开拓药业

VOLUNTARY ANNOUNCEMENT (2) UPDATES IN RELATION TO LONG-TERM SAFETY PHASE III CLINICAL TRIAL OF KX-826 FOR THE TREATMENT OF AGA The Long-term phase III Safety Clinical Trial is a multi-center, open-label study designed to evaluate the long-term safety of the topical use of KX-826 for the treatment of AGA patients in China (treatment period of 52 weeks). The Long-term Safety Clinical Trial involves a total of 16 clinical research centers in China, and Professor Jianzhong Zhang (張建中) from Peking University People’s Hospital is the lead principal investigator. The primary endpoint of the trial is the incidence of treatment-emergent adverse events (“TEAE”) occurred during the study. Secondary endpoints include efficacy as measured by the change in the target area non-vellus hair counts (“TAHC”) from baseline and other safety indicators. This trial adopted KX-826 tincture 0.5% BID as the drug-related dosage. The analysis results of 95 male patients who completed 52 weeks’ treatments showed: Regarding safety, KX-826 tincture demonstrated great safety and tolerability as a whole, without any serious adverse events (“SAE”) related to the drug reported. The common (incidence≥5%) treatment related adverse events (“TRAE”) were itching at application sites, and most of them were mild, not affecting the daily life of patients. In terms of efficacy, after 12, 24, 36 and 52 weeks’ treatment, both TAHC and target area non-vellus hair width (“TAHW”) showed an increase from baseline, among which, the TAHC increased 9.5%, 13.0%, 11.4% and 9.7% respectively, TAHW increased 12.1%, 18.6%, 15.7% and 10.0% respectively, with statistically significant results. This results were significantly better than the that of 24 weeks in previous 0.5% phase III clinical trial. At 24 weeks, the patients with the ≥ 10 hairs/cm2 change in TAHC from baseline accounted for 60.2%, the patients with the ≥ 20 hairs/cm2 change accounted for 28.9%, the patients with the ≥ 30 hairs/cm2 change accounted for 18.0%. At 52 weeks, the patients with the ≥ 10 hairs/cm2 change in TAHC from baseline accounted for 48.4%, the patients with the ≥ 20 hairs/cm2 change accounted for 20.4%, the patients with the ≥ 30 hairs/cm2 change accounted for 11.8%. The hair growth assessment (“HGA”) indicators from investigators and patients both experienced various degrees of improvement from baseline, demonstrating a trend in efficacy. The results showed that as assessed by investigators, 60.9%, 69.5%, 64.0% and 54.0% of patients had improved their hair growth from baseline after the treatment of 12, 24, 36 and 52 weeks respectively (HGA score ≥1). By order of the Board KINTOR PHARMACEUTICAL LIMITED Hong Kong, 16 October 2024

VOLUNTARY ANNOUNCEMENT (1) COMPLETION OF FIRST SUBJECT ENROLLMENT IN PIVOTAL CLINICAL TRIAL OF KX-826 TINCTURE 1.0% FOR THE TREATMENT OF MALE ADULT AGA IN CHINA; AND The board (the “Board”) of directors (the “Directors”) of the Company is pleased to announce that on 15 October 2024, the Company has completed the first subject enrollment in the pivotal clinical trial (the “Pivotal Clinical Trial”) of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of male adult androgenetic alopecia (“AGA”) in China. The Pivotal Clinical Trial is a multi-center, randomized, double-blind, vehicle controlled phase II/III study with adaptive designs to evaluate the efficacy and safety of KX-826 tincture 1.0% for the topical treatment of male adults with AGA in China. The Pivotal Clinical Trial adopts phase II/III operational seamless design, namely 2-in-1 design, Professor Jianzhong Zhang (張建中) and Professor Cheng Zhou (周城) from Peking University People’s Hospital are the lead principal investigator. The Pivotal Clinical Trial includes two phases, phase II dose exploration stage and phase III confirmatory stage, phase II Clinical Trial plans to involve 10 clinical research centers in China, phase II Clinical Trial plans to involve 25 clinical research centers in China. Phase II has three treatment groups that include KX-826 tincture 0.5% BID (“twice-a-day”) group (low-dose group), KX-826 tincture 1.0% BID group (high-dose group), and KX-826 tincture vehicle group (control group) in a 1:1:1 allocation ratio, with 30 patients enrolled in each group and 90 patients enrolled in total, and treatment period of 24 weeks with dosage as required will be conducted. Phase III has three treatment groups that include KX-826 tincture 0.5% BID group (low-dose group), KX-826 tincture 1.0% BID group (high-dose group), and KX-826 tincture vehicle group (control group) in a 1:1:1 allocation ratio, with 222 patients enrolled in each group and 666 patients enrolled in total, and treatment period of 24 weeks with dosage as required will be conducted. The Company’s preclinical studies have shown that the KX-826 tincture 1.0% has significantly increased the retention concentration of the tincture on human scalp cells compared to the KX-826 tincture 0.5% used in the previous phase III clinical trial, and is expected to enhance the clinical efficacy. The clinical trial of KX-826 tincture 1.0% is expected to maintain excellent safety profile and present superior efficacy compared to the KX-826 tincture 0.5%. By order of the Board KINTOR PHARMACEUTICAL LIMITED   Hong Kong, 16 October 2024

KX-826 Tincture 1.0% Trial Treat Male Adult AGA Approved By NMPA (05/24/2024) Kintor announced that the clinical trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of male adult androgenetic alopecia (“AGA”) in China (the “Clinical Trial”) was cleared by the National Medical Products Administration (the “NMPA”) recently.  The Clinical Trial is aimed to evaluate the efficacy and safety of KX-826 tincture 1.0% for the topical treatment of male adults with AGA in China. The Company’s preclinical studies have shown that the KX-826 tincture 1.0% has significantly increased the retention concentration of the tincture on human scalp cells compared to the KX-826 tincture 0.5% used in the previous phase III clinical trial, and is expected to enhance the clinical efficacy. Dr. Youzhi Tong, the founder, chairman and CEO of Kintor Pharma, said,"KX-826 is one of the core drugs of the Group. Since its development, it has completed multiple clinical trials for the treatment of male and female AGA in China and the United States, which has demonstrated excellent safety profile and efficacy trend. Our Company will further explore the value of KX-826 for AGA. In the meanwhile, we also conducting or planning multiple clinical trials of KX-826 for the treatment of AGA and acne, continuing to explore the value of KX-826 in the field of dermatology."

First Subject Enrollment in GT20029 China Phase 2 Trial for Acne Suzhou, June 17, 2024-Kintor Pharmaceutical Limited (“Kintor Pharma”), announced that the Company has completed the first subject enrollment in the phase II clinical trial in China of its in-house developed androgen receptor proteolysis targeting chimera (“PROTAC”) compound GT20029 for the treatment of acne. Developed by the Company’s in-house PROTAC platform, GT20029 is the first topical PROTAC compound which has entered the phase II clinical stage worldwide. The Phase II Clinical Trial is a multi-center, randomized, double-blind, placebo-controlled study, which is designed to evaluate the efficacy, safety and pharmacokinetics of GT20029 for the treatment of acne through the adoption of GT20029 0.5% once-a-day (“QD”) and 1% QD as the drug-related dosage. The Phase II Clinical Trial involves a total of 10 clinical research centers in China, and Professor Xiang Leihong from Fudan University Huashan Hospital is the lead principal investigator. In November 2022 and February 2023, the Company respectively announced the positive top-line data for the phase I clinical trial of GT20029 for the treatment of androgenetic alopecia (“AGA”) and acne in China (healthy subjects) and in the U.S. (healthy subjects and subjects with AGA or acne). The data demonstrated good safety, tolerability and pharmacokinetics of GT20029 in healthy subjects and subjects with AGA or acne. In April 2024, the phase II trial of GT20029 for AGA has reached the primary endpoints.

GT20029 China Phase II Trial For AGA Reached Primary Endpoint Suzhou, April 21, 2024 – Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the China phase II clinical trial of its first-in-class androgen receptor (AR) proteolysis targeting chimera (PROTAC) compound GT20029 tincture for treating male androgenetic alopecia (AGA) has reached its primary endpoint with statistically significant and clinically meaningful results, demonstrating good safety and tolerability. Based on these results, Kintor Pharma plans to initiate a phase III clinical trial in China and a phase II clinical trial in the U.S. for male AGA, and is also preparing a phase II clinical trial of GT20029 for treating acne. The Phase II Clinical Trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of GT20029 for male AGA, and determining the recommended dosage for the phase III clinical trial. Conducted at 12 clinical research centers in China, the trial was led by Professor Yang Qinping from Fudan University Huashan Hospital. The primary endpoint was the average change from baseline in non-vellus target area hair counts (TAHC) after 12 weeks of treatment compared to placebo. Safety assessments included adverse events, lab tests, subjective evaluations, and dermatological assessments. The trial enrolled 180 male AGA patients, divided into once daily (QD) and twice weekly (BIW) dosing cohorts, each with control (placebo) and experimental (GT20029 tincture) groups, receiving either 0.5% or 1% doses. Results showed: ▪ Efficacy: GT20029 tincture demonstrated statistically significant and clinically meaningful efficacy compared to placebo in both QD and BIW cohorts. The 0.5% QD GT20029 group showed a 16.80 hairs/cm² increase from baseline, 6.69 hairs/cm² more than placebo (P<0.05). The 1.0% BIW group showed an 11.94 hairs/cm² increase from baseline, 7.36 hairs/cm² more than placebo (P<0.05). The BIW cohort indicated a dose-response relationship. ▪ Safety: GT20029 tincture showed good safety and tolerability, with adverse event incidence comparable to placebo. No adverse sexual events were observed. ▪ Optimal Dosage: The 1% BIW dosage was identified as optimal for the phase III clinical trial in China. GT20029 is the world’s first dermatological topical AR degrader developed by Kintor Pharma’s PROTAC platform and is the first topical PROTAC compound to complete phase I clinical trials in both China and the U.S. It targets AR proteins for degradation via recruitment to E3 ubiquitin ligase, acting locally on peripheral skin tissues to avoid systemic exposure and reduce AR sensitivity to androgens in local hair follicles and sebaceous glands. This makes GT20029 a promising treatment for both AGA and acne, with a favorable safety profile and the potential for convenient, less frequent dosing.