Completion of Long-term Safety Clinical Trial of KX-826 Tincture 1.0% For The Treatment of Male A...

Suzhou, 3 November, 2026-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the long-term safety clinical trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of androgenetic alopecia has completed follow-up visits for the subjects, demonstrating favorable safety.

In accordance with the ICH-E1 guidance principle and the requirements of the National Medical Products Administration of the PRC Announcement (No. 88 of 2019) on the Application of “E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions”, KX-826 tincture 1.0%, as a drug intended for the long-term treatment of non-life-threatening conditions (chronic or intermittent use for more than 6 months), is required to undergo a 1-year long-term trial to assess its safety. To meet the above-mentioned requirements, the Long-term Safety Clinical Trial adopted a multi-center, open-label design and aims to evaluate the long-term safety of the topical use of KX-826 tincture 1.0% for the treatment of AGA patients in China (treatment period of 1 year).

The Long-term Safety Clinical Trial involves a total of 12 clinical research centers in China, with Professor Jianzhong Zhang (张建中) and Professor Cheng Zhou (周城) from Peking University People’s Hospital serving as the lead principal investigators. The primary endpoint of the trial is the incidence of treatment-emergent adverse events that occurred during the study and other safety indicators. This trial adopted KX-826 tincture 1.0% BID (i.e. twice a day) as the drug-related dosage. The results of the clinical trial exhibited satisfactory safety.

As an essential trial for the submission of the new drug application (NDA) for KX-826, the results of the Long-term Safety Clinical Trial further validate the safety and efficacy of long-term use of KX-826. These results, together with other materials including the positive phase III clinical trial results announced in March 2026, will be incorporated into the main NDA submission package and submitted to the NMPA in the near future.

About Kintor Pharmaceutical Limited

Founded in 2009, Kintor Pharmaceutical Limited focuses on developing and commercializing potential "first-in-class" and "best-in-class" innovative drugs and functional cosmetics, aiming to be a leading enterprise in such areas, and establish a “troika” business model formed by R&D business of innovative topical drugs, B2B business of functional cosmetic raw materials and B2C business of functional cosmetic products. After several years' development, the Company has developed diverse product pipeline built on dermatology related diseases. The products cover diseases with high incidence rate globally and extend to functional cosmetics, which can meet the needs of clinical dermatology and cosmetics consumers worldwide. Kintor Pharma's layout includes innovative small molecule and biologic drugs, consisting of five productsunder clinical development and several preclinical research programs. Kintor Pharma has been granted more than 100 patents worldwide. On 22 May 2020, Kintor Pharma was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK. For more information, please visit www.kintor.com.cn.

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