Canbridge submits NDA in China for breast cancer drug Nerlynx

Canbridge Life Sciences Ltd. (Beijing, China) said China's National Medical Products Administration (NMPA) accepted an NDA for Nerlynx neratinib as an extended adjuvant treatment for adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

Canbridge gained exclusive rights in February from Puma Biotechnology Inc. (NASDAQ:PBYI) to develop and commercialize Nerlynx in China, including Hong Kong and Macau, and Taiwan. Puma received $30 million up front and is eligible for regulatory milestones of up to $40 million, plus sales-based milestones and double-digit royalties (see "Canbridge Licenses Chinese Rights to Puma's Nerlynx")...