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泰恩康CKBA软膏Ⅱ期临床试验取得积极结果
Zheng Quan Ri Bao Zhi Sheng· 2025-08-04 10:13
本报讯 (记者王镜茹)8月4日,广东泰恩康医药股份有限公司(以下简称"泰恩康")发布公告,其自 主研发的,用于治疗非节段型白癜风的1类创新药CKBA软膏Ⅱ期临床试验取得积极结果。 泰恩康董事长兼总经理郑汉杰表示:"CKBA白癜风Ⅱ期临床结果的理想数据令我们倍感振奋,将立即 启动突破性疗法认定申请工作,并全力推动Ⅲ期临床试验进程,力争早日将这一创新药物带给患者。" 研究显示,高剂量组患者疾病好转及复色比例达36%,药物展现出积极的疗效和良好的安全性。基于这 一理想结果,泰恩康计划近期向国家药品监督管理局药品审评中心(CDE)提交该适应症的突破性疗法 认定(BTD)申请,并加速推进Ⅲ期临床试验。 本次临床试验由国内知名白癜风专家、杭州市第三人民医院皮肤病研究所所长许爱娥教授担任主要研究 者,试验主要评价指标为面颈部白癜风评分指数(VASI)的改善比例。 许爱娥解读结果时表示:"考虑到临床上颈部复色难度通常高于面部,若仅评估面部复色程度,CKBA 的有效率预期会更高。"她同时认为,光疗(如NB-UVB或308nm准分子激光)是白癜风临床治疗的重 要手段,而CKBA源自天然乳香活性小分子,兼具强效抗炎与抗氧化作用,未 ...
8月4日晚间重要公告一览
Xi Niu Cai Jing· 2025-08-04 10:11
Group 1 - Weihai Guangtai reported a net profit of 83.32 million yuan for the first half of 2025, a year-on-year decrease of 22.41%, while total revenue reached 1.425 billion yuan, an increase of 10.91% [1] - Haowei Group expects a net profit increase of 39.43% to 49.67% for the first half of 2025, estimating a profit range of 1.906 billion to 2.046 billion yuan [1] - Tengda Construction won a bid for a project worth 118 million yuan, with a construction period of 500 calendar days [1] Group 2 - Shanda Power plans to use up to 520 million yuan of idle raised funds for cash management, investing in safe and liquid products with a term not exceeding 12 months [3] - Rundu Co., Ltd. received approval for the listing application of its chemical raw material drug, which is suitable for surgical treatment in adults and children over one month old [4] - Zhongyuan Qihua's subsidiary's clinical trial application for a drug aimed at treating pulmonary fibrosis has been accepted [4] Group 3 - Shanghai Xiba plans to establish a joint venture with Yuyuan Rare Earth, focusing on advanced materials for lithium-ion solid-state batteries, with a registered capital of 200 million yuan [6] - Aorite's senior management plans to reduce their holdings by up to 62,500 shares, accounting for 0.02% of the company's total equity [7] - Yipin Hong's subsidiary's clinical trial application for a new oral drug for endometriosis has been accepted [8] Group 4 - Haya Pharmaceutical plans to lease idle assets covering 22,671.39 square meters for a period of 10 years [9] - Southern Precision Engineering applied for a credit limit of 50 million yuan from a bank for operational purposes [11] - Jindawei's subsidiary established a joint venture with a registered capital of 5 million yuan, focusing on the sale of food additives and health products [12] Group 5 - Gaode Infrared signed a product order contract worth 307 million yuan, expected to account for 11.46% of the company's audited revenue for 2024 [13] - Xichang Electric will implement a low valley electricity price policy starting September 1, 2025, which is expected to reduce net profit by approximately 5.55 million yuan [14] - Huyou Pharmaceutical's first subject has been dosed in a Phase I clinical trial for a drug targeting advanced solid tumors [16] Group 6 - Chuanheng Co., Ltd. received a patent for a dust removal system in mining operations [17] - Spring Wind Power's application for issuing convertible bonds has been accepted by the Shanghai Stock Exchange [18] - Liuyao Group plans to repurchase shares worth between 100 million and 200 million yuan [19] Group 7 - Baiyun Electric has obtained a commitment letter for a stock repurchase loan of up to 18 million yuan [20] - Tonghe Pharmaceutical received a patent for a method of preparing an intermediate for a migraine treatment drug [21] - Tainkang's subsidiary's Phase II clinical trial for a drug for vitiligo has shown significant efficacy and safety [23] Group 8 - Yuhua Tian's secretary and deputy general manager resigned for personal reasons [24] - Heizhima's controlling shareholder is planning a change in control, leading to a temporary suspension of stock trading [25] - Keda Li's subsidiary completed a capital increase, raising its registered capital to 700 million yuan [26] Group 9 - Fangda Special Steel's shareholder plans to reduce holdings by up to 1% of the company's shares [28] - ST Pava's director is under investigation for alleged embezzlement, but the company's operations remain normal [29] - Jiachuan Video's controlling shareholder is planning a change in control, resulting in a temporary stock suspension [32] Group 10 - Danhua Technology will change its stock name to Jinmei Technology starting August 7, 2025, due to a relocation of its registered office [33] - Morning Wind Technology's shareholder plans to reduce holdings by up to 1% of the company's shares [34] - Leshan Electric will adjust residential gas prices starting September 1, 2025, which is expected to increase gross profit by approximately 2.7 million yuan [35] Group 11 - SAIC Motor reported a total vehicle sales of 337,500 units in July 2025, a year-on-year increase of 34.22%, with significant growth in new energy vehicle sales [36] - LIGONG Navigation's shareholders plan to reduce holdings by up to 3% of the company's shares [37] - United Imaging's employee stock ownership platform plans to reduce holdings by up to 1.62% of the company's shares [38] Group 12 - Beiqi Blue Valley's subsidiary reported a 6.38% decline in sales in July 2025 [39] - Watson Bio's clinical research application for an mRNA vaccine has been accepted [40]
200亿元潜在蓝海!泰恩康全球首创CKBA软膏白癜风II期临床获成功,近期将提交突破性疗法认定申请
Zheng Quan Shi Bao Wang· 2025-08-04 09:24
据华福证券研报,中国白癜风患者超2200万人,影响患者的社交和人际关系、健康情况。白癜风现有疗 法缺陷多,当前主流白癜风治疗药物包括钙调神经磷酸酶抑制剂、糖皮质激素等,在疗效、安全性和长 期用药依从性方面或多或少存在缺陷,且现有化药均为off-label用药,亟待有对症药物上市,经过华福 证券测算,中国白癜风创新药潜在市场空间或超200亿元。目前国内白癜风的研发格局良好,赛道拥挤 度低。 泰恩康董事长兼总经理郑汉杰先生表示:"CKBA白癜风II期临床结果的理想数据令我们倍感振奋。这不 仅是对我们研发策略的肯定,也为急需安全有效长期疗法的患者带来了希望。我们将立即启动突破性疗 法认定申请工作,并全力推动III期临床试验进程,力争早日将这一创新药物带给患者。"郑汉杰强调, 相较目前在研的免疫抑制剂疗法,CKBA凭借其独特的作用机制和优异的安全性,有望成为需要长期治 疗的白癜风患者的重要治疗突破。 广东泰恩康(301263)医药股份有限公司(以下简称"泰恩康")今日宣布,其自主研发的1类创新药CKBA 软膏用于治疗非节段型白癜风的II期临床试验取得积极结果。研究显示,高剂量组患者疾病好转及复色 比例达36%,药物展 ...
泰恩康: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
Ge Long Hui· 2025-08-04 08:32
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 ...
化学制药板块8月4日涨0.48%,海辰药业领涨,主力资金净流入9700.43万元
Zheng Xing Xing Ye Ri Bao· 2025-08-04 08:30
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
Zhi Tong Cai Jing· 2025-08-04 08:02
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。 ...
泰恩康(301263.SZ)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
智通财经网· 2025-08-04 08:00
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。 ...
泰恩康(301263.SZ):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
Ge Long Hui A P P· 2025-08-04 07:57
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 ...
泰恩康: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
Zheng Quan Shi Bao Wang· 2025-08-04 07:53
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]
泰恩康:CKBA软膏白癜风适应症II期临床试验结果达到预期目标
Mei Ri Jing Ji Xin Wen· 2025-08-04 07:53
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。 ...