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恒瑞医药回应“林普利塞片新适应症上市申请未获批”:合作伙伴主动撤回

Jiangsu Hengrui Pharmaceuticals responds to "the application for new indications for Linpuliset tablets not approved": partner actively withdrew.

Breakings ·  Jun 7 16:44
Jiangsu Hengrui Pharmaceuticals told Caijing that the application for the new indication of Linpulise tablet was voluntarily withdrawn. Yingli Pharmaceutical is stepping up its randomized controlled study of PTCL for new indications with the hope of resubmitting the application. According to the National Medical Products Administration website, the notification letter for Linpulise tablets from Yingli Pharmaceutical was recently delivered, which means that the new indication of the drug has not been approved. It is understood that the company submitted an application for the drug to treat relapsed refractory peripheral T-cell lymphoma (PTCL) last year. The first indication for the drug, which is used to treat relapsed or refractory follicular lymphoma in adult patients who have received at least two systemic treatments in the past, was approved on November 8, 2022. (Caijing reporter He Fan)

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