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从百济神州(06160)研发日,看其以全球创新为核心的强劲内生增长力
智通财经网· 2025-06-30 06:48
近年来,凭借自身强劲的新药研发、完善的全球临床开发能力、高标准的质量管理体系、深耕国际市场的商业化能力等优势,百济神州(06160)在全球化 和"源头创新"的道路上越走越远。 在此过程中,百济神州不断强化和巩固自身在血液学领域的领导力,持续推进肿瘤学研发管线,并建立了多种潜在的同类最佳或同类首创资产和组合。百济 神州正处于发展的关键转折点,目前拥有40多款处于临床开发和商业化阶段的产品。未来18个月内,预计将迎来20项里程碑进展。如今,这些成果都集中体 现在近期百济神州召开的投资者研发日活动中。 会上,百济神州相关负责人介绍了其最新研发进展,包括具有显著临床潜力的BCL-2抑制剂索托克拉、BTK CDAC BGB-16673、CDK4抑制剂BGB-43395及 B7-H4 ADC等产品,彰显了百济神州的创新韧性和其以全球创新为核心的强劲内生增长力。 为了进一步巩固血液瘤治疗领导力,百济神州以泽布替尼为基石进行渐进式布局。目前公司潜在同类最佳BCL2抑制剂索托克拉以及靶向BTK的嵌合式降解 激活化合物(CDAC)BGB-16673正是其中的关键锚点。 以BTK CDAC BGB-16673为例,作为公司当前临床 ...
第五套上市标准激发创新药企活力 19家生物医药企业科创板“落地生金”
Mei Ri Jing Ji Xin Wen· 2025-06-18 16:15
每经记者|金喆 每经编辑|陈俊杰 6月18日,中国证监会发布《关于在科创板设置科创成长层 增强制度包容性适应性的意见》(以下简称《科创板意见》),上海证券交易所(以下简称上交 所)就同步制订的2项配套业务规则公开征求意见。 上交所相关负责人回答记者问时表示,"更加注重企业科技创新能力,允许符合科创板定位、尚未盈利或存在累计未弥补亏损的企业在科创板上市",是设立 科创板并试点注册制的标志性改革之一。 另一方面,企业的科技创新活动具有研发周期长、持续投入大、不确定性强等特点,科技型企业、尤其是未盈利科技型企业股票的投资风险高于一般企业。 为了进一步推进投融资平衡发展,上交所落实《科创板意见》要求,在科创板设置科创成长层并建立配套持续监管机制,在满足科创企业发行上市合理需求 的同时,加强针对性的风险提示和投资者合法权益保护。 《每日经济新闻》记者了解到,6年来,54家未盈利企业成功登陆科创板。在科创板助力下,这批企业正在快速步入研发成果兑现周期,迈向商业化发展新 阶段。其中,20家按照第五套上市标准上市的生物医药企业中,有19家实现核心产品上市。业内人士表示,未来"H+A"双平台运作成创新药企首选。 19家生物医药 ...
近60项科研成果集体亮相米兰 科创板创新药驶入“自主创新”快车道
Zhong Guo Jing Ying Bao· 2025-06-16 10:42
Core Insights - The 2025 European Hematology Association (EHA) annual meeting showcased nearly 60 clinical research results from four Chinese innovative drug companies, highlighting China's scientific strength in developing innovative therapies for hematological cancers [1] - The collective breakthroughs of these companies at international platforms like ASCO and EHA signify a strategic shift in China's innovative drug industry from "fast following" to "independent innovation" [1] - The EHA annual meeting is a significant academic event in the global hematology field, attracting over 10,000 professionals from more than 100 countries [1] Company Highlights - BeiGene presented four major oral reports at the EHA meeting, demonstrating key breakthroughs in its pipeline for hematological cancer treatments [1] - The next-generation BCL2 inhibitor, Sotorasib, combined with Baiyueze®, achieved total response rates of 96% and 79% for patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma, respectively [2] - The potential first-in-class BTK degrader BGB-16673 showed promising early data for treating CLL and Waldenström's macroglobulinemia [2] - Innovent Biologics had 25 studies presented as posters at the EHA meeting, focusing on new BTK inhibitors and BCL2 inhibitors for various lymphomas [2] Research Developments - The combination of Mesutoclax and Obinutuzumab for first-line treatment of CLL/SLL showed a total response rate of 97.6% in a cohort of 42 newly diagnosed patients, with a registration phase III clinical trial now underway [3] - Dizhizhi Pharmaceuticals showcased multiple research advancements covering T-cell and B-cell lymphomas, including the JAK1 inhibitor, Gyrizhe®, which demonstrated effective maintenance treatment in peripheral T-cell lymphoma [3] - Micu Biotech presented 19 new research results on its selective HDAC inhibitor, Sitarabin, across various hematological malignancies, indicating significant tumor response and broad application prospects [4]
再增一单!未盈利企业IPO申请获上交所受理
证券时报· 2025-06-14 00:14
未盈利企业科创板IPO申请再增一单! 6月13日,上交所官网显示,被业界称为"半导体'独角兽'"的上海超硅半导体股份有限公司(以下简称"上海超硅")科创板IPO申请获上交所受理。这是"科创板八 条"发布后,又一家未盈利企业科创板IPO申请获受理。 去年6月,证监会发布的《关于深化科创板改革 服务科技创新和新质生产力发展的八条措施》(简称"科创板八条")明确提出,进一步完善科技型企业精准识别机 制,支持优质未盈利科技型企业在科创板上市。一年来,上交所坚持稳中求进、综合施策,目标导向、问题导向,尊重规律、守正创新的原则,严把"硬科技"入口 关,积极推进优质未盈利企业在科创板发行上市。 未盈利企业科创板IPO申请陆续获受理 上海超硅是国内最早从事集成电路大尺寸硅片的企业之一,是国家级高新技术企业,曾获评专精特新"小巨人"企业、知识产权优势企业,还曾入选2024全球独角兽 榜。 根据招股书申报稿,上海超硅拟融资49.65亿元,拟投向集成电路用300毫米薄层硅外延片扩产项目和高端半导体硅材料研发项目等。 截至2024年底,上海超硅仍处于亏损状态。事实上,"科创板八条"发布以来,已陆续有3家未盈利企业科创板IPO申请陆续 ...
再增一单!未盈利企业IPO申请获上交所受理
证券时报· 2025-06-14 00:13
未盈利企业科创板IPO申请再增一单! 6月13日,上交所官网显示,被业界称为"半导体'独角兽'"的上海超硅半导体股份有限公司(以下简称"上海超硅")科创板IPO申请获上交所受理。这是"科创板八 条"发布后,又一家未盈利企业科创板IPO申请获受理。 6年实践检验 创新底色转化为现实生产力 去年6月,证监会发布的《关于深化科创板改革 服务科技创新和新质生产力发展的八条措施》(简称"科创板八条")明确提出,进一步完善科技型企业精准识别机 制,支持优质未盈利科技型企业在科创板上市。一年来,上交所坚持稳中求进、综合施策,目标导向、问题导向,尊重规律、守正创新的原则,严把"硬科技"入口 关,积极推进优质未盈利企业在科创板发行上市。 未盈利企业科创板IPO申请陆续获受理 上海超硅是国内最早从事集成电路大尺寸硅片的企业之一,是国家级高新技术企业,曾获评专精特新"小巨人"企业、知识产权优势企业,还曾入选2024全球独角兽 榜。 根据招股书申报稿,上海超硅拟融资49.65亿元,拟投向集成电路用300毫米薄层硅外延片扩产项目和高端半导体硅材料研发项目等。 截至2024年底,上海超硅仍处于亏损状态。事实上,"科创板八条"发布以来,已 ...
再增一单!“科创板八条” 发布一年来未盈利企业IPO申请陆续获受理
Zheng Quan Shi Bao Wang· 2025-06-13 15:40
Core Viewpoint - The acceptance of Shanghai Super Silicon's IPO application on the Sci-Tech Innovation Board marks a significant step in embracing unprofitable technology companies, reflecting the capital market's commitment to supporting hard technology enterprises and new productive forces [1][2]. Group 1: Company Overview - Shanghai Super Silicon is one of the earliest companies in China engaged in large-size silicon wafers for integrated circuits and is recognized as a national high-tech enterprise [2]. - The company plans to raise 4.965 billion yuan for projects related to the production of 300mm thin silicon epitaxial wafers and high-end semiconductor silicon material research and development [2]. - As of the end of 2024, Shanghai Super Silicon is still in a loss-making state [2]. Group 2: Industry Context - Since the introduction of the "Sci-Tech Innovation Board Eight Measures," three unprofitable companies have had their IPO applications accepted by the Shanghai Stock Exchange [2]. - The acceptance of Shanghai Super Silicon's IPO application indicates a broader trend of the capital market welcoming hard technology enterprises, with ten other unprofitable companies currently undergoing IPO reviews [2][8]. - The Sci-Tech Innovation Board has seen a total of 54 companies go public while unprofitable, primarily in the new generation information technology and biopharmaceutical sectors [5][6]. Group 3: Policy Support - The "Sci-Tech Innovation Board Eight Measures" aims to enhance the identification mechanism for technology companies and support high-quality unprofitable tech firms in going public [1][8]. - Recent policies have been implemented to provide a more inclusive environment for unprofitable companies, signaling a commitment to fostering innovation and technological advancement [8][9]. - The China Securities Regulatory Commission emphasizes the need for effective market mechanisms combined with proactive government support to facilitate the listing of quality unprofitable tech companies [9][10].
长风药业在港交所递交IPO申请;圣湘生物拟500万元受让圣维斯睿10%股权 | 医药早参
Mei Ri Jing Ji Xin Wen· 2025-06-12 23:58
每经记者|林姿辰 每经编辑|马子卿 丨2025年6月13日 星期五丨 点评:本事件表明百济神州的"百悦泽"片剂与已有剂型的生物等效性一致且更易服用,有望提升患者依 从性,扩大市场应用范围。此次获批将进一步巩固百济神州在全球血液肿瘤治疗领域的竞争力,增强投 资者对其未来业绩增长的信心,推动公司股价和市值提升,也体现了其研发实力和国际化布局的成果。 NO.4 荣昌生物释放产品对外授权预期后股价上涨 6月12日,港股创新药板块大涨,荣昌生物盘中涨超20%,截至收盘上涨17.55%。消息面上,公司于11 日在微信公众号发文,称6月4日至7日,第62届欧洲肾脏病学会年会(ERA)在奥地利维也纳召开。"现 场更有多位跨国医药公司BD经理主动接洽,围绕泰它西普的国际合作、技术授权等商业拓展方向展开 深度交流。" NO.1 圣湘生物拟500万元受让圣维斯睿10%股权 6月12日,圣湘生物发布公告,称公司拟以自有资金人民币500万元受让SEPSET BIOSCIENCES,INC.所 持有的湖南圣维斯睿生物科技有限公司10%股权。圣维斯睿专注于脓毒症诊断产品的研发与产业化,用 于急诊科和重症医学科等科室的急性感染患者,预测患者 ...
港股创新药板块直线反弹!可T+0交易的港股创新药ETF(159567)现涨0.64%,实时换手率突破27%排名同指数第一
Mei Ri Jing Ji Xin Wen· 2025-06-06 02:18
Group 1 - The Hong Kong stock market saw a high opening but closed lower, with the innovative drug sector initially weakening before rebounding. Notable stocks included Green Leaf Pharmaceutical rising over 5%, and others like Kangnuo Pharmaceutical-B, United Pharmaceutical, and CSPC Pharmaceutical rising over 2% [1] - The Hong Kong innovative drug ETF (159567) experienced a net inflow of over 80 million yuan in the past 20 trading days, indicating high market interest [1] - Leading domestic innovative pharmaceutical companies showcased their achievements at the ASCO annual meeting, with Heng Rui Pharmaceutical presenting four studies as oral reports and five as rapid oral reports, highlighting their academic and clinical significance [1] Group 2 - The innovative drug ETF (159567) tracks the Guozheng Hong Kong Stock Connect Innovative Drug Index, with 90% of its weight in innovative drug companies, making it the highest among all medical theme indices, poised to benefit from trends like AI-enabled drug development and the international expansion of domestic innovative drugs [2] - The innovative drug ETF (159992) tracks the innovative drug index, which includes leading companies in the innovative drug industry chain, benefiting from AI advancements and the introduction of a new insurance category for high-priced innovative drugs [2] - East Wu Securities noted that China's innovative drug licensing transactions are entering a booming phase, driven by improved internal R&D capabilities and increased international trust in Chinese drug pipelines [2]
对外授权交易频现 创新药出海加速
Zhong Guo Zheng Quan Bao· 2025-06-05 20:46
Group 1 - Hansoh Pharmaceutical granted Regeneron Pharmaceuticals exclusive overseas licensing for its GLP-1/GIP dual receptor agonist HS-20094, which has completed multiple Phase II clinical trials and is currently in Phase III trials in China [1][2] - The licensing agreement includes an upfront payment of $80 million, potential milestone payments of up to $1.93 billion, and double-digit royalties on future sales [2][3] - Recent licensing deals by Chinese pharmaceutical companies indicate a growing trend, with 33 license-out transactions completed in Q1 2025, totaling $36.633 billion, a year-on-year increase of approximately 258% [1][6] Group 2 - The licensing deal with Pfizer for the PD-1/VEGF dual antibody SSGJ-707 includes a record upfront payment of $1.25 billion, with potential milestone payments reaching $4.8 billion [3] - Other companies, such as Sinovant and Ansai, have also announced licensing agreements, indicating a robust market for Chinese pharmaceutical innovations [3][4] - The 2025 ASCO annual meeting showcased over 70 original research results from China, highlighting the international competitiveness of Chinese innovative drugs [4][5] Group 3 - The overall trend shows that Chinese innovative drugs are gaining global value, with a significant increase in licensing transactions and amounts [6][7] - The pharmaceutical industry is expected to see steady recovery, driven by the growing demand for innovative therapies and the improvement in the quality and quantity of domestic innovative drugs [7]
恒瑞医药港股首秀暴涨30%!ASCO重磅会议来了,关注哪些数据?T+0交易的恒生生物科技ETF(513280)涨超2%!
Xin Lang Cai Jing· 2025-05-23 03:43
今日(5.23)恒瑞医药重磅登陆港股,A股和港股创新药板块齐涨。可T+0交易的恒生生物科技ETF(513280)涨超2%,成交额已超昨日全 天!生物药ETF(159839)涨超1.2%。 消息面上,国内创新药龙头企业恒瑞医药今日正式登陆港交所,开盘即涨超29%获市场热捧。火热情绪带动医药板块,荣昌生物、金斯瑞 生物科技涨超5%,信达生物、石药集团涨超4%。 会议方面,美国临床肿瘤学会(ASCO)年会将于2025年5月30日至6月3日在伊利诺伊州芝加哥举行。多家创新药企已披露将在ASCO年会 上报告的研究进展。 据港交所披露,恒瑞医药本次公开发售获454.85倍超额认购,国际配售也实现17.09倍认购,最终确定公开发售占比21.5%、国际配售占比 78.5%的分配方案。 认购火热的背后是恒瑞医药不俗的业绩。2024年报显示,恒瑞医药营业收入279.85亿元,同比增长22.63%;归母净利润达63.37亿元,同比 大增47.28%。值得关注的是,恒瑞医药的创新药收入(不含税)已攀升至131亿元规模,占整体营收比重突破45%大关。目前每年保持2-3 个创新药获批上市,且根据管线储备测算,2025-2027年有望迎来 ...