Recently, Hengrui Pharmaceuticals has received the Certificate of Drug Registration issued by the State Drug Administration, which approves Thiotepa for Injection (Trademark: Ruihang®, two specifications of 15mg and 100mg) to be listed in Class 3 of the Chemical Drugs, with the indication of "This product is suitable for the pre-treatment of allo-HSCT for children with β-thalassemia major (<18 years of age)". The indication of the product is "This product is suitable for allogeneic hematopoietic stem cell transplantation (allo-HSCT) pretreatment for children (<18 years old) with beta-thalassemia major". Thiotepa for injection is the first generic product in China and has been approved for sale in the United States and Europe. Thiotepa is the first Thiotepa product approved for transplantation preconditioning in China.

Beta-thalassemia (β-thalassemia for short) is a common hemolytic disease in clinic, and there are about 300,000 patients with severe and intermediate β-thalassemia in China at this stage.1 Currently, the main therapeutic measures are blood transfusion therapy, iron removal therapy and hematopoietic stem cell transplantation, of which transplantation is an important means of curing β-thalassemia in clinic, and it can improve the survival rate of the patients up to 90%.2 In recent years, more and more patients with β-thalassemia have gained better quality of survival through transplantation. In recent years, an increasing number of patients with β-degenerative anemia have achieved a better quality of survival through transplantation.

Pretreatment is an important part of the transplantation system, and the ideal pretreatment drug needs to combine good efficacy with low toxicity and side effects. Thiotepa is a broad-spectrum antitumor drug with strong cytotoxicity for pre-transplantation myeloablative preconditioning, which is well recognized and used worldwide. Thiotepa-containing pretreatment regimen has the core advantages of comprehensive marrow purification, promotion of hematopoietic stem cell implantation, and good tolerability, which can improve the success rate of transplantation and reduce the recurrence rate of the disease after transplantation3, and is expected to help transplantation to cure children with severe β-degenerative anemia.

The original research product of Thiotepa for injection has not yet been approved for marketing in China. The Company's Thiotepa for injection will be approved for sale in the United States and Europe in 2018 and 2022. In recent years, Hengrui Pharmaceuticals has continued to increase the implementation of its internationalization strategy, and has continued to promote overseas registration applications, and has obtained more than 20 registration approvals in Europe, the United States and Japan, including injections, oral preparations and inhalational anesthetics, and the company's products have entered more than 40 countries, and continues to accelerate the development of the global market and focus on emerging markets.

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