This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

开始日期2026-09-01

申办/合作机构

Georgetown University

[+1]

NCT07371897

/ Not yet recruiting临床3期IIT

A Randomized, Open-label, Multi-center Phase III Clinical Study of Toripalimab Combined With Cisplatin and Docetaxel Versus Toripalimab Alone as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer.
Eligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation).
We will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects.
Taking part is voluntary and you can leave the study at any time.

开始日期2026-06-30

申办/合作机构

中山大学

NCT07550842

/ Not yet recruiting临床1期

An Open, Multi-center Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Among them, small cell lung cancer (SCLC) accounts for approximately 14% of all newly diagnosed lung cancers. Small cell lung cancer (SCLC) is a highly heterogeneous and aggressive disease with poor survival outcomes.
A 2-stage system dividing patients into limited and extensive disease was developed in 1973 by the United States (US) Veteran's Administration Lung Cancer Study Group (VALG), which has been used to this day. Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival. However, the majority (approximately 70%) of patients with SCLC are diagnosed with extensive-stage SCLC (ES-SCLC), which has poor survival prospects. Chest pain, dyspnea, and cough are among the most frequent disease-related symptoms experienced by patients with SCLC. Immune checkpoint inhibitors in combination with platinum-based systemic therapy can palliate symptoms and prolong survival for patients with ES-SCLC. However, long-term survival is rare.
The current standard first-line treatment for patients with ES-SCLC is immune checkpoint inhibitors in combination with platinum-based systemic therapy. Despite the impressive high objective response rates (approximately 60%-80%) observed with first-line treatment regimens, the median overall survival (OS) of patients rarely exceeds 16 months, and the median progression-free survival (PFS) is also limited to around 5 months. Second-line and subsequent therapeutic options are limited. The main treatment drugs include Topotecan, Lurbinectedin, Tarlatamab, etc., with objective response rates rarely exceeding 40%. Therefore, there is a significant need for improved novel treatment options for patients with ES-SCLC.
This is a multi-center, open-label study. The study is designed to evaluate the safety, tolerability, and preliminary efficacy of Toripalimab in combination with BL0020 in patients with ES-SCLC who have relapsed or progressed following first-line platinum-based systemic treatment regimen.

开始日期2026-06-16

申办/合作机构

上海弼领生物技术有限公司

100 项与特瑞普利单抗相关的临床结果

登录后查看更多信息

100 项与特瑞普利单抗相关的转化医学

登录后查看更多信息

100 项与特瑞普利单抗相关的专利（医药）

登录后查看更多信息

648

项与特瑞普利单抗相关的文献（医药）

2026-05-01·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

作者: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

2026-05-01·ANNALS OF PHARMACOTHERAPY

Toripalimab and Penpulimab: Targeting PD-1 in Recurrent or Metastatic Nasopharyngeal Carcinoma

Review

作者: Reeves, David J. ; Hockett, Josie J. ; Keller, Molly E.

Objective::

The objective of this review is to evaluate clinical data regarding use of toripalimab and penpulimab use in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and to assess their impact on patient care.

Data sources::

A literature search of PubMed, Cochrane library, and clinicaltrials.gov was performed using toripalimab, Loqtorzi, JS001 , penpulimab , and AK105 .

Study selection and data extraction::

Inclusion was limited to English-language publications evaluating toripalimab and penpulimab for RM-NPC management.

Data synthesis::

Toripalimab and penpulimab are the first US Food and Drug Administration (FDA)-approved immune checkpoint inhibitors for RM-NPC. Both agents block the PD-1/PD-L1 interaction between tumor and T cells, enhancing anti-tumor immune responses. In the first-line setting, toripalimab plus chemotherapy achieved a median progression-free survival (PFS) of 21.4 months and overall response rate (ORR) of 78.8%. Penpulimab plus chemotherapy demonstrated a median PFS of 9.6 months and ORR of 68.1%. Toripalimab/chemotherapy was associated with an improved overall survival (hazard ratio [HR] = 0.63, P = .008); penpulimab/chemotherapy overall survival data were not yet mature. As monotherapies, ORRs were 20.5% for toripalimab and 28.0% for penpulimab. Common adverse effects include immune-related adverse effects such as hypothyroidism and rash.

Relevance to patient care and clinical practice in comparison to existing drugs::

These agents offer crucial new therapeutic options for RM-NPC, previously managed primarily with chemotherapy. The data supporting toripalimab use are currently more mature; however, penpulimab may offer an alternative for patients unable to tolerate cisplatin due being studied in combination with carboplatin.

Conclusion::

Toripalimab and penpulimab significantly improve outcomes in RM-NPC. Their use is anticipated to expand into additional settings and malignancies as research matures.

2026-04-01·MedComm

Neoadjuvant Toripalimab Plus Axitinib for Nonmetastatic Clear Cell Renal Cell Carcinoma With Tumor Thrombus: A Combined Analysis of Two Phase II Clinical Trials

Article

作者: Huang, Jiwei ; Yang, Guoqiang ; Ma, Xin ; Wang, Baojun ; Wang, Yaohui ; Zhang, Yibo ; Yue, Xiuzheng ; Zhang, Xu ; Gu, Liangyou ; Shi, Changwei ; Liang, Qiyang ; Peng, Cheng ; Huang, Qingbo ; Song, Jialong ; Zhao, Houming ; Wu, Zhuolong ; Wang, Dongxing ; Wang, Haiyi ; Li, Jinhang

ABSTRACT:

Neoadjuvant immunotherapy‐based combination holds promises in reducing surgical risk and improving survival for renal cell carcinoma (RCC) with venous tumor thrombus (VTT). However, its role in RCC–VTT has been less explored. To evaluate the efficacy and safety of neoadjuvant toripalimab plus axitinib in nonmetastatic RCC–VTT, we conducted a combined analysis of two Phase II trials with similar design. Thirty‐four patients with nonmetastatic clear cell RCC (ccRCC) and Mayo Level 0–IV VTT were enrolled. Toripalimab plus axitinib was administered for up to 12 weeks before surgery. The primary endpoint was objective response rate (ORR). In this study, the ORR and disease control rates were 41% (14 out of 34) and 97% (33 out of 34), respectively. 47% (16 out of 34) patients experienced a reduction in VTT levels. Grade 3 treatment‐related adverse events (TRAEs) occurred in 24% (eight out of 34) patients, and no Grade 4 or 5 TRAEs were observed. Thirty patients were eligible for surgery, and the surgical strategy was simplified in 53% (16 out of 30) patients. One‐year disease‐free survival and overall survival were 76.7% (95% CI, 59.1–88.2%) and 91.2% (95% CI, 77.0–97.0%), respectively. Multiomics analysis revealed the nonresponder group exhibited significant tumor heterogeneity and a stroma‐characterized tumor microenvironment. In conclusion, neoadjuvant toripalimab plus axitinib was clinically active and safe in patients with nonmetastatic ccRCC–VTT.

3,482

项与特瑞普利单抗相关的新闻（医药）

2026-04-30

·药时空

中国创新药，可以开始看业绩了

中国从2023年以来，讲BD讲newco。这些叙事固然好，但它们共同的特征是——本土商业化的现金流，始终游离在聚光灯之外。不过，2026年一季报，打下了一道光。君实生物Q1营收7.26亿元，同比增长45%；迪哲医药Q1营收2.53亿元，同比增长58%；信达生物Q1产品收入超38亿元，同比增长超50%。三家公司的财报背后，有一个共同的结构性信号：中国的大量biopharma，正在集体经历从研发驱动亏损到商业化驱动盈利的史诗级跃迁。如果现在这个节点再不认真对待大型biopharma本土商业化，恐怕要错过很多机会了。 01 君实生物：拓益的飞轮，与第二条腿的初现君实核心财务数据：Q1营业收入7.26亿元，同比+45.1%；拓益国内销售6.23亿元，同比+39.4%；经营现金流+0.58亿元，由负转正。 2026年一季度，君实生物交出的一张成绩单可以从三个维度来拆解：首先是营收，总营收7.26亿元，同比增长45%，增速延续了2024年以来的上行趋势。核心产品特瑞普利单抗（拓益®）国内销售收入约6.23亿元，同比增长约39.4%——这已是拓益连续多个季度保持30%以上的同比增速。然后是利润端，归母净亏损仅2056万元，但扣除股份支付影响后，归母净利润实为正向的4344万元。换句话说，君实生物的核心商业化业务，已在本季度实现单季盈利。这是一个具有里程碑意义的节点，核心单季度已经开始盈利，君实总算不在“失血”。最后现金流体现上，君实经营活动现金流净额+5785万元，相比上年同期的-2433万元实现了本质性改善。经营造血能力的转变是最实诚的财务指标之一。回顾2024年全年数据，拓益国内销售收入达15.01亿元，同比增长约66%。而这一增长并非单纯的市场自然扩张，而是由多重催化剂精准叠加而成。适应症矩阵快速丰富。2024年新增四个适应症获批（晚期三阴性乳腺癌一线、晚期肾细胞癌一线、广泛期小细胞肺癌一线，NSCLC围手术期），加上2025年3月获批的晚期肝癌一线，目前拓益在国内已获批12项适应症，全部纳入国家医保目录，在黑色素瘤、非小细胞肺癌围手术期、肾癌、三阴性乳腺癌四大领域均为唯一医保PD-1。其医保医保踩节奏踩得异常得准：2026年1月1日起，拓益新增2项适应症正式纳入2025年版国家医保目录，踩准了Q1传统销售淡季的放量窗口。此外，君实的昂戈瑞西单抗（PCSK9单抗）则是第二条腿刚刚站稳的信号。 2025年12月纳入国家医保目录，2026年一季度即为其进入医保后的第一个完整季度。公司未披露具体销售数字，但合同负债科目由年末的2,218万元大幅增至报告期末的6790万元（反映预收款项增加），印证了产品放量的加速迹象。与此同时，君实生物的研发费用同比下降19.4%（3.51亿降至2.82亿），但这是在主动聚焦资源后的有意为之，重心集中在三条国际化竞争管线：PD-1/VEGF双抗（JS207）、EGFR/HER3 ADC（JS212）和PD-1/IL-2融合蛋白（JS213）。展望2026年全年，有两件事将决定君实能否延续目前放量的势头：一是JS001sc（皮下注射制剂）的获批时间与商业化节奏；二是昂戈瑞西单抗在医保第一年的渗透数据。从季度趋势看，2025年全年拓益国内销售收入约在20亿元左右，2026年全年有望向25亿元以上冲击。配合研发费用进一步收窄，君实的核心业务利润率有望在2026年全年实现系统性改善，届时Non-IFRS归母盈利有较大概率成为市场讨论的焦点。 02 迪哲医药——舒沃替尼兑现期迪哲医药核心财务数据：Q1营业收入2.53亿元，同比+58.2%；归母净亏损0.96亿元（上年同期1.93亿元）；研发费用率74%（上年同期132%）。迪哲医药是三家公司中体量最小的，但其2026年一季报的含金量绝不亚于另外两家——因为这是舒沃哲®（舒沃替尼）和高瑞哲®（戈利昔替尼）同时进入医保后的第一季度交卷。 2024年全年营收3.60亿元，同比增长294%（当年戈利昔替尼6月底刚上市，绝大部分贡献仍来自舒沃替尼）。2025年两款产品首个医保年度的一季度，同比增长接近翻倍。2026年Q1单季营收再达2.53亿元，同比增长58%——这意味着即便在2025年已出现强劲医保放量效应的高基数上，2026年一季度仍实现了超预期的增长。核心驱动因素可以简单归纳为：医保覆盖扩大了患者可及性，加上两款产品在各自适应症中的唯一性地位（舒沃替尼是EGFR exon20ins NSCLC国内唯一医保药物，戈利昔替尼是外周T细胞淋巴瘤全球唯一的JAK/STAT新机制药），形成了极低的处方替换压力。但或许其看点更在于全球化和ASCO。 2026年一季报中最值得大书特书的进展，是悟空28（WU-KONG28）一线治疗EGFR exon20ins NSCLC的III期注册研究达到主要终点，取得阳性顶线结果——这是全球首个在随机对照III期临床研究中，针对该适应症一线治疗取得阳性结果的口服靶向药。该研究结果入选2026 ASCO年会最新突破摘要（LBA）口头报告，是EGFR exon20ins领域全球唯一获ASCO LBA的药物。这意味着着舒沃替尼原本只是获批后线适应症的产品（FDA已于2025年7月批准其在美上市用于二/后线），一旦一线适应症获批，其在中国及美国市场的峰值销售预测将被系统性上修。此前有机构预测美国市场峰值可能突破10亿美元。此外，迪哲的第四代EGFR TKI DZD6008（针对C797X经治患者）入选2026 ASCO年会口头报告，迪哲已连续三年在ASCO拿下口头报告，全球源头创新的品牌标签正在持续加固。迪哲商业化效率提升在费用结构上有清晰体现：研发费用同比下降10.7%（2.10亿降至1.88亿），销售费用几乎持平（约1.24亿），而收入增长了58%，销售费用率从2025年Q1的77%压缩到约49%。这种收入增速远超费用增速的剪刀差，是走向盈利的必要条件。当然，迪哲目前仍是单季亏损近1亿元的状态。资产负债表上约17.11亿元的交易性金融资产（主要为理财产品），提供了充裕的现金储备。市场期待的路径是：如果2026年全年营收达10亿元以上，且研发费用维持合理控制，迪哲在2027-2028年前后实现Non-GAAP盈利存在现实可能性。 03 信达——老二哥带头核心财务数据：Q1产品收入>38亿元，同比增长>50%；2025年全年产品收入119亿元，同比增长45%；2027年产品收入目标200亿元。信达生物2026年一季度披露产品收入超过38亿元，同比增长超50%。这可以按照两条线来拆解增长来源。其一是肿瘤产品的持续放量，以信迪利单抗（达伯舒®）为核心。合作方礼来的财报数据显示，2025年Q1信迪利单抗销售收入约10亿元，剔除汇率影响同比增长19%。这一增速较2024年全年36%的增速有所放缓，但营收总量对于PD-1而言已经很高。其二是综合产品线的跃升式放量——这才是Q1超50%增速中超越信迪利单抗本身增速的核心驱动。信达在公告中特别点名了三款产品：玛仕度肽、托莱西单抗（PCSK9单抗）和替妥尤单抗（IGF-1R单抗）。玛仕度肽：中国减重/糖尿病市场的原创GLP-1/GCGR双靶点激动剂，2025年获批后进入商业化快速爬坡期。尽管面对司美格鲁肽和替尔泊肽两大强敌，玛仕度肽的差异化卖点（双靶点带来的代谢综合益处、减重深度数据）在核心患者群体中已建立初步认知。有机构预测非肿瘤产品收入将从2024年约5.4亿元快速增长至2026年逾30亿元，玛仕度肽是最大贡献变量。托莱西单抗：中国首个自主研发获批上市的PCSK-9抑制剂，2024年11月纳入医保，年治疗费用降至约2,600元（每六周给药方案）。同类产品纳入医保后通常可实现年销售额6-10亿元，且国产唯一，先发优势非常显著。替妥尤单抗：2025年3月获批，国内首个甲状腺眼病（TED）靶向生物药，定价仅进口药Tepezza的1/15。而Tepezza 2025年全球销售额达19亿美元。信必敏以极高性价比切入，竞品中最快者也仅处于临床II期，具备多年的国内市场独占期。三款产品不约而同具备一个共同特征：在各自细分领域中具备国产唯一或定价碾压的竞争优势，准入门槛极低，且受益于信达强大的商业化平台——超3,300人的销售队伍，覆盖超5,100家医院，边际推广成本极低。此外，信达在公告中还特别提到，五款TKI（酪氨酸激酶抑制剂）新增纳入国家医保目录后实现快速放量，包括达伯乐（洛普替尼，ROS1抑制剂）、奥壹新（爱万替尼，EGFR抑制剂）、捷帕力（奥普尼布，BTK抑制剂）等2025年新上市肿瘤小分子。这些产品的单品体量不大，但作为一个整体，它们代表了信达商业化平台规模效应的充分释放——利用同一销售团队的覆盖网络推广新品种，边际获客成本极低，是信达区别于单产品公司最重要的结构性优势。公司如果要达到200亿目标，需要2026-2027年两年复合增速约30%左右，从目前的增速来看，达到这个目标确实不算难。结语：中国创新药估值体系长期以来有一个根本缺陷：它高度依赖未来不确定性事件的折现——BD会不会发生，这使得股价极易受情绪和小道消息左右，投资者定价极为困难。但2026年Q1的财报，给这个市场提供了一个新的估值锚点：商业化现金流。当君实开始以季度为单位展示核心利润为正，当迪哲的单季营收向10亿年化冲击，当信达的产品收入以50%的速度向百亿冲刺——这些公司的估值上，已经可以分拆一部分，向传统估值（PE）靠拢了。创新药第二个10年，公司们交了高分答卷。而投资者需要建立与之匹配的新分析框架：既看管线期权价值，也看商业化现金流质量；既看峰值销售预测，也看费用率的收敛轨迹。两者结合，才能在中国创新药的这一新周期中，找到真正的定价锚点。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

财报

2026-04-30

·PRNewswire

2026 ESMO GC | Mabwell to Present Latest Clinical Data on 9MW2821 for Cervical Cancer in Oral and Poster Presentations

SHANGHAI, April 30, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that two latest clinical study results of its novel Nectin‑4 targeting ADC (R&D code: 9MW2821) in cervical cancer will be presented respectively as an oral presentation and a poster presentation, at the 2026 European Society for Medical Oncology Gynaecological Cancers (ESMO GC) Annual Congress in Copenhagen, Denmark, June 17–19, 2026. Oral Presentation Title: Bulumtatug Fuvedotin (BFv, 9MW2821), a nectin-4 antibody-drug conjugate, in patients with recurrent or metastatic cervical cancer: Updated results from a phase I/II study. Abstract No.: 28RO Presenter: Prof. Yang Huijuan, Fudan University Shanghai Cancer Center Session Date and Time: 6/17/2026 2:45PM-4:10PM (local time) Poster Presentation Title: Preliminary results of Bulumtatug Fuvedotin (BFv, 9MW2821) in combined with Toripalimab in patients with recurrent or metastatic cervical cancer: A cohort from a Phase Ib/II Clinical Study. Abstract No.: 36P Principal Investigator: Prof. Lou Hanmei, Zhejiang Cancer Hospital Prof. Wang Yudong, International Peace Maternity and Child Health Hospital of China Welfare Institute Session Date and Time: 6/18/2026 12:45PM-1:30PM (local time) About Mabwell Mabwell (688062.SH, 02493.HK) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell's mission is "Explore Life, Benefit Health" and its vision is "Innovation, from Ideas to Reality." For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell 21% more press release views with Request a Demo

抗体药物偶联物临床结果

2026-04-29

·手机新浪网

君实生物的前世今生：营收24.98亿高于行业平均，净利润-10.09亿低于同类

君实生物成立于2012年12月27日，于2020年7月15日在上海证券交易所上市，注册地址位于上海，办公地址位于上海和香港。它是国内创新药领域的领先企业，专注于单克隆抗体药物研发，具备强大的技术研发实力和全产业链优势。君实生物主营业务为单克隆抗体药物和其他治疗型蛋白药物的研发与产业化，以及单克隆抗体药物研发的技术服务与技术转让等。所属申万行业为医药生物 - 生物制品 - 其他生物制品，涉及新冠药物、精准医疗、创新药等概念板块。经营业绩：营收行业第十，净利润第三十四 2025年，君实生物营业收入为24.98亿元，行业排名10/34，高于行业平均数17.75亿元和中位数9.99亿元，但远低于行业第一名长春高新的120.83亿元和第二名康弘药业的45.85亿元。主营业务构成中，抗肿瘤类药物21.4亿元占比91.57%，技术许可及特许权使用收入1.61亿元占比6.88%，其他(补充)3618.55万元占比1.55%。净利润为 -10.09亿元，行业排名34/34，远低于行业第一名三生国健的28.92亿元和第二名通化东宝的11.97亿元，也低于行业平均数2.5亿元和中位数5306.14万元。资产负债率高于同业平均，毛利率高于同业平均偿债能力方面，2025年君实生物资产负债率为51.09%，高于去年同期的44.98%，且高于行业平均26.98%。从盈利能力看，2025年毛利率为81.33%，高于去年同期的78.92%，也高于行业平均70.69%。董事长熊俊薪酬391.35万元，同比增加8.02万元控股股东和实际控制人均为熊俊、熊凤祥。董事长熊俊，1974年2月出生，中国国籍，无境外永久居留权。他于1996年7月获中南财经大学经济学学士学位，2007年12月获香港中文大学工商管理硕士学位。自2015年3月至今担任公司董事长，2016年1月至2018年1月担任公司总经理；还担任上海宝盈资产管理有限公司执行董事等职务。2025年薪酬391.35万，较2024年的383.33万增加8.02万。总经理邹建军，1971年7月出生，2024年1月至今担任公司总经理兼首席执行官。她毕业于第四军医大学，有丰富的医学工作经验。2025年薪酬989.44万，较2024年的898.74万增加90.7万。 A股股东户数较上期减少2.42% 截至2025年12月31日，君实生物A股股东户数为3.5万，较上期减少2.42%；户均持有流通A股数量为2.19万，较上期增加2.49%。截止2026年3月31日，君实生物十大流通股东中，创新药（159992）位居第十大流通股东，持股830.30万股，为新进股东。华夏上证科创板50成份ETF（588000）、易方达上证科创板50ETF（588080）退出十大流通股东之列。中航证券指出，2025年公司实现营业收入24.98亿元，同比增长28.23%；归母净亏损8.75亿元，同比减亏31.68%。业务亮点如下：1. 药品销售收入23.01亿元，同比大幅增长40.32%，核心产品特瑞普利单抗国内销售收入20.68亿元，同比增长约37.72%，海外销售收入约4084万美元，同比激增113%。2. 费用管控成效显著，销售费用率和管理费用率下降。3. 产品医保覆盖率提升，君适达首次纳入国家医保目录，代理的速舒进入超九百家医疗机构。4. 研发投入强劲，多个管线进展顺利，如BTLA单抗与PD - 1联合治疗局限期小细胞肺癌的国际多中心III期临床研究预计2026年完成入组等。预计公司2026 - 2028年收入分别为33.70亿元、44.49亿元和54.06亿元，归母净利润分别为 -4.16亿元、0.85亿元和4.68亿元，维持“买入”评级。太平洋证券指出，2025年公司实现收入24.98亿元，同比增长28.23%，归母净利润为 -8.75亿元，同比减亏31.68%，在手现金32.15亿元。业务亮点如下：1. 拓益（特瑞普利单抗）销售收入保持高增速，国内市场实现销售收入20.68亿元，同比增长37.72%。2. PD1皮下剂型12项肿瘤适应症NDA获得受理，PD1/VEGF积极推进多项联合用药临床。3. JS004（BTLA）联合特瑞普利单抗治疗LS - SCLC已进入III期临床研究阶段，JS213（PD - 1/IL - 2）的I期临床研究在海外及国内同步推进等。测算出目标市值为545亿元人民币，对应股价为53.12元，维持“买入”评级。图：君实生物营收及增速图：君实生物净利润及增速声明：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，不代表新浪财经观点，任何在本文出现的信息均只作为参考，不构成个人投资建议。如有出入请以实际公告为准。如有疑问，请联系biz@staff.sina.com.cn。

100 项与特瑞普利单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15043

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
转移性黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
不可切除的黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
晚期肝细胞癌	中国	上海君实生物医药科技股份有限公司	2025-03-18
转移性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	欧盟	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	冰岛	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	挪威	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
三阴性乳腺癌	中国	上海君实生物医药科技股份有限公司	2024-06-18

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
HER2阳性尿路上皮癌	申请上市	中国	上海君实生物医药科技股份有限公司	2025-08-09
肿瘤	申请上市	加拿大	Apotex, Inc.	2024-12-01
复发性鼻咽癌	申请上市	欧盟	Tmc Pharma (Eu Ltd.	2022-11-14
复发性非鳞状非小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2024-04-03
难治性经典霍奇金淋巴瘤	临床3期	中国	上海君实生物医药科技股份有限公司	2023-12-28
局限期小细胞肺癌	临床3期	美国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	比利时	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	法国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	德国	上海君实生物医药科技股份有限公司	2023-11-15

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07281716 (AACR2026)	临床1/2期	转移性微卫星稳定结直肠癌 MSS	21	Nadunolimab 5mg/kg + Toripalimab 240mg (chemotherapy-refractory metastatic microsatellite stable colorectal cancer)	選願範製蓋襯網淵範遞(壓積齋壓願壓獵艱蓋獵) = 壓醖餘製憲構遞齋夢獵窪淵範顧獵醖壓蓋鑰選 (艱築壓願繭網衊淵餘範, 5.7 ~ 52.1) 更多	积极	2026-04-20
ESMO_ELCC2026	N/A	局部晚期非小细胞肺癌新辅助	9	Toripalimab + chemotherapy	鑰壓構鑰範願積蓋淵齋(餘網餘選築製蓋遞顧願) = 鹹觸壓獵蓋襯構簾構廠製壓積艱網製選壓壓蓋 (餘醖衊築廠夢築鏇願襯 ) 更多	积极	2026-03-25
ChiCTR2400082830 (NEXTORCH, ESMO_ELCC2026)	临床2期	非小细胞肺癌IIIB期新辅助	12	3 cycles of toripalimab combined with chemotherapy followed by 2 cycles of toripalimab	積選鏇壓獵鹹衊簾顧觸(廠願壓廠繭鏇憲網淵繭) = 製糧鹽齋鹽選製積膚艱壓糧壓繭鑰鬱鏇淵積築 (壓鹹窪醖選遞築廠繭顧, 51.6 ~ 97.9) 更多	积极	2026-03-25
NCT03430297 (Pubmed \| JAMA Oncol)	临床3期	肢端雀斑恶性黑色素瘤一线	256	Toripalimab 240 mg	衊獵製蓋繭簾觸構鬱蓋(膚遞顧鹽製製簾簾糧襯) = 製選壓艱簾餘醖遞衊衊願窪選膚膚鏇選遞簾積 (艱鑰網積淵鹹糧繭壓餘, 6.2 ~ 17.8) 更多	积极	2026-03-01
				Dacarbazine 1000 mg/m2	衊獵製蓋繭簾觸構鬱蓋(膚遞顧鹽製製簾簾糧襯) = 膚鬱壓鏇鏇艱憲壓築獵願窪選膚膚鏇選遞簾積 (艱鑰網積淵鹹糧繭壓餘, 4.4 ~ 14.9) 更多
NCT05979740 (DECIDING-I, ASCO_GU2026)	临床1期	非肌层浸润性膀胱肿瘤 HER2-positive	6	Disitamab vedotinToripalimabedotin + Disitamab vedotinToripalimab (HER2-positive + Muscle Invasive Bladder Cancer + Radiotherapy)	艱築壓膚網憲膚鹹餘築(衊艱觸餘艱製遞網積餘) = 襯夢艱鏇鏇構憲夢觸網襯齋淵築醖襯顧鹽廠餘 (壓餘鹽鏇構淵艱窪鏇鑰 )	积极	2026-02-26
NCT05297552 (RC48-C017, ASCO_GU2026)	临床2期	HER2阳性肌层浸润性膀胱癌新辅助 HER2-expressing	47	Disitamab vedotin + Toripalimab	築齋窪襯網淵遞簾範獵(網襯壓艱遞鹽憲糧鑰襯) = 夢齋遞鑰獵醖鹽衊窪艱觸憲鹽觸夢獵築艱願醖 (淵憲製蓋壓繭醖艱觸範, 77.8 ~ 96.5) 更多	积极	2026-02-26
NCT04250948 (NEOSUMMIT-01, ASCO_GI2026)	临床2期	胃食管交界处癌	108	Toripalimab plus SOX/XELOX chemotherapy	艱鏇糧廠鬱鹽範襯艱廠(築構獵鑰獵鬱廠衊醖觸) = 醖憲鹹積簾鹽遞襯選醖襯鏇觸選憲襯憲遞淵糧 (襯願廠艱鬱觸選鏇憲夢, 63.6 ~ 87.7) 更多	积极	2026-01-08
				SOX/XELOX chemotherapy	艱鏇糧廠鬱鹽範襯艱廠(築構獵鑰獵鬱廠衊醖觸) = 憲艱淵繭鬱膚鬱鬱膚餘襯鏇觸選憲襯憲遞淵糧 (襯願廠艱鬱觸選鏇憲夢, 43.3 ~ 73.0) 更多
NCT03581786 (JUPITER-02, ESMO_ASIA2025)	临床3期	鼻咽癌一线	289	Toripalimab 240 mg + Gemcitabine-Cisplatin (GP)	構製觸齋壓艱網艱齋鬱(醖膚膚窪願願簾鬱蓋鹹) = 觸選鹹廠選鹽廠窪淵範鏇壓淵膚簾網夢衊餘齋 (壓醖夢獵遞網膚顧憲蓋 )	积极	2025-12-06
				Placebo + Gemcitabine-Cisplatin (GP)	構製觸齋壓艱網艱齋鬱(醖膚膚窪願願簾鬱蓋鹹) = 糧憲願鏇醖鬱糧願蓋簾鏇壓淵膚簾網夢衊餘齋 (壓醖夢獵遞網膚顧憲蓋 )
ASH2025	N/A	肿瘤 PD-1 \| PD-L1 \| CTLA-4	84,885	Atezolizumab	顧窪膚繭醖醖鏇襯製膚(構鬱繭醖製齋選衊遞構) = 鹹觸簾鏇遞糧構醖獵築鹹範觸糧選構艱構衊憲 (積餘構壓遞鬱構簾願簾 ) 更多	积极	2025-12-06
				toripalimab	顧窪膚繭醖醖鏇襯製膚(構鬱繭醖製齋選衊遞構) = 襯獵範獵蓋膚鏇顧繭憲鹹範觸糧選構艱構衊憲 (積餘構壓遞鬱構簾願簾 ) 更多
NCT03829969 (JUPITER-06, ESMO_ASIA2025)	临床3期	转移性食管鳞状细胞癌一线 PD-L1 expression \| tumor mutation burden (TMB) \| copy number alteration-corrected TMB (ccTMB)	514	Toripalimab plus chemotherapy	蓋壓膚廠範遞憲艱鏇膚(顧鏇夢選鑰觸醖繭膚遞) = 蓋觸願範獵網鹽繭膚夢築遞艱積選積鏇觸憲醖 (願築遞廠簾鏇衊餘鏇鹽 ) 更多	积极	2025-12-06
				Placebo plus chemotherapy	蓋壓膚廠範遞憲艱鏇膚(顧鏇夢選鑰觸醖繭膚遞) = 衊憲構鹽艱選構顧膚壓築遞艱積選積鏇觸憲醖 (願築遞廠簾鏇衊餘鏇鹽 ) 更多