Hengrui Pharmaceuticals announced on May 25th that recently, the company received the "Drug Supplement Application Approval Notice" approved and issued by the National Drug Administration, and the company's Mesna Injection passed the quality and efficacy consistency evaluation of generic drugs. Becoming the first domestically produced and evaluated product of this variety. As of now, Hengrui Pharmaceutical has invested 5.17 million yuan in research and development expenses for the consistency evaluation of this product.
The original drug was developed by Asta Medica AG and was approved for sale in Germany in December 1979. It was approved for entry into the Chinese market in 2002. In 2021, the global sales volume of Mesna related formulations was approximately $41.7 million. There have been multiple approved versions of Mesna raw materia in China, and Hengrui Pharmaceuticals started the consistency evaluation of this product in 2020, making it the first enterprise
What is Mesna?
Sodium 2-mercaptoethanesulfonate is a white hygroscopic powder with a specific odor, which is easily oxidized, especially in humid environments. When in contact with oxygen, it quickly decomposes into dimes sodium (Equation II). It is an auxiliary use of anti-tumor drugs, and can be used as a urethral protectant.
Its principle of action is:Mesna raw powdercombines with toxic substances such as acrolein, a metabolite of ifosfamide and cyclophosphamide after large dosage use, to generate stable and non-toxic thioether, which can be discharged with metabolism, thus preventing and alleviating the symptoms of hemorrhagic cystitis caused by it.
What is the purpose of the approved product?
The purpose of this product is to prevent the side effects of urological squamous cells such as exudative cystitis caused by chemotherapy and radiotherapy for tumors with high demand for cyclophosphamide or ifosfamide. It can be used as a protective film for urinary system when used in combination with the anti-tumor chemotherapy drug ifosfamide or cyclophosphamide.
Mesna is similar to Cystine acid-Cystine in physiology. In human body, the drug quickly undergoes the catalytic reaction rate of enzyme to become its kind of compound mesna disulfide. Mesna can also react with other internal potassium thiocyanate (such as cystine) to form mixed disulfide. This kind of disulfide can temporarily reduce the level of potassium thiocyanate in blood. After using this product, only a small amount of therapeutic drugs exist in the systemic blood respiratory system in the form of potassium thiocyanate. Mesna disulphide is stable, it permeates the respiratory system and is quickly transported to renal function. In renal tubular squamous epithelial cells, many mesna disulfides are remelted into free potassium thiocyanate. In this way, mesna can maintain the bladder together with cyclophosphamide, ifosfamide 4- hydroxy compounds and acrolein in urine.
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