CANbridge Pharmaceuticals Receives Marketing Approval for NERLYNX® (neratinib) in China

BEIJING & SHANGHAI

CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) 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. CANbridge acquired the exclusive NERLYNX development and commercial rights from Puma Biotechnology, Inc. for China, Taiwan, Hong Kong and Macao in 2018.

“We thank Puma for the cooperative relationship that, along with the responsiveness of the National Medical Products Administration, allowed us to achieve NERLYNX market approval just 18 months after submission, a testament to the CANbridge regulatory expertise,” said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc.. “Women in China with early stage breast cancer now have first-time access to oral adjuvant therapy.”

“Reducing the risk of recurrence in HER2-positive early stage breast cancer patients remains paramount for Puma and our global partners,” added Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. “Marketing approval in the region represents an important milestone as we continue to execute on our global commercial strategy. We thank and congratulate CANbridge for reaching this important milestone.”

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. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. is a China-focused 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 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 greater China, 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), in greater China, as well as rights to other novel candidates.

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

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