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Bayer's Copanlisib lyophilized preparation for injection is planned to be included in the priority review program

 Last Update: 2021-04-24
 Source: Internet
 Author: User

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On April 7, CDE's official website revealed that Bayer's Copanlisib lyophilized preparation for injection was planned to be included in the priority review process.

Copanlisib is an intravenously injected phosphatidylinositol-3-kinase (PI3K) inhibitor.

In October 2020, Bayer announced the results of a phase 3 clinical study CHRONOS-3.

Copanlisib was first approved by the FDA for accelerated marketing in September 2017 for the treatment of adult patients suffering from recurrent follicular lymphoma and who have received at least two systemic therapies.

In addition, Copanlisib is also carrying out a phase III study of CHRONOS-4 (domestic registration number: CTR20160362) combined with standard immunochemotherapy for the treatment of recurrent iNHL.

The fastest progress in the research and development of this target in China is Bayer's Copanlisib, Novartis's Apieliser and Buparlisib, Roche's Taselisib and GDC-0077 are all in the phase III clinical stage.

Reference source: Medicine Rubik's Cube, Medicine First Time

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