Amifostine

Normal tissue injury induced by radiotherapy and chemotherapy is a core clinical pain point that limits the therapeutic dose of tumors and reduces the quality of life of patients. Amifostine, as a broad-spectrum cytoprotective agent, provides a mature solution to this dilemma. This drug is a thiophosphate prodrug. After entering the body, it can be activated by alkaline phosphatase to generate free sulfhydryl compounds, which selectively scavenge oxygen free radicals produced by radiotherapy and chemotherapy, while reducing the accumulation of chemotherapeutic drugs in normal tissues without reducing the effect of anti-tumor therapy. Clinically, it is mainly used to alleviate the nephrotoxicity and hematological toxicity in patients with solid tumors such as lung cancer, ovarian cancer and breast cancer when receiving chemotherapy with cisplatin, cyclophosphamide, etc. It can also reduce the incidence of oral mucositis and xerostomia caused by radiotherapy for head and neck tumors, and the applicable population covers adult patients with solid tumors who need to receive radiotherapy and chemotherapy.

The global amifostine market size was approximately USD 180 million in 2023, and it is expected to grow steadily at a compound annual growth rate of 3.2% from 2024 to 2030. The growth momentum mainly comes from the rising incidence of tumors and the increasing clinical attention to the management of adverse reactions of radiotherapy and chemotherapy. The domestic market has formed a competitive pattern where the original research drugs and generic drugs coexist. A total of 6 enterprises hold the approval documents of amifostine preparations, and 3 enterprises have completed the registration of active pharmaceutical ingredients. The terminal sales in public hospitals exceeded RMB 300 million in 2023. The overall supply pattern is stable, and the drug has not yet been included in the national centralized volume-based procurement catalog.

The original research enterprise of amifostine is MedImmune, a US-based company, and the original research trade name is Ethyol. The core compound patent expired in the United States in 2007, and the compound patent in China also expired in 2008. The originally marketed dosage form is powder for injection, with specifications including 500 mg/vial and 1 g/vial. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* by the National Medical Products Administration (NMPA) of China. At present, there are 3 A-status registration numbers for amifostine active pharmaceutical ingredients in China, and 12 approval documents for domestic amifostine injections. The original research preparation has not been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the demands for impurity research and quality control in the research and development and production of amifostine, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide reliable material basis support for pharmaceutical enterprises in consistency evaluation, quality standard establishment and routine release testing.