Recently, Jiudian Pharmaceutical's Crisaborole Ointment officially received a registration approval from the National Medical Products Administration (NMPA), deemed to have passed the generic drug consistency evaluation. The product is a National Medical Insurance Category B drug, indicated for the topical treatment of mild-to-moderate atopic dermatitis in adults and children aged 3 months and older. The approval marks a new breakthrough for Jiudian Pharmaceutical in the topical drug sector, expanding the therapeutic indications of its topical product portfolio from anti-inflammatory and analgesic fields to the regulation of cutaneous immune-inflammatory responses.

Atopic dermatitis is a chronic, recurrent, inflammatory skin disease, and its prevalence among children in China has been increasing year by year. For a long time, topical treatments for mild-to-moderate atopic dermatitis have relied primarily on glucocorticoids and calcineurin inhibitors. However, long-term use of corticosteroids carries risks, and some drugs have restrictions on use in young children, representing a clear unmet clinical need.

Crisaborole is a novel small-molecule, non-hormonal, non-steroidal anti-inflammatory phosphodiesterase 4 (PDE-4) inhibitor. By inhibiting intracellular PDE-4 activity, it reduces the production of pro-inflammatory cytokines, thereby effectively alleviating symptoms such as skin inflammation, erythema, and pruritus. Crisaborole is the first non-hormonal topical PDE-4 inhibitor approved in China and is currently the only topical PDE-4 inhibitor approved for use in patients aged 3 months and older with mild-to-moderate atopic dermatitis in the country.

The product was previously included in China's second batch of "Clinically Urgent Overseas New Drugs." It offers good efficacy, precise targeting, and favorable skin penetration, providing greater convenience for patients with atopic dermatitis. Since the original drug was approved for marketing in China in July 2020, the market for Crisaborole Ointment has grown rapidly. In 2021, its growth rate at urban public hospitals and county-level public hospitals exceeded 1,300%. By 2024, the product's sales in China's three major terminal markets approached CNY 200 million, with a three-year compound annual growth rate of 95.03%, demonstrating strong market acceptance and broad development prospects.

Jiudian Pharmaceutical has long been dedicated to the field of "topical transdermal drug delivery," particularly establishing a strong industry reputation in the local analgesic sector. The official approval of Crisaborole Ointment further enriches Jiudian's topical product portfolio. Looking ahead, Jiudian Pharmaceutical will continue to focus on clinical needs, accelerate R&D innovation, and produce more novel and effective medicines to benefit the public.