On August 20, 2018 CANbridge Life Sciences, a biotech company privately-held and headquartered in Beijing, China, reported that it 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 (Press release, Boehringer Ingelheim, AUG 20, 2018, View Source [SID1234529004]).
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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 successful 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 US-based AVEO in 2016 after the completion of US Phase 1 trial in solid tumors and will now commence Phase Ib/III study in China.
Dr. Jiali Luo, General Manager and Site Head of Boehringer Ingelheim BioChina, congratulates CANbridge for the progress achieved with CAN017: "Through our supplies at the highest global quality standards, we are committed to providing CANbridge with full support to commercialization. We are proud of being CANbridge’s partner to serve cancer patients with this important medicine".