Paclitaxel

SAN FRANCISCO and SUZHOU, China, Feb. 12, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent",HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in the pivotal Phase 3 clinical study (HeriCare-Breast01). The trial is evaluating the company's developed IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer. IBI354 has two pivotal Phase 3 trials ongoing (HeriCare-Ovarian01, HeriCare-Breast01), which holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity". HeriCare-Breast01 (NCT07377643) is a multicenter, randomized, open-label, active-controlled study designed to evaluate the safety and efficacy of IBI354, with or without pertuzumab, compared with the current standard-of-care, paclitaxel plus trastuzumab and pertuzumab (THP). The primary endpoint is progression-free survival (PFS). Previously, in a multicenter Phase 1/2 study in participants with advanced solid tumors, a total of 88 participants with HER2-positive breast cancer were enrolled（the median prior treatment lines was 4) and were treated with 6-15 mg/kg doses of IBI354. As of March 24, 2025, the overall confirmed objective response rate (cORR) was 59.1% and the disease control rate (DCR) was 90.9%. Among them, ORR reached 72.4% and DCR reached 89.7% in 29 breast cancer participants treated with 9mg/kg Q3W. The median follow-up time of 9mg/kg Q3W dose group was 13.6 months as of the cut-off date, and progression-free survival (PFS) was 14.1 month (95%CI: 8.3, NC). The data were presented at the ASCO 2025[Link]. IBI354 also demonstrated an excellent safety profile in this Phase 1/2 clinical study (n=368). No DLT was occurred up to 18mg/kg dose group. The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) in 9mg/kg Q3W dose group was 21.0%, the incidence of TRAEs leading to dose interruption was 9.9%, the incidence of TRAEs leading to dose reduction was 1.2%, the overall incidence of TRAEs leading to discontinuation was 1.2%, and no TRAE leading to death reported. The most common TRAEs are white blood cell count decreased, nausea and anemia. The incidence of interstitial lung disease was only 1.2%, all were grade 1. The Principal Investigator of the HeriCare-Breast01 study, Binghe Xu, academician of the Chinese Academy of Engineering from Cancer Hospital Chinese Academy of Medical Sciences, stated, "We are pleased to complete the first patient enrollment for the HeriCare-Breast01 study at our center. Although first-line treatment for HER2-positive advanced breast cancer has improved substantially—with the THP regimen delivering durable responses for many patients—important clinical challenges remain. These include treatment discontinuation driven by toxicity and limited tolerability of currently available ADCs, particularly among older patients and those with comorbid conditions. As a next-generation HER2-targeted ADC, IBI354 has shown compelling antitumor activity in Phase 1/1b studies, achieving class-leading ORR and DCR, alongside a notably favorable safety profile. In particular, IBI354 has demonstrated reduced incidence of key adverse events such as interstitial lung disease (ILD), peripheral neuropathy, and neutropenia. This "high-efficacy, low-toxicity" therapeutic window may allow a broader range of patients to achieve sustained, high-quality treatment outcomes. We look forward to the Phase 3 HeriCare-Breast01 study to further validate this potential and advancing IBI354 toward becoming a new standard of care in the first-line treatment for HER2-positive advanced breast cancer. " Dr. Zhou Hui, Chief R&D Officer (Oncology) of Innovent, stated, "The initiation of the pivotal Phase 3 HeriCare-Breast01 trial in China marks a significant milestone in the clinical translation of Innovent's ADC pipeline. Leveraging the world's leading antibody engineering and differentiated linker-payload technologies, Innovent has established a highly competitive and innovative TOPO1i ADC technology platform SoloTx®. IBI354 has demonstrated a compelling safety and efficacy profile in early-stage studies, strongly validating the strengths of our SoloTx® ADC platform. IBI354 holds strong potential to offer a new first-line treatment option for patients with HER2-positive advanced breast cancer—one that combines durable antitumor activity with favorable long-term tolerability. Looking ahead, Innovent will continue to advance innovation of next-generation IO+ADC, with a steadfast commitment to delivering improved therapeutic outcomes for cancer patients." About Breast Cancer Breast cancer is one of the most common cancers among women worldwide. Approximately 1.3 million women are diagnosed with breast cancer each year, and about 30% of them develop locally advanced or metastatic breast cancer. The clinical proportion of HER2-positive breast cancer is approximately 20%[1]. Previous studies have demonstrated that overexpression of this HER2 gene plays a significant role in the occurrence and development of invasive breast cancer and is associated with an increased recurrence rate and poor prognosis [2]. At present, no ADC targeting HER2 has been fully approved for first-line treatment of advanced breast cancer in China. There is an urgent need for new drugs to improve the prognosis of patients. About IBI354 IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent's proprietary SoloTx® ADC platform. Based on this platform, Innovent is promoting clinical trial studies multiple self-developed ADC molecules, which have shown promising safety and efficacy signals. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Starting from the urgent clinical needs, in addition to the Phase 3 studies (HeriCare-Breast01 and HeriCare-Ovarian01) already initiated in BC and PROC, Innovent will explore IBI354 in multiple solid tumor indications. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. SOURCE Innovent Biologics 21% more press release views with Request a Demo

（一）重要意义 1. 高水平科技自立自强是应对百年变局、掌握国家发展命运的根本支撑。 当前，新一轮科技革命和产业变革加速突破，全球创新版图与产业格局进入深度重构期。科技创新已成为国际战略博弈的主要战场，围绕制高点的竞争空前激烈。2月9日，“十五五”开局之年首次考察，习近平总书记来到北京亦庄国家信创园，再次将目光投向科技创新，深刻指出“建设社会主义现代化强国，关键在科技自立自强”。这一判断有着极强的现实针对性：我国在部分领域已形成先发优势，但原始创新能力仍需增强，关键核心技术“卡脖子”问题依然突出。要防止再度陷入“追赶—落后—再追赶”的被动循环，必须抓住换道超车的历史机遇，以科技突破抢占制高点、掌握主动权。与“十四五”相比，“十五五”规划建议不仅要求科技“自立自强”，更强调了“高水平”——这不仅是量的进阶，更是质的跃升，意味着要从重点领域突破转向系统性创新能力建设，从技术追赶走向原始创新引领。 2. 高水平科技自立自强是发展新质生产力、建设现代化产业体系的核心引擎。 科技创新是发展新质生产力的核心要素，其突破程度“很大程度上决定未来产业发展的速度、广度、深度”。从中国科学院天津工业生物所打破国外垄断的“微生物平行生物反应器”，到合肥“量子大道”自主可控的超导量子计算机；从紫杉醇绿色生物合成路径的十年攻关，到可控核聚变“双亿度”稳态运行的重大突破——这些鲜活的创新实践揭示了一个根本逻辑：新质生产力的爆发，离不开基础研究的厚积薄发；现代化产业体系的竞争力，取决于关键核心技术的自主掌控。当前我国研发经费投入强度已达2.8%，首次超越OECD国家平均水平，创新指数跻身全球前十。但投入强度的提升必须转化为创新效能的质变，以高水平科技供给为产业升级开辟新空间、注入新动能。 3. 高水平科技自立自强是凝聚强国力量、实现民族复兴伟业的战略基石。 从“两弹一星”的举国攻坚，到载人航天、探月探火的自主跨越，历史反复证明：科技兴则民族兴，科技强则国家强。站在“十五五”开局的历史关口，科技创新不仅关乎经济发展，更关乎国家安全、民生福祉和民族尊严。无论是生物制造领域的合成生物学突破，还是脑机接口技术为渐冻症患者重建沟通通道；无论是国产大飞机翱翔蓝天，还是新能源汽车销量占比跨越50%——每一项科技突破都在定义着中国式现代化的新高度，也在汇聚起亿万人民对国家未来最坚定的信心。以高水平科技自立自强引领强国建设，是时代的召唤，更是历史的责任。（二）重要举措 第一，强化战略导向与体系布局，打好关键核心技术攻坚战。 必须坚持“产业出题、科技答题”，把国家战略需求作为科技攻关的根本指向。要充分发挥新型举国体制优势——这不仅是大规模资源投入，更是“战略耐心”的制度保障。中国人民大学商学院教授徐佳宾指出，未来产业具有前沿不确定性、系统复杂性，市场机制在基础研究、长期投入领域存在“失灵”风险，而新型举国体制能够以国家战略为引领，提供市场无法保障的长期稳定投入。2026年，国务院国资委明确将抓好国家科技重大专项实施，突出原始创新导向，集中力量攻克一批辐射性、全局性、战略性技术。从生物反应器到量子计算，从可控核聚变到6G通信，攻关清单的背后，是对“把各种优质要素集合起来”制度优势的充分释放。 第二，推动科技创新与产业创新深度融合，打通从实验室到生产线的高速路。 “融合”不是物理叠加，而是化学反应。中建兴业突破“实验室孤岛”，将光伏幕墙技术深度嵌入工程体系，产品可抵御17级台风、转化效率达20%，年均产出630万度绿电——这是科技创新与场景引领双轮驱动的生动注脚。中国社会科学院工业经济研究所研究员时杰评价，这证明企业能在工程型、系统型创新中发挥风险承载、场景开拓的核心作用。2026年，工信部将做强一批高水平制造业中试平台，打造全国制造业中试服务网络，经过中试验证的科技成果产业化成功率可达80%以上。同时，推进科技成果“先使用后付费”改革试点，培育全国一体化技术市场，让更多“藏在深闺”的创新成果走向产业一线。 第三，强化企业科技创新主体地位，激发微观主体创新活力。 很多未来产业的兴起，是靠企业一步步突破带动的。从北京芯智达“新型研发机构+临床机构+企业”的创新联合体，到中国聚变能源有限公司从院所“唱主角”向企业“挑大梁”的体制跨越——企业的角色正从科技成果的承接者，跃升为技术策源、生态构建、市场转化的主导力量。2026年，国务院国资委将进一步健全国有企业打造原创技术策源地的政策体系，建立容错机制，完善科技创新和战略性新兴产业投资评价方式，扩大职务科技成果赋权改革试点范围。同时，工信部明确新培育一批“小巨人”企业、制造业单项冠军企业，加紧清理拖欠企业账款，坚决遏制新增拖欠。让企业敢投入、愿投入、能投入，是科技创新体制改革的硬核检验。 第四，优化要素配置与制度供给，以金融活水滋养创新沃土。 科技创新是长跑，需要资本“长情”陪伴。2月9日，沪深北交易所一揽子再融资优化举措落地，精准疏通科创企业融资堵点。核心突破有三：一是将未盈利科创企业再融资间隔期从18个月大幅缩减至6个月，贴合创新企业“研发投入连续、盈利周期滞后”的客观规律；二是将“轻资产、高研发投入”认定标准扩展至主板，允许补充流动资金超出30%部分用于研发；三是允许破发企业通过竞价定增、可转债募集资金投向主业，保障研发不掉线。南开大学金融学教授田利辉评价，新规引导资本向新一代信息技术、高端装备、生物医药等战略领域集聚，是资本精准服务科技自立自强的制度创新。 第五，构建具有全球竞争力的开放创新生态，以人才高地托举创新高地。 科技竞争归根结底是人才竞争。2026年内蒙古全区科技工作会议部署“九项行动”，明确提出一体推进教育科技人才发展，强化规划衔接、政策协同、资源统筹、评价联动，以科技项目为牵引深化科教融汇、产教融合。北京市“智能脑机系统增强计划”孵化芯智达公司，由知名神经生物学家罗敏敏担任首席科学家——这是科学家直接下场创业、科研机构与产业资本深度绑定的典型实践。下一步，要深化科技人才评价改革，破除“唯论文、唯职称、唯学历、唯奖项”，建立以创新价值、能力、贡献为导向的评价体系。同时，积极扩大国际科技合作参与度，在开放合作中提升自主创新能力，构建具有全球吸引力的创新生态。 第六，坚持统筹发展与安全，以科技治理现代化护航创新行稳致远。 科技越向高精尖迈进，治理越需敏捷与智慧。一方面，要加快数据、算法、算力等新型要素的基础制度建设。国务院国资委明确强化全链条数据治理能力，推进“算力+电力”协同发展，夯实人工智能产业基础底座。另一方面，要完善科技创新伦理规范与风险防范机制。对于脑机接口、基因编辑、人工智能等前沿领域，既不能因噎废食、束缚创新，也不能放任自流、突破底线。必须在鼓励探索的制度环境下划定清晰红线，确保科技创新始终朝着增进人类福祉的正确方向前进。（三）面试金句 “科技突破的程度，很大程度上决定未来产业发展的速度、广度、深度。” 这是对科技创新战略地位最凝练、最深刻的概括。高水平科技自立自强，不是选择题，而是必答题；不是百米冲刺，而是耐力长跑。 “产业出题、科技答题”——科技创新不能困在实验室里“孤芳自赏”。 真正的创新价值，必须在解决产业最具体、最真实痛点的过程中创造和验证。从天津生物反应器的“卡脖子”突围，到合肥量子大道的集群突破，无一不是“出题”与“答题”的双向奔赴。 企业是科技创新的“出题人”“答题人”“阅卷人”。 强化企业科技创新主体地位，不是给政策标签，而是建制度保障——让企业愿意投长线、敢于闯无人区，让企业家精神与科学家精神交相辉映。 基础研究是科技创新的“总开关”，是未来产业的“种质资源库”。 没有十年磨一剑的冷板凳，就没有量子计算、合成生物学的热突破。必须以前瞻性、战略性、体系化布局，以制度确定性对冲技术不确定性。 金融活水要精准滴灌，而非大水漫灌。 再融资新政将未盈利企业间隔期从18个月缩至6个月，看似是“放”，实则是基于对创新规律深刻理解的“精准”——在研发最吃劲的时候托一把，比任何锦上添花都更有价值。 高水平科技自立自强，不是关起门来搞创新，而是在开放中提升自主能力。 既要敢在国际前沿“无人区”插上中国旗帜，也要以全球视野吸引顶尖人才、融入创新网络，在更高水平的开放合作中锻造不可替代的核心竞争力。 今天的未来产业，就是明天的战略性新兴产业、后天的支柱产业。 十五五开局之年的每一次攻关、每一项突破，都在为十年后的中国积蓄动能、埋下伏笔。这是科技创新的时间哲学，更是大国博弈的战略定力。