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更新于：2026-08-08
Tamgiblimab
更新于：2026-08-08
概要
基本信息
原研机构 |
在研机构- |
非在研机构 |
权益机构- |
最高研发阶段无进展临床1期 |
首次获批日期- |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
Sequence Code 453739034H
来源: *****
Sequence Code 453739061L
来源: *****
关联
4
项与 Tamgiblimab 相关的临床试验NCT04672369
An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
开始日期2021-06-06 |
申办/合作机构 |
NCT04672356
An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
开始日期2021-01-25 |
申办/合作机构 |
CTR20202565
评估IBI939联合信迪利单抗治疗晚期肺癌受试者的安全性、耐受性和有效性的开放性I期临床研究
1）Ia期：评估IBI939联合信迪利单抗在标准化疗失败的晚期肺癌受试者中的安全性、耐受性和初步疗效； 2）Ib期：评估IBI939联合信迪利单抗与信迪利单抗单药一线治疗晚期NSCLC受试者的疗效；
开始日期2021-01-20 |
申办/合作机构 |
100 项与 Tamgiblimab 相关的临床结果
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100 项与 Tamgiblimab 相关的转化医学
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100 项与 Tamgiblimab 相关的专利（医药）
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27
项与 Tamgiblimab 相关的新闻（医药）2026-07-23
This Tamgiblimab Biologics Sequence Review Report was produced with PatSnap Biology Modality MCP workflows. It connects patent-scale similarity search, sequence retrieval, pairwise alignment and antibody–antigen evidence in a reproducible screen. Explore the PatSnap MCP servers used in this report.
Review date: 23 July 2026. This report supports R&D and IP triage; it is not a legal opinion, freedom-to-operate conclusion or validity analysis. A sequence hit does not establish infringement. “Claimed” is a database annotation that still requires family consolidation, live-claim review and jurisdiction-specific claim construction.
Executive sequence-risk thesisTamgiblimab is an antibody directed to TIGIT. Public therapeutic sequence data from Thera-SAbDab PL132, Oxford Protein Informatics Group supplied the query material: VH 122 aa, VL 107 aa. PatSnap’s all-patent protein search returned a closest review hit at 100.00% query identity across 122/122; the returned record was marked Yes.
The screening conclusion is elevated diligence priority, not “blocked” or “clear.” Similarity is most informative when interpreted by chain, CDR/framework location, construct architecture, target evidence and the language of live claims. Constant-region reuse or a common light chain can produce high percentages without proving asset-level collision, while a small number of substitutions in a CDR or linker junction can be disproportionately important.
Sequence scope and MCP workflowThe review began with traceable Thera-SAbDab PL132, Oxford Protein Informatics Group query sequences. Each available VH, VL and secondary arm was submitted with ls_sequence_search_submit against ALLPATENT protein records, using gaps, E-value ≤1×10−5, identity 70–100%, query coverage 80–100% and a 500-record task cap. Results were retrieved with ls_sequence_search_get_results; the closest informative hit was resolved with ls_sequence_fetch and compared using ls_sequence_alignment. ls_patent_sequence_fetch and ls_antibody_antigen_search supplied patent and target context.
Similarity search readoutQuerySearch volumeLeading evidenceVH (122 aa)500 returned records100.00% identity; 122/122; claimed: YesVL (107 aa)500 returned records100.00% identity; 107/107; claimed: YesThe largest chain-level result set contained 500 records. These are search records, not unique inventions, enforceable claims or independent families. Publications can repeat the same sequence across jurisdictions, examples, comparators and continuations. Deduplication by earliest priority, applicant, simple family and legal status is required before business conclusions.
Module-level reading of the constructThe available query set contains 2 independently searchable chain module(s). For this single-pair format, heavy- and light-variable evidence should still be interpreted together. A highly conserved light chain can be shared across unrelated heavy chains, while a heavy-chain match may include common framework and constant-region sequence outside the specificity-defining CDRs.
The chain totals also provide a practical specificity check. A chain that repeatedly reaches the task cap is less discriminating at the raw-sequence level than a chain with a smaller, concentrated result set. Reviewers should therefore prioritize the rarest domain or junction, then use the more widely reused chain as corroboration. This ordering reduces the risk of treating platform-level or germline similarity as evidence of an asset-level collision.
Pairwise alignment: what the closest hit meansThe selected VH comparison reported 122/122 identical positions, query coverage 122/122, E-value 5.48612e-88 and 0/122 gaps. The matched subject sequence was resolved as sequence 453738951, 122 aa, annotated “unnamed sequence”.
Percentage identity alone is not a claim chart. The next review should map every mismatch to IMGT/Kabat position, CDR or framework, constant region, linker boundary and any claimed SEQ ID. For multispecific assets, each arm should also be searched independently because a full-construct query can obscure highly conserved binding modules.
Antibody–antigen and patent-sequence evidenceThe exact asset-name filter did not return a direct antibody–antigen relation. Because naming and alias coverage varies across patent records, the result should be supplemented with target-level and development-code searches; it must not be read as negative biological or patent evidence.
No directly named patent sequence set was resolved from the first antibody–antigen record. That absence is an evidence-coverage limitation, not evidence of patent clearance; family and alias searches remain necessary.
Evidence strength and blind spotsThe evidence is strongest for the exact query sequences, the returned alignment coordinates and the patent records directly resolved by the MCP tools. It is weaker where therapeutic aliases are absent, where a publication supplies fragments instead of the administered construct, or where the result set is capped before all lower-ranked families are reviewed. Antibody names can also refer to a parental molecule, biosimilar, anti-drug antibody or comparator; the underlying sequence and target annotation must be read before attributing a record to Tamgiblimab.
Patent sequence listings are deliberately broad and can contain screening libraries, consensus sequences, controls, antigens, primers and manufacturing elements alongside candidate therapeutics. Conversely, relevant claims may define a molecule through CDR combinations, percentage-identity thresholds, functional binding language or genus formulas without reproducing the exact commercial sequence. This is why the report combines sequence similarity with antibody–antigen evidence and still stops short of a legal conclusion.
Patent-risk interpretationDimensionScreening signalRequired next checkSequence proximity100.00% closest reviewed identityConsolidate families and map mismatches by domain.Claim annotationYesRead live independent and dependent claims in relevant jurisdictions.Target evidenceNo exact-name hitSearch aliases, development codes and each target separately.Legal conclusionNot determinedAssess priority, ownership, licensing, prosecution, validity and territorial status with counsel.Diligence actionsConfirm that the reviewed sequence matches the clinical or commercial construct rather than an early lead or analytical reference.Repeat searches for CDR-only queries, junctions and nucleotide sequences, then cluster records by patent family.Annotate each high-identity hit by VH/VL domain, CDR, framework, Fc and linker position.Retrieve the underlying sequence listing and verify the returned sequence number and “claimed” annotation against the filed document.Build jurisdiction-specific claim charts for live families and document licenses or platform rights affecting TIGIT programs.Rerun the MCP workflow at the transaction or development decision date because sequence and legal-status coverage changes.Bottom lineTamgiblimab has a traceable therapeutic sequence. The combination of 100.00% closest-hit identity, Yes claim annotation, an exact-name evidence gap and 0 directly fetched patent sequences supports elevated diligence priority. The defensible outcome is a prioritized, domain-aware family and claim review—not a binary clearance statement.
Explore PatSnap Open Platform MCP Servers to produce sequence similarity and patent-risk reports for antibodies, proteins, peptides and nucleic-acid assets.
Sources and methodology notesQuery sequences: Thera-SAbDab PL132, Oxford Protein Informatics Group. Core similarity, sequence, alignment, patent-sequence and antibody–antigen evidence was retrieved through PatSnap Biology Modality MCP on 23 July 2026. Database annotations and legal status can change; rerun at the decision date.
2026-06-24
·药弈
一个靶点的兴衰，一部肿瘤免疫的缩影
2020年5月，罗氏公布CITYSCAPE研究数据——Tiragolumab联合阿替利珠单抗在PD-L1高表达NSCLC中，ORR达到惊人的66%，几乎是单药的3倍。整个行业为之沸腾，TIGIT被冠以"下一代PD-1"的光环。
然而仅仅五年后，从罗氏到默沙东，从百济到Arcus/吉利德，全球范围内已投入超过200亿美元研发费用，6款以上TIGIT单抗在III期临床中接连失利，数十个项目黯然终止。
TIGIT到底是一个怎样的靶点？为何从万众瞩目的"希望之星"跌落神坛？抗体工程的优化能否挽救这个靶点？双抗路线又能否柳暗花明？
这是一个关于靶点验证、资本狂热与科学理性的故事。一、靶点生物学：复杂的免疫调控网络1.1 TIGIT的结构与表达
TIGIT（T cell immunoreceptor with Ig and ITIM domains）是2009年由基因泰克首次发现的共抑制受体，属于免疫球蛋白超家族。其结构包括：
胞外段：一个免疫球蛋白可变（IgV）结构域，特征性的（V/I）（S/T）Q、AX₆G和T（F/Y）PX₁G亚基序，介导与配体的"锁-钥"反式相互作用。
跨膜区：单次跨膜结构。
胞内段：含有免疫受体酪氨酸抑制基序（ITIM）和Ig尾酪氨酸（ITT）样基序，是传递抑制信号的关键。
表达分布：TIGIT主要表达于活化的CD4⁺T细胞、CD8⁺T细胞、调节性T细胞（Treg）、自然杀伤（NK）细胞和滤泡辅助性T细胞。在肿瘤微环境中，TIGIT在耗竭性T细胞和肿瘤浸润Treg上高表达，与PD-1存在显著共表达（70%以上）。1.2 配体系统：三重结合的复杂性
TIGIT有三个已知配体，亲和力呈梯度分布：配体别名亲和力表达分布PVRCD155、Necl-5最高肿瘤细胞、树突状细胞、内皮细胞、成纤维细胞PVRL2CD112、Nectin-2中等抗原呈递细胞、单核细胞、部分肿瘤细胞PVRL3CD113、Nectin-3较低上皮细胞、部分肿瘤细胞
关键机制：TIGIT与共刺激受体CD226（DNAM-1）竞争性结合相同配体（尤其是CD155），但TIGIT的亲和力显著高于CD226。这构成了一个精细的调控平衡——当TIGIT高表达时，会"抢占"配体，抑制CD226介导的激活信号。
这种"竞争抑制"模式与PD-1/PD-L1的"直接抑制"模式有本质区别，也决定了TIGIT靶点的成药性逻辑与PD-1截然不同。1.3 三重免疫抑制机制
TIGIT通过三重机制发挥免疫抑制作用，比PD-1的调控网络更为复杂：
第一，直接抑制T细胞活化。TIGIT结合CD155后，通过胞内ITIM和ITT样基序招募SHIP-1磷酸酶，抑制PI3K-Akt和NF-κB信号通路，下调TCR信号，减少IFN-γ、TNF-α等效应细胞因子产生。
第二，间接增强Treg功能。TIGIT在Treg上高表达，与其免疫抑制功能正相关。TIGIT⁺Treg通过上调IL-10和Fgl2的分泌，增强对效应T细胞的抑制；同时TIGIT信号可稳定Foxp3表达，维持Treg的免疫抑制表型。
第三，通过树突状细胞介导免疫抑制。TIGIT与DC上的CD155结合后，反向信号诱导DC产生IL-10，同时下调IL-12分泌，削弱DC的抗原呈递能力，形成"肿瘤细胞→DC→T细胞"的多级免疫抑制链条。1.4 NK细胞调控：常被忽视的维度
TIGIT也是NK细胞的重要抑制性受体。阻断TIGIT可直接增强NK细胞的细胞毒性和细胞因子分泌。在免疫源性低的"冷肿瘤"中，NK细胞的作用可能比T细胞更关键——这也是TIGIT靶点区别于PD-1的重要特征之一。
然而，硬币的另一面是：TIGIT抗体的Fc功能可能导致NK细胞的"自相残杀"（fratricide）——当抗体结合NK细胞表面的TIGIT后，Fc段可能通过FcγR介导的机制引发NK细胞之间的相互杀伤。这一机制可能部分解释了部分临床研究中观察到的疗效矛盾。
TIGIT的生物学复杂性既是潜力也是陷阱。相比PD-1相对单一的T细胞抑制通路，TIGIT同时调控T细胞、NK细胞、Treg和DC四种免疫细胞。但这种多维度调控也意味着，简单的抗体阻断可能带来难以预测的净效应——激活与抑制并存，最终疗效取决于多种因素的动态平衡。二、靶点验证历程：从狂热到理性的十五年2.1 为什么TIGIT曾被称为"下一代PD-1"？
TIGIT赛道的兴起源于三个核心逻辑，每一个在当时看来都极具说服力：
第一，机制互补性。PD-1主要通过抑制TCR下游信号发挥作用，而TIGIT通过CD226通路调控，两者在耗竭T细胞上共表达，双重阻断理论上可产生协同效应。临床前模型中，联合阻断TIGIT和PD-1/PD-L1确实显示出优于单药的抗肿瘤活性。
第二，CITYSCAPE研究的爆炸性数据。2020年5月，罗氏公布II期CITYSCAPE研究结果：在PD-L1高表达（TPS≥50%）NSCLC亚组（约80例）中，Tiragolumab + 阿替利珠单抗对比安慰剂 + 阿替利珠单抗，ORR达到66% vs 24%，中位PFS为未达到 vs 4.1个月（HR=0.31）。
这一数据远超市场预期——PD-1单药在PD-L1高表达人群的ORR通常在30-40%。2021年1月，FDA授予该方案突破性疗法认定（BTD）。但需要注意的是，这只是小样本亚组分析，统计学效力有限。
第三，商业想象力。PD-1/PD-L1市场已达数百亿美元规模，如果TIGIT能在PD-1基础上再提升疗效，将成为新的"超级炸弹"。各大药企纷纷入场，巅峰时期全球有超过60个TIGIT项目在研。2.2 泡沫破裂：III期接连失利
然而，CITYSCAPE的惊艳表现并没有在III期延续。从2022年开始，TIGIT领域进入了"兵败如山倒"的模式：时间公司药物研究适应症结果2022.03罗氏TiragolumabSKYSCRAPER-02ES-SCLC一线未达PFS主要终点2022.05罗氏TiragolumabSKYSCRAPER-01NSCLC（PD-L1高）一线未达PFS共同终点2023.11默沙东VibostolimabKeyVibe-003NSCLC（PD-L1≥1%）一线未达PFS2024.05GSK/iTeosBelrestotug-NSCLC终止开发2024.12默沙东Vibostolimab-黑色素瘤等终止开发2025.04百济神州OciperlimabAdvanTIG-302NSCLC（PD-L1高）一线中期分析OS无望，终止2025.12Arcus/吉利德DomvanalimabSTAR-221胃/胃食管结合部癌一线未达OS主要终点2026.04Arcus/吉利德DomvanalimabSTAR-121 / EDGE-LungNSCLC一线因疗效不足终止
累计研发投入：据估计，全球药企在TIGIT靶点上已投入超过200亿美元，但至今尚无产品获批上市。这可能是肿瘤免疫领域最昂贵的一次"试错"。
TIGIT的兴衰轨迹完美诠释了创新药研发的"双相情感障碍"——从早期数据惊艳时的极度乐观，到III期失败后的极度悲观。客观来看，II期数据并非完全没有参考价值，但行业倾向于用最乐观的方式解读早期信号，并以此驱动大规模的资本投入和管线布局。当潮水退去，才发现大多数人都在裸泳。三、关键临床数据深度解析3.1 Tiragolumab（罗氏）：先驱的滑铁卢
作为TIGIT领域的先驱和标杆，罗氏Tiragolumab的临床数据最具代表性，也最值得深入分析。
SKYSCRAPER-01研究（NSCLC一线，PD-L1高表达）：
这是TIGIT领域最受关注的III期研究。入组534例PD-L1 TPS≥50%的IV期NSCLC患者，随机接受Tiragolumab + 阿替利珠单抗或安慰剂 + 阿替利珠单抗。主要终点为PFS和OS。
结果令人失望：
• 中期PFS未达到统计学显著性（HR≈0.85）
• 第二次中期OS（2023年8月）：联合组22.9个月 vs 单药组16.7个月（HR=0.81，95%CI 0.63-1.03），p=0.045（未达预设边界）
• 最终分析（2024年）：OS仍未达统计学意义
• ORR：联合组55.6% vs 对照组38.3%（有改善但未转化为生存获益）
这里有一个值得注意的矛盾：ORR和PFS有改善趋势，但OS未达统计学意义。这提示TIGIT抗体可能带来了早期缓解但未能持久——免疫细胞被短暂激活后迅速进入更深的耗竭状态，或者被抗体的Fc功能反向清除。
SKYSCRAPER-02研究（ES-SCLC一线）：
490例未经治疗的广泛期小细胞肺癌患者，方案为Tiragolumab + 阿替利珠单抗 + 化疗对比安慰剂 + 阿替利珠单抗 + 化疗。结果几乎是"完败"：
• 中位PFS：5.4个月 vs 5.6个月（HR≈1.0，几乎无差异）
• 中位OS：13.6个月 vs 13.6个月（完全相同）
• 中国队列事后分析显示一定生存趋势（OS 18.7 vs 13.5个月，HR=0.89），但无统计学意义
SCLC的全面失败进一步打击了市场信心——连PD-1已经证明有效的适应症，加上TIGIT都没有增益，这个靶点的价值到底在哪里？3.2 Vibostolimab（默沙东）：IgG1的另一种尝试
默沙东的Vibostolimab是一款全人源IgG1κ型抗TIGIT抗体，结合表位为TIGIT的CC'C''FG环区域，具有完整Fc功能，可介导ADCC/ADCP。
KeyVibe-003研究（NSCLC一线，PD-L1≥1%）：对比Vibostolimab + 帕博利珠单抗 vs 帕博利珠单抗单药，2023年11月公布未达到PFS主要终点。2024年底默沙东全面终止Vibostolimab的临床开发。
值得注意的是，Tiragolumab和Vibostolimab虽然都是IgG1型、都有完整Fc功能、结合表位也相似，但最终结局高度一致——均未能在III期证明生存获益。这说明失败不是某个药物的问题，而是靶点本身或开发策略的共性问题。3.3 Domvanalimab（Arcus/吉利德）：Fc沉默路线的尝试与失败
Domvanalimab是Arcus Biosciences开发的Fc沉默型TIGIT抗体，通过Fc区域突变（L234A/L235A/P329G）实现Fc沉默，理论上避免FcγR介导的免疫细胞耗竭和潜在毒性。
这款药物曾被视为TIGIT领域的"黑马"，因为它解决了业界对Fc功能的一大担忧——即Fc介导的效应T细胞和NK细胞清除。
ARC-7研究（NSCLC一线，PD-L1高表达）：
• II期随机研究，入组150例PD-L1 TPS≥50%的NSCLC
• 三组设计：zimberelimab（PD-1）单药、domvanalimab + zimberelimab、三药联合（+ etrumadenant）
• 结果（2022年公布）：ORR联合组41% vs 单药组27%；中位PFS联合组12.0个月 vs 单药组5.4个月（HR=0.55）
• 安全性亮眼：≥3级TRAEs 47% vs 58%（联合组反而更低）
ARC-10研究（NSCLC一线，PD-L1高表达）：
• II期随机，95例PD-L1 TPS≥50%患者
• 结果（2025年公布）：中位PFS联合组11.5个月 vs 单药组6.2个月（HR=0.69）；中位OS联合组未达到 vs 单药组24.4个月（HR=0.64）
EDGE-Gastric研究（胃癌/胃食管结合部癌一线）：
• II期多臂研究，domvanalimab + zimberelimab + FOLFOX化疗
• 结果（2025年10月更新）：确认ORR 54%（ITT人群），中位PFS约12个月，中位OS 26.7个月
• PD-L1高表达亚组ORR达67%，6个月PFS率93%
这些II期数据不可谓不亮眼——PFS HR 0.55、OS HR 0.64，放在任何靶点上都是值得推进的信号。于是Arcus/吉利德快速推进了多项III期研究。
然而，STAR-221研究（胃癌/胃食管结合部癌一线）在2025年12月公布的中期分析中，未达到OS主要终点。紧接着在2026年4月，Arcus宣布终止NSCLC领域的STAR-121和EDGE-Lung研究。
Domvanalimab的失败最令人唏嘘——它一度被认为是"最有可能成功的TIGIT单抗"，它的II期数据质量甚至优于当年罗氏的CITYSCAPE，但最终仍未能逃脱III期魔咒。
即使是Fc沉默设计，即使在II期看到了令人鼓舞的PFS和OS趋势（HR 0.64），在以PD-1+化疗为标准对照的III期试验中仍然失败。这提示TIGIT靶点的问题可能不只是Fc设计，而是更深层的机制问题——或者说，II期数据的可靠性本身就值得审视。3.4 国内产品：百济折戟， others跟进
欧司珀利单抗（百济神州）：
作为国内TIGIT管线的"标杆"，欧司珀利单抗曾被寄予厚望。诺华曾以3亿美元首付款引进其海外权益。它采用了相对少见的IgG4型设计。
AdvanTIG-302研究（III期，NSCLC一线，PD-L1高表达）是其关键试验——直接头对头对比帕博利珠单抗。这个设计本身就非常激进，反映了行业对TIGIT的过高预期。
2025年4月，百济宣布该研究中期分析显示OS无望，终止试验。详细数据显示：
• 中位OS：联合组约26个月 vs 帕博利珠单抗组约24个月（数值略有延长但无统计学意义）
• ≥3级不良反应：联合组显著高于对照组
也就是说，疗效提升有限，但毒性显著增加——这是最差的一种结果。
其他国内项目大多处于早期临床阶段：信达生物IBI939（IgG4型）、康方生物AK127（单抗）及AK130（TIGIT/TGF-β双抗）、君实生物JS009、恒瑞医药SHR-1706等。随着全球TIGIT热度退潮，这些项目的推进速度预计将放缓。四、技术路线差异：抗体设计的成败关联4.1 Fc功能之争：不是答案的核心矛盾
Fc功能是TIGIT领域争论最激烈的技术话题，也是各公司差异化布局的核心方向：Fc设计代表药物理论逻辑临床结局IgG1（完整Fc）Tiragolumab、VibostolimabADCC清除TIGIT⁺Treg，增强免疫III期失败IgG4Ociperlimab低ADCC，安全性优先III期失败Fc沉默突变Domvanalimab完全避免Fc介导的免疫细胞耗竭III期失败
一个值得注意的事实是：无论何种Fc设计，TIGIT单抗均未能在III期证明OS获益。这提示Fc功能可能不是TIGIT靶点的核心矛盾——更深层的机制问题（如生物标志物缺失、通路冗余）尚未解决。不同Fc设计可能在特定亚组中存在差异，但在未经选择的人群中影响有限。4.2 双特异性抗体：最后的希望？
在单抗全线受挫的背景下，PD-1/TIGIT双抗成为TIGIT领域仅存的亮点。阿斯利康的Rilvegostomig（AZD2936）是其中进展最快的产品。
ARTEMIDE-01研究（I/II期）显示，在PD-L1 TPS≥50%的NSCLC一线治疗中，ORR达61.8%，中位PFS达12.3个月，化疗初治亚组PFS更是达到21.2个月。这组数据让人依稀看到了当年CITYSCAPE的影子。
目前阿斯利康正在推进多项III期研究，结果预计2026-2027年陆续读出。双抗究竟是机制上的真正突破，还是又一次"II期惊艳、III期翻车"的轮回，尚需时间检验。· · ·
（上篇完，下篇继续解读：适应症布局分析、竞争格局复盘、失败深层原因拆解、未来终局判断与行业启示）
主要参考来源
罗氏、默沙东、Arcus/吉利德、百济神州、阿斯利康等公司官方公告与临床数据公布；ASCO、ESMO、AACR、WCLC等国际学术会议公布数据
⚠️ 本账号所刊载内容仅供医学专业人士学术交流使用，不构成任何诊疗建议。医学问题请咨询专业医疗机构。药弈聚焦领域前沿，追踪新药管线，解读临床进展，拆解方案设计与审批逻辑
细胞疗法临床3期免疫疗法临床结果
2023-08-23
Remarkable achievements with accelerated growth and improved efficiency to underpin sustainable growth
ROCKVILLE, M.D. and SUZHOU, China, Aug. 23, 2023 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, announces its 2023 interim results and major company business updates.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Today is our 12th anniversary since we incorporated Innovent in 2011. Since last year, we have clearly outlined two strategic goals for the second decade of our business operation, which are to achieve sustainable growth and global innovation. During the first half of 2023, we have made remarkable achievements that solidify our ability to establish a sustainable business foundation as Innovent is growing stronger and healthier. We achieved strong revenue performance and improved operational efficiency that underline our sustainable business model; we continued to develop a more diversified pipeline portfolio and enhanced R&D strategy that ensures sustainable growth; and we improved financial margins and maintained high resilience that help us manage risks and enjoy sustainability in the long run. These significant progresses reinforce our confidence and commitment to our strategic goals, through further expansion of commercial portfolio, improvement of operational efficiency, and innovation through advanced R&D platform for the global market. We will uphold the vision of 'to become a global premier biopharmaceutical company' and create sustainable value for patients, employees, shareholders and the society."
Solidified business operations with strong revenue performance and improved financials
S
trong
revenue growth: Total revenue RMB2
,
701
.5 million in the first half of 2023, an increase of
20.6% compared with the first half of 2022; product sales revenue RMB2,457.5 million in the first half of 2023, an increase of
20
.4% compared with the same period of prior year, with particularly stronger growth since Q2, mainly driven by fast ramp-up of product sales volume as we fully leveraged the clinical value of our novel medicines with broad NRDL coverage and a diversified oncology portfolio.
Enhanced operational efficiency under a sustainable business model:
We further improved the productivity and efficiency of our commercial operations. The agile organization benefits from a scientific and systematic resource allocation system that enables more mature and fast responses to the changing environment.
The selling and marketing expenses was
54.5% of total product revenue in the first half of 2023, representing a decrease of
12.2% compared to
66.7% in the first half of 2022.
Core financial margins improvements: Loss Before Interest, Taxes, Depreciation and Amortization ("LBITDA") decreased remarkably by 74.2% to RMB267.4 million from RMB1,035.7 million in the same period of 2022, brought by our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model.
Expansion of commercial portfolio into ten approved products, including: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®,
FUCASO® (new product, for the treatment of RRMM) and
SINTBILO® (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia).
NRDL coverage further expanded, benefiting broader patient groups: two additional indications (1L GC and 1L ESCC) of TYVYT® (sintilimab injection), olverembatinib for the first listing, and multiple additional indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection), and SULINNO® (adalimumab injection) were included in the updated NRDL. The updated NRDL has taken effect on March 1st, 2023.
Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: expansive coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 talents. The Company is also strategically establishing commercial presence in certain non-oncology therapeutic areas in light of the first approved drug SINTBILO® in cardiovascular area and accelerated development for multiple high value late-stage candidates, aimed for a more diversified and long-term growth.
Broad pipeline across therapeutic areas to deliver differentiated innovation and growth potential
We have built a strong pipeline with over 30 innovative drug candidates, among which 10 products are approved, 8 assets are in NDA review or pivotal registrational clinical trials, and approximately 20 assets in early Phase 1/2 clinical studies.
Oncology: leverage extensive portfolio and navigate novel modalities and therapies to strengthen our foundation
Pioneered the development of three drug candidates for treatment of lung cancer:
IBI344 (ROS1): Ongoing pivotal Phase 2 for ROS1 positive NSCLC
IBI351 (KRASG12C): Ongoing pivotal Phase 2 for KRASG12C mutated NSCLC
IBI126 (CEACAM5 ADC): Ongoing Phase 3 for CEACAM5 highly expressed NSCLC
Received preliminary positive data for multiple innovative molecules with global potential
：
Bispecific antibodies with global innovation: IBI363 (PD-1/IL-2) and IBI389 (CLDN18.2/CD3) with preliminary positive clinical signals observed, IBI334 (EGFR/B7H3) is planned to enter first-in-human study shortly
Monoclonal antibodies in PoC exploration: IBI110 (LAG3) , IBI939(TIGIT), IBI310 (CTLA-4)
Deeply invested in ADC proprietary platform as a new wave of global innovation:
IBI343 (CLDN18.2 ADC) : Phase 1 multi-regional clinical trial ongoing in Australia and China. IBI343 has potential best-in-class profiles with differentiated design for potential wide therapeutic window and high potency.
More than 10 differentiated ADC projects in IND-enabling stage.
Cardiovascular and metabolism (CVM) : first product approved and prioritized clinical development of multiple best-in-class assets based on robust data readout
SINTBILO® (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia
Mazdutide (GLP-1R/GCGR): potential best-in-class GLP-1 dual agonist. Phase 3 registrational studies of mazdutide 6mg in obesity and type 2 diabetes are ongoing. The Phase 2 clinical study of mazdutide higher-dose 9mg met the 24-week primary endpoint, showing bariatric surgery-equivalent 15.4% weight loss efficacy for moderate to severe obesity and a consistently favorable safety profile.
IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients, with overall superior efficacy and good safety profile.
Autoimmune: select novel targets to treat unmet needs in various autoimmune diseases
IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. The Phase 3 registrational clinical study is ongoing.
IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis reached positive topline results.
IBI355 (CD40L) and IBI356 (OX40L): innovative autoimmune molecules will enter first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases.
Ophthalmology: accelerate two Phase III trials for two important assets
IBI302 (VEGF/C)
: Phase 3 study ready to start in the second half of 2023 for the treatment of nAMD, based on the observed longer durability and potential effect in anti-macular atrophy in Phase 2 studies.
IBI311 (IGF-1R): quickly advanced into Phase 3 registrational study, eyeing on urgent unmet need in the treatment of TED in China.
IBI324
(VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are in the Phase 1 stage. The potential differentiation versus existing therapy brought by their innovative mechanisms and molecule designs as bispecific antibodies will be explored.
Global innovation continues as core long-term strategy
Innovent Academy as the innovation powerhouse continues to advance science to deliver differentiated molecules in oncology and non-oncology areas:
In the first half of 2023, Innovent Academy has successfully delivered four high quality novel molecules into IND enabling stage.
Further investment in our ADC platform and antibody platform, as preliminary differentiated efficacy and safety signals are observed for the FIC and BIC molecules generated from the platforms.
A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, as another important growth pillar of global innovation as oncology counterparts.
P
roduct
development platform utilizes scientific and efficient approaches to
scout
opportunities for innovative pipeline in early-stage MRCT clinical development
Exploring the early-to-mid stage pipeline with global potential in ongoing PoC studies, with several molecules in the oncology and ophthalmology fields.
Further explore the early clinical development of novel molecules with global potential, such as PD-1/IL-2, CLDN18.2 ADC in Phase 1 multi-regional clinical trials with preliminary differentiated clinical data observed
140,000L GMP certified production capacity which is currently one of the largest stainless steel bioreactor production capacity in China, adhering to high-standard quality compliance to GMP and providing cost advantage further strengthen our market competitiveness.
Compliance and governance continued strengthening in active support to social responsibilities
In active support to the sustainable development goals (SDGs) of the United Nations, we continued to adhere to the people-oriented principle, operate with integrity, take high quality as the cornerstone, follow green ecological guidance, drive development with innovation, effectively protect the rights and interests of all stakeholders, and proactively fulfill our social responsibilities.
We also paid more attention to governance upgrade compliance operation, operational efficiency improvement, high-quality innovation, diversification and empowerment of employees and low-carbon development, and strived to promote inclusive healthcare, enabling more patients to have equal access to affordable, high-quality and innovative medicines.
Financial Highlights for the First Half of Year 2023
Total revenue was RMB2,701.5 million, an increase of 20.6% compared to the same period of prior year.
LBITDA for the reporting period was RMB267.4 million, a notably decrease of 74.2% or RMB 768.3 million from RMB1,035.7 million for the same period of prior year.
Loss for the reporting period was RMB190.4 million, a notably decrease of 82.5% or RMB 894.9 million from RMB 1,085.3 million for the same period of prior year.
*The remarkably decrease was mainly due to our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model.
*The Loss for the reporting period was mainly due to continuous investment in R&D to support our long-term strategic goal of global innovation.
R&D expenses was RMB826.3 million; cash and short-term financial assets was RMB8,526.5 million, or approximately USD1.2 billion, which enables us to focus on the long-term sustainable development.
About Innovent
"Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases.
Innovent has 10 products in the market. These include: TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). In addition, one assets are under NMPA NDA review, seven assets are in Phase III or pivotal clinical trials, and 17 more molecules are in clinical studies.
Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.
Disclaimer: Innovent does not recommend any off-label usage.
Note:
TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, olverembatinib, FUCASO® and SINTBILO® are not approved products in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab injection, Innovent)
HALPRYZA® (rituximab injection, Innovent)
SULINNO® (adalimumab injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.
CYRAMZA® (ramucirumab injection, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.
Retsevmo® (selpercatinib capsules, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.
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.
Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
SOURCE Innovent Biologics
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 非小细胞肺癌 | 临床1期 | 中国 | 2021-01-20 | |
| 小细胞肺癌 | 临床1期 | 中国 | 2021-01-20 | |
| 晚期癌症 | 临床1期 | 中国 | 2020-05-15 | |
| 血液肿瘤 | 临床申请批准 | 中国 | 2020-05-26 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | 非小细胞肺癌 一线 | 42 | 願願製廠鹹餘簾艱獵鹹(積築範選壓壓鬱鹽夢糧) = 積顧鏇觸顧獵艱製醖網 夢鹹鹹顧範製壓餘淵積 (鹽簾艱醖範繭繭觸觸網 ) 更多 | 积极 | 2023-05-31 | ||
願願製廠鹹餘簾艱獵鹹(積築範選壓壓鬱鹽夢糧) = 繭憲築範築構艱鏇壓蓋 夢鹹鹹顧範製壓餘淵積 (鹽簾艱醖範繭繭觸觸網 ) 更多 | |||||||
临床1期 | 非小细胞肺癌 一线 | 42 | 蓋膚築夢壓範繭衊製簾(積憲築選衊膚窪鹹窪願) = 構簾鹽鬱糧夢鑰窪鑰繭 顧觸餘觸窪廠願鹽鹹糧 (構範壓鏇鏇願願夢鏇顧 ) 更多 | 积极 | 2023-03-01 | ||
蓋膚築夢壓範繭衊製簾(積憲築選衊膚窪鹹窪願) = 淵艱鹽壓積鹹構襯鏇憲 顧觸餘觸窪廠願鹽鹹糧 (構範壓鏇鏇願願夢鏇顧 ) 更多 | |||||||
临床1期 | 42 | (arm A) | 顧襯衊觸網獵齋製構衊(廠積醖夢衊鹹夢蓋淵糧) = 齋衊衊觸淵鑰鑰觸觸遞 製齋壓膚網網鹽顧鬱壓 (選憲獵蓋廠遞築鹹築願, 46.0 ~ 83.5) 更多 | 积极 | 2022-12-08 | ||
(arm B) | 顧襯衊觸網獵齋製構衊(廠積醖夢衊鹹夢蓋淵糧) = 餘鹽製鬱積築襯鬱憲憲 製齋壓膚網網鹽顧鬱壓 (選憲獵蓋廠遞築鹹築願, 31.6 ~ 86.1) 更多 |
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