Asciminib Hydrochloride

最近几周，医药行业密集交出了2026年上半年成绩单。 把跨国药企（MNC）和国内创新药企的财报摊开放在一起看，一张前所未有的对比图浮现出来：阿斯利康中国区五年来首次半年度负增长，默沙东暴跌33%，罗氏中国制药下滑9%；而同一张表格的另一半，百济神州净利润暴增627%、翰森制药翻倍、信达生物产品收入增长55%、荣昌生物一举扭亏赚了47亿。 这不是偶尔的此消彼长。这是一场静默的权力交接。一、MNC的中国时刻：集体踩下刹车 阿斯利康上半年中国区收入35.1亿美元，同比下滑5%。作为常年霸榜MNC中国区营收第一的"中国通"，AZ这次翻车的直接原因很清晰——达格列净在第十一批集采中因报价超出限价直接出局，同时美国仿制药获批上市。这款去年全球卖了84亿美元的王牌产品，正在经历专利悬崖最疼痛的阶段。 但AZ至少还有ADC管线接力：Enhertu上半年全球终端销售29.61亿美元，泰瑞沙仍稳居EGFR市场头把交椅。剔除集采影响后，AZ中国的生物制药和罕见病业务实际上还在增长。 默沙东的处境更难。HPV疫苗暂停向中国发货的余波未平，2025年上半年暴跌70%之后，2026年同期又跌33%。新的压力来自成熟产品：西格列汀在第十批集采中最高中选价仅0.22元/片，而原研挂网价5.29元/片，价差超过20倍。不过，Q2降幅已收窄至9%，最剧烈的失速阶段或许正在过去。 罗氏中国制药业务下降9%，但这是另一种逻辑。罗氏正在经历产品代际切换：赫赛汀、安维汀、美罗华三款老药退场，赫双妥、优罗华、罗视佳等新一代产品接棒。这是一次主动换挡，不是被动的降价碾压。 赛诺菲中国区同样下滑，诺和诺德持平。 唯一的例外是礼来——中国区16.35亿美元，同比增长78%。这源于2025年末的一项激进决策：将GLP-1产品大幅降价，以价格换规模。效果立竿见影，但也早早透支了利润空间。二、"你必须拼命奔跑，才能留在原地" 诺华是中国区唯一保持正增长（+13%）的MNC，中国区半年销售额达到25亿美元。但把镜头拉远，全球层面的数据暴露了一个更深层的问题。 上半年，诺华新药拼尽全力跑出15%的纯销量增长——Kisqali增加10.78亿美元、Kesimpta增加6.12亿美元、Pluvicto增加4.68亿美元、Scemblix增加4.59亿美元，合计增长26.17亿美元。但Entresto（诺欣妥）和Promacta两款老药因专利到期合计减少28.17亿美元。新药好不容易跑出来的增量，刚好被老药的专利悬崖吞掉。 更残酷的是，全球降价压力又削掉了3个百分点。最终，诺华真实的固定汇率业绩是下降2%。仅仅靠着3个百分点的汇率正面影响，才在报表上保住了1%的表面微增。核心营业利润下降6%，净利润下降16%。 有公众号给诺华的故事起了一个精准的标题："你必须拼命奔跑，才能留在原地。" 诺华的解法是大举并购——上半年投资活动净现金流出148.41亿美元，是2025年同期的近8倍。用120亿美元收购Avidity押注xRNA技术，真金白银地买时间、买管线、买下一个十年的增长空间。 这个故事不只属于诺华。AZ、罗氏、默沙东、赛诺菲都在经历类似的阵痛：老药专利到期速度超过新药获批速度，中国集采和全球仿制药双面夹击，既要保利润又得烧钱并购。MNC的光环并没有消失，但增长引擎确实在普遍降速。三、中国创新药的爆发时刻 桌子另一边，是完全不同的景象。 百济神州交出了一份堪称炸裂的半年报：营收222.2亿元，同比增长26.8%；归母净利润32.71亿元，同比增长627.1%。上半年利润已超过2025年全年总和。 真正值得关注的不只是增速，而是增速的构成。百济上半年218亿元来自产品销售收入，几乎没有依赖BD首付款这类一次性收益。泽布替尼全球销售161.27亿元，其中美国市场113.90亿元，占全球的70.6%。更重要的是，Q2泽布替尼在BTK抑制剂赛道首次超越伊布替尼，成为全球BTK药王。一款中国原创的小分子药物，在美国卖到了品类第一。这是中国制药史上从来没有发生过的事。 更令人意外的是百济的毛利率——整体90%，海外高达97%。这个数字和茅台差不多。创新药在海外赚的，是纯纯的品牌溢价。 信达生物走的是一条不同的路。上半年产品收入超82亿元，同比增长55%，仅半年就追平了2024年全年。核心引擎是玛仕度肽——这款GLP-1/GIP双靶点药物在减重和糖尿病双适应症上同时放量，在司美格鲁肽和替尔泊肽两座大山之间硬生生抢出了一条路。肿瘤板块五款新纳入医保的TKI持续渗透，同时引入礼来的阿贝西利切入乳腺癌赛道，形成"肿瘤基本盘 + 代谢新增量"的双轮驱动。 翰森制药上半年收入65.06亿元，增长44.2%；净利润27.26亿元，增长111.5%。创新药与合作产品收入占比从61.8%飙升至77.4%。这家曾经以仿制药起家的老牌药企，转型速度远超市场预期。 恒瑞医药上半年营收157.61亿元，增长15.9%；净利润44.5亿元，增长29.7%。最值得注意的数字是创新药收入占比——首次突破60%，达到61.69%。当一家年营收超300亿的药企创新药占比过半，它就不再是"正在转型"，而是"已经转型完毕"了。 海思科净利润暴增513%-575%，达到7.9-8.7亿元。荣昌生物更是直接扭亏为盈，净利润约47亿元，其中与艾伯维的RC148授权协议贡献了主要增量。四、谁在坠落，谁在起飞 如果说中国创新药企是上半年最大的赢家，那传统中药企则是最大的失意者。 片仔癀2025年营收下降16.56%、净利润下降27.49%，创下上市以来首次双降。同仁堂营收下降11.6%、净利润下降19.1%，五年内首次营收下滑。 把这几组数据放在一起：百济+627%、翰森+111%、海思科+513%、荣昌扭亏47亿 vs 片仔癀-27%、同仁堂-19%。 冰与火之间，隔着两个字：创新。五、三个结构性信号 翻完这十几份财报，有几点观察值得记录。 第一，集采正在成为MNC中国区的"分水岭"。达格列净丢标直接拖累AZ转负。诺欣妥在第12批集采中诺华被迫降价中标，11个仿制药虎视眈眈。默沙东的西格列汀被仿制药以20倍价差碾压。MNC未来在中国能不能保持增长，关键看两个能力：一是老药在集采里的报价策略，二是新药获批上市的速度能不能跑赢老药退出的速度。目前来看，后者的加速度还不够。 第二，中国创新药已经不在"讲PPT"阶段了。百济泽布替尼超越伊布替尼是一个分水岭。这不是BD授权拿回来的里程碑付款，不是"卖青苗"的一次性收入，而是靠自己组建的海外销售团队在美国市场一块一块吃下来的份额。信达的玛仕度肽在GLP-1红海里硬抢份额、翰森的创新药占比冲向八成、恒瑞的创新药收入跨过60%——这些都不是未来时，而是进行时。 第三，营收结构的"含创量"决定了股价的质量。靠仿制药吃饭的企业都在缩水，靠创新药赚钱的企业都在涨。这个规律在2026年上半年被验证得更加彻底。A股医药板块整体下跌13.6%，但创新药板块逆势增长39.9%。资本市场已经用钱投票了。 回到这篇文章的标题。诺华那篇解读有一句精准的总结：你必须拼命奔跑，才能留在原地。这句话不仅适用于诺华，也适用于所有MNC在中国市场。 而桌子对面的中国创新药企，已经不只是在奔跑——它们在加速超车。 2026年上半年的财报季，正在重新划分中国医药市场的权力版图。 作者：医药行业资深从业者，拥有一线管理经验 免责声明：本文基于各公司公开财报及媒体报道整理，所有数据均来自公开披露。文中对公司经营策略的判断为个人行业观察，不构成任何投资建议。提及的个股股价及估值数据仅供参考。素材来源清单 序号 公司/事件 核心来源 1 百济神州2026半年报 公司公告（A股/H股），2026-08-06 2 恒瑞医药2026半年报 公司公告，阿斯达克财经，2026-06-22 3 信达生物2026上半年产品收入 公司公告，2026-08-05 4 翰森制药2026半年报 公司公告，阿斯达克财经 5 石药创新2026半年度业绩预告 公司公告，2026-07-27 6 海思科2026半年度业绩预告 人民网/证券日报，2026-08-05 7 荣昌生物2026半年度业绩预告 财联社，2026-08-05 8 阿斯利康2026半年报 21世纪经济报道/经济参考报，2026-07-27/08-05 9 诺华2026半年报 ZAKER/医线Insight 10 罗氏2026半年报 经济参考报，2026-07-30 11 默沙东/礼来/诺和诺德中国区 搜狐/动脉网整理 12 MNC中国区综合对比 动脉网，《AZ霸榜第一、礼来暴涨73%、默沙东大降》，2026-08 13 片仔癀/同仁堂业绩 上海证券/齐鲁智慧媒体云 14 医药板块整体数据 齐鲁智慧媒体云/财联社，2026-07/08

Announced positive Phase 1 clinical data for ELVN-001 in CML, demonstrating encouraging ELVN-001 efficacy data and a favorable safety and tolerability profile Reached alignment with the FDA on key Phase 3 trial design components Strong balance sheet with $895 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into 2030 BURLINGAME, Calif., Aug. 5, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. "The second quarter was an important period for Enliven as we announced compelling updated clinical data for ELVN-001, reached alignment with the FDA on key components of the ENABLE-2 Phase 3 2L+ trial design, and significantly strengthened our balance sheet," said Rick Fair, Chief Executive Officer of Enliven. "The updated Phase 1 data support ELVN-001's potential to become a best-in-class treatment for patients living with CML. Combined with our recent regulatory and financial progress, we are well positioned to initiate ENABLE-2 later this year and rapidly advance ELVN-001 across all lines of CML therapy." ELVN-001 Program Highlights ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with chronic myeloid leukemia (CML). In June 2026, the Company announced positive data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377). The data were presented in an oral presentation at the European Hematology Association (EHA) Congress by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. Highlights include: 61% overall major molecular response (MMR) and 48% MMR achievement by 24 weeks in the 80 mg once daily (QD) Phase 1b cohort. Response rates were higher in earlier-line patients, with 67% overall MMR and 55% achieving MMR by 24 weeks among patients with only one or two prior unique tyrosine kinase inhibitors (TKIs). Patients previously treated with asciminib achieved response rates comparable to the overall efficacy-evaluable population. Favorable safety and tolerability profile with 161 patients enrolled and a median treatment duration of 35 weeks, as of the March 10, 2026 cutoff. Key outcomes from the End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA): 80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial. ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician's choice of an ATP-competitive TKI. Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026. FDA granted Fast Track Designation to ELVN-001. Collectively, these data and regulatory milestones continue to support advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, which the Company expects to initiate in the second half of 2026. Second Quarter 2026 Financial Results Cash position: As of June 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $895.2 million, which is expected to provide cash runway into 2030. Research and development (R&D) expenses: R&D expenses were $29.0 million for the second quarter of 2026, compared to $21.5 million for the second quarter of 2025. General and administrative (G&A) expenses: G&A expenses were $8.2 million for the second quarter of 2026, compared to $7.1 million for the second quarter of 2025. Net loss: Enliven reported a net loss of $32.5 million for the second quarter of 2026, compared to a net loss of $25.3 million for the second quarter of 2025. About Enliven Therapeutics Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California. To learn more, visit and connect with us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential profile, safety, tolerability, efficacy and potential best-in-class profile of ELVN-001; the interpretation of data from the ongoing ENABLE trial and regulatory milestones supporting the advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, and the timing of such advancement; the continued conduct, design, objectives, endpoints, and future clinical evaluation of ELVN-001, including the planned ENABLE-2 Phase 3 trial, the potential timing of initiation of ENABLE-2; the potential timing for advancing ELVN-001 across all lines of CML therapy; the potential timing and outcome of further FDA discussions and the finalization of additional Phase 3 trial design details, including a planned End-of-Phase 2 meeting and the timing of such meeting; Enliven's expected cash runway; and statements by Enliven's Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation, the potential for interim, topline and preliminary results from Enliven's clinical trials to materially change as additional patient data become available or following more comprehensive review; the potential for results from the ongoing or any future clinical trial of ELVN-001 to differ from the results of earlier trials of ELVN-001; ELVN-001 failing to demonstrate sufficient safety, efficacy, tolerability, durability, differentiated attributes or therapeutic benefit in current or future clinical trials; risks associated with unexpected events during the remainder of the ENABLE trial including serious adverse events, toxicities, dose reductions, discontinuations or other undesirable side effects; delays or difficulties in recruiting, enrolling or maintaining patients in ELVN-001 clinical trials; the risks of delays in completing the ongoing ENABLE trial or initiating ENABLE-2; Enliven failing to complete the ongoing ENABLE trial, to present additional data, to initiate ENABLE-2 or to advance ELVN-001 through clinical development; regulatory authorities disagreeing with Enliven's clinical trial design, dose selection, endpoints or interpretation of data, or requiring additional studies or diagnostics; developments relating to Enliven's competitors and industry which may affect the development or potential market opportunity for ELVN-001; and the potential inability of Enliven to obtain regulatory approval for, or ultimately commercialize or license, ELVN-001 or other product candidates; Enliven's ability to obtain or maintain the benefits associated with Fast Track designation; Enliven's limited resources; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and Form 10-Q filed with the SEC and in Enliven's future SEC filings. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. SOURCE Enliven Therapeutics, Inc. 21% more press release views with Request a Demo