Drug License in China
South Korea’s leading drug maker Hanmi Pharmaceutical Co. (CEO Lee Gwan-sun) announced on Nov. 23 that it has signed a license agreement with Chinese biotechnology company ZAI Lab Limited to grant exclusive rights of its novel EGFR targeted therapy for lung cancer, or HM61713, in China, including Hong Kong and Macao.
With the latest deal, ZAI Lab will acquire exclusive rights in China to develop, manufacture and commercialize HM61713. In July this year, Hanmi and Germany’s Boehringer Ingelheim entered into an exclusive license and collaboration agreement for the development and global commercialization rights, except South Korea, China and Hong Kong, of HM61713 (BI1482694)
Under the latest agreement, the Korean drug maker will receive an upfront payment of US$7 million (8.27 billion won) and get an additional US$85 million (100.39 billion won) for clinical development and commercialization. It will be also eligible for two-digit royalties after the launch of HM61713.
The license agreement with ZAI Lab reflects the fact that the population of non-small cell lung cancer (NSCLC) patients in China, which HM61713 targets, are more than a half of all NSCLC patients in the world. According to the Global Data, 46 percent of all NSCLC patients in the world this year a rein China, and by 2020, the Chinese patient population is predicted to rapidly increase to up to 62 percent of the total.
Hanmi Pharmaceutical CEO Lee Gwan-sun said, “Through our collaboration with ZAI Lab with well-built, experienced R&D capability, the possibility to develop HM61713 as a first-in-class drug in China is now open. We look forward to providing innovative treatment options to Chinese patients suffering from non-small cell lung cancer.”
Meanwhile, HM61713 selectively inhibits the mutation of signal delivery substance EGFR involved in the growth of cancer cells, and is evaluated as a third-generation EGFR tyrosine kinase inhibitor (TKI), which overcomes resistance and side effects after administration with previous EGFR TKIs.
The company officially presented the safety and efficacy results from the Phase I/II study of HM61713 in patients with EGFR mutation-positive NSCLC who failed previous EGFR TKIs at the 51st American Society of Clinical Oncology (ASCO) Annual Meeting taking place in May.