Deck Pharma's first new drug approved in China

Article source: Pharmaceutical Guanlan

On December 16, the official website of China's National Medical Products Administration (NMPA) announced that a new anti-cancer drug Selinexor (ATG-010) was approved

It is worth mentioning that this is a new drug introduced by Deqi Pharma, and it is also the first new drug approved in China by Deqi Pharma since its establishment

Image source: NMPA official website

Celiniso was originally developed by Karyopharm Therapeutics

In the United States, Celiniso has been approved by the FDA to treat multiple indications, including multiple myeloma and diffuse large B-cell lymphoma

Earlier, Deqi Pharmaceuticals obtained the exclusive development and commercialization rights of Celiniso in many Asia-Pacific markets including Greater China and South Korea

At the end of July this year, Deqi Pharmaceuticals announced that the new drug listing application of Celiniso and dexamethasone has been approved by the Ministry of Food and Drug Safety (MFDS) priority review process for the treatment of at least four previous treatments (including Four-line therapy including two proteasome inhibitors, two immunomodulators, and CD38 monoclonal antibody) for adult patients with relapsed or refractory multiple myeloma, and single-agent therapy for relapsed or refractory patients who have previously received at least second-line treatment Treatment of adult patients with diffuse large B-cell lymphoma (rrDLBCL)

In early 2021, Celiniso submitted a new drug marketing application in China and was included in the priority review in February

According to public news, Deqi Pharmaceutical has made preparations in advance for the commercialization of the drug

Reference materials:

[1] Information to be obtained for the drug approval certificate issued by the National Medical Products Administration of China on December 16.