• Strategic partnership to commercialize BioNTech´s mRNA-based molecular breast cancer stratification test MammaTyper® in China
• Shuwen to undertake clinical study for Chinese regulatory approval and become exclusive distributor in China
• Partners combine their expertise in in-vitro diagnostics and clinical testing services to allow precise characterization of breast cancer tumor types
Mainz, Germany and Deqing, China, December 3, 2015 – BioNTech Diagnostics GmbH, a fully owned subsidiary of BioNTech AG, and Shuwen Biotech Co. Ltd. today announced a strategic partnership to commercialize BioNTech’s molecular breast cancer stratification test MammaTyper® in China.
Under the terms of the agreement, Shuwen will undertake clinical studies for regulatory approval of MammaTyper® in China, and will become the exclusive distributor in China.
BioNTech’s CE-IVD marked MammaTyper® test is a molecular diagnostic test for stratification of breast cancer by molecular subtyping of routine tumor tissue samples. Based upon precise measurements of gene expression by RNA analysis, MammaTyper® has the potential to significantly improve the standard of diagnosis and ultimately treatment of breast cancer patients.
Correct identification of the molecular subtype of breast cancer is a prerequisite for optimal treatment of patients. With over 200,000 newly detected breast cancer cases every year in China, making MammaTyper® available in China will offer an essential diagnostic tool for the personalized treatment of breast cancer in China.
Dr. Sierk Poetting, CFO of BioNTech AG and Managing Director of BioNTech Diagnostics commented: “We are very pleased to partner with Shuwen Biotech. BioNTech is committed to making truly personalized medicine broadly available in oncology and this partnership offers a unique opportunity to access the Chinese market through Shuwen, a highly innovative and rapidly growing company, allowing MammaTyper® to be used in one of the largest populations in the world. This is a strategic long term cooperation to establish and strengthen our position in the Chinese oncology diagnostics market and will pave the way for launching our own personalized immunotherapies for the treatment of cancer in China.”
Jay Z. Zhang, Chairman and Chief Executive Officer of Shuwen Biotech Co. Ltd, added: “Through in-licensing and international collaborations, Shuwen aims to benefit the Chinese people with a full menu of the most innovative diagnostic tests for disease prevention, diagnosis and treatment. We are on track to deliver on this strategy. The partnership with BioNTech provides an exceptional opportunity for Shuwen Biotech to expand its portfolio in cancer testing.”
The application of MammaTyper® in China as well as globally has the potential to significantly improve the standard treatment of breast cancer patients. Importantly, the test has wide applicability and all breast cancer patients may benefit from molecular cancer subtyping using MammaTyper®. The molecular diagnostics test is highly reproducible and accurate, and overcomes the problem of subjective interpretation that occurs with current testing methods. MammaTyper® is accompanied by RNXtract®, a CE/IVD marked sample preparation kit from FFPE tissue samples.
