On April 26, 2018 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that it received an Import Medical Device Market Approval from the China Food and Drug Administration (CFDA) for CAN002 as a cancer adjuvant therapy, on April 2, 2018. CAN002, marketed as Caphosol in 47 countries, is an oral rinse for the treatment of oral mucositis, the inflammation and ulceration of the mucous membranes lining the mouth that occurs frequently in cancer patients undergoing high-dose chemotherapy, radiation and hematopoietic stem cell transplants (Press release, CANbridge Life Sciences, APR 26, 2018, View Source [SID1234525762]). CAN002 is CANbridge’s first commercialized product.
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In 2014, CANbridge entered into an exclusive partnership with EUSA Pharma for the right to commercialize Caphosol in China. EUSA Pharma is a specialty pharmaceutical company with a focus on oncology and oncology supportive care, with commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world.
"We are delighted with the approval by the CFDA of CAN002, which marks our transition into a commercial stage company," said James Xue PhD, Chairman and CEO, CANbridge Life Sciences. "There is currently no standard-of-care in China for this painful and often debilitating condition that affects so many patients undergoing cancer treatment, as well as those dealing with other diseases. We are particularly proud to be able to bring this proven treatment to patients in mainland China, as we continue in our mission to shorten the runway between Western approval and availability in China. With CAN030 (Nerlynx) queued up as the next product closest to market, we anticipate CANbridge’s accelerated growth as a commercial company."
About CAN002 (Caphosol)
Caphosol is a supersaturated calcium phosphate oral rinse solution to treat oral mucositis (OM)—inflammation and ulcers in the mouth— caused by radiation, high-dose chemotherapy, and bone-marrow transplants to treat blood cancers. Approved in 48 countries, it has demonstrated robust clinical efficacy in preventing and treating OM, and has an excellent safety profile. The incidence of oral mucositis varies across cancer patient populations. However, according to the Oncology Nursing Society, it affects almost all patients undergoing radiation therapy for head and neck cancers; 80% of patients under going a stem cell transplant to treat blood cancer; and nearly half (40%) of patients receiving standard chemotherapy.