The listing application for Luspatercept, an innovative drug for blood diseases, was reviewed as a priority by CDE

On February 4, 2021, Shishi Meishiguibao China announced that its red blood cell maturant Luspatercept (English product name Reblozyl Chinese Chinese; The listing application for Liblotzer has been formally accepted by the Drug Review Center (CDE) of the State Drug Administration and has been granted priority review qualification for adult β-thalassemia patients who require regular infusion of red blood cells (RBC).
2018, we have had the privilege of witnessing the 'speed of new drugs in China' being constantly refreshed.
we sincerely thank the Chinese government for its innovative policy support for optimizing drug review and approval and accelerating clinically urgent drug research and development.
"Luspatercept is the first innovative blood disease drug in China to be included in the priority review after submitting data from overseas clinical trials to CDE," said Dr. Cai Xuexuan, Vice President of Global Research and Development and Head of Research and Development in China.
believes the innovative drug will fill the gap in the treatment of thalassemia in China and change the lives of patients.
" life-long blood transfusions are difficult to guarantee, and the treatment of poverty is difficult to solve β-thalassemia is a hereditary blood disease characterized by anaemia due to a decrease or deficiency in the synthesis of the β globin peptide chain.
severe β-thalassemia is a rare disease with chronic hemolysis anemia.
currently rely on life-long blood transfusions, iron therapy or hematopoietic stem cell transplants to sustain their lives.
reality, China's heavy-duty β-thalassemia treatment is facing multiple dilemmas.
blood supply is tight, the supply of blood products is unstable, and long-term blood transfusion can lead to iron overload, increased financial burden and potential risk of infection, which makes life-long blood transfusion difficult to protect.
the need for innovative drugs is imminent between patients.
the world's first creative mechanism, the emergence of "hands" to protect the lives of Chinese patients Luspatercept is expected to break China's β-thalassemia treatment difficulties.
, the world's first recombinant fusion protein drug, Luspatercept improves hemoglobin levels by promoting the maturation of late red blood cells.
The 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, such as long-term iron overload leading to iron deposition in the heart, liver, etc., which can lead to heart failure, cirrhosis, and even death.
According to a Global Phase III clinical study called BELLIEVE based on this Luspatercept inclusion priority review, 21.4% of patients were treated with a blood transfusion burden that was more than 33% lower than the baseline, significantly better than the placebo group (4.5%), and significantly lower iron overload in patients, potentially improving the quality of life of patients.
" inclusion of Luspatercept in the priority review also marked the smooth progress of Shishi Shiguibao's 'China Strategy 2030'.
"With the recent launch of 'China Strategy 2030', we are committed to becoming a leader in core therapeutic areas such as oncology, hematology, immunology, and so on," said Dr. Cai Xuexuan, Vice President of Global Research and Development and Head of Research and Development in China.
next five years, we will accelerate the introduction of nearly 30 innovative drugs or adaptive disorders.
most of them have the potential to become the first (first-in-class) or best-in-class product in the relevant field.
we will take concrete actions to 'lead science and change patient lives' and promote the implementation of the 'Healthy China 2030' national strategy.
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