Bleomycin

In the clinical treatment of malignant tumors such as malignant lymphoma and squamous cell carcinoma, the selection of chemotherapy drugs is directly related to the survival benefit of patients. Bleomycin is an alkaline glycopeptide anti-tumor antibiotic with a unique mechanism of action. It can intercalate into the DNA strands of tumor cells, induce single-strand and double-strand DNA breaks, and inhibit the DNA synthesis of tumor cells, without causing obvious myelosuppressive effects. It is often used as one of the core components of combination chemotherapy regimens. The clinical indications of this drug cover Hodgkin lymphoma, non-Hodgkin lymphoma, squamous cell carcinoma of the skin, head and neck, and esophagus, testicular cancer, etc. It can also be used for the local treatment of malignant pleural effusion, and the applicable population includes treatment-naive and relapsed patients with the above-mentioned tumor types.

The global bleomycin market size has maintained steady growth in recent years. In 2023, the market size was approximately USD 270 million, with a compound annual growth rate of around 3.2%. Due to the early launch time of this drug, generic drugs have gradually dominated the market after the expiration of the patent. Currently, generic drugs account for more than 75% of the global market. The Chinese market has a high degree of localization. Bleomycin API and preparations produced by local enterprises have basically met domestic clinical needs, and only a small number of high-end preparations rely on imports. The price is significantly affected by the centralized procurement policy. After being included in the centralized procurement in 2021, the terminal price of the preparations has dropped by more than 60%.

The original developer of bleomycin is Nippon Kayaku Co., Ltd., and the original brand name is Bleocin®. Its core compound patent expired around 1993 in major global markets. At present, the main dosage form approved for the original product is bleomycin hydrochloride for injection, with a conventional specification of 15 mg per vial. The original preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, as of now, a total of 4 enterprises have obtained CDE registration numbers (status A) for bleomycin API, and multiple domestic enterprises have obtained marketing approval for bleomycin hydrochloride for injection preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for quality research of bleomycin, CATO provides 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 products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can directly support the quality research, stability study and registration declaration of APIs, helping relevant enterprises shorten the R&D cycle and reduce compliance risks.