Thiotepa

In the multi-line treatment of hematological malignancies and solid tumors, alkylating agents have always been one of the basic medication options. As a representative variety of ethylenimine alkylating agents, thiotepa forms cross-links with cellular DNA to inhibit DNA synthesis and cell mitosis, and it is a cell cycle non-specific drug. It is widely used in the clinical treatment of breast cancer, ovarian cancer, bladder cancer and malignant body cavity effusion. Meanwhile, it is also one of the core medications in the conditioning phase of hematopoietic stem cell transplantation, covering adult and pediatric patients with hematological tumors and transplantation-adapted populations with solid tumors, and is an indispensable component of multidisciplinary combined treatment regimens.

As a classic anti-tumor drug that has been in clinical use for more than 60 years, the global market size of thiotepa was close to US$400 million in 2023, with a compound annual growth rate maintained at around 7%. The growth momentum mainly comes from the expansion of clinical demand for hematopoietic stem cell transplantation. The domestic market is currently dominated by imported preparations and a small number of domestic generic drugs. After the national medical insurance negotiation in 2021, the annual treatment cost of thiotepa preparations dropped from more than 300,000 yuan to about 80,000 yuan, which greatly improved the accessibility for patients and also drove the continuous rise in demand for upstream API. At present, the domestic API gap of this variety is still relatively obvious.

The original research enterprise of thiotepa is Riemser Arzneimittel AG of Germany, with the original brand name Thioplex. Its core compound patent has expired globally, and currently only peripheral patents related to preparation processes are retained in major markets. The dosage form approved by the original research is powder for injection, with specifications including 15mg/vial and 100mg/vial, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Second Batch)*. At present, a total of 3 domestic enterprises have obtained A-status registration numbers for thiotepa API through the CDE registration platform, and another 8 domestic thiotepa injections have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for thiotepa API. Most of the products are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the full-process needs of pharmaceutical enterprises in API R&D, quality research and declaration.