Beijing-based CANbridge Life Sciences has received clinical trial application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with its drug candidate CAN017.

Boehringer Ingelheim’s biopharmaceutical contract manufacturing business, known as Boehringer Ingelheim BioXcellence, is providing the chemistry, manufacturing, and control (CMC) services for CAN017 since the collaboration started in August 2016. Boehringer Ingelheim BioChina supported the application approval by GMP compliant manufacturing and support for China CTA regulatory filing services from CMC perspective.

CAN017 is an ErbB3 (HER3) inhibitory antibody for the treatment of esophageal squamous cell cancer (ESCC). ESCC is the most prevalent form of esophageal cancer and occurs primarily in Asia with 50% cases in China. CANbridge acquired the development rights of CAN017 from U.S,-based AVEO in 2016 after the completion of U.S. Phase 1 trial in solid tumors and will now commence Phase Ib/III study in China.

“Through our supplies at the highest global quality standards, we are committed to providing CANbridge with full support to commercialization,” said Dr. Jiali Luo, general manager and site head, Boehringer Ingelheim BioChina. “We are proud of being CANbridge’s partner to serve cancer patients with this important medicine.”