The application for listing of Trotsip for the injection of Baishi Meishiguibao was accepted for priority review

On February 6, CDE's official website revealed that The New Base Pharmaceuticals, a subsidiary of Shishi Shiguibao Pharmaceuticals, had filed a domestic application for listing and was accepted.
the drug is a red blood cell ripening agent for adult patients with β-thalassemia who need regular infusions of red blood cells (RBC).
BMS press release, this is the company's first innovative blood disease drug to be included in the priority review after submitting data from offshore clinical trials to the CDE.
the drug was not clinically tested in China and was listed directly using overseas clinical data, refreshing the "China speed" of the market for new imported drugs.
injection is the world's first red blood cell ripening agent for regulating late-stage red blood cell maturation, using Luspatercept, the English-language trade name Reblozyl, self-created Chinese commodity name: Liblozer.
developed Luspatercept in a joint effort with Acceleron before integrating with Shishi Shiguibao.
According to Insight Global's new drug library, Luspatercept was first approved by the U.S. FDA in November 2019 for the treatment of adult β-thalassemia patients who require regular infusion of red blood cells (RBCs), an adaptive disorder that is currently listed in Canada and the European Union.
In addition, Luspatercept has been approved in the United States and the European Union for the treatment of marrow proliferative abnormal syndrome (MDS) associated with cyclic iron granulocytes or bone marrow proliferating abnormalities/bone marrow proliferating tumors associated with cyclic iron granulocytes and platelet growth associated with anemia.
Luspatercept Adaptation Global State from insight database () β-thalassemia is a hereditary blood disease characterized by anaemia caused by a decrease or deficiency in the synthesis of the β globin peptide chain, and is one of the most common hereditary hemoglobin diseases worldwide.
the prevalence rate of the whole population in China is 0.67%, while in the high-risk areas of the South, the average prevalence rate is about 2%.
severe β-thalassemia is chronic, hemolytic anemia, and patients rely on life-long blood transfusions, iron therapy, or hematopoietic stem cell transplants to sustain their lives.
, however, tight blood sources, unstable supply of blood products, and long-term blood transfusions can lead to iron overload, increased financial burden and potential risk of infection, which make life-long blood transfusions difficult to protect.
the need for innovative drugs is imminent between patients.
the world's first recombinant fusion protein drug, Rotsip improves hemoglobin levels by promoting the maturation of late red blood cells.
new mechanism will hopefully reduce patients' dependence on blood transfusion and iron treatment, improve treatment compliance, and avoid the potential risks of repeated blood transfusions.
In a global Phase III clinical study called BELIEVE based on this Luspatercept inclusion priority review, BELEVE is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study that compares the efficacy of Luspatercept plus Best Support Therapy (BSC) and Placebo-BSC for adults with thalassemia patients who need regular infusion of red blood cells β
trials were conducted in 65 clinical trial centers in 15 countries in a total of 336 patients.
results showed that 21.4 percent of patients treated with Luspatercept had a blood transfusion burden that was more than 33 percent lower than the baseline, significantly better than the placebo group (4.5 percent), and significantly lower iron overload, which could improve the quality of life of patients.
expect the drug review and approval to proceed smoothly, to provide domestic patients with treatment advantages of new drug options, to help patients improve the quality of life.