Idorsia’s QUVIVIQ expands into China as Simcere receives NDA approval – Idorsia and Simcere update their licensing agreement

Core Viewpoint - Idorsia Ltd. has announced a significant milestone in its collaboration with Simcere Pharmaceuticals, with the approval of QUVIVIQ (daridorexant) for insomnia treatment in China, leading to a milestone payment of USD 50 million and updated licensing terms [2][5][6]. Group 1: Approval and Licensing Agreement - Simcere Pharmaceuticals has received approval from the Chinese National Medical Products Administration for QUVIVIQ, which treats adult patients with insomnia without psychotropic drug control labeling [2][5]. - Idorsia and Simcere have updated their licensing agreement for QUVIVIQ in China, which includes an approval milestone payment of USD 50 million and potential commercial milestone payments of up to USD 93 million [3][5][6]. - The agreement allows Simcere exclusive rights to develop and commercialize QUVIVIQ in the Greater China region, which includes Mainland China, Hong Kong, and Macau [6]. Group 2: Company Statements and Future Plans - André C. Muller, CEO of Idorsia, praised the collaboration with Simcere, highlighting the rapid approval process of 2.5 years since the signing of the license agreement, and expressed optimism about QUVIVIQ becoming a global brand [4]. - Ren Jinsheng, Chairman and CEO of Simcere, emphasized the importance of the clinical results that enabled the approval and the commitment to making QUVIVIQ available to patients suffering from chronic insomnia [5]. - Arno Groenewoud, CFO of Idorsia, noted that the updated agreement reflects Simcere's confidence in QUVIVIQ's potential and their significant investment in the approval process [6].