Bristol-Myers Squibb's 'first-in-class' anemia treatment expected to be approved in China soon

Article source: Pharmaceutical Guanlan

The latest announcement on the official website of China’s National Medical Products Administration (NMPA) shows that the status of the listing application for luspatercept for injection filed by Celgene, a subsidiary of Bristol-Myers Squibb (BMS), has been updated to “under approval”.

Screenshot source: NMPA official website

Beta-thalassemia is a hereditary blood disorder characterized by anemia caused by reduced or absent beta-globin peptide synthesis

Rottecept is currently approved in the United States, Canada and the European Union for the treatment of adult patients with beta-thalassemia who require regular red blood cell transfusions, and in the United States and the European Union for the treatment of anemia in patients with certain blood disorders

In February 2021, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration accepted the marketing application of rotacept for injection and included it in priority review as a "conditionally approved drug" for treatment Adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions

According to an earlier press release issued by Bristol-Myers Squibb, the listing application of Rottecept in China was included in priority review based on a randomized, double-blind, placebo-controlled, multicenter global Phase 3 clinical trial called BELIEVE.

The results of the BELIEVE clinical study showed that after rotercept treatment, 21.

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References:

[1] China National Medical Products Administration Drug Registration Progress Inquiry.

[2] Bristol-Myers Squibb’s innovative hematology drug Luspatercept received priority review from CDE.