Core Insights - Guangdong Tianenkang Pharmaceutical Co., Ltd. announced positive results from the Phase II clinical trial of its innovative drug CKBA ointment for treating non-segmental vitiligo, showing a 36% improvement in disease and repigmentation rates in the high-dose group [1] - The company plans to submit a Breakthrough Therapy Designation (BTD) application to the National Medical Products Administration (NMPA) and accelerate the Phase III clinical trial [1] Company Developments - The Phase II clinical trial was led by Professor Xu Aie, a renowned vitiligo expert, who noted that the efficacy rate of CKBA could be higher if only facial repigmentation is assessed [1] - CKBA is derived from natural frankincense active small molecules, exhibiting strong anti-inflammatory and antioxidant properties, which may enhance efficacy when used in conjunction with phototherapy [1] Industry Context - Vitiligo is a chronic autoimmune skin disease affecting over 22 million people in China, with existing treatments having significant limitations [2][3] - Current mainstream treatments include calcineurin inhibitors and corticosteroids, which have drawbacks in efficacy, safety, and long-term adherence [3] - The potential market for innovative vitiligo drugs in China is estimated to exceed 20 billion yuan, indicating a significant opportunity for new therapies [3]

初步研究结果显示，高剂量组CKBA软膏1.5%BID剂量组的面颈部白癜风评分指数达到F-VASI50和F- VASI25的受试者比例均优于溶媒组(安慰剂组)，其中疾病好转及不同程度复色患者占比为36%(18/50)。 本项临床试验，试验用药品相关不良事件(TEAE)主要为瘙痒、红斑，严重程度均为1-2级，较为轻微， 其中高剂量组CKBA软膏1.5%BID剂量组和溶媒组(安慰剂组)的发生率分别为18%和12%；未发生与试验 用药品相关的严重不良事件(SAE)。表明CKBA软膏具有良好的安全性和耐受性。 本次临床研究初步数据结果显示，CKBA软膏高剂量组面颈部白癜风评分指数优于安慰剂组，具有明显 疗效，同时报告不良事件发生率低、无与试验用药品相关的严重不良事件(SAE)。CKBA作为非免疫抑 制剂，有望为需要长期用药的白癜风患者提供一种安全有效的创新治疗方案。 格隆汇8月4日丨泰恩康(301263.SZ)公布，近日，广东泰恩康医药股份有限公司控股子公司江苏博创园 生物医药科技有限公司(简称"博创园")自主研发的1类创新药CKBA软膏白癜风适应症II期临床试验已于 近日完成数据整理并揭盲。初步结果表明，CKBA软膏 ...

Group 1 - The chemical pharmaceutical sector increased by 0.48% on August 4, with Hai Chen Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3583.31, up 0.66%, while the Shenzhen Component Index closed at 11041.56, up 0.46% [1] - Hai Chen Pharmaceutical's stock price rose by 20.01% to 41.27, with a trading volume of 285,300 shares and a transaction value of 1.101 billion [1] Group 2 - The top gainers in the chemical pharmaceutical sector included Han Yu Pharmaceutical, which rose by 19.98% to 24.32, and Guangsheng Tang, which increased by 18.18% to 120.90 [1] - The sector saw a net inflow of 97.0043 million in main funds, while retail investors contributed a net inflow of 1.279 billion [2] - The main funds showed significant net outflows in several companies, including Hai Chen Pharmaceutical, which had a net inflow of 182 million, but retail investors had a net outflow of 579.696 million [3]

泰恩康（301263）(301263.SZ)发布公告，近日，公司控股子公司江苏博创园生物医药科技有限公司(简 称"博创园")自主研发的1类创新药CKBA软膏白癜风适应症II期临床试验已于近日完成数据整理并揭 盲。初步结果表明，CKBA软膏在非节段型白癜风患者中表现出积极的疗效和良好的安全性，试验结果 理想，达到预期目标，支持继续开展III期确证性临床试验，相关研究数据也将在近期提交CDE进行突破 性疗法申请和注册临床的沟通交流。 此次CKBA软膏白癜风适应症获得II期临床试验研究初步结果且达到预期目标，进一步验证了CKBA作 为首个靶向T细胞脂肪酸代谢通路的FIC(First-in-Class)创新小分子药物在自身免疫性疾病领域的巨大开 发潜力。公司将加快推进白癜风适应症III期临床试验和玫瑰痤疮适应症II/III期临床试验，并持续深入开 展CKBA在靶点和作用机制方面的基础研究，进一步拓展其在自身免疫性疾病领域的相关适应症。 ...

此次CKBA软膏白癜风适应症获得II期临床试验研究初步结果且达到预期目标，进一步验证了CKBA作 为首个靶向T细胞脂肪酸代谢通路的FIC(First-in-Class)创新小分子药物在自身免疫性疾病领域的巨大开 发潜力。公司将加快推进白癜风适应症III期临床试验和玫瑰痤疮适应症II/III期临床试验，并持续深入开 展CKBA在靶点和作用机制方面的基础研究，进一步拓展其在自身免疫性疾病领域的相关适应症。 智通财经APP讯，泰恩康(301263.SZ)发布公告，近日，公司控股子公司江苏博创园生物医药科技有限公 司(简称"博创园")自主研发的1类创新药CKBA软膏白癜风适应症II期临床试验已于近日完成数据整理并 揭盲。初步结果表明，CKBA软膏在非节段型白癜风患者中表现出积极的疗效和良好的安全性，试验结 果理想，达到预期目标，支持继续开展III期确证性临床试验，相关研究数据也将在近期提交CDE进行突 破性疗法申请和注册临床的沟通交流。 ...

初步研究结果显示，高剂量组CKBA软膏1.5%BID剂量组的面颈部白癜风评分指数达到F-VASI50和F- VASI25的受试者比例均优于溶媒组(安慰剂组)，其中疾病好转及不同程度复色患者占比为36%(18/50)。 本项临床试验，试验用药品相关不良事件(TEAE)主要为瘙痒、红斑，严重程度均为1-2级，较为轻微， 其中高剂量组CKBA软膏1.5%BID剂量组和溶媒组(安慰剂组)的发生率分别为18%和12%；未发生与试验 用药品相关的严重不良事件(SAE)。表明CKBA软膏具有良好的安全性和耐受性。 本次临床研究初步数据结果显示，CKBA软膏高剂量组面颈部白癜风评分指数优于安慰剂组，具有明显 疗效，同时报告不良事件发生率低、无与试验用药品相关的严重不良事件(SAE)。CKBA作为非免疫抑 制剂，有望为需要长期用药的白癜风患者提供一种安全有效的创新治疗方案。 格隆汇8月4日丨泰恩康(301263.SZ)公布，近日，广东泰恩康医药股份有限公司控股子公司江苏博创园 生物医药科技有限公司(简称"博创园")自主研发的1类创新药CKBA软膏白癜风适应症II期临床试验已于 近日完成数据整理并揭盲。初步结果表明，CKBA软膏 ...

Core Viewpoint - The announcement indicates that the clinical trial for the innovative drug CKBA ointment for vitiligo has shown positive efficacy and safety, supporting further development into Phase III trials [1] Company Summary - TianKang (301263) announced the completion of data organization and unblinding for the Phase II clinical trial of CKBA ointment [1] - The trial results indicate that CKBA ointment has demonstrated positive effects in non-segmental vitiligo patients, achieving expected goals [1] - The company plans to submit relevant research data to the CDE for breakthrough therapy application and clinical registration communication [1] Industry Summary - The successful results of the CKBA ointment trial may enhance the company's position in the dermatological treatment market, particularly for vitiligo [1] - The ongoing development of innovative drugs in the industry reflects a growing focus on addressing unmet medical needs in dermatology [1]

每经AI快讯，8月4日，泰恩康（301263）(301263.SZ)公告称，公司控股子公司博创园研发的1类创新药 CKBA软膏白癜风适应症II期临床试验已完成，结果显示积极疗效和良好安全性，达到预期目标，支持 继续开展III期试验。此次CKBA软膏白癜风适应症获得II期临床试验研究初步结果且达到预期目标，进 一步验证了CKBA作为首个靶向T细胞脂肪酸代谢通路的FIC(First-in-Class)创新小分子药物在自身免疫 性疾病领域的巨大开发潜力。公司将加快推进白癜风适应症III期临床试验和玫瑰痤疮适应症II/III期临床 试验，并持续深入开展CKBA在靶点和作用机制方面的基础研究，进一步拓展其在自身免疫性疾病领域 的相关适应症。 ...

Core Viewpoint - The announcement indicates that the clinical trial for the innovative drug CKBA ointment, developed by the subsidiary Bochuangyuan of TianKang (301263), has shown positive efficacy and safety in treating non-segmental vitiligo, supporting the continuation to Phase III trials [1] Group 1: Clinical Trial Results - The Phase II clinical trial data for CKBA ointment has been organized and unblinded, revealing promising results [1] - In the high-dose group (1.5% BID), the proportion of subjects achieving F-VASI50 and F-VASI25 scores was better than that of the placebo group, with 36% (18 out of 50) showing improvement and varying degrees of repigmentation [1] - The main adverse events reported were mild itching and erythema, classified as grade 1-2, with no serious adverse events occurring during the trial [1]

证券代码：301263 证券简称：泰恩康 公告编号：2025-048 广东泰恩康医药股份有限公司 关于控股子公司 CKBA 软膏白癜风适应症获得 II 期 临床试验研究初步结果且达到预期目标的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记 载、误导性陈述或者重大遗漏。 近日，广东泰恩康医药股份有限公司（以下简称"公司"）控股子公司江 苏博创园生物医药科技有限公司（以下简称"博创园"）自主研发的 1 类创新 药 CKBA 软膏白癜风适应症 II 期临床试验已于近日完成数据整理并揭盲。初步 结果表明，CKBA 软膏在非节段型白癜风患者中表现出积极的疗效和良好的安 全性，试验结果理想，达到预期目标，支持继续开展 III 期确证性临床试验， 相关研究数据也将在近期提交 CDE 进行突破性疗法申请和注册临床的沟通交 流。现将相关情况公告如下： 一、项目主要内容 1、药品名称：CKBA 软膏 2、临床试验题目：在非节段型白癜风受试者中评估赛克乳香酸（CKBA） 软膏安全性、有效性的多中心、随机、双盲、平行、溶媒对照、剂量探索 II 期 临床试验 3、申办单位：江苏博创园生物医药科技有限公司 二、临 ...