Zanubrutinib

一、创新药长期成长逻辑：政策护航+技术突破+出海红利 2026年，创新药行业进入高质量发展的黄金期，政策、技术、市场三重驱动构筑长期成长基石。政策端，医保谈判常态化兼顾创新激励，对ADC、双抗、GLP-1等前沿领域给予优先支持，鼓励源头创新；技术端，国内药企在大分子、基因治疗、AI制药等领域持续突破，研发管线从fast follow向first-in-class跃迁；市场端，国内老龄化加剧带来慢性病刚需，海外市场对国产创新药认可度提升，出海授权与商业化提速。具备硬核研发实力、丰富管线储备、全球化布局的龙头，将穿越周期，享受行业增长红利。二、长期看好的十家创新药龙头企业梳理恒瑞医药（600276） 国产创新药绝对龙头，研发投入断层领先，年研发投入超60亿元，覆盖肿瘤、自免、代谢、麻醉四大黄金赛道。已获批19款1类创新药，PD-1单抗、阿帕替尼等核心产品进入医保放量期。ADC管线布局密集，与默沙东达成56亿美元Trop2 ADC授权合作，出海进程加速。2026年一季度创新药营收占比超60%，长期成长确定性强。百济神州（688235） 全球化创新药标杆，国内药企出海领军者。核心产品泽布替尼全球获批，成为首款在美销售额破10亿美元的国产创新药。管线覆盖血液瘤、实体瘤，替雷利珠单抗、泽布替尼等产品全球商业化落地。中美欧三地布局研发与销售网络，海外收入占比超60%。2026年一季度营收同比增长44.21%，全球化成长空间广阔。信达生物（688180） 国产PD-1龙头，双抗与ADC领域布局领先。核心产品信迪利单抗医保覆盖率超82%，年治疗费用优势显著。双抗产品卡度尼利单抗（PD-1/CTLA-4）全球获批，成为首款上市的肿瘤免疫双抗。管线梯队完善，国际化临床推进顺利，2026年一季度创新药营收稳步增长。荣昌生物（688331） 国产ADC赛道领军者，维迪西妥单抗（HER2 ADC）为国内首款自研ADC，获FDA批准上市。与艾伯维达成26亿美元全球授权合作，出海里程碑兑现。自免领域产品泰它西普获批，双轮驱动业绩增长。2026年一季度ADC订单持续放量，商业化加速推进。科伦药业（002422） 复杂注射剂+创新药双轮驱动，ADC赛道黑马。核心产品SKB264（TROP2-ADC）进入临床III期，疗效对标海外重磅产品。输液业务提供稳定现金流，支撑创新药研发投入。管线覆盖肿瘤、自免、代谢，2026年一季度创新药临床进展顺利，商业化可期。君实生物（688180） 创新药出海先行者，PD-1单抗特瑞普利单抗海外获批。布局双抗、ADC、新冠口服药等前沿领域，管线丰富。与阿斯利康合作推进海外商业化，2026年一季度海外授权收入稳步增长。研发投入持续加码，first-in-class药物临床推进顺利。康方生物（9926.HK） 双抗赛道龙头，卡度尼利单抗全球获批，实体瘤适应症覆盖广泛。PD-1/CTLA-4双抗开坦尼年销售额破20亿元，依沃西头对头击败海外K药。管线布局双抗、ADC、小分子，国际化授权合作进展顺利。2026年一季度双抗产品放量，业绩高增。药明康德（603259） 全球CXO绝对龙头，创新药“卖水人”。覆盖药物发现到商业化生产全产业链，在手订单超580亿元。TIDES业务（多肽/寡核苷酸）受益GLP-1浪潮，同比增长96%。海外收入占比超75%，深度绑定全球顶尖药企。2026年一季度CDMO业务营收同比增长30%+，业绩稳健。华东医药（000963） 医美+创新药双轮驱动，慢性病与医美赛道协同发展。创新药布局GLP-1、自免、肿瘤，多款产品进入临床后期。医美产品少女针、濡白天使放量，贡献高毛利。2026年一季度创新药+医美业务双增长，业绩稳健高增。信立泰（002294） 心血管国产替代领军者，聚焦高血压、冠心病、心衰等慢性病。核心产品氯吡格雷、替格瑞洛通过一致性评价，市占率稳步提升。创新药布局S086、复格列汀等，填补国内空白。2026年一季度创新药营收同比增长35%，慢性病刚需支撑业绩稳健。三、长期配置核心逻辑：四大维度锁定优质龙头（一）核心逻辑：研发硬实力+管线高景气+出海潜力+业绩兑现 研发硬实力：优先选择研发投入高、研发团队规模大、first-in-class药物布局深的企业，技术壁垒构筑护城河；2.管线高景气：聚焦ADC、双抗、GLP-1、自免等黄金赛道，管线梯队完善、临床进度快的企业；3.出海潜力：海外授权金额大、商业化团队完善、产品全球获批的企业，享受全球化红利；4.业绩兑现：创新药营收占比高、毛利率稳定、现金流充足、商业化落地明确的企业。（二）长期价值：行业集中度提升+国产替代加速+全球化空间广阔 创新药行业优胜劣汰加剧，资源向头部集中，龙头份额持续提升；国产替代从仿制药向创新药延伸，高端市场逐步突破；全球化从产品出口向授权合作、海外商业化升级，成长空间打开。具备核心竞争力的龙头，将长期受益行业增长与格局优化。 以上分析基于公开信息梳理，仅供参考，不构成任何投资建议。

Eleven sites open for patient enrollment in TakeAim CLL combination study with zanubrutinib; Company reaffirms guidance for dosing of initial five patients by end of July 2026 with data expected December 2026; Stockholders approve reverse stock split LEXINGTON, Mass., June 26, 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 that eleven clinical sites have been initiated and are now open for patient enrollment in its Phase 2 TakeAim CLL study evaluating emavusertib in combination with zanubrutinib in patients with Chronic Lymphocytic Leukemia. The Company also reaffirmed its guidance for the dosing of the initial five patients in the TakeAim CLL study by the end of July 2026, with data expected in December 2026. In addition, the Company reported that its stockholders approved a reverse stock split proposal at the special meeting of stockholders held on June 25, 2026. TakeAim CLL Update Eleven clinical sites are now open for enrollment in the TakeAim CLL study, reflecting strong investigator interest in the combination of emavusertib and zanubrutinib as a strategy to enable dual blockade of NF-kB, a key driver of CLL disease. The Company reaffirmed its expectations to announce the dosing of the initial five patients in the TakeAim CLL combination study with zanubrutinib by the end of July 2026, with data expected in December 2026. "We are pleased with both our operational progress in the CLL study and the strong support from our shareholders as we work to regain compliance with the NASDAQ bid price listing requirement," said James Dentzer, President and CEO of Curis, "and we look forward to building on those successes in the weeks and months to come." Special Meeting Vote Results At the Company's special meeting of stockholders held on June 25, 2026, stockholders approved a proposal to amend the Company's Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding shares of common stock at a ratio ranging from 1-for-5 to 1-for-25, in furtherance of the Company's regaining compliance with Nasdaq's $1.00 bid price rule, with the final ratio to be determined at the discretion of the Company's Board of Directors. The Company intends to announce the specific ratio and effective date in advance of the reverse stock split becoming effective. Curis's shares of common stock will continue to trade on the Nasdaq Capital Market under the ticker symbol "CRIS." Additional information regarding the reverse stock split proposal can be found in the Company's definitive proxy statement filed with the Securities and Exchange Commission on June 5, 2026, available at and . About the TakeAim CLL Study The TakeAim CLL is an open label phase 2 study of emavusertib in combination with zanabrutinib 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), measurable residual disease positive (MRD+) as determined by the ClonoSEQ assay and actively taking zanubrutinib for at least 12 months. 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 regaining compliance with Nasdaq's bid price rule, the dosing of the first five patients in the TakeAim CLL study and the timing of initial data from such 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. SOURCE Curis, Inc. 21% more press release views with Request a Demo