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西点药业:公司始终将创新作为核心驱动力
Zheng Quan Ri Bao Wang· 2025-08-04 10:41
Core Viewpoint - The company emphasizes innovation as its core driving force and employs a dual-track strategy of "independent research and joint development" to advance its R&D efforts in innovative drug development, particularly focusing on areas such as anemia and the circulatory system [1] Group 1: R&D Strategy - The company is committed to enhancing its pipeline through various strategies, including technology introduction and changes in drug marketing authorization holders [1] - The core ongoing project involves expanding new indications for the drug Ruixiangsu capsules, with recent achievements including two invention patents for its applications in treating lymphatic reflux disorders and viral pneumonia, both currently in preclinical research [1] Group 2: Product Development - In addition to developing novel small molecule compounds, the company is also focused on improving existing products to enhance their clinical value and lifecycle [1] - The company plans to continuously increase investment in innovative drug R&D and expand its reserve of new technologies and products [1] Group 3: Communication and Reporting - The company will provide timely updates on its progress through regular reports and interim announcements [1]
泰恩康CKBA软膏Ⅱ期临床试验取得积极结果
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 ...
君实生物跌1.1% 9年连亏2020年上市2募资共86亿元
Zhong Guo Jing Ji Wang· 2025-08-04 09:13
中国经济网北京8月4日讯 君实生物(688180.SH)今日股价下跌,截至收盘报37.66元,跌幅1.10%。该股 目前处于破发状态。 君实生物于2020年7月15日在上交所科创板上市,发行数量为8713万股,发行价格为55.50元/股,保荐 机构、主承销商为中国国际金融股份有限公司,联席主承销商为国泰君安证券股份有限公司、海通证券 股份有限公司(2家公司现已合并为国泰海通证券股份有限公司)。 上市首日,君实生物股价最高报220.40元,此后该股一路震荡下滑。该股目前处于破发状态。 君实生物首次公开发行股票募集资金总额为48.36亿元,扣除发行费用后,募集资金净额为44.97亿元, 较原计划多17.97亿元。君实生物于2020年7月8日发布的招股说明书显示,该公司计划募集资金27.00亿 元,分别用于创新药研发项目、君实生物科技产业化临港项目、偿还银行贷款及补充流动资金。 君实生物首次公开发行股票募的发行费用为3.39亿元,其中,保荐及承销费用3.20亿元。 君实生物2022年度向特定对象发行A股股票募集资金情况为,根据中国证监会出具的《关于同意上海君 实生物医药科技股份有限公司向特定对象发行股票注册的批复》 ...
创新驱动+全球布局显成效 百奥赛图-B上半年收入大增50%,实现持续盈利
Zhi Tong Cai Jing· 2025-08-04 08:46
Core Viewpoint - 百奥赛图-B (02315) reported a significant increase in revenue and profitability for the first half of 2025, driven by innovation, market expansion, and optimized management strategies [1] Financial Performance - The company expects revenue for the first half of 2025 to reach between RMB 616 million and RMB 626 million, representing a year-on-year growth of approximately 50.1% to 52.5% [1] - Research and development expenses are projected to be between RMB 206.1 million and RMB 216.1 million, reflecting a year-on-year increase of about 27.5% to 33.6% [1] - The anticipated net profit is between RMB 42.7 million and RMB 52.7 million, indicating a turnaround from previous losses [1] Market Expansion - The company has strengthened its overseas market presence by expanding its sales team and improving its sales system, leading to rapid growth in international business [1] - The release of R&D demand from domestic biopharmaceutical companies has provided development opportunities, particularly in preclinical products and services [1] Technological Edge - 百奥赛图 has established a strong technological barrier with its unique gene editing technology and animal model platform, focusing on over 20 key disease areas and thousands of high-value target models [3] - The company serves nearly 900 pharmaceutical and research institutions globally, completing over 5,300 drug evaluation projects, which supports its preclinical products and services business [3] Diversified Revenue Streams - The antibody licensing and development business is supported by the RenMice platform, which has created a resource library of over one million fully human antibody molecules [4] - By the end of 2024, the company has established around 200 cooperation agreements with various domestic and international pharmaceutical companies, with over 50 licensed projects covering multiple innovative targets [4] - The ongoing expansion of clinical pre-service scale and growth in antibody licensing business is expected to enhance the company's value in the innovative drug industry chain [4]
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 ...
一品红(300723.SZ)子公司创新药APH03621片获得临床试验注册申请受理
智通财经网· 2025-08-04 08:13
Group 1 - The core point of the article is that Yipinhong (300723.SZ) announced that its wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of its innovative drug APH03621 from the National Medical Products Administration [1] - APH03621 is a new oral, non-peptide small molecule gonadotropin-releasing hormone receptor antagonist (GnRH-ant) developed by the company, intended for the treatment of endometriosis [1]
一品红:全资子公司创新药APH03621片获得临床试验注册申请受理
Xin Lang Cai Jing· 2025-08-04 08:11
Core Viewpoint - The company announced that its wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of its innovative drug APH03621 from the National Medical Products Administration, marking a significant step in the drug's development for the treatment of endometriosis [1] Group 1 - The innovative drug APH03621 is classified as a Class 1 chemical drug and has not been marketed domestically or internationally [1] - The drug is specifically intended for the treatment of endometriosis, a condition that affects many women [1]
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 ...