biosciences. “Asymchem exceeded our expectations by integrating innovative concepts into the process, helping us advance our mission to transform the oncology therapeutics landscape and meet patients’ unmet needs.”

The success of this collaboration underscores both companies’ dedication to excellence and quality in drug development. Elut Hsu, President of Asymchem, remarked, “With Asymchem’s premier CDMO services and AUM’s innovative cancer research, we are well-positioned to make a significant impact on the lives of cancer patients around the globe.”

About Asymchem: Founded in 1999, Asymchem is a prominent global integrated Contract Development and Manufacturing Organization (CDMO) that offers innovative drug R&D and manufacturing services. The company is supported by 7,000 employees across China, the US, and the EU. Asymchem’s mission is to enhance efficiency through continuous technological innovation for more intelligent, eco-friendly, and cost-effective manufacturing, facilitating pharmaceutical clinical research and commercialization, backed by a strong record of successful regulatory inspections.