Idorsia Ltd announced that its partner Simcere Pharmaceuticals Group Ltd has received approval from the Chinese National Medical Products Administration for QUVIVIQ (daridorexant) for the treatment of adult patients with insomnia characterized by difficulty falling asleep and/or maintaining sleep. The approval notably comes with no psychotropic drug control labeling, marking a significant regulatory milestone for the insomnia treatment in China.
Rapid Development Timeline Achieves Regulatory Success
The approval represents an exceptionally fast development timeline, achieved in just 2.5 years since Idorsia and Simcere signed their licensing agreement in 2022. André C. Muller, Chief Executive Officer of Idorsia, highlighted the collaborative effort's success: "Together they have been able to take our drug from pre-IND, through to local Phase 1 and Phase 3, and then filing, resulting in this approval at an incredible pace of 2.5 years since the signing of the license agreement."
The clinical results from both global and local trials enabled QUVIVIQ to secure approval without psychotropic drug control labeling in China. Ren Jinsheng, Chairman and Chief Executive Officer of Simcere, emphasized the clinical significance: "Importantly, the clinical results achieved in both the global and local trials have enabled QUVIVIQ to be approved with no psychotropic drug control labeling in China."
Updated Financial Terms Strengthen Partnership
Concurrent with the approval announcement, Idorsia and Simcere have updated their licensing agreement terms. Under the revised agreement, Idorsia will receive an approval milestone payment of $50 million, representing an additional $30 million compared to the original terms. The company will also be eligible for commercial milestone payments of up to $93 million and low- to high-single-digit tiered royalties on future net sales.
Arno Groenewoud, Chief Financial Officer of Idorsia, explained the strategic rationale: "The updated agreement with Simcere allows both companies to streamline the collaboration. The increased milestone payment of USD 50 million in 2025 underscores Simcere's commitment and confidence in the potential of QUVIVIQ, following its significant investment in sealing this approval for Chinese patients and the corresponding launch preparations."
Global Market Expansion Strategy
The Chinese approval significantly expands QUVIVIQ's global footprint, with the treatment now available across major markets including North America, Europe, Japan, and China. Muller expressed satisfaction with the global expansion: "I'm very happy as QUVIVIQ becomes a truly global brand, now available to millions of patients in North America, Europe, Japan and China, and we aim to continue this expansion to new territories."
Under the original 2022 licensing agreement, Simcere holds exclusive rights to develop and commercialize QUVIVIQ in the Greater China region, encompassing Mainland China, Hong Kong, and Macau. Simcere has committed to making the treatment available to patients suffering from chronic insomnia across this region.
