Canbridge gets marketing approval of Nerlynx in China

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner CANbridge Pharmaceuticals, Inc. has received marketing approval of NERLYNX® (neratinib) in mainland China from the National Medical Products Administration (NMPA) of China.

NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage human epidermal growth factor receptor 2 (HER2) positive breast cancer, to follow adjuvant trastuzumab-based therapy.

“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.”

Alan H. Auerbach, Chief Executive Officer and President of Puma, said: “Reducing the risk of recurrence in HER2-positive early stage breast cancer patients remains paramount for Puma and our global partners. 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.