Filter News

CANbridge Receives China Food and Drug Administration Approval for CAN002 as Cancer Adjuvant Therapy

Published: Apr 26, 2018

First CANbridge Commercial Product
 
BEIJING--(BUSINESS WIRE)-- CANBridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced 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. CAN002 is CANbridge’s first commercialized product.

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.

About CANbridge Life Sciences

CANbridge Life Sciences, Ltd. is a clinical-staged 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 exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX® (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China), which was approved by the FDA, in 2017, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and which CANbridge is developing as CAN030. CANbridge plans to target HER2-positive cancers, including breast and gastric. CANbridge has a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, which CANbridge is developing as CAN008, for the treatment of glioblastoma multiforme (GBM) in greater China CANbridge received China Food and Drug Administration (CFDA) approval to commence a Phase II/III Trial in GBM in mainland China, which it expects to initiate later this year. CANbridge has a world-wide license (ex-North America) to develop, manufacture and commercialize AVEO Oncology’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV203, which it will develop as CAN017. CANbridge also has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments. Caphosol has been approved for commercialization by the CFDA.

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.

 

Back to news