NEW YORK – Canbridge Pharmaceuticals said on Thursday that it has received approval from China's National Medical Products Administration to market neratinib (Puma Biotechnology's Nerlynx) as an extended adjuvant treatment of patients with early-stage, HER2-positive breast cancer after treatment with trastuzumab (Genentech's Herceptin).
In February, the US Food and Drug Administration approved neratinib in combination with the chemotherapy capecitabine for advanced or metastatic HER2-positive breast cancer patients who have received two or more anti-HER2 therapies.
Neratinib was first approved by the FDA in 2017 as an extended adjuvant therapy for patients with early-stage HER2-overexpressed or amplified breast cancer, following adjuvant treatment with trastuzumab. The drug is also approved in Europe, Canada, Australia, Hong Kong, Singapore, and Argentina as an extended adjuvant therapy for early-stage breast patients after they receive adjuvant therapy with trastuzumab.
In 2018, Chinese company Canbridge acquired the exclusive rights to develop and commercialize neratinib in China, Taiwan, Hong Kong, and Macao. Under the agreement, Puma will receive an upfront payment of $30 million and potential milestone payments totaling up to $40 million. In addition, Puma will receive royalties on neratinib sales in greater China.
Last week, Puma said that it entered into an exclusive licensing agreement with South Korean company Bixink Therapeutics to commercialize neratinib in South Korea.