Finasteride

Suzhou, 2 May, 2025-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that a clinical observational study of KX-826 in combination with minoxidil for the treatment of male adults with AGA in China has reached the primary endpoint. In order to obtain assessments of efficacy, dosage, and patients number prior to conducting a large-scale phase III clinical trial, so as to optimize the design of phase III clinical trial protocol and ensure future clinical success, the Company initiated a clinical observational study of KX-826 in combination with minoxidil for the treatment of male adults with AGA in China in March 2024 under the collaboration with two domestic hospitals. The clinical observational study is an open-label, randomized controlled study to evaluate the efficacy and safety of KX-826 in combination with minoxidil for the topical treatment of male adults with AGA in China, and to optimize the design of the formal future phase III clinical trial protocol, including key factors such as dose selection and patient enrollment number, based on the study results.The clinical observational study involves a total of 2 clinical research centers in China, with Professor Leiwei Jiang (江蕾薇) from First People’s Hospital of Guiyang and Professor Jinzhe Hu (金哲虎) from Yanbian University Hospitalas the lead principal investigator. The primary endpoint of the study is the change in the target area non-vellus hair counts (“TAHC”) from baseline after 24 weeks’ treatment. Secondary endpoints include the hair growth assessment (“HGA”) from investigators and patients. Safety indicators include adverse events, clinical laboratory test and assessment of local tolerance. A total of 75 male patients with AGA in China were enrolled in the study and were randomly assigned to KX-826 tincture 0.5% BID (i.e. twice a day) with minoxidil tincture 5% BID group (the “Combination Drugs Group”) and minoxidil tincture 5% BID group (the “Monotherapy Group” or “Minoxidil Group”) with 40 patients in the Combination Drugs Group and 35 patients in the Monotherapy Group. Results of the study showed thatregarding efficacy, the Combination Drugs Group demonstrated statistically significant therapeutic efficacy and clinical significance compared to the Minoxidil Group. After 24 weeks of treatment, the TAHC of the Combination Drugs Group showed an increase of 30.54 hairs/cm2 from baseline, which was 10.29 hairs/cm2 more than the Minoxidil Group, with statistically significant results (P=0.0075). At week 24, there were 4 patients with TAHC change from baseline ≤0 hairs/cm², all of which are in the Minoxidil Group. At week 24, there were 49 patients with TAHC change from baseline ≥20 hairs/cm², with 30 patients in the Combination Drugs Group and 19 patients in the Minoxidil Group. At week 24, there were 11 patients with TAHC change from baseline ≥40 hairs/cm², with 10 patients in the Combination Drugs Group and 1 patient in the Minoxidil Group. Compared to the Minoxidil Group, the Combination Drugs Group showed a numerical increase in both HGA indicators from investigators and patients. At week 24, there were 24 patients with HGA investigators of 3, with 14 patients in the Combination Drugs Group and 10 patients in the Minoxidil Group. At week 24, there were 15 patients with HGA patients of 3, with 8 patients in the Combination Drugs Group and 7 patients in the Minoxidil Group.in terms of safety, the Combination Drugs Group exhibited good safety and tolerability in the Clinical Observational Study, with both groups showing comparable incidence of adverse events during the treatment. In addition, no unexpected adverse events were observed during the study.KX-826 has a differentiated mechanism of action compared to minoxidil. Minoxidil primarily enhances nutrient supply to the scalp in hair loss areas, while KX-826 and Finasteride show an upstream-downstream mechanism, both targeting the modulation of local androgen microenvironment. The aforesaid two key pathways have been clinically validated for their efficacy in preventing hair loss and promoting regrowth, with the combination therapy leveraging the synergistic combination of above-mentioned mechanism of action to significantly enhances AGA treatment efficacy. The clinical observational data showed that after 24 weeks of treatment, the Combination Drugs Group demonstrated a significant difference in TAHC compared to the Minoxidil Group, and its proportion in patients with TAHC change from baseline ≥20 hairs/cm² and ≥40 hairs/cm² further validates the clinical advantages of the combination therapy in the AGA field, not only significantly enhancing the clinical benefits for patients undergoing treatment, but also expanding the patient group that can benefit from it. Based on these research findings, the Company has greater confidence in the therapeutic potential of the patent-approved combination therapy and will systematically advance the phase III clinical trials in stages.About Kintor Pharmaceutical LimitedFounded 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. After several years' development, the Company has developed diverse product pipeline built on dermatology and oncology 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.

北京时间2025年5月2日，开拓药业（股票代码：9939.HK），宣布一项KX-826与米诺地尔联合治疗中国成年男性脱发临床观察试验已达到主要研究终点。为在开展大型III期临床试验前获得疗效、剂量和患者数量的预判以完善III期临床方案设计进而确保未来临床的成功，本公司于2024年3月联合国内两家医院启动了一项KX-826与米诺地尔联合治疗中国成年男性脱发临床观察试验。该项临床观察试验是一项开放标签、随机对照研究，旨在评估KX-826联合米诺地尔外用治疗中国成年男性脱发的有效性和安全性，并基于试验结果，优化未来正式III期临床试验方案设计，包括剂量选择、入组患者数量等关键要素。该项临床观察试验在全国2家临床研究中心开展，由贵阳市第一人民医院江蕾薇教授和延边大学附属医院金哲虎教授担任主要研究者。该试验的主要终点是第24周目标区域非毳毛数量（「TAHC」）较基线的变化，次要终点包括研究者和受试者的毛发生长评估（「HGA」）。安全性评价指标包括不良事件、临床实验室检查及局部耐受性评估。该试验共入组75例中国成年男性AGA患者，随机分配至0.5%KX-826酊BID（即每日两次）联合5%米诺地尔酊BID（「联合用药组」）和5%米诺地尔酊BID（「单药组」或「米诺地尔组」），其中联合用药组40例，单药组35例。试验结果显示：有效性方面。与米诺地尔组相比，联合用药组显示出统计学显著的疗效优势及临床意义。治疗24周后，联合用药组的TAHC较基线增加30.54根/cm2，较米诺地尔酊组增加10.29根/cm2，结果具有统计学意义（P=0.0075）。第24周TAHC较基线变化≤0根/cm2共有4例患者，全部为米诺地尔组。第24周TAHC较基线变化≥20根/cm2共有49例患者，即联合用药组30例和米诺地尔组19例。第24周TAHC较基线变化≥40根/cm2共有11例患者，即联合用药组10例和米诺地尔组1例。与米诺地尔组相比，联合用药组的研究者和受试者的HGA指标均有数值上的增加。第24周HGA研究者评估=3分共有24例患者，即联合用药组14例和米诺地尔组10例。第24周HGA受试者评估=3分共有15例患者，即联合用药组8例和米诺地尔组7例。安全性方面。联合用药组在临床观察试验显示出良好的安全性和耐受性，两组在治疗过程中发生的不良事件相当。此外，该试验未观察到非预期不良事件。KX-826具有与米诺地尔差异化的作用机制，米诺地尔主要作用机制是增加脱发区皮肤的养份供给，而KX-826与非那雄胺为上下游的作用机制，两者的主要作用机制均为改变局部的雄激素微环境。前述二个主要通路均已获临床验证的防脱生发疗效，联合用药可基于上述二个作用机制的协同组合，显著提升AGA治疗效果。临床观察数据显示，治疗24周后，联合用药组的TAHC较米诺地尔组呈现显著差异，其在TAHC较基线变化≥20根/cm2及≥40根/cm2的患者人数占比进一步验证了联合疗法于AGA领域的临床优势，不仅显著增加接受治疗的患者获益效果且有望扩展患者获益人群。基于该研究成果，公司对已获专利授权的联合疗法治疗潜力更具信心，后续将有序推进III期临床试验。 关于开拓药业开拓药业成立于2009年，专注发展潜在“first-in-class”和“best-in-class”创新药物和功效性化妆品的研发及产业化，致力成为行业内的领军企业。公司经过多年的发展，以皮科领域和肿瘤相关疾病为核心，研发多通道产品组合，产品覆盖全球高发病率疾病，并外延至功效性化妆品领域，可满足全球范围内的皮科临床需求及化妆品消费者需求。开拓药业前瞻性布局了包含小分子创新药及生物创新药的多元化产品管线，包括5款正在开展临床研究的产品以及多个正在进行临床前研究的项目。公司在全球拥有超百项已获得及申请中的专利。2020年5月22日，开拓药业正式在香港联合交易所有限公司主板挂牌上市，股票代码：9939.HK。欢迎访问公司网站：www.kintor.com.cn