CANbridge Pharmaceuticals Receives Marketing Approval for Nerlynx® (Neratinib) in Taiwan


BEIJING & SHANGHAI--CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions, announced that it 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. 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.


About HER2-Positive Breast Cancer

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.


About CANbridge Pharmaceuticals Inc.

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.


For more on CANbridge Pharmaceuticals Inc., please go to


Forward Looking Statements

This article contains forward-looking statements that reflect our current expectations and views of future events, including but are not limited to those regarding the therapeutic potential of and potential clinical development and commercialization plans for CANbridge’s pipeline candidates, its strategic and financial plans and expectations as well as financial projections.

In some cases, forward-looking statements can be identified by words or phrases such as “may,”“will,” “expect,”“anticipate,”“aim,”“estimate,”“intend,”“plan,”“believe,”“is/are likely to,”“potential,”“continue”or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements include statements relating to: our goals and strategies; our future business development, financial conditions and results of operations; results of our clinical trials and preclinical studies; the expected growth of the pharmaceutical industry in China; the impact of COVID-19; our expectations regarding demand for and market acceptance of our products and services; our expectations regarding our relationships with our distributors, customers, business partners and our other stakeholders; competition in our industry; and relevant government policies and regulations relating to our industry.

Although we believe that our expectations expressed in these forward-looking statements are reasonable, our expectations may later be found to be incorrect. Our actual results could be materially different from our expectations. Known and unknown risks, uncertainties and other factors may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Management’s expectations and, therefore, any forward-looking statements in this presentation could also be affected by risks and uncertainties relating to a number of other factors, many of which are beyond CANbridge’s control. All information in this article is as of the date hereof, and CANbridge disclaims any obligation to update or revise such information unless required by law.

CANbridge Pharmaceuticals Inc.
James Xue

Deanne Eagle
Planet Communications