PRIME OFFERS ACCELERATED ASSESSMENT FOR TREATMENTS ADDRESSING UNMET NEEDS
Beijing, China, July 26, 2017 — CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, congratulates Germany’s Apogenix AG, on having received a PRIME designation from the European Medicines Agency (EMA) for APG101 (Asunercept) for the treatment of glioblastoma. The PRIME designation, launched in 2016, facilitates development of medicines that target an unmet need, and includes accelerated assessment and open dialogue between the drug developer and regulators. Selection criteria are similar to those of Breakthrough Designation Program at the Food and Drug Administration (FDA).
CANbridge has an exclusive license to develop and commercialize APG101, in glioblastoma multiforme, in China, Macao, Hong Kong and Taiwan, where it is being developed as CAN-008. CAN-008 is currently in a Phase I/II trial in glioblastoma multiforme (GBM) in Taiwan.
“This designation from the EMA acknowledges the potential high value of this treatment for glioblastoma, a cancer with few treatment options in the West or in Asia,” said James Xue PhD, CANbridge Chairman and CEO. “We wish to congratulate Apogenix on this important validation.”
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.