4 October 2018 - - Chinese biopharmaceutical company CANbridge Pharmaceutical Inc., which is developing Western drug candidates in China and North Asia, has filed a New Drug Application to China's National Medical Products Administration for Nerlynx (neratinib) for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy, the company said.
The NMPA has accepted the NDA application.
Nerlynx was approved in the United States for the same indication in July, 2017 and in the European Union, for the extended adjuvant treatment of hormone receptor positive HER2-positive early stage breast cancer, in September, 2018.
CANbridge licensed exclusive development rights to Nerlynx, which CANbridge is developing as CAN030, in greater China (China, Taiwan, Hong Kong and Macao) from Puma biotechnology, Inc. earlier this year.
The company is a clinical-stage bio-pharmaceutical company accelerating development and commercialisation 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.
The company 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).
Nerlynx has been approved in the United States for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and in the European Union for the extended adjuvant treatment of hormone receptor positive HER2-positive early stage breast cancer.
CANbridge is developing Nerlynx as CAN030 and plans to target HER2-positive cancers, including breast and gastric.
The company has a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, in greater China, which CANbridge is developing as CAN008, for the treatment of glioblastoma multiforme.
CANbridge received the National Medical Products Administration approval to commence a Phase II/III GBM Trial in mainland China, which it expects to initiate later this year.
CANbridge has a world-wide license (ex-North America) to develop, manufacture and commercialise AVEO Oncology's clinical-stage ErbB3 inhibitory antibody candidate AV203, which it is developing as CAN017.
It also has an agreement with EUSA Pharma to commercialise Caphosol in China for the prevention and treatment of oral mucositis caused by cancer treatments. Caphosol has been approved for commercialization by the NMPA.
CANbridge is privately-held and headquartered in Beijing, China.