3D Medicines (Sichuan) Co., Ltd. and Suzhou Alphamab Co., Ltd. announced that the US 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.”