/KINTOR PHARMA-B - VOLUNTARY ANNOUNCEMENT - POSITIVE INTERIM RESULT IN LONG-TERM HUMAN SAFETY TRIAL OF KT-939 AND COMMENCING OF REGISTRATION APPLICATION FOR THE NEW RAW MATERIAL
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KINTOR PHARMA-B - VOLUNTARY ANNOUNCEMENT - POSITIVE INTERIM RESULT IN LONG-TERM HUMAN SAFETY TRIAL OF KT-939 AND COMMENCING OF REGISTRATION APPLICATION FOR THE NEW RAW MATERIAL

HKEXnews
2026/06/10[Other - Business Update]

KINTOR PHARMA-B - VOLUNTARY ANNOUNCEMENT - POSITIVE INTERIM RESULT

IN LONG-TERM HUMAN SAFETY TRIAL OF KT-939 AND COMMENCING OF REGISTRATION APPLICATION FOR THE NEW RAW MATERIAL

開拓藥業有限公司 *

KINTOR PHARMACEUTICAL LIMITED

(Incorporated in the Cayman Islands with limited liability)

(Stock code: 9939)

VOLUNTARY ANNOUNCEMENT

POSITIVE INTERIM RESULT

IN LONG-TERM HUMAN SAFETY TRIAL OF KT-939 AND

COMMENCING OF REGISTRATION APPLICATION FOR THE NEW

RAW MATERIAL

This is a voluntary announcement made by Kintor Pharmaceutical Limited (the "Company", together with its subsidiaries, the "Group") to update its shareholders and potential investors on the latest developments regarding the key product, KT-939 of the Group, including the following aspects:

  1. Long-Term Human Safety Trial of KT-939

Reference is made to the voluntary announcement of the Company dated 9 September 2025, in relation to the long-term human safety trial (the "Long-Term Safety Trial") of KT-939, for which the enrollment of all subjects was completed in September 2025.

The Long-Term Safety Trial is an open-label, single-arm, single-center study designed to evaluate the potential for long-term topical use of cosmetics containing the raw material KT-939 to induce adverse skin reactions in humans, with a primary focus on the safety of topical application of 0.2% KT-939 for 52 consecutive weeks.

The interim results show that a total of 119 subjects received continuous administration of KT-939 for 28 consecutive weeks, and none of them experienced any adverse skin reactions, including cosmetic contact dermatitis, cosmetic photosensitivity dermatitis, cosmetic hyperpigmentation, cosmetic contact urticaria, and cosmetic acne, fully demonstrating the excellent safety profile of KT-939. The Company will continue to advance the Long-Term Safety Trial, which is expected to be completed in September of this year.

  1. Launch of the Registration Application for the New Raw Material KT-939

According to the Regulations on Supervision and Administration of Cosmetics, which took effect in 2021, new cosmetic raw materials for high-risk cosmetics such as freckle-removing and whitening products must be registered and approved by the National Medical Products Administration ("NMPA") in China before they can be marketed. When submitting an application, the Company must provide a complete set of technical documentation, including safety assessments, efficacy studies, manufacturing processes, and quality control procedures.

The Company has recently commenced the rolling submission of registration application materials, and the relevant technical document has been formally submitted to the National Institutes for Food and Drug Control (the "NIFDC"), an affiliate of the NMPA, to conduct technical communication and exchanges. The Company then will follow the guidance provided by the NIFDC to steadily advance the application process for KT-939 as a new cosmetic raw material.

  1. Business Partnership Progress on the KT-939

Although the market expansion efforts for KT-939 have been hindered by competitors, the Company remains committed to an open and collaborative approach, aiming to providing global consumers with high-quality and innovative whitening cosmetics products. The Company is comprehensively advancing partnerships with international and domestic cosmetics brands, raw material suppliers, and end-product developers.

According to China's cosmetics regulations, a special cosmetics registration certificate shall be obtained for cosmetic products with whitening efficacy before launch. Meanwhile, the state encourages simultaneous registration applications for special cosmetic products and innovative raw materials. Guided by the above policy, the Company expects to enter into strategic partnerships with more domestic and international brands in whitening category to jointly advance product development and market layout.

  1. Patent Application Progress of KT-939 Series Innovative Compounds

Since its inception, the Company has been engaged in the research and application of innovative drugs and active compounds, particularly in the field of small molecules. By combining AI technology with chemical design, the Company has filed and obtained more than 100 national patents, thereby establishing a technical protection mechanism for products.

The Company is accelerating the process of securing global patent rights for KT-939 and its analog series. In accordance with the PCT international patent regulations, this project has entered the examination process in relevant countries, and priority review has recently been requested in certain key regions. Through a comprehensive global intellectual property network, the Company will provide robust legal protection for the subsequent clinical development and commercialization of KT-939.

By order of the Board

KINTOR PHARMACEUTICAL LIMITED

Dr. Youzhi Tong

Chairman of the Board, Executive Director and Chief Executive Officer

Hong Kong, 10 June 2026

As at the date of this announcement, the executive Directors are Dr. Youzhi Tong and Dr. Xiang Ni; the non-executive Directors are Mr. Yunfei Chen and Ms. Geqi Wei; and the independent non-executive Directors are Dr. Michael Min Xu, Mr. Wallace Wai Yim Yeung and Prof. Liang Tong.

  • For identification purpose only