Kintor Pharma-B (09939) has announced an update regarding the long-term human safety study for KT-939, which completed enrollment of all participants in September 2025.
This long-term safety study is an open-label, single-arm, single-center investigation designed to assess the potential for human skin adverse reactions from the long-term topical use of cosmetics containing the KT-939 ingredient.
The primary focus is on the safety of applying 0.2% KT-939 topically to the skin for 52 consecutive weeks.
Interim results show that, after 119 subjects used KT-939 continuously for 28 weeks, none experienced any skin adverse reactions.
These include cosmetic contact dermatitis, cosmetic photosensitive dermatitis, cosmetic pigmentary skin disorders, cosmetic contact urticaria, and cosmetic acne, fully demonstrating the favorable safety profile of KT-939.
The company will continue to advance this long-term safety trial, which is expected to be completed in September of this year.
According to the Cosmetic Supervision and Administration Regulations implemented in 2021, new cosmetic ingredients for high-risk categories such as spot-removing and whitening must undergo registration and approval by the National Medical Products Administration before they can be marketed.
Submission for registration requires a complete set of technical documentation, including safety assessments, efficacy studies, preparation processes, and quality control.
The company has recently commenced the process of rolling submission of the registration application documents, with the relevant technical materials formally submitted to the National Institutes for Food and Drug Control (NIFDC) under the NMPA for technical communication and exchange.
The company will subsequently follow the guidance from the NIFDC to steadily advance the new cosmetic ingredient registration application for KT-939.
Although the market and commercial development work for KT-939 has faced interference from competitors, the company remains committed to an open cooperation model, aiming to provide global consumers with high-quality innovative cosmetic whitening products.
The company's collaborations with international and domestic cosmetic brand owners, cosmetic raw material suppliers, and cosmetic finished product developers are being comprehensively advanced.
Under China's cosmetic management regulations, cosmetic products with whitening efficacy must obtain a special cosmetic registration certificate before they can be marketed.
Simultaneously, the state encourages the concurrent submission of registration applications for special cosmetics and innovative ingredients.
Based on this policy direction, the company looks forward to establishing strategic partnerships with more domestic and international cosmetic brand companies in the whitening category to jointly advance product development and market positioning.
Since its establishment, the company has long been engaged in the research and application of innovative drugs and active compounds, particularly in the small molecule field.
By combining AI technology with chemical design, the company has applied for and been granted over a hundred national patents, establishing a technical protection mechanism for its products.
The company is comprehensively accelerating the global patent confirmation process for KT-939 and its analog series.
In accordance with PCT international patent rules, this project has successively entered the examination procedures in relevant countries, and priority review has been applied for in some core regions recently.
The company will leverage a robust global intellectual property network to provide solid legal protection for the subsequent clinical development and commercialization of KT-939.
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