奥雷巴替尼(耐立克)
Search documents
亚盛医药上涨5.43%,报29.1美元/股,总市值27.16亿美元
Jin Rong Jie· 2025-12-16 15:18
据交易所数据显示,12月16日,亚盛医药(AAPG)开盘上涨5.43%,截至22:34,报29.1美元/股,成交 1.79万美元,总市值27.16亿美元。 财务数据显示,截至2025年06月30日,亚盛医药收入总额2.34亿人民币,同比减少71.63%;归母净利 润-5.91亿人民币,同比减少462.43%。 资料显示,亚盛医药集团是一家立足中国、面向全球的生物医药企业,致力于在肿瘤、乙肝及与衰老相 关的疾病等治疗领域开发创新药物。2019年10月28日,亚盛医药在香港联交所主板挂牌上市,股票代 码:6855.HK。亚盛医药拥有自主构建的蛋白-蛋白相互作用靶向药物设计平台,处于细胞凋亡通路新药研 发的全球前沿。公司已建立拥有9个已进入临床开发阶段的1类小分子新药产品管线,包括抑制Bcl-2、 IAP或MDM2-p53等细胞凋亡通路关键蛋白的抑制剂;新一代针对癌症治疗中出现的激酶突变体的抑制剂 等,为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司正在中国、美 国、澳大利亚及欧洲开展40多项临床试验。用于治疗慢性髓细胞白血病的核心品种奥雷巴替尼(商品名: 耐立克)曾获中国国家药品监督管理局 ...
亚盛医药20251212
2025-12-15 01:55
Q&A 亚盛医药在 2025 年 ASCO 会议上有哪些重要数据和成果? 亚盛医药在 ASH 会议上重点展示了丽沙托克拉(Lisatoclax)的临床数 据,尤其是在复发难治 CLL 患者中取得 63%的总缓解率,且安全性良 好,为 BTK 抑制剂耐药患者提供了新选择。该药物仅用 11 年便获批, 显示出高效的研发速度。 奥雷巴替尼(耐立克)一线治疗 Ph+ ALL 患者联合低强度化疗,3 个月 MRD 阴性 CRR 达 64%,优于伊马替尼的 Falcon Trial(34%)。二 线治疗中,MMR 率和 CCR 率随时间增加,对一线使用达沙替尼或尼洛 替尼的患者疗效更佳。 针对罕见 FGFR 重排血液肿瘤(MNFGFR),陈树林教授团队的研究显 示,大部分患者在两个月内达到 C2、CH2L 和 CRH 反应,5 例实现完 全分子学缓解,部分患者通过干细胞移植实现无疾病残留存活。 亚盛医药的 EED 抑制剂研究在贫血和多发性骨髓瘤模型中显示出潜力, 与 Forcan 公司药物效果相当甚至更好,并与帕博利珠单抗联合使用产 生显著效果,目前正推进多个适应症的一期临床。 亚盛医药在 2025 年 ASCO 会议上 ...
亚盛医药-B涨超6% 耐立克 POLARIS-1研究获美国FDA和欧洲EMA批准
Zhi Tong Cai Jing· 2025-12-05 01:41
亚盛医药-B(06855)涨超6%,截至发稿,涨5.67%,报64.2港元,成交额1993.31万港元。 消息面上,12月5日,亚盛医药-B发布公告,公司原创1类新药奥雷巴替尼(商品名:耐立克 )联合化疗治 疗新诊断费城染色体阳性(Ph+)急性淋巴细胞白血病(ALL)患者的全球注册III期临床研究(POLARIS-1, NCT06051409)获美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)同意开展。作为耐立克 在欧 美监管机构获批的第二个全球注册III期研究,POLARIS-1研究在多国家多中心同步入组,将加速耐立克 全球特别是欧美市场的上市进程。 值得一提的是,POLARIS-1研究的最新进展也将在即将召开的2025年美国血液学会( American Society of Hematology,ASH)年会上亮相,这是该研究数据的首次公布。目前已披露的摘要数据显示:在耐立克 联合低强度化疗治疗的初治Ph+ ALL患者中,三周期分子MRD(微小残留病)阴性率、分子MRD阴性 CR(完全缓解)率均可达65%左右,较国外同类产品在同样条件下的疗效明显提升;即使是对一些高危亚 型如携带IKZF1plu ...
港股异动 | 亚盛医药-B(06855)涨超6% 耐立克®POLARIS-1研究获美国FDA和欧洲EMA批准
智通财经网· 2025-12-05 01:39
消息面上,12月5日,亚盛医药-B发布公告,公司原创1类新药奥雷巴替尼(商品名:耐立克)联合化疗治 疗新诊断费城染色体阳性(Ph+)急性淋巴细胞白血病(ALL)患者的全球注册III期临床研究(POLARIS-1, NCT06051409)获美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)同意开展。作为耐立克在欧美 监管机构获批的第二个全球注册III期研究,POLARIS-1研究在多国家多中心同步入组,将加速耐立克全 球特别是欧美市场的上市进程。 值得一提的是,POLARIS-1研究的最新进展也将在即将召开的2025年美国血液学会( American Society of Hematology,ASH)年会上亮相,这是该研究数据的首次公布。目前已披露的摘要数据显示:在耐立克 联合低强度化疗治疗的初治Ph+ ALL患者中,三周期分子MRD(微小残留病)阴性率、分子MRD阴性 CR(完全缓解)率均可达65%左右,较国外同类产品在同样条件下的疗效明显提升;即使是对一些高危亚 型如携带IKZF1plus基因变异的患者也达到了很好的疗效。同时,该联合方案的安全性表现优异,副作 用发生率低且可控制。 智通财经AP ...
亚盛医药-B涨超3% 首次揭示奥雷巴替尼通过调控脂质代谢发挥抗肿瘤作用全新机制
Zhi Tong Cai Jing· 2025-11-26 03:05
Core Viewpoint - Ascentage Pharma-B (06855) saw a rise of over 3%, currently trading at HKD 64.35 with a transaction volume of HKD 46.0484 million, following the announcement of positive clinical trial results for its novel drug Olverembatinib (brand name: Nairike) in treating gastrointestinal stromal tumors (GIST) [1] Group 1: Clinical Trial Results - On November 25, Ascentage Pharma announced that the research results of its original Class 1 new drug Olverembatinib for GIST were published in the prestigious journal Signal Transduction and Targeted Therapy, which has an impact factor of 52.7 [1] - The study demonstrated that Olverembatinib shows good efficacy and safety in SDH-deficient GIST, revealing a novel mechanism of anti-tumor action through lipid metabolism regulation [1] - The Phase I study evaluated the safety and anti-tumor activity of Olverembatinib in 66 patients with unresectable/metastatic GIST and other solid tumors, including 26 patients with SDH-deficient GIST who had failed prior treatment with tyrosine kinase inhibitors (TKIs) [1] Group 2: Significance of the Study - This is the largest prospective clinical trial conducted to date for this rare subtype of GIST [1]
港股异动 | 亚盛医药-B(06855)涨超3% 首次揭示奥雷巴替尼通过调控脂质代谢发挥抗肿瘤作用全新机制
智通财经网· 2025-11-26 02:58
Core Viewpoint - Ascentage Pharma-B (06855) saw a stock increase of over 3%, currently trading at HKD 64.35 with a transaction volume of HKD 46.048 million, following the announcement of positive clinical trial results for its novel drug Olarebactam (brand name: Nairike) in treating gastrointestinal stromal tumors (GIST) [1] Group 1: Clinical Trial Results - Ascentage Pharma announced the successful publication of research results for Olarebactam in the international journal "Signal Transduction and Targeted Therapy," which has an impact factor of 52.7 [1] - The study demonstrated that Olarebactam shows good efficacy and safety in treating SDH-deficient GIST, revealing a novel mechanism of action through lipid metabolism regulation [1] - The Phase I trial evaluated the safety and anti-tumor activity of Olarebactam in 66 patients with unresectable/metastatic GIST and other solid tumors, including 26 patients with SDH-deficient GIST who had failed prior treatment with tyrosine kinase inhibitors (TKIs) [1] - This trial is noted as the largest prospective clinical study to date targeting this rare subtype of GIST [1]
亚盛医药上涨5.35%,报47.4美元/股,总市值44.06亿美元
Jin Rong Jie· 2025-08-18 15:54
Core Viewpoint - As of August 18, 2023, AAPG's stock price increased by 5.35%, reaching $47.4 per share, with a total market capitalization of $4.406 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a year-on-year increase of 56.2% [1]. Financial Performance - AAPG's total revenue for the fiscal year ending December 31, 2024, is projected to be 981 million RMB, reflecting a significant year-on-year growth of 341.77% [1]. - The net profit attributable to shareholders is expected to be -405 million RMB, which indicates a year-on-year increase of 56.2% [1]. Upcoming Events - AAPG is scheduled to disclose its mid-year report for the fiscal year 2025 on August 20, 2023, after the market closes (Eastern Time) [2]. Company Overview - AAPG is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases. The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [3]. - AAPG has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway. The company has a pipeline of nine clinical-stage Class 1 small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway [3]. - The core product, Olarebatin (brand name: Nairike), has been approved in China and is included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022). It has also received various designations from the FDA and the EU [3]. - AAPG has engaged in over 40 clinical trials across China, the U.S., Australia, and Europe, and has established collaborations with leading biotech and pharmaceutical companies and academic institutions globally [3].
亚盛医药上涨3.16%,报42.45美元/股,总市值39.46亿美元
Jin Rong Jie· 2025-08-14 13:44
本文源自:金融界 财务数据显示,截至2024年12月31日,亚盛医药收入总额9.81亿人民币,同比增长341.77%;归母净利 润-4.05亿人民币,同比增长56.2%。 资料显示,亚盛医药集团是一家立足中国、面向全球的生物医药企业,致力于在肿瘤、乙肝及与衰老相 关的疾病等治疗领域开发创新药物。2019年10月28日,亚盛医药在香港联交所主板挂牌上市,股票代 码:6855.HK。亚盛医药拥有自主构建的蛋白-蛋白相互作用靶向药物设计平台,处于细胞凋亡通路新药研 发的全球前沿。公司已建立拥有9个已进入临床开发阶段的1类小分子新药产品管线,包括抑制Bcl-2、 IAP或MDM2-p53等细胞凋亡通路关键蛋白的抑制剂;新一代针对癌症治疗中出现的激酶突变体的抑制剂 等,为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司正在中国、美 国、澳大利亚及欧洲开展40多项临床试验。用于治疗慢性髓细胞白血病的核心品种奥雷巴替尼(商品名: 耐立克)曾获中国国家药品监督管理局新药审评中心(CDE)纳入优先审评和突破性治疗品种,并已在中国 获批,是公司的首个上市品种。目前,耐立克已被成功纳入《国家基本医疗保险、工伤 ...
亚盛医药上涨3.23%,报41.5美元/股,总市值38.58亿美元
Jin Rong Jie· 2025-08-13 13:53
Core Viewpoint - As of August 13, 2023, AAPG's stock price increased by 3.23% to $41.5 per share, with a total market capitalization of $3.858 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][3]. Company Overview - AAPG is a biopharmaceutical company based in China with a global focus, dedicated to developing innovative drugs for the treatment of cancer, hepatitis B, and age-related diseases [2]. - The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - AAPG has developed a proprietary drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway [2]. Product Pipeline - The company has established a pipeline of nine Class 1 small molecule new drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2, IAP, and MDM2-p53 [2]. - AAPG is the only innovative company globally with clinical development products in all key proteins of the apoptosis pathway [2]. - The core product, Aorebatin (brand name: Nairike), has been approved in China and is included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) [2]. Clinical Trials and Regulatory Approvals - The company is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - AAPG has received multiple designations from the FDA, including orphan drug status and fast track designation for four investigational new drugs [2]. - The company has undertaken several national science and technology major projects, including five under the "Major New Drug Creation" initiative [2]. Collaborations and Talent - AAPG has established global collaborations with leading biotechnology and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer [2]. - The company has built an international team with extensive experience in original drug research and clinical development [2].
亚盛医药上涨2.38%,报43.0美元/股,总市值39.97亿美元
Jin Rong Jie· 2025-08-06 17:22
Core Viewpoint - As of August 7, 2023, AAPG's stock price increased by 2.38% to $43.00 per share, with a total market capitalization of $3.997 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][2]. Group 1: Company Overview - AAPG is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases [2]. - The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - AAPG has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway [2]. Group 2: Product Pipeline and Clinical Development - The company has a pipeline of nine Class 1 small molecule new drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway [2]. - AAPG is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - The core product, Orebatinib (brand name: Nairike), has received priority review and breakthrough therapy designation from the China National Medical Products Administration and has been approved for sale in China [2]. Group 3: Regulatory Approvals and Collaborations - Orebatinib has been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) in China and has received multiple designations from the FDA, including orphan drug status and fast track designation [2]. - AAPG has been involved in several national science and technology major projects, including five projects under the "Major New Drug Creation" initiative [2]. - The company has established global collaborations with leading biotech and pharmaceutical companies and academic institutions, enhancing its research and development capabilities [2].