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Press Release

Global First IND for Subcutaneous Injectable anti-PD-L1 Domain Antibody Receives FDA Approval

Suzhou Alphamab Co.,Ltd.
Posted on: 30 Nov 16

3D Medicines (Sichuan) Co., Ltd. and Suzhou Alphamab Co., Ltd. announced today that the U.S. FDA has completed its review of the IND for their drug KN035 and informed the pharmaceutical company of their approval.

KN035, originally developed by Alphamab, is a fusion protein of anti-PD-L1 single domain antibody and Fc. KN035 has unique features, such as, better penetration, sc injection, high affinity, better stability and good PK profiles.

Alphamab and 3D Medicines reached a global co-development agreement early this year. Alphamab is responsible for manufacturing of KN035 and 3D Medicines for clinical development, registration, and marketing globally.

“To our knowledge, this represents one of the very few cases for a US IND approval for which a Chinese company completed the whole process,” said Dr. Ting Xu, Chairman and CEO of Alphamab. “We are thrilled by the milestone achievement. With KN035 as a building block for bi-specifics, Alphamab has also initiated the development of next-generation immuno-oncology therapeutics.”

Dr. John Gong, CEO of 3D Medicines added “We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to initiating this study shortly. We believe KN035 is a truly differentiated anti-PD-L1 product for immune-oncology therapy, its unique features, such as, subcutaneous injection, will significantly improve the quality of life for American cancer patients.”

About Suzhou Alphamab Co., Ltd.

Suzhou Alphamab Co., Ltd., founded in 2009, is a leading biotechnology company in China focused on the discovery, development and manufacture of innovative biologics. With multiple proprietary platforms in protein engineering, antibody screening and multi-specifics, Alphamab has created a robust pipeline of over 20 innovative biologics programs in immune-oncology, infertility, infectious diseases and others. Alphamab is striving to develop 1st-in-class or best-in-class medicines to address unmet medical needs globally.

About 3D Medicines

3D Medicines (3DMed) is a leading precision medicine company in China. 3DMed's platforms, including next-generation sequencing, the world's largest PDC bank for liver cancer, and an Oncology Data Service Platform (OncoDSP), which can guide clinicians to choose right treatment for patients and help to develop effective medicines to treat cancer. Based on the precision medicine and biomarker driven drug development strategy, 3D Medicines has several anticancer drug candidates under preclinical development.

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Business Wire

Last updated on: 30/11/2016

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