Topotecan

As a topoisomerase I inhibitor chemotherapeutic drug, topotecan exerts cytotoxic effects by reversibly binding to the topoisomerase I-DNA complex and preventing the re-ligation of broken single-stranded DNA, thereby interfering with the DNA replication and transcription processes of tumor cells. Clinically, it is mainly used for patients with metastatic ovarian cancer who have failed initial chemotherapy or sequential chemotherapy, as well as patients with small cell lung cancer who are intolerant to first-line chemotherapy or have failed chemotherapy. It can also be combined with cisplatin for the treatment of advanced cervical cancer that cannot be treated with surgery and radiotherapy, and is an important later-line treatment option in the field of recurrent and refractory gynecological tumors and neuroendocrine tumors.

At present, the global market size of topotecan is approximately USD 320 million. Driven by the steady increase in the number of patients with recurrent ovarian cancer and small cell lung cancer, the compound annual growth rate in the past three years has maintained at 4.7%. In terms of the domestic market, with the implementation of the centralized procurement policy, the winning bid price of topotecan preparations has dropped by nearly 65%, the overall market size has stabilized at RMB 230 million, and the accessibility of medication has been greatly improved. In terms of the competitive landscape, there are more than 12 existing generic drug enterprises, and the API supply side is still dominated by imported products and leading local enterprises. After centralized procurement, the demand of preparation enterprises for high-quality and cost-controllable APIs continues to be released.

The original developer of topotecan is GlaxoSmithKline, with the original brand name Hycamtin. Its core compound patent in the United States expired in 2007, and its compound patent in China expired in 2008. The main dosage forms approved for the original drug include freeze-dried powder for injection (specifications: 1mg, 4mg) and capsules (specifications: 0.25mg, 1mg). The original topotecan for injection has been included in the China Listed Drug Catalogue and is also listed as a reference preparation by the FDA. Up to now, there are 6 pieces of topotecan API registration information on the API registration platform of China CDE, among which 3 have been activated and are available for preparation use. The domestically approved topotecan preparations for marketing include two dosage forms, injection and capsule, with a total of more than 20 preparation approvals. (Data as of December 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of topotecan impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and preparation consistency evaluation.