Zanubrutinib

LEXINGTON, Mass., July 30, 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 in patients with Chronic Lymphocytic Leukemia (CLL). Previously, Curis announced that 11 clinical sites had opened for enrollment in the TakeAim CLL study and 10 patients had been consented in that study. Today, Curis is announcing that it has achieved the previously stated goal of dosing the first five patients in the TakeAim CLL study and reaffirmed its expectation to report initial CLL data in 5-10 patients in December 2026. "We are encouraged by our progress in the CLL study as patient enrollment continues to exceed expectations," said James Dentzer, Chief Executive Officer of Curis. "The excitement among clinicians and patients reflects the clear unmet need in CLL, where emavusertib has the potential to change the treatment landscape when combined with approved BTK inhibitors." "BTK inhibitors have improved outcomes for patients with CLL; however, most patients still achieve only partial response and continue to have measurable residual disease (MRD) despite continuous, indefinite BTKi therapy," said Ahmed Hamdy, Chief Medical Officer of Curis. "This chronic BTKi dosing can lead to BTKi resistance, bleeding risk, cardiovascular events, and eventual CLL relapse. Combining emavusertib with an approved BTKi offers the potential to deepen responses, promote conversion to complete remission, undetectable MRD, and the potential for fixed-duration treatment. While we are still in the early days of the study, and the number of patients is small, we are greatly encouraged that the combination of emavusertib and zanubrutinib appears to be well tolerated and may be demonstrating early evidence of deepening responses in CLL patients." 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 (uMRD). 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. 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 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

十年磨一剑。从2015年成立到2025年盈利，由西湖大学校长施一公院士联合创办的药企诺诚健华，终于熬了出来！依托核心产品放量及全球授权合作，2025年其两大关键财务指标双双转正，实现净利润6.42亿，经营活动现金流8300多万，开始盈利。并且，在2026年一季度，公司再接再厉，实现扣非净利润9500多万，同比大增约6000%。众所周知，扣非净利润剔除了政府补助、资产处置、一次性授权收入等非经常性损益，只保留企业主营业务的真实利润。这也就意味着，诺诚健华彻底告别“阶段性盈利”，走完了“药物研发—上市—商业化—产生正向现金流”的完整商业闭环。 避开内卷，代表作奥布替尼在创立之初，诺诚健华就瞄向了血液瘤、自免这两大方向。这一选择，在当时看来似乎并非明智之举。一来，2015年国内创新药行业正迎来第一波热潮。PD-1靶点凭借广谱抗癌的特性，几乎成了“必争之地”，前后有几十家公司扎堆布局。业内玩家普遍抱着“快做、快上、快抢市场”的心态，me-too药遍地开花。二来，血液瘤患者群体不如肺癌、肝癌等实体瘤庞大，国内血液肿瘤患者总体发病率相对较低，以淋巴瘤这一较大亚型为例，发病率仅约为6.68人/10万人。同时，自身免疫病的研发周期更长、临床难度更高。但是，公司联合创始人施一公、崔霁松想得很简单，做药的本质是解决临床需求，而不是跟风追逐。奥布替尼便是这一理念下的首款重磅成果，也是诺诚健华近十年发展的核心基石。此药从公司成立到2020年末获批上市，仅耗时5年，首发对症复发/难治性慢性淋巴细胞白血病、小淋巴细胞淋巴瘤。后续，奥布替尼应用范围持续拓宽。截至2025年末，产品已累计获批4项适应症，专注血液瘤各细分类型，是国内唯一获批复发/难治性边缘区淋巴瘤适应症的BTK抑制剂。具体来说，这款药兼具疗效与性价比优势。与伊布替尼、阿卡替尼、泽布替尼等竞品相比，奥布替尼治疗复发/难治性套细胞淋巴瘤的患者客观缓解率达81.1%，数据位居前列，且患者三级及三级以上的不良反应发生率只有约35%，低于泽布替尼及阿卡替尼的50%。正因此，凭借高靶点选择性、患者耐受性好的差异化优势，奥布替尼被纳入CSCO淋巴瘤诊疗指南多项适应症I级推荐方案。治疗费用方面，诺诚健华的奥布替尼各适应症均已纳入国家医保目录，月度治疗费用约1万元，要比伊布替尼低约4000-8000元，同阿卡替尼、泽布替尼相当。所以，上市五年时间，奥布替尼的收入一路飞增。2025年，此药销售额14.1亿，同比增长超40%。 研发闯关，三款新药丰收外界大多只看到奥布替尼上市后快速放量、进医保、稳坐国内BTK抑制剂第一梯队，却很少知道它在研发阶段数次遭遇重大难题。最经典的一个坎，是药物溶解性难题。奥布替尼的分子本身难溶于水，直接做成药片人体吸收差，药效会大打折扣。2016年项目卡在这里时，施一公帮忙引荐了制剂领域顶尖专家，最终团队采用固体分散体技术，通过喷雾干燥将药物打成无定形超细粉末，成功解决了吸收难题。这套制剂技术并非绝密或者壁垒高得难以触及，却是很多同行懒得花时间打磨的细节。也恰恰是这些小事积累起来，造就了奥布替尼后来的差异化优势。实际上，诸多研发细节早已写进了诺诚健华年报的核心技术平台里。公司已构建起化合物优化、药物晶型研究、难溶性药物增溶制剂技术研发及产业化等五大平台，为后续新药研发与上市“保驾护航”。在2025年，奥布替尼适应症拓展之后，公司又迎两大商业化管线落地。先是5月，国内首个CD19靶向单抗坦昔妥单抗获批上市，用于联合来那度胺治疗特定类型的复发/难治性弥漫大B细胞淋巴瘤。该药于9月正式开出首批处方，启动商业化。接着12月，公司首款实体瘤药物第二代泛TRK抑制剂佐来曲替尼获批上市，用于治疗NTRK基因融合阳性实体瘤，同时也有力解决了第一代药物的常见耐药难题。至此，诺诚健华已手握三款获批上市的创新药。新品密集落地与老品持续放量之下，公司业绩也开始飞跃。2025年，诺诚健华药品销售收入达14.42亿，同比增长43%，这部分纯粹的主营业务收入，是公司可持续造血的根基。叠加部分海外授权合作收入，诺诚健华全年营收23.75亿，同比大增超135%。之后，在2026年一季度，公司药品销售收入4.5亿，同比仍然增长约45%，顺势带动整体营收5.29亿，扣非净利润0.95亿，飙升近6000%。可见，诺诚健华近来的业绩增长并非依赖一次性收益的纸面繁荣，而是实打实的创新药物放量。历经十年沉淀，公司逐步具备了“卖药赚钱、自主造血”的可持续经营能力。手握现金70亿， 管线接力在创新药行业，单次业绩爆发、单款大单品走红并不稀缺，多数药企都曾凭借一款产品实现盈利。比如艾力斯依靠伏美替尼一举扭亏、翰森制药靠阿美替尼撑起绝大部分营收，均是单品拉动业绩的典型。但长期看，仅依靠单一产品存在增长天花板。对于创新药企来说，能不能持续走下去，核心至少有两点：一看账上的钱够不够，二看后续的管线能不能接力。从资金储备层面来看，截至2025年末，诺诚健华在手的货币资金超70亿。这个资金储备是比较充裕的。因为当年公司研发投入约9.5亿，即便算上全部销售、管理费用，一年合计也才17亿出头。按这个消耗速度，仅现有现金储备能支撑4-5年的正常运营。更关键的是，诺诚健华的造血能力还在增强。目前三款上市产品中，坦昔妥单抗、佐来曲替尼均为2025年新获批产品，尚处于商业化放量初期，销售额还有较大的提升空间，能持续带来现金流入。为匹配新品商业化节奏，公司持续完善产能与团队布局。产能端，诺诚健华已完成广州生产基地一、二、三期全面建设，基地符合全球主流地区的GMP标准，年产能可达10亿片量级，能够充分保障产品供应。同时，公司搭建的商业化团队，具备成熟的学术推广、终端拓展与渠道运营能力。例如奥布替尼，上市不到五年便在团队努力下成功覆盖了全国30个省市自治区。管线储备层面，血液瘤领域，诺诚健华在奥布替尼之外，布局了下一代核心管线产品mesutoclax（ICP-248）。作为新型高选择性BCL-2抑制剂，该产品覆盖慢性淋巴细胞白血病（CLL）、小淋巴细胞瘤（SLL）等多个核心适应症。临床数据显示奥布替尼联合ICP-248对42例初诊CLL/SLL患者的客观缓解率达到100%，且治疗期间未报告导致停药或死亡的不良事件。目前，ICP-248联合奥布替尼一线治疗CLL/SLL的进展已推进至临床三期，有可能成为血液瘤领域新的生力军。在自身免疫疾病这一块，诺诚健华是“老品迭代+新品攻坚”两手准备。独特的作用机制下，血液瘤之外，奥布替尼还有治疗自免疾病的可能。2026年4月，此药针对系统性红斑狼疮的III期临床研究成功完成首例患者入组；5月底，奥布替尼用于治疗原发免疫性血小板减少症的上市申请获得受理，成为国内首个进入上市申报阶段的BTK抑制剂自身免疫适应症。另一边，公司两款自主研发的TYK2抑制剂也在快速推进。其中，ICP-332的特应性皮炎适应症与ICP-488的银屑病适应症皆已进入临床III期，处于上市前夜。可以说，在血液瘤及自免这两大领域，诺诚健华正全面开花。当然，新药在未上市获批前，始终存在不确定性。如临床数据未达预期、进度落后竞品从而失去先机等都会带来挑战，这也是所有创新药企的共性难题。结语回望诺诚健华的十年，它的突围从来不是偶然，更不是运气加持，而是长期主义的结果。当部分药企开始走捷径的时候，公司选择不扎堆热门靶点、不做同质化仿创，沉下心去做临床刚需。是的，做药无捷径，深耕方致远。以上分析仅代表个人观点，不构成任何具体的投资建议，投资者需结合市场变化及自身风险承受能力独自决策。股市有风险，入市需谨慎。来源：投研邦