Bristol-Myers Squibb's 'Rottercept' to be approved for beta thalassemia

On January 24, the official website of NMPA showed that Celgene Pharmaceuticals, a subsidiary of Bristol-Myers Squibb Pharmaceuticals, entered the administrative approval stage for its marketing application for “Rotesipro for Injection” and is expected to be approved for import in the near future

Earlier, according to a BMS press release, this was the company's first innovative blood disease drug that was included in priority review after submitting overseas clinical trial data to CDE

From: NMPA official website

Luspatercept for injection (English trade name Reblozyl, self-made Chinese trade name: Liblozyl) is a world-first erythrocyte maturation agent used to regulate late erythrocyte maturation

Historical Pharmaceutical Transactions of Rottesip

From: Insight database (http://db.

According to Insight's global new drug library, Luspatercept was approved by the US FDA as early as November 2019, and has also been approved in Canada and the European Union

Beta-thalassemia is a hereditary blood disorder characterized by anemia caused by the reduction or lack of β-globin peptide chain synthesis, and it is one of the most common inherited hemoglobin disorders worldwide

However, the shortage of blood sources, unstable supply of blood products, and long-term blood transfusion can lead to iron overload in patients, increased economic burden, and potential risk of infection, all of which make lifelong blood transfusion difficult to guarantee

As the world's first recombinant fusion protein drug, rotacept increases hemoglobin levels by promoting the maturation of advanced red blood cells

The marketing application for rottercept is based on data from a global Phase III clinical study called BELIEVE

The results showed that after Luspatercept treatment, 21.

It is expected that after the drug is launched, it can provide domestic patients with new drug options with therapeutic advantages and help related patients improve their quality of life