Servier has been actively working to get its brain cancer drug vorasidenib into global markets. After its approval for marketing in the United States on Aug 6, 2024, the drug has been approved in Canada, Australia, Israel, the United Arab Emirates, and Switzerland, respectively. Now, the new therapy has also gained access to China's Hainan Boao Lecheng International Medical Tourism Pilot Zone (Lecheng), one step closer to being the first-in-class targeted therapy of dual inhibitor IDH to receive a New Drug Application (NDA) approval in China.
China allows hospitals in Lecheng to use novel drugs and medical devices approved outside of China to meet urgent clinical demand in the country. The approval process in Lecheng takes only months, compared with years to get the Chinese NDA approval. So far, over 400 innovative drugs and devices have been launched in Lecheng, according to Hainan’s provincial government.
Servier is also in discussions with authorities in Beijing’s Tianzhu Comprehensive Bonded Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, which have similar policies to Lecheng, to get Vorasidenib launched in local hospitals.
To accelerate the approval and marketing of this innovative drug, a related real-world study(RWS) is expected to be conducted in the Lecheng pilot zone to evaluate the drug’s safety and effectiveness in the Chinese population.
Companies are motivated to do RWS studies in Lecheng because the data generated from Chinese patients can accelerate the NDA approval process in the country. For example, it took Gavreto (pralsetinib) only seven months to get conditional approval in China, thanks to RWE data generated in Lecheng, according to CStone, the biotech that acquired Gavreto’s China rights from Blueprint in 2018. Novartis also used RWE data to gain approval for Leqvio (inclisiran) in China just nine months after filing the NDA application.
According to Lecheng, 16 out of 40 drugs and devices that conducted RWS studies in the zone were approved in China in a shorter-than-usual time frame. China has been encouraging the use of RWS data to support drug and medical device approvals since 2020, when the NMPA issued three guidelines on this topic.
In addition to the RWS studies, Servier is also conducting a phase III clinical bridging trial in China to expedite the NDA approval for Vorasidenib. The study is enrolling 58 patients aged 12 and older who have undergone surgery for grade 2 glioma with IDH mutation.
Ultimately, Servier wants to make this new treatment available for all patients in China as soon as possible. “Servier, as an independent group governed by a non-profit foundation, has always prioritized addressing patients` medical needs and we are committed to work together with healthcare professionals to improve patients’ treatment outcomes and quality of life. This commitment drives our investment in research and the development of innovative therapies.” stated Servier China’s general manager, Manuel Ruiz. “The success of Vorasidenib’s launch in Bo’ao is rooted in the belief that every patient should have access to the best treatments available, and we are committed to making that a reality here in China.”