Chlorquinaldol

Gynecological infection is a highly prevalent disease among women, and the precision and safety of local anti-infective therapy have long been the focus of clinical attention. Chlorquinaldol is a quinoline derivative anti-infective drug. It exerts broad-spectrum antibacterial, antifungal and antiprotozoal effects by inhibiting DNA synthesis and metabolic enzyme activity of pathogenic microorganisms. It is often clinically administered locally for the treatment of various vaginal infections such as bacterial vaginosis, trichomonal vaginitis, vulvovaginal candidiasis, etc. It can also be used for local anti-infective intervention of cervicitis, and the applicable population covers adult women with indications of reproductive tract infection. The local administration mode greatly reduces the risk of adverse reactions of systemic medication.

The global market size of chlorquinaldol has maintained steady growth in recent years. In 2023, the global market size was approximately USD 120 million, among which the gynecological local medication field accounted for more than 85%. The growth rate of the Chinese market is higher than the global average, with a compound annual growth rate of 7.2% from 2021 to 2023, which is mainly benefited from the improvement of the coverage of primary gynecological diagnosis and treatment. In terms of the competitive landscape, the original research products still account for about 40% of the global market share. Domestic generic drug enterprises mainly focus on the production of local preparations, and the supply of active pharmaceutical ingredients (APIs) has long been dependent on imports. In recent years, local enterprises have started the registration and declaration of APIs, and the import substitution space is clear.

The original research enterprise of chlorquinaldol is Merck Group, and the original research trade name is "Chlorquinaldol/Promestriene Vaginal Tablets" (compound preparation). The core compound patent expired globally in 2004. The main dosage form of the original research marketed product is vaginal tablet, with the specification of each tablet containing 200mg chlorquinaldol and 10mg promestriene. This compound preparation has been included in the *Catalogue of Chemical Reference Preparations (Second Batch)* of China, and is also listed in the FDA Reference Preparations Catalogue. Up to now, there is no single-component chlorquinaldol preparation approved for marketing in China. No enterprise has submitted the A-status registration number of chlorquinaldol API on the CDE API registration platform, and only the registration applications submitted by 2 enterprises are in the review and approval stage. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of chlorquinaldol impurity reference standards, which can cover the whole process quality control requirements from R&D to registration and declaration. 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 Chinese Pharmacopoeia and FDA, which can help enterprises shorten the R&D cycle and reduce registration risks.