SUZHOU, China--(BUSINESS WIRE)-Suzhou Alphamab Co., Ltd. announced today that the IND for its leading bispecific program KN026 has been approved by the CFDA, marking a significant milestone for Alphamab in developing world-class bispecific biologics.

“The regulatory agency well recognized the quality and innovation of this bispecific biologics. We are quite excited about the opportunity to develop this improved therapy with better efficacy and lower costs for millions of cancer patients”

KN026 is an anti-Her-2 heterodimer, based on the company’s proprietary Fc based bispecific platform (CRIB) with the same format and size of natural IgG antibody. It has demonstrated an excellent pre-clinical profile in binding affinity, efficacy, safety, and PK. KN026 showed better efficacy activity in about 40% of Her-2+ tumor cell lines and multiple in vivo tumor models, as compared to the combo of Trastuzumab and Pertuzumab. The CMC process for KN026 is very robust, consistently with the titer of 3+ g/L for multiple large-scale batches.

The targeted indications for KN026 are primarily breast cancer and gastric cancer with Her-2 expression. Alphamab will soon start the phase I trial in China, followed by clinical development in the US and Japan. Currently the global annual sales of Trastuzumab and Pertuzumab is about $10 billion.

“The regulatory agency well recognized the quality and innovation of this bispecific biologics. We are quite excited about the opportunity to develop this improved therapy with better efficacy and lower costs for millions of cancer patients,” said Dr. Ting Xu, Chairman and CEO of Alphamab.

Dr. Xu added, “Due to challenges in product PK and CMC scale-up, the progress of bispecific biologics development has been slow in the past three decades with only two marketed bispecific antibodies worldwide. Alphamab has developed a cutting-edge bispecific platform and validated it through the development of KN026. We also look forward to partnering with pharma/biotech companies on this leading platform.”