奥雷巴替尼

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亚盛医药-B(06855):APG-2575国内获批,首款国产Bcl-2上市
Soochow Securities· 2025-07-11 13:57
证券研究报告·海外公司点评·药品及生物科技(HS) 亚盛医药-B(06855.HK) APG-2575 国内获批,首款国产 Bcl-2 上市 2025 年 07 月 11 日 买入(维持) | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入(百万元) | 225.09 | 980.65 | 519.00 | 3,215.00 | 2,095.00 | | 同比(%) | 6.24 | 335.68 | (47.08) | 519.46 | (34.84) | | 归母净利润(百万元) | (925.64) | (405.43) | (726.53) | 1,097.79 | (841.66) | | 同比(%) | (4.84) | 56.20 | (79.20) | 251.10 | (176.67) | | EPS-最新摊薄(元/股) | (2.66) | (1.16) | (2.08) | 3.15 | (2.42) | | P/E(现价 ...
亚盛医药上涨3.85%,报42.94美元/股,总市值37.47亿美元
Jin Rong Jie· 2025-07-09 13:44
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、工伤保险和生育保险药 品目录(2022年)》。该品种还获得了美国FDA快速通道资格、孤儿药资格认定、以及欧盟孤儿药资格认 定。截至目前,公司共有4个在研新药获得16项FDA和1 ...
广东发布首批创新药械产品目录 10款抗癌创新药上榜
Nan Fang Du Shi Bao· 2025-07-04 02:40
近日,广东省工业和信息化厅、广东省卫生健康委员会、广东省医疗保障局、广东省药品监督管理局公布了广东省已获批创新药械产品目录(第一批),共 涉及107种创新药械,其中创新药有46种。通知指出,请省内各公立医疗机构按照《关于进一步推动广东生物医药产业高质量发展的行动方案》等有关要 求,加快推动创新药械入院应用。 在上述抗癌创新药目录中,上榜最多的企业是康方,旗下共有3款药物入选。其中,卡度尼利单抗注射液在今年5月获批的联合含铂化疗联合或不联合贝伐珠 单抗一线治疗持续、复发或转移性宫颈癌的新适应症,实现了对宫颈癌治疗的全线覆盖,填补了国内一线宫颈癌患者免疫治疗的空白。 南都记者统计发现,在此次公布的创新药品中,抗癌类创新药物有10种,占比22%,覆盖了多种高发恶性肿瘤,展现了广东省在肿瘤治疗领域的研发和制造 实力。 以下为此次目录中公布的10种抗癌创新药: | 名称 | 持有人/注册人 | 生产企业 | 可治疗癌种(仅供参考,具体适应症及 | | --- | --- | --- | --- | | | | | 用药方案需咨询医生) | | 奥雷巴替尼 | 广州顺健生物医药科技 | (1) 苏州 亚盛药业有限公司;( ...
亚盛医药上涨4.14%,报41.5美元/股,总市值36.15亿美元
Jin Rong Jie· 2025-07-03 13:44
Group 1 - The core viewpoint of the article highlights the significant growth in revenue and net profit for Ascentage Pharma (AAPG), with a total revenue of 981 million RMB, representing a year-on-year increase of 341.77%, and a net profit of -405 million RMB, showing a year-on-year growth of 56.2% as of December 31, 2024 [1][2][3] Group 2 - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases, and was listed on the Hong Kong Stock Exchange on October 28, 2019 [2] - The company has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway, with a pipeline of nine clinical-stage Class 1 small molecule drugs [2] - Ascentage Pharma's core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from the Chinese National Medical Products Administration and is included in the National Basic Medical Insurance Drug List [2] - The company has received multiple orphan drug designations and fast track designations from the FDA for four investigational new drugs, demonstrating its strong research and development capabilities [2] - Ascentage Pharma has established global collaborations with leading biotech and pharmaceutical companies and academic institutions, and is committed to addressing unmet clinical needs for patients worldwide [2]
诺诚健华(09969) - 2024 FY - 电话会议演示
2025-07-02 06:33
Pushing the Frontier of Healthcare Innovation - InnoCare Introduction February 2, 2024 Disclaimer These materials are for information purposes only and do not constitute or form part of an offer or invitation to sell or issue or the solicitation of an offer or invitation to buy or subscribe for securities of InnoCare Pharma Limited (the "Company") or any of its holding company or subsidiaries in any jurisdiction. No part of these materials shall form the basis of or be relied upon in connection with any con ...
亚盛医药上涨4.17%,报38.7美元/股,总市值33.72亿美元
Jin Rong Jie· 2025-06-24 13:48
本文源自:金融界 6月24日,亚盛医药(AAPG)开盘上涨4.17%,截至21:30,报38.7美元/股,成交5.31万美元,总市值33.72 亿美元。 作者:行情君 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 ...
东吴证券晨会纪要-20250623
Soochow Securities· 2025-06-23 02:32
证券研究报告 东吴证券晨会纪要 东吴证券晨会纪要 2025-06-23 宏观策略 [Table_MacroStrategy] 宏观点评 20250619:美联储全年降息或不及 2 次——2025 年 6 月 FOMC 会议点评 核心观点:6 月 FOMC 如期不降息,同时在声明中删除了更高失业率与 通胀的判断。经济预测中美联储下调了美国 GDP 增速预期,上调了失业 率与 PCE 通胀预期,判断经济前景将更加滞胀。虽然更滞胀的经济预期 并未让今年的点阵图中值发生变化,但点阵图分布明显更鹰派。发布会上 鲍威尔对经济保持信心、对通胀保持耐心,表示按兵不动是最佳策略。向 前看,相对于增长的下行风险,美联储仍然更担心通胀的上行风险与不确 定性,更晚降息更有利于确保关税带来的通胀冲击是一次性而非持续性 的;同时特朗普对美联储货币政策独立性的干预仍然存在,这或打乱、延 后美联储原有的降息进程。因此我们预期今年全年降息次数或不及 2 次。 风险提示:特朗普政策落地节奏与预期相差较大;美联储维持高利率水平 时间过长,引发金融系统流动性危机;通胀下行速率不及预期。 宏观点评 20250618:"1+6"体系精准支持硬科技企业 ...
亚盛医药-B(06855.HK):多项临床亮相ASCO和EHA大会 优秀数据助力管线商业化
Ge Long Hui· 2025-06-21 02:52
Core Insights - The clinical data for Aosheng Pharmaceutical's core product, Orebatinib, presented at the EHA annual meeting indicates its potential to improve long-term outcomes for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) through various combination therapies [1] - Aosheng Pharmaceutical's APG-2575 showed promising results in treating myeloid malignancies, enhancing its commercial prospects against competitors like Venetoclax [2] - The company is expected to experience rapid revenue growth due to the sales ramp-up of Orebatinib and potential payments from Takeda, with revenue forecasts for 2025-2027 indicating significant increases [3] Group 1: Orebatinib Clinical Data - Orebatinib combined with Belinostat in a single-arm clinical trial for Ph+ or Ph-like ALL showed a median follow-up of 17 months, with a complete response (CR) rate of 100% after one treatment cycle and an overall survival (OS) rate of 100% at 18 months [1] - In the Orebatinib combined with VP regimen for adult Ph+ ALL, the overall response rate (ORR) was 100%, with a CR rate of 97.3% and a 2-year OS rate of 96.3% [1] Group 2: APG-2575 Clinical Data - The ASCO annual meeting revealed that APG-2575 combined with Azacitidine in a clinical study for previously treated or untreated myeloid malignancies had an ORR of 31.8%, with 4.6% of patients achieving a partial response (PR) [2] - The data suggests that APG-2575 may have a competitive edge over Venetoclax, particularly in differentiated indications, and the company is also exploring potential markets in MDS and MM [2] Group 3: Revenue Forecast and Investment Outlook - The company anticipates rapid revenue growth, maintaining revenue forecasts of 519 million yuan and 3.215 billion yuan for 2025 and 2026, respectively, with an additional forecast of 2.095 billion yuan for 2027 [3] - The strong growth outlook is supported by the overseas market potential and the expected sales increase of Orebatinib, leading to a "buy" rating for the stock [3]
亚盛医药上涨10.46%,报34.95美元/股,总市值30.45亿美元
Jin Rong Jie· 2025-06-18 14:33
Core Viewpoint - As of June 18, 2023, AAPG's stock price increased by 10.46%, reaching $34.95 per share, with a total market capitalization of $3.045 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, focusing on global markets, 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 included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (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 participated in 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 biotech 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].
全球生物医药版图有了“慧湖坐标”
Su Zhou Ri Bao· 2025-06-16 21:47
Core Insights - The Suzhou Dushu Lake Science and Education Innovation Zone is emerging as a significant hub for biopharmaceutical innovation and investment in China, showcasing a strong ecosystem that integrates academia, research institutions, enterprises, and investment agencies [1][2][4] Group 1: Industry Growth and Performance - The biopharmaceutical industry in Dushu Lake has shown remarkable growth, with 2025 Q1 sales of the drug Zebutinib reaching $792 million, a 62% increase year-on-year, helping the company achieve profitability [2] - The region has witnessed the emergence of 19 publicly listed biopharmaceutical companies, with a total revenue of 37.369 billion yuan in the previous year [1] - Major pharmaceutical companies are increasingly relying on Chinese biopharmaceutical firms for innovative drug pipelines, establishing China as a "supermarket" for innovative drugs [3] Group 2: Strategic Initiatives and Support - The "Suzhou Industrial Park Action Plan for Accelerating the Development of Biopharmaceuticals and Health Industry (2025-2027)" has been launched, focusing on eight key areas to support industry growth [4] - The Dushu Lake area is implementing a comprehensive support system for startups, including full-cycle support from R&D to production, and encouraging leading companies to enhance global competitiveness through mergers and acquisitions [5] - A new risk assurance product, "Yuan Yan Bao," has been introduced to mitigate risks associated with technology transfer, enhancing the security of innovation projects [7] Group 3: Innovation and Collaboration - The Dushu Lake Science and Education Innovation Zone is working to bridge the gap between laboratory research and practical application, aiming to facilitate the transition from original research to market-ready products [6] - The establishment of a national technology transfer center in collaboration with educational institutions aims to streamline the commercialization of scientific research [6] - The region is fostering a "worry-free" ecosystem for technology transfer, ensuring that various elements such as capital, platforms, and talent converge to support innovation [7]