CANbridge Submits Ind Application for CAN008 PHII/III Trial in GBM in China
First Chinese Trial for CANbridge
Beijing, China, July 18, 2017 — CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that it has submitted an Investigational New Drug (IND) application to the China Food and Drug Administration (CFDA) for a Phase II/III clinical study of lead candidate, CAN008, for the treatment of glioblastoma multiforme (GBM). The trial will be CANbridge’s first trial in mainland China. The company is currently conducting CAN008 Phase I/II trial in GBM in Taiwan.
“The IND submission to the CFDA for CANbridge’s first clinical trial in China marks a major milestone for the company,” said James Xue PhD, CANbridge Chairman and CEO. “It denotes our entry into the regulatory pathway in China, which is crucial to the execution of our strategy to bring promising Western drug candidates to the Chinese population for severely underserved medical conditions.”
CAN008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan.
About CANbridge Life Sciences
CANbridge Life Sciences, Ltd. is a bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets for commercialization in China and North Asia. CANbridge has an agreement with EUSA Pharma, to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it is being developed as CAN008, and a world-wide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV203, renamed by CANbridge as CAN017.
Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions.
CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.
CANbridge Life Sciences