7 August 2020 - - China-based biopharmaceutical company CANbridge Pharmaceuticals Inc has received marketing approval from the Taiwan Food and Drug 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.

Nerlynx was approved in Hong Kong in 2019 and in mainland China earlier this year. CANbridge acquired the exclusive Nerlynx development and commercial rights from Puma biotechnology, Inc. for Greater China in 2018.

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive.

HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

CANbridge Pharmaceuticals Inc. is a biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers, focusing on products that are unavailable or address unmet medical needs.

CANbridge has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases.

In greater China, where it is a recognized leader in orphan diseases, CANbridge has an exclusive licensing agreement to commercialize Hunterase, an enzyme replacement therapy for the treatment of Hunter syndrome, developed by GC Pharma and marketed in more than ten countries worldwide.

The CANbridge oncology portfolio includes exclusive rights to develop and commercialize Puma biotechnology's Nerlynx (neratinib), which was recently approved in greater China, as well as rights to other novel candidates.