标题：Hengrui Medicine AlertRetagliptin filing has been withdrawn
发布日期：2016-04-11 7:57:08
内容： We expect delay for the launch of Retagliptin Hengrui withdrew the application of Retagliptin, an innovative DPP-IV inhibitorfor type 2 diabetes. The company indicated that it is challenging to predict thetimeline for re-filing, however a completely new phase 3 study appearsunnecessary. Management previously expected the product launch in 2017and we expect delay given the withdrawal and uncertainly in re-filling. Wecontinue to believe the company has one of the best pipelines and R&Dcapabilities in China. What’s New? Hengrui withdrew the application of Retagliptin On April 8, the company announced on Shanghai Stock Exchange that it hadwithdrawn the application of Retagliptin from CFDA. The announcement didnot provide a detailed explanation for the withdrawal but the company wouldre-file the application as soon as possible. Retagliptin is a Class 1.1 new drugfor the treatment of type 2 diabetes. Management previously expected thelaunch of Retagliptin in 2017 and it would be the first DPP-4 inhibitordeveloped by a domestic company. According to the company, clinical trialsfor this drug started in March 2009 and the manufacturing approval was filedin 2H15. The total R&D spending on this product amounted to RMB101m atpresent.
发布日期：2016-04-11 7:57:08
内容： We expect delay for the launch of Retagliptin Hengrui withdrew the application of Retagliptin, an innovative DPP-IV inhibitorfor type 2 diabetes. The company indicated that it is challenging to predict thetimeline for re-filing, however a completely new phase 3 study appearsunnecessary. Management previously expected the product launch in 2017and we expect delay given the withdrawal and uncertainly in re-filling. Wecontinue to believe the company has one of the best pipelines and R&Dcapabilities in China. What’s New? Hengrui withdrew the application of Retagliptin On April 8, the company announced on Shanghai Stock Exchange that it hadwithdrawn the application of Retagliptin from CFDA. The announcement didnot provide a detailed explanation for the withdrawal but the company wouldre-file the application as soon as possible. Retagliptin is a Class 1.1 new drugfor the treatment of type 2 diabetes. Management previously expected thelaunch of Retagliptin in 2017 and it would be the first DPP-4 inhibitordeveloped by a domestic company. According to the company, clinical trialsfor this drug started in March 2009 and the manufacturing approval was filedin 2H15. The total R&D spending on this product amounted to RMB101m atpresent.
