CANbridge Receives Hong Kong Department of Health Market Approval for NERLYNX®

BEIJING

CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, announced that it received market approval from the Department of Health in Hong Kong for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early‑stage hormone receptor positive HER2-overexpressed/amplified breast cancer, and who completed adjuvant trastuzumab-based therapy less than one year ago. This is the first targeted therapy approved in the CANbridge oncology platform and the first NERLYNX approval in greater China. CANbridge acquired the exclusive NERLYNX development and commercial rights for China, Taiwan, Hong Kong and Macao in 2018, and submitted the NDA for NERLYNX to the National Medical Products Administration (NMPA) in China for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, last year.

“The rapid and smooth advancement of NERLYNX through the Hong Kong regulatory process to market approval is a testament to the quality of our regulatory expertise, and the CANbridge commitment to bring new treatments to underserved patient populations in greater China,” said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. “With this first targeted therapy approved in our oncology platform, CANbridge is able to provide women in Hong Kong, with HER2-positive breast cancer at risk of recurrence, a new and vital treatment option shortly after it was approved in the West.”

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Research has shown that trastuzumab treatment can reduce the risk of early-stage HER2-positive breast cancer returning after surgery. However, up to 25% of patients treated with trastuzumab experience recurrence. There were 4,391 reported new cases of all types of breast cancer in Hong Kong in 2017, according to a report released by the Hong Kong Registry, Hospital Authority. Of these, it is reasonable to assume that 20-25% could be HER2-positive.

About Neratinib

Neratinib is a potent irreversible tyrosine kinase inhibitor that inhibits tumor growth and metastasis through the blocking of the pan-HER family (HER1, HER2 and HER4) and downstream signal transduction. Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. Neratinib was also approved by the European Medical Agency (EMA) in September, 2018.

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. is a China-based biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers, focusing on products that are unavailable or address medical needs that are underserved in the region.

CANbridge has been widely recognized as a leader in orphan diseases in China. It has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases. In addition, it 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. CANbridge also has an oncology portfolio, which includes exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX® (neratinib), approved in the US, and rights to other novel candidates.

For more on CANbridge Pharmaceuticals Inc., please go to www.canbridgepharma.com

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