Ibrutinib

今天，创新药板块又涨了。 中证沪港深创新药产业指数涨超4%，近4个交易日累计涨幅接近13%。甘李药业封板涨停，中国生物制药、科伦药业、百奥赛图等大面积飘红。资金连续多日净流入，创新药ETF近5天吸金超5亿。 表面看，催化剂是7月3日国家药监局的一纸新规——细胞与基因治疗药品纳入"30日审评通道"，审批时间直接减半。但政策点火只是表层，板块能走出这种级别的涨幅，背后有更扎实的东西。 简单说就是三段论闭环了：业绩好，单品卖得好，授权卖得好。一、业绩好：不只是"好转"，是全面超预期 药明康德一季度营收124亿，首次单季突破百亿。更关键的是，在手订单接近600亿，是去年全年收入的1.3倍。公司说"不排除上调全年指引"，这种底气来自实实在在的订单。 百济神州连续四个季度盈利。2025年全年经调整净利润9.18亿美元，从"烧钱黑洞"变成了"盈利标杆"。今年一季度净利润又做到16亿，全年收入指引上调到63到65亿美元。 恒瑞医药一季度创新药销售收入45亿，同比增长25.75%，占药品销售比重首次突破60%。作为国内最大的传统药企，这个数字意味着行业已经彻底从"仿制药主导"跨入了"创新药主导"时代。 三家风格完全不同——药明是卖水人，百济是单点突破，恒瑞是全面开花——但财报指向同一个方向：基本面已经实质性改善了。二、单品卖得好：国产"重磅炸弹"批量来了 百济神州的泽布替尼，2025年全球卖了39亿美元，增长49%。在美国慢性淋巴细胞白血病新患者处方中，市场份额已经超过伊布替尼和阿卡替尼，全球BTK抑制剂做到了第一。这是中国药企第一次在全球主流市场硬碰硬赢了跨国巨头。 百利天恒的BL-B01D1今年6月获批上市，是全球第一款双抗ADC。食管鳞癌的临床研究拿到了生存期和疾病无进展双阳性结果，填补了标准治疗的空白。7月6日同一天，公司还启动了另一款药直接对标DS-8201的头对头试验。DS-8201是ADC领域公认的"天花板"，敢直接对标本身就说明底气。 恒瑞手握19款已上市的1类创新药，非肿瘤创新药收入近乎翻倍，GLP-1等代谢领域的新药正在接力。 一句话说：以前中国生物医药只有"在研故事"，现在有了"销售数字"。三、授权卖得好：MNC用真金白银投票 2026年上半年，中国创新药对外授权交易总金额达到997亿美元。什么概念？差不多是2024年全年的两倍，2025年全年的73%。全球医药交易前十名中，中国企业占了八个席位。 首付款合计55亿美元，同比增长124%，平均单笔首付款1.8亿美元。五年前这个数字还只是几千万美元。 石药集团和阿斯利康签的GLP-1授权总金额达到185亿美元，是中国药企单笔最大纪录。百利天恒和BMS的双抗ADC授权84亿美元，首付款8亿美元创国产ADC出海纪录。还有科伦博泰和默沙东的ADC合作，也是累计超百亿。 更重要的是合作模式在升级——以前是卖单一分子权益，现在是技术平台合作、海外共同开发。跨国药企买的不是某个分子的运气，而是中国企业的持续研发能力。四、三段论为什么重要 业绩好说明基本盘没问题，单品卖得好说明产品力被市场验证，授权卖得好说明全球竞争力被MNC用真金白银认证。 三条逻辑链互相验证，层层递进，不再是"讲故事"阶段——而是"基本面驱动"阶段。 沿着产业链看，上游耗材的国产替代（层析填料国产化率才10%）、CXO的订单确定性格局、中游创新药的全球突破，每个环节都有清晰的传导链。政策端也给了助攻：生物医药2026年首次被列为"新兴支柱产业"，与集成电路、航空航天并列。 一个产业的长期叙事，正在变成季度财报上的数字。

LEXINGTON, Mass., July 6, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today announced an important enrollment milestone in its TakeAim CLL study. On June 26, 2026, Curis announced that eleven clinical sites had opened for enrollment in the TakeAim CLL study. Today, Curis is announcing that it has consented the first six patients in that study – and reaffirmed its guidance for the dosing of five CLL patients by the end of July 2026, with initial CLL data expected in December 2026. "We are encouraged by the strong interest among clinical sites and key opinion leaders in our TakeAim CLL study that has enabled us to exceed expectations for site activation and enrollment," said James Dentzer, Chief Executive Officer of Curis. "It reflects the clear unmet need in CLL and the excitement for the potential of emavusertib to fundamentally change the treatment paradigm in CLL." In CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim CLL Study is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTK inhibitors (BTKi) block the BCR pathway; emavusertib blocks the TLR pathway. BTKi is the current standard of care in CLL. In the registrational study for the BTKi zanubrutinib, 93% of patients were able to achieve an objective response, but only 7% achieved complete response2. More recent clinical studies have demonstrated that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (MRD). About the TakeAim CLL Study The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), with measurable residual disease (MRD+) as determined by the clonoSEQ assay and actively taking zanubrutinib for at least 12 months. Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL study by the end of July, with initial data expected in December 2026. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 and FLT3 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) of emavusertib in combination with the BTK inhibitor, ibrutinib, in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and in the TakeAim CLL Phase 2 study (CA-4948-203) of emavusertib in combination with the BTK inhibitor, zanubrutinib, in chronic lymphocytic leukemia (CLL). The Company's monotherapy and combination studies in acute myeloid leukemia (AML) are substantially complete, with additional funding the Company plans to continue development of emavusertib in AML. Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene Discovery Technologies Limited, has the exclusive license to emavusertib (CA-4948). For more information, visit Curis's website at . Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning Curis's expectations with respect to the dosing of the first five patients and initial data from the TakeAim CLL study. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "likelihood", "continue," "potential," "opportunity," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. Curis is dependent on the success of emavusertib and any delays in the development of emavusertib could have a material adverse effect on its business. There can be no guarantee that the collaboration agreement with Aurigene or the CRADA with NCI will continue for their full terms, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Curis will require substantial additional capital to fund its business. Based on its available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months from the date of this press release. Curis will require substantial additional funding to fund the development of emavusertib through regulatory approval and commercialization, and to support its continued operations. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate the development of emavusertib, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, emavusertib, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA, EMA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control, including its ability to regain and maintain its listing on the Nasdaq Capital Market, could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K, and the factors that are discussed in other filings that Curis periodically makes with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. __________________________ 1 Bennett, Curr Opin Hematol. 2022 2 Zanubrutinib USPI. SOURCE Curis, Inc. 21% more press release views with Request a Demo