SUZHOU, China, April 21, 2024 /PRNewswire/ -- 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 (the 'Phase II Clinical Trial') of its in-house developed first-in-class androgen receptor ('AR') proteolysis targeting chimera ('PROTAC') compound GT20029 tincture for the treatment of male androgenetic alopecia ('AGA') has reached the primary endpoint, with statistically significant and clinically meaningful results, as well as good safety and tolerability.

中国苏州，2024年4月21日/PRNewswire/--Kintor Pharmaceutical Limited（“Kintor Pharma”，香港交易所：9939），一家开发创新小分子和生物治疗剂的临床阶段生物技术公司，宣布其内部开发的用于治疗男性雄激素性脱发（“AGA”）的一流雄激素受体（“AR”）蛋白水解靶向嵌合体（“PROTAC”）化合物GT20029酊剂的中国II期临床试验（“II期临床试验”）已达到主要终点，具有统计学意义和临床意义的结果，以及良好的安全性和耐受性。

Based on the results of the Phase II Clinical Trial, the company will actively deploy subsequent clinical strategies for GT20029, such as initiating a phase III clinical trial in China and a phase II clinical trial in the U.S. for male AGA. In addition, the company is also preparing to conduct a phase II clinical trial of GT20029 for the treatment of acne..

根据II期临床试验的结果，公司将积极部署GT20029的后续临床策略，例如在中国启动III期临床试验，在美国启动男性AGA的II期临床试验。此外，该公司还准备进行GT20029治疗痤疮的II期临床试验。。

The Phase II Clinical Trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of GT20029 for treating male AGA, and to determine the recommended dosage for phase III clinical trial. This trial involves a total of 12 clinical research centers in China, and Professor Yang Qinping from Fudan University Huashan Hospital is the leading principal investigator (leading PI).

II期临床试验是一项多中心，随机，双盲，安慰剂对照研究，旨在评估GT20029治疗男性AGA的疗效和安全性，并确定III期临床试验的推荐剂量。该试验涉及中国总共12个临床研究中心，复旦大学华山医院的杨秦平教授是首席首席研究员（首席PI）。

The primary endpoint of this trial is the average change from baseline in non-vellus target area hair counts ('TAHC') after 12 weeks of treatment in comparison to placebo. Safety assessments included adverse events, laboratory tests, subjective evaluations of the topical medication and dermatological assessments.

该试验的主要终点是与安慰剂相比，治疗12周后非绒毛靶区毛发计数（“TAHC”）与基线的平均变化。安全性评估包括不良事件，实验室检查，局部用药的主观评估和皮肤病学评估。

The trial enrolled 180 male AGA patients, divided into once daily ('QD') and twice weekly ('BIW') dosing cohorts, each with control groups (dosing placebo) and experiment groups (dosing GT20029 tincture), receiving either 0.5% or 1% doses. The results showed:.

该试验招募了180名男性AGA患者，分为每日一次（“QD”）和每周两次（“BIW”）给药组，每组有对照组（服用安慰剂）和实验组（服用GT20029酊剂），接受0.5%或1%剂量。结果显示：。

In terms of efficacy, GT20029 tincture demonstrated statistically significant therapeutic efficacy and clinical significance compared to placebo in both the QD and BIW dosing cohorts. After 12 weeks of treatment, the 0.5% QD GT20029 group showed an increase of 16.80 hairs/cm² from baseline, which was 6.69 hairs/cm² more than the placebo group, with statistically significant results (P<0.05).

就疗效而言，与安慰剂相比，GT20029酊剂在QD和BIW给药组中均显示出统计学上显着的治疗效果和临床意义。治疗12周后，0.5%QD GT20029组比基线增加16.80发/cm²，比安慰剂组增加6.69发/cm²，具有统计学意义（P＜0.05）。

The TAHC of GT20029 1.0% BIW group showed an increase of 11.94 hairs/cm² from baseline, which was 7.36 hairs/cm² more than the placebo, also yielding statistically significant results (P<0.05). For the BIW cohort, the study indicated a dose-response relationship among different doses of GT20029..

GT20029 1.0%白车身组的TAHC比基线增加了11.94发/cm²，比安慰剂组增加了7.36发/cm²，也产生了统计学上显着的结果（P＜0.05）。对于白车身队列，该研究表明不同剂量的GT20029之间存在剂量反应关系。。

Regarding safety, GT20029 tincture demonstrated good safety and tolerability, with the incidence of adverse events during treatment comparable to that of placebo. In addition, no adverse sexual events were observed during the trial.

关于安全性，GT20029酊剂表现出良好的安全性和耐受性，治疗期间不良事件的发生率与安慰剂相当。此外，在试验期间未观察到不良性事件。

The 1% BIW dosage of GT20029 was identified as the optimal dosing level in the Phase II Clinical Trial and has been recommended for the phase III clinical trial for male AGA in China.

GT20029的1%白车身剂量被确定为II期临床试验的最佳剂量水平，并被推荐用于中国男性AGA的III期临床试验。

As the world's first dermatological topical novel AR degrader developed using the company's in-house developed PROTAC platform, GT20029 is the first topical PROTAC compound that has completed phase I clinical trials both in China and the U.S.. It works by targeting AR proteins for degradation via recruitment to E3 ubiquitin ligase.

作为世界上第一个使用公司内部开发的PROTAC平台开发的皮肤科局部新型AR降解剂，GT20029是第一个在中国和美国完成I期临床试验的局部PROTAC化合物。它通过招募E3泛素连接酶来靶向AR蛋白降解。

GT20029 acts locally on peripheral skin tissues, avoiding systemic exposure and reducing the sensitivity of AR to androgens in local hair follicle sebaceous gland. Hence, it is developed by the Group for treating both AGA and acne..

GT20029局部作用于周围皮肤组织，避免全身暴露并降低AR对局部毛囊皮脂腺中雄激素的敏感性。因此，它是由该小组开发的，用于治疗AGA和痤疮。。

Dr. Youzhi Tong, the founder, chairman and CEO of Kintor Pharma, said, 'As the pioneering topical PROTAC drug, GT20029's phase II clinical trial has attracted significant attention. The conclusion of phase I clinical trials in China and the U.S. has provided crucial safety and pharmacokinetics data at both local and systemic levels.

Kintor Pharma的创始人、董事长兼首席执行官Youzhi Tong博士说，“作为开创性的局部PROTAC药物，GT20029的II期临床试验引起了极大的关注。中国和美国的I期临床试验结论为当地和全身水平提供了至关重要的安全性和药代动力学数据。

Our phase II clinical trial has further affirmed the safety profile of this innovative PROTAC technology for sustained local applications. More importantly, our trial is the first one to demonstrate the initial therapeutic benefits of topical PROTAC compound. A better AGA treatment for calls for fast efficacy, superior results, and reduced administration frequency.

我们的II期临床试验进一步证实了这种创新PROTAC技术在持续局部应用中的安全性。更重要的是，我们的试验是第一个证明局部PROTAC化合物的初始治疗益处的试验。更好的AGA治疗需要快速疗效，优异的结果和减少的给药频率。

We are poised to demonstrate these objectives in our upcoming GT20029 clinical trials.'.

我们准备在即将进行的GT20029临床试验中证明这些目标。”