Kangzhe Pharmaceutical (00867): Innovative drug rucotinib phosphate cream Belutuo® increases atopic dermatitis indications (AD) application approved for marketing in China

Zhitong Financial App News, Kangzhe Pharmaceutical (00867) issued an announcement. Its subsidiary Demei Pharmaceutical Co., Ltd. (collectively known as “Demei Pharmaceutical”, an innovative pharmaceutical company specializing in skin health, is applying for independent listing on the main board of the Hong Kong Stock Exchange Limited. For details, see the announcement issued by the Company on April 22, 2025) was approved by the China National Drug Administration (NMPA) on September 2, 2026 for mild moderate atopic dermatitis (AD) New Drug Launch A license application (NDA) was applied for, and a drug registration certificate was obtained on September 3, 2026. The product is used for the local short-term and non-persistent chronic treatment of mild to moderate atopic dermatitis in children 2 years and older and adults without impaired immune function when other topical medications are poorly controlled or not recommended. The current NDA for AD indications was approved by the NMPA Drug Evaluation Center for “new varieties, dosage forms and specifications of pediatric drugs that meet the physiological characteristics of children” to be included in the list of priority review varieties, effectively shortening the review cycle and speeding up the approval of this AD indication.

In January 2026, Balutuo® was approved by China's NDA, making it the first topical JAK inhibitor approved in China for the treatment of vitiligo. The approval of the AD Indication NDA marks the successful expansion of Valuteur® into the second field of indication. It will provide new AD therapies proven to be safe and effective by clinical data for AD patients aged 2 and above.

Demei Pharmaceuticals has built a comprehensive “treatment+care” solution for AD, including topical topical formulations - Bellutuo® (mild to moderate AD), injectable biological agents - Comecipimab injection MG-K10 (moderate to severe AD), oral small molecule targeted drugs - CMS-D001 (moderate to severe AD), and daily repair - Hezero relief product series to meet the management needs of AD patients from treatment to daily care.

Lucotinib phosphate cream is an innovative cream made from rucotinib, a selective JAK1/jAK2 inhibitor developed by InCyte. Valutol® has successfully reached the main end point in a randomized, double-blind, placebo clinical study of mild to moderate AD, that is, the proportion of subjects who used the product for 8 weeks, achieved an overall evaluation (IGA) score of 0 or 1 point, and improved by at least 2 points from the baseline, which was significantly higher than that of placebo (63.0% vs. 9.2%, P<0.001). As a key secondary endpoint, the proportion of participants who achieved an improvement of at least 75% (EASI 75) in the eczema area and severity index score for 8 weeks of treatment with Balutyl® compared to the baseline was also significantly better than placebo (78.0% vs. 15.4%, P<0.001). In terms of safety, most of the adverse events (TEAE) that occurred during the treatment period were mild or moderate in severity. There was no TEAE that led to the termination of the study drug, and overall safety tolerability was good. AD is a chronic, recurrent, and inflammatory skin disease. The main clinical symptoms are dry skin, chronic eczema-like skin damage, and obvious itching, which may seriously affect the patient's quality of life. According to estimates, there were more than 54 million patients with atopic dermatitis in China in 2024. Based on the SCORAD score, the proportion of mild to moderate atopic dermatitis was 98%, or more than 52.5 million patients. Topical medication is the most basic treatment for AD. Traditional topical drugs, such as topical glucocorticoids (TCS) and topical calcineurin inhibitors (TCIs), have long-term adverse effects or clinical pain points with limited efficacy, and there is an urgent need for new clinical treatment options.

Following the approval of Belutuo® as an indication for vitiligo, the AD indication NDA has now been approved, which will further expand the clinical application space of the product. At the same time, it will also strengthen Demei Pharmaceuticals' strategic layout in the field of skin treatment, and collaborate with the innovative drug Yilutu (tirikizumab injection), the exclusive drug Xiliaotul (polysulfonic acid mucopolysaccharide cream), and a series of new drugs and dermatological-grade skincare products that are currently in the commercialization stage in terms of expert networks and market resources to enhance the market competitiveness and brand influence of Demei Pharmaceuticals in the field of skin health.

On December 2, 2022, the Group obtained exclusive licensing rights for products developed, registered and commercialized in mainland China, the Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan and 11 Southeast Asian countries (regions) through a cooperation and licensing agreement with Incyte for products produced in the region. Demei Pharmaceutical has re-licensed the relevant rights for lucotinib phosphate cream in regions other than mainland China to the Group (excluding Demei Pharmaceuticals).

Incyte has the global development and commercialization rights for lucotinib phosphate cream and sells it in the US and Europe under the name Opzelura®. Opzelura® and the Opzelura® logo are registered trademarks of Incyte. In the US, rucotinib phosphate cream is the first topical JAK inhibitor approved by the US Food and Drug Administration (FDA). It can be used for topical treatment of non-segmental vitiligo in adults and children aged 12 years and above; and local short-term and discontinuous chronic treatment of mild to moderate AD in children aged 2 and above who are not immunocompromised when other topical medications are poorly controlled or not recommended. In Europe, lucotinib phosphate cream is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents aged 12 and above, and for treating TCS and moderate AD in adults with poor efficacy or unrecommended use of TCS and TCIS.