Start up. Grow up. Succeed.

Chinese FDA Grants MammaTyper® Innovative Product Status for Expedited Approval

BioNTech Diagnostics GmbH, a fully owned subsidiary of BioNTech AG, and its Chinese partner Shuwen Biotech Co. Ltd. today announced that the Chinese FDA (CFDA) has granted the “Innovative Medical Product” status for MammaTyper®, a real-time PCR kit for breast cancer stratification.

Mainz, Germany and Deqing, China, August 19, 2016 - This diagnostic product will undergo a special process designed by the CFDA to expedite the regulatory approval of innovative products. MammaTyper® met the highly stringent criteria set by the CFDA for products entering the fast-track procedure. Since the program was initiated in March 2014, only ten in vitro diagnostics devices (IVD) have been granted access to the special approval process.

"We are very pleased that the CFDA has recognized the innovative and significant clinical value of MammaTyper®," stated Jay Z. Zhang, Chairman and CEO of Shuwen Biotech. "We will work closely with the CFDA towards an expedited approval to allow Chinese breast cancer patients to have full access to the clinical benefit of MammaTyper®."

Dr. Sierk Poetting, CFO of BioNTech AG and Managing Director of BioNTech Diagnostics, commented: "This is a major milestone for MammaTyper® and we are very pleased with the CFDA's recognition. We congratulate our colleagues at Shuwen for their accomplishment in obtaining the special approval process from the CFDA for MammaTyper®. We look forward to expanding the access to MammaTyper® to one of the largest populations in the world."

The CE-IVD marked MammaTyper® test is a molecular diagnostic test for breast cancer stratification with FFPE tumor tissue samples. Based on 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.

For more information, please contact:

BioNTech AG

Regina Jehle
Tel: +49 (0) 6131 9084 1273
Hume Brophy (for BioNTech AG)
Mary Clark, Eva Haas, Hollie Vile
Tel: +44 (0) 20 7862 6381

Shuwen Biotech Co. Ltd
Grace Lou
Tel: +86 572 889 9881

About BioNTech AG:
BioNTech AG is an immunotherapy leader with bench-to-market capabilities, developing truly personalized, well-tolerated and potent treatments for cancer and other diseases. Established by clinicians and scientists the Group is pioneering disruptive technologies ranging from individualized mRNA based medicines through innovative Chimeric Antigen Receptors / T-cell Receptor-based products and novel antibody checkpoint immunomodulators. BioNTech's clinical programs are supported by an in-house molecular diagnostics unit whose products include MammaTyper® a molecular in-vitro diagnostic kit, marketed under CE and IVD marking in Europe and certain other countries. Founded in 2008, BioNTech is privately held and shareholders include the MIG Fonds, Salvia, and the Strüngmann Family Office, with the Strüngmann Family Office as the majority shareholder.
Information about BioNTech is available at

About BioNTech Diagnostics GmbH:
BioNTech Diagnostics is a fully-owned subsidiary company within the BioNTech AG Group. The ISO 9001/13485 certified company has extensive product and service offerings ranging from biomarker discovery and validation through molecular screening assays, patient stratification and companion diagnostics to clinical monitoring, all to international regulatory standards. Early detection of diseases that have a high mortality rate and the appropriate selection of therapies are crucial for a successful treatment of patients. BioNTech Diagnostics' mission is to provide new and innovative diagnostic tests to extend lives of patients, improve their quality of life and support the use of appropriate therapy for each individual patient.

About Shuwen Biotech Co. Ltd.:
Based in China and led by U.S. diagnostic industry veterans, Shuwen Biotech is an integrated diagnostic company engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine. The company strives to provide China's doctors and their patients with a comprehensive menu of the most innovative diagnostic products and services for improved disease prediction, screening, diagnosis, prognosis and treatment. Shuwen offers, in China, molecular diagnostic kits and LDT services for personalized medicine in cancer and other diseases.
More information about Shuwen Biotech Co. Ltd. can be found at