Benvitimod

Chronic inflammatory skin diseases such as psoriasis and atopic dermatitis have long been faced with the clinical dilemmas of repeated and refractory conditions and obvious side effects of topical medication. The advent of benvitimod provides a brand-new option for the topical treatment of such diseases. As a non-hormonal small-molecule inflammation inhibitor, it exerts its effects by inhibiting the release of pro-inflammatory cytokines, blocking T cell activation and skin inflammatory reactions mediated by inflammatory mediators. Compared with traditional glucocorticoids, it has no risks of skin atrophy, hyperpigmentation and other adverse events associated with long-term use. It is clinically mainly used for the topical treatment of mild to moderate plaque psoriasis in adults, and can also be used for symptomatic intervention of chronic inflammatory skin diseases such as atopic dermatitis, which is suitable for dermatosis patients who need long-term maintenance medication.

In recent years, the global market size of psoriasis medications has exceeded 20 billion US dollars, among which topical medications account for approximately 17%, with a compound annual growth rate maintained at around 5.8%. As the world's first topical dermatological medication of the aryl hydrocarbon receptor modulator class, benvitimod, with its advantages of being non-hormonal and high safety, has become a key variety in the field of topical psoriasis treatment in China. At present, there are no generic products available in the domestic market, and the original research product is in the exclusive supply stage. In 2023, the total sales volume in domestic public hospitals and retail terminals exceeded 320 million yuan. With the improvement of clinical awareness and the expansion of indications, the market growth rate is expected to reach more than 12% in the next 3 years.

The original research enterprise of benvitimod is Guangdong Zhonghao Pharmaceutical Co., Ltd., and the brand name of the original research product is "Xinbike". The expiration date of its compound patent in China is 2031. At present, the main dosage form approved in China is benvitimod cream, with a specification of 10g:0.1g (1%). This product has been included in the China Listed Drug Catalog, and is used as a reference preparation for generic research and development. In terms of API registration, only the A-status registration number associated with the original research is valid at present, and no APIs from other enterprises have passed the review of the Center for Drug Evaluation (CDE). The only preparation approved for marketing in China is the original research benvitimod cream. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for benvitimod API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in generic drug research and development, quality research and daily quality control.