A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.

开始日期2026-10-01

申办/合作机构-

NCT07652762

/ Recruiting临床1期IIT

An Open-Label Phase Ib Clinical Study Evaluating the Safety, Tolerability, and Efficacy of IN10018 in Combination With Dalpiciclib in Participants With Progressive Meningiomas

This open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Progressive meningiomas are tumors arising from the membranes surrounding the brain that have continued to grow or have returned after previous treatment.
Participants will receive both study drugs by mouth in 28-day treatment cycles. IN10018 will be taken once daily throughout each cycle, and dalpiciclib will be taken once daily for 21 days followed by 7 days without dalpiciclib. Treatment may continue until the tumor progresses, unacceptable side effects occur, or another reason for stopping treatment applies.
The study includes a dose-confirmation phase and a dose-expansion phase. The main goals are to evaluate side effects and determine a recommended dose of the combination for further study. Researchers will also assess whether the treatment can shrink tumors or delay tumor growth, measure how the drugs are processed in the body, and explore tumor and blood biomarkers that may be associated with treatment response.

开始日期2026-08-01

申办/合作机构

首都医科大学

NCT07441174

/ Recruiting临床1/2期

A Multicenter, Open-Label, Phase Ib/II Clinical Trial of IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors

This is a multicenter, open-label, Phase Ib/II clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.

开始日期2026-02-28

申办/合作机构

应世生物科技（上海）有限公司

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100 项与伊费替尼相关的转化医学

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100 项与伊费替尼相关的专利（医药）

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项与伊费替尼相关的文献（医药）

2026-11-01·MATRIX BIOLOGY

Tumor FAK supports fibrillar collagen expression in ovarian cancer ascites

Article

作者: Heino, Jyrki ; Boyer, Antonia ; Schlaepfer, David D ; Rappu, Pekka ; Khan, Safir Ullah ; Ojalill, Marjaana ; Stupack, Dwayne G ; Zhang, Yichi ; Chen, Xiao Lei ; McHale, Michael T ; Suwal, Ujjwal ; Haanen, Terrance J

High-grade serous ovarian cancer (HGSOC) is a lethal malignancy where matrix proteins enhance ascites-associated recurrent tumor growth. Elevated focal adhesion kinase (FAK/PTK2) and collagen protein expression support tumor survival, chemoresistance, and immune evasion. However, the sources and regulation of collagen production within HGSOC tumorspheres is unclear. Using CRISPR-mediated FAK knockout and FAK re-expression in two syngeneic HGSOC models (MOVCAR and KMF), FAK loss impaired tumorsphere growth in vitro and in vivo while reducing collagen expression, as determined by RNA sequencing, quantitative RT-PCR, and protein mass spectrometry. FAK re-expression promoted spontaneous metastatic ovarian tumor dissemination. Integrated bioinformatic analyses of MOVCAR, KMF, and HGSOC patient datasets identified 56 common mRNAs co-elevated with PTK2, including COL3A1 and COL5A2. Single-cell RNA sequencing of murine KMF ascites revealed a subset of tumor cells expressing Col3a1 and Col5a2 that exhibited epithelial-to-mesenchymal pathway enrichment that was diminished by genetic or pharmacologic FAK inhibition. In primary HGSOC ascites samples, FAK inhibitor (IN10018 or VS-4718) or FAK protein degrader (PROTAC) treatment selectively reduced COL1A1, COL3A1, and COL5A2 mRNA levels in tumor cells. Further, human OVCAR8 spheroid COL1A1, COL3A1, and COL5A2 mRNA and spheroid structure were significantly impacted by FAK inhibition and blocking anti-α1 or anti-β1 integrin antibodies. As elevated PTK2 and COL3A1 expression correlate with poor ovarian cancer patient survival, and FAK, α1, and β1 integrin inhibition reduced spheroid COL3A1 protein levels, our findings support a feed-forward linkage whereby FAK regulates fibrillar collagen acting in part via collagen binding integrins supporting HGSOC tumorsphere survival and metastatic spread.

2026-09-01·LANCET ONCOLOGY

Ifebemtinib plus garsorasib in previously treated metastatic colorectal cancer with KRASG12C mutation: a multicentre, randomised, phase 1b/2 trial

Article

作者: Wang, Zaiqi ; Zhang, Baoyuan ; Lin, Rongbo ; Luo, Yongzhong ; Zhang, Yiping ; Zhu, Liming ; Li, Xingya ; Liu, Ying ; Song, Zhengbo ; Shi, Huaqiu ; Zhu, Yinxin ; Yuan, Yuan ; Cheng, Xiangdong

BACKGROUND:

Ifebemtinib is a potent oral focal adhesion kinase inhibitor. Preclinical evidence supports combining ifebemtinib with the KRAS^G12C inhibitor garsorasib. This study aimed to evaluate this combination in KRAS^G12C-mutated solid tumours.

METHODS:

This multicentre, phase 1b/2 study had a phase 1b component to establish the recommended phase 2 dose and a phase 2 multitumour expansion component. In phase 1b, the safety and tolerability of ifebemtinib combined with garsorasib was assessed using a 3 + 3 design in KRAS^G12C-mutated solid tumours. No dose-limiting toxic effects were observed, and the recommended phase 2 dose was established as ifebemtinib 100 mg orally once daily plus garsorasib 600 mg orally twice daily. Here, we report the results of the cohort of previously treated KRAS^G12C-mutated metastatic colorectal cancer from phase 2 expansion. Eligible patients (aged ≥18 years) who had histologically confirmed locally advanced or metastatic colorectal cancer harbouring the KRAS^G12C mutation, an Eastern Cooperative Oncology Group performance-status score of 0 or 1, and had disease progression after previous irinotecan-based or oxaliplatin-based combination therapy, were recruited from seven of nine participating tertiary hospitals in China. On the basis of the recommended phase 2 dose, phase 2 comprised a single-arm study to evaluate the safety and efficacy of ifebemtinib combined with garsorasib and an open-label, randomised study in which patients were randomly assigned (1:1) to receive ifebemtinib plus garsorasib or garsorasib alone, by use of centralised computer-generated block randomisation with no stratification. Investigators were masked to the block size. The primary efficacy endpoint of phase 2 was investigator-assessed objective response rate (Response Evaluation Criteria in Solid Tumours, version 1.1), assessed in the safety analysis set in the single-arm study and in all randomly assigned patients (intention-to-treat population) in the randomised study. At least six objective responses (safety analysis set) were required in the single-arm study to proceed to the randomised study. This study is registered with ClinicalTrials.gov, NCT06166836 and NCT05379946, and is active but not recruiting.

FINDINGS:

Between April 7, 2023 and Dec 13, 2024, 51 patients were enrolled in phase 2 (15 in the single-arm study and 36 in the randomised study). In the single-arm study, the median age was 53 years (IQR 39 to 63), nine (60%) patients were female, six (40%) were male, and all were Asian. In the randomised study, the median age was 51 years (IQR 42 to 59) in the combination group and 63 years (IQR 54 to 66) in the monotherapy group, 24 (67%) were female, 12 (33%) were male, and all patients were Asian. In the single-arm part, the confirmed objective response rate was 46·7% (95% CI 21·3 to 73·4). Seven patients had partial responses, triggering progression to the randomised study. In the randomised study, the confirmed objective response rate was 38·9% (95% CI 17·3 to 64·3) with the combination therapy versus 16·7% (95% CI 3·6 to 41·4) with garsorasib alone (between-group difference 22·2%, 95% CI -7·7 to 49·1; one-sided p=0·068). In the single-arm study, grade 3 treatment-related adverse events occurred in four (27%) of 15 patients, and in the randomised study, grade 3 treatment-related adverse events occurred in six (33%) of 18 patients in the combination group and five (28%) of 18 in the garsorasib group. Grade 3 treatment-related adverse events occurring in at least two patients were diarrhoea (six [18%]), proteinuria (two [6%]), and intestinal obstruction (two [6%]) in patients treated with combination therapy (combined), and increased alanine aminotransferase and γ-glutamyltransferase (two [11%] each) in patients treated with garsorasib alone. Serious adverse events occurred in ten (30%) patients in the combination group and in four (22%) patients in the monotherapy group. One patient in the garsorasib monotherapy group died due to the underlying malignancy within 30 days after completing study treatment, which was reported as a serious adverse event. The death was assessed by the investigators as not related to garsorasib. No grade 4 treatment-related adverse events or treatment-related deaths were reported across all cohorts.

INTERPRETATION:

The combination of ifebemtinib and garsorasib showed promising anticancer activity and manageable safety profile in previously treated patients with KRAS^G12C-mutated metastatic colorectal cancer. Although the improvement in response rate did not reach statistical significance in the randomised study, these findings support further evaluation of ifebemtinib plus garsorasib in this population.

FUNDING:

InxMed, InventisBio, National Natural Science Foundation of China, the Jian Bing Ling Yan + X Research and Development Program of Zhejiang Province, and the Zhejiang Province Medical and Health Science and Technology Plan Project.

2026-09-01·Lancet Respiratory Medicine

Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial

Article

作者: Wang, Zaiqi ; Lin, Rongbo ; Yuan, Yuan ; Luo, Yongzhong ; Zhang, Yiping ; Liu, Ying ; Li, Xingya ; Song, Zhengbo ; Lv, Tangfeng ; Zhang, Ling ; Zhu, Yinxin ; Zhu, Liming ; Shi, Huaqiu

BACKGROUND:

Ifebemtinib, a potent selective oral inhibitor of FAK, has shown preclinical synergistic activity with KRAS^G12C inhibitors. Garsorasib is a novel KRAS^G12C inhibitor approved in China for patients with KRAS^G12C-mutated non-small-cell lung cancer (NSCLC). This study aimed to evaluate the safety and efficacy of ifebemtinib plus garsorasib in KRAS^G12C-mutated solid tumours.

METHODS:

This multicentre study had a phase 1b component to establish the recommended phase 2 dose and a phase 2 multitumour expansion. Here, we report the results of the single-arm, Simon's two-stage cohort of first-line KRAS^G12C-mutated NSCLC from phase 2 expansion. The study was conducted at eight sites in China. Eligible patients were adults with pathologically confirmed locally advanced or metastatic NSCLC who were harbouring a KRAS^G12C mutation, were treatment-naive, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Enrolled patients received ifebemtinib (100 mg orally once a day) in combination with garsorasib (600 mg orally twice a day) in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent, initiation of new therapies, or death. The primary endpoint was objective response rate (ORR), as assessed by investigators, in all patients who received at least one dose of study treatment. The same population was included in safety analyses. This study is registered with ClinicalTrials.gov (NCT06166836 and NCT05379946) and is active but not recruiting.

FINDINGS:

Between April 21, 2023, and Dec 27, 2023, 33 first-line patients with NSCLC (two [6%] female and 31 [94%] male) were enrolled and received at least one dose of ifebemtinib plus garsorasib. As of Sept 16, 2025, median follow-up duration was 21·5 months (IQR 21·0-23·9). Confirmed ORR was 82% (27 of 33 patients; 95% CI 64·5-93·0). All 33 (100%) patients reported treatment-emergent adverse events, with 11 (33%) patients experiencing grade 3 or 4 events, of which eight (24%) were related to study drugs. The most frequent treatment-emergent adverse events of grade 3-4 were grade 3 proteinuria, diarrhoea, anaemia, hypertension, and pneumonia, each occurring in two (6%) of 33 patients. Serious adverse events occurred in nine (27%) of 33 patients, with intracranial haemorrhage and pneumonia being the only events reported in at least two patients (two [6%] each). No treatment-related deaths were reported.

INTERPRETATION:

The dual-oral chemotherapy-free regimen of ifebemtinib plus garsorasib had encouraging efficacy with a manageable safety profile as first-line treatment for KRAS^G12C-mutated NSCLC. A randomised phase 3 study has been initiated to further validate these findings against standard-of-care in the first-line setting (NCT07174908).

FUNDING:

InxMed, InventisBio, the National Natural Science Foundation of China, the Jian Bing Ling Yan + X Research and Development Programme of Zhejiang Province, and the Zhejiang Province Medical and Health Science and Technology Plan Project.

297

项与伊费替尼相关的新闻（医药）

2026-10-19

·戊戌数据

【可视化看板】2026.10.12-10.16药品注册受理情况

药品注册受理一周情况（2026年10月12日—10月16日）统计周期：2026年10月12日—10月16日查询时间：2026年10月18日 | 数据可能动态更新，请以官方最新公示为准本周CDE受理416个受理号，化药占比49.3%，1类创新药（化药新药+进口）46个受理号、23个品种、1类生物制品40个受理号；NMPA本周批准生产/进口105个受理号（批准生产99、批准进口6），其中1类创新药0个。统计周期：2026-10-12（周一）至2026-10-16（周五），按受理号计数。上周（10-05至10-09）基数含国庆假期后半段，环比偏高，仅作趋势参考。一、受理总况药品类型受理号数占比环比变化化药 205 49.3% +99.0% 中药 114 27.4% +107.3% 生物制品 97 23.3% +259.3%合计416100.0%+124.9% 生物制品内部：治疗用93个、预防用4个。上周各类为化药103、中药55、治疗用生物制品27、预防用0，合计185。数据来源：戊戌数据「MCP」服务 — 药品注册审批库（yaopinzc）。二、化药受理（205个） 2.1 按申请类型 2.2 按注册分类（仅新药+进口+仿制，131个）注：本周无单独的2.1类、2.2类、5.2类新药/进口/仿制申报，仅出现2.1/2.3、2.2/2.4合并标注各1个。 2.3 化药1类创新药（新药+进口，46个受理号 / 23个品种）药品名称注册分类申请类型企业名称承办日期 Fenebrutinib片 1 进口罗氏 10-12 LY5830966片 1 进口礼来 10-12 HP570片 1 新药海创药业 10-12 WYY026B注射液 1 新药红惠新医药 10-13 CS23546片 1 新药微芯生物 10-13 ARTS-023片 1 新药安锐生物 10-13 注射用DL001 1 新药成都登隆 10-13 Zoldonrasib片 1 新药百济神州 10-13 BGB-58067片 1 新药百济神州 10-13 BI 456906注射液 1 进口勃林格殷格翰 10-13 GVV858 1 进口诺华 10-13 SIM0712胶囊 1 新药先声药业 10-14 ACT001胶囊 1 新药尚德药缘 10-14 SYH2078注射液 1 新药石药中诺 10-14 YH601软膏 1 新药杭州禹泓 10-15 FY105注射液 1 新药北京福元 10-15 IN10018片 1 新药应世生物 10-15 TLL-041片 1 新药杭州高光 10-15 BPI-572270胶囊 1 新药杭州景曜 10-15 ART104注射液 1 新药苏州昂拓 10-15 VC005片 1 新药威凯尔 10-16 Retatrutide注射液 1 进口礼来 10-16 LW402片 1 新药上海长森 10-16 另有12个1类补充申请受理号（健康元JKN2404、丽珠利民、恒瑞HRS-6213、安迪科氟[18F]唑洛妥、武田Zasocitinib、杨森Seltorexant、礼来LY3819469/LY4337713等），不属首次申报，未列入上表。图片数据来源：戊戌数据-药品注册数据库（篇幅原因，展示部分数据，更多详细数据，网站免费查询）。 2.4 重点品种：Retatrutide（礼来） · 靶点/机制与适应症：GLP-1R/GCGR/GIPR三受体激动剂，开发方向为肥胖/超重与2型糖尿病。据戊戌数据全球新药库，其Ⅱ期数据显示治疗48周体重降幅最高达26.6%。 · 境内里程碑：2025-09-12以5个受理号（JXHL2500276–280）递交进口IND，2025-12-01获临床默许。 · 本次申报：2026-10-16以4个受理号（JXHL2600450–453）再次承办，申请类型为进口、注册分类1类。三、生物制品受理本周生物制品受理97个，治疗用93个，预防用4个，一次性进口6个；注册分类1类共52个受理号（其中新药/进口40个、补充申请12个）。下表为新药/进口口径的1类品种明细（类别均为治疗用）。药品名称注册分类企业名称承办日期注射用QLS5314 1 齐鲁制药 10-12 SYS6072 1 石药巨石 10-12 9MW5211注射液 1 迈威生物 10-12 LY888891混悬液 1 礼来 10-12 注射用HS-20122 1 翰森生物 10-12 抗狂犬病组合抗体 1 成大生物 10-12 注射用LM-338 1 礼新医药 10-12 注射用GB268 1 亿腾医药 10-12 QH104A细胞注射液 1 清辉联诺 10-12 SIBP-A21注射液 1 上海生研所 10-13 注射用TJ101 1 正大天晴 10-13 AI-081注射液 1 昂科免疫 10-13 IMC-003 1 宜明凯尔 10-13 SHR-6129注射液 1 盛迪亚 10-13 SI-B001双抗 1 百利多特 10-13 LK101注射液 1 未披露 10-14 注射用BAT7112 1 百奥泰 10-14 SSGJ-706注射液 1 三生制药 10-14 SPGL008注射液 1 赛保尔 10-14 注射用BG-T0050 1 百济神州 10-14 泰利奇拜单抗 1 智翔金泰 10-14 IBI324 1 信达生物 10-14 重组E型肉毒毒素 1 河北封章 10-14 SYS6095注射液 1 抗创联 10-14 KYS202010A冻干 1 康缘药业 10-14 注射用BC602 1 宝船生物 10-15 RH125注射液 1 瑞吉生物 10-15 LY-M001注射液 1 凌意生物 10-15 DS001冻干粉针 1 达迈生物 10-15 HS-20169注射液 1 翰森生物 10-15 注射用MCLA-129 1 贝达药业 10-15 注射用BGB-B2033 1 百济神州 10-15 脐带间充质干细胞 1 光琇高新 10-16 JNJ-98768111 1 强生 10-16 SCTB41注射液 1 神州细胞 10-16 SCTC21C注射液 1 神州细胞 10-16 数据来源：戊戌数据「MCP」服务 — 药品注册审批库（yaopinzc）。图片数据来源：戊戌数据-药品注册数据库（篇幅原因，展示部分数据，更多详细数据，网站免费查询）。 💊 重点品种：泰利奇拜单抗（智翔金泰，GR1802） · 靶点/机制：IL-4受体α亚基（IL-4Rα）靶向单抗，属中国生物药1类。 · 研发状态：戊戌数据全球新药库显示其最高研发状态为NDA/BLA，2026-10-14在境内递交上市申请（CXSS2600163）。 · 本次申报：2026-10-14承办，治疗用生物制品、1类、新药上市申请，审评通道为“上市”。四、中药受理中药受理114个，补充申请106个，新药IND 3个，NDA 4个，仿制药1个。药品名称申请类型注册分类企业名称承办日期消炎解毒合剂新药 2.2 湖北一恩 10-12 半夏白术天麻汤颗粒新药 3.1 神威药业 10-12 健脑通络颗粒新药 1.1 武汉博锦泰 10-14 芍药甘草汤颗粒新药 3.1 康缘药业 10-15 金菊消痤颗粒新药 1.1 重庆希尔安 10-15 金花清感颗粒新药 2.3 聚协昌 10-16 易黄汤颗粒新药 3.1 贵阳新天 10-16 四季抗病毒合剂仿制 4 安徽神农百草 10-15 本周1款中药仿制药：安徽神农百草药业申报四季抗病毒合剂。中药1.1类新药2个（健脑通络颗粒、金菊消痤颗粒），均为IND阶段。图片数据来源：戊戌数据-药品注册数据库（篇幅原因，展示部分数据，更多详细数据，网站免费查询）。想查更多？药达·isearch 免费体验文末「阅读原文」直达戊戌数据 · 可视化看板数据来源：药达isearch（https://isearch.wuxuwang.com）戊戌数据（www.wuxuwang.com）内容仅供参考，不构成投资或用药建议 END ★ 点击下方卡片，发现更多精彩

2026-10-17

·医疗资源共享综合服务平台

【KRAS抑制剂硫酸索西美雷塞片（济乐美）联合强效FAK抑制剂IN10018】→ 招募初治KRAS G12C突变非鳞状非小细胞肺癌患者进行中

项目简介本临床药物为KRAS抑制剂；目前招募初治KRAS G12C突变的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者；年龄：18~75岁；能够提供肿瘤组织样本在中心实验室进行以下检测：确认KRAS G12C阳性，进行PD-L1表达水平检测；ECOG评分为0或1；排除已知合并其它已获批靶向疗法的驱动基因突变；排除既往接受过免疫检查点抑制剂治疗，且因irAE终止治疗或研究者评估不适合接受免疫检查点抑制剂治疗；脑转移患者需治疗后稳定4周以上；全国多中心。实验名称及药物一项比较硫酸索西美雷塞片联合IN10018对比替雷利珠单抗联合含铂双药化疗一线治疗KRAS G12C突变的局部晚期或转移性非鳞状非小细胞肺癌参与者的随机、对照、开放性、多中心III期临床研究。硫酸索西美雷塞片（商品名：济乐美，代号：JMKX001899/JMKX1899）为一款新型、高效、口服的KRAS抑制剂。其可通过与KRAS（G12C）特异地、不可逆的结合，阻止GDP转化为GTP，维持在失活状态，从而抑制下游通路的激活，抑制胞外调节蛋白激酶（ERK）磷酸化，阻止肿瘤细胞的增殖和生长，促进细胞凋亡。临床前研究数据显示，与同靶点产品相比，JMKX001899具有较强的脑通透性，且没有心脏毒性和药物-药物相互作用风险。体内外研究结果表明，JMKX001899抗肿瘤作用明确，在多个肿瘤模型中均表现出显著的抑瘤效果，可显著抑制肿瘤细胞生长，且量效关系明显。此外，该产品给药后快速分布至靶器官，安全性好，治疗窗宽。值得一提的是，2026年2月28日，国家药监局（NMPA）官网显示，济民可信的1类创新药KRAS G12C抑制剂硫酸索西美雷塞片获批上市，适用于至少接受过一种系统性治疗的KRAS G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者。硫酸索西美雷片的获批是基于一项在中国开展的注册II期临床研究数据。研究结果表明，在至少接受过一种系统性治疗失败的KRAS G12C突变型晚期NSCLC患者中，该药物展现了强劲的疗效信号。经独立审查委员会（IRC）评估，确认客观缓解率（ORR）为52.4%，疾病控制率（DCR）为87.6%，中位无进展生存期（PFS）为7.2个月。在安全性方面，最常见的治疗相关不良反应（TRAE）为丙氨酸氨基转移酶升高（66.2%）、天冬氨酸氨基转移酶升高（62.8%）、贫血（31.7%）、γ-谷氨酰转移酶升高（26.2%）和血液碱性磷酸酶升高（22.1%）。导致治疗中断、剂量减少和永久停药的TRAE分别为24.1%、10.3%和2.1%。IN10018是一种高度选择性的强效黏着斑激酶（FAK）抑制剂。研究成果表明IN10018有望通过克服肿瘤基质纤维化屏障和调节肿瘤免疫抑制性微环境，实现突破肿瘤防御机制，克服耐药和转移，成为多种治疗方案的基石分子。研究药物：硫酸索西美雷塞片联合IN10018（III期）登记号：CTR20263527 试验类型：对照试验（VS 替雷利珠单抗联合含铂双药化疗）适应症：KRAS G12C突变非鳞状非小细胞肺癌（一线）申办方：浙江杭煜制药有限公司用药周期硫酸索西美雷塞片的规格：250mg；用法用量：500mg PO，QD；用药时程：每3周一个治疗周期。IN10018片的规格：25mg、50mg；用法用量：100mg PO，QD；用药时程：每3周一个治疗周期。对照药如下：替雷利珠单抗注射液的规格：100mg/10ml/瓶；用法用量：静脉给药，200mg；用药时程：每3周一个治疗周期，最长2年。注射用培美曲塞二钠的规格：0.1g；用法用量：500mg/m2。用药时程：每3周一个治疗周期。卡铂注射液的规格：10ml：100mg；用法用量：按照AUC和内生肌酐清除率计算；用药时程：每3周一个治疗周期，最多4周期。研究中心江西南昌、赣州、宜春湖南长沙四川遂宁、成都湖北武汉、荆州辽宁沈阳浙江杭州、台州上海山西太原云南昆明安徽合肥、阜阳江苏南京、徐州、无锡、苏州山东青岛、济南、临沂、济宁、滨州广东江门、汕头、佛山、广州、梅州、深圳广西南宁、柳州河南安阳、新乡、洛阳、郑州北京福建福州甘肃兰州贵州贵阳、遵义河北保定、石家庄黑龙江哈尔滨吉林长春浙江丽水、台州、宁波、杭州、温州重庆具体启动情况以后期咨询为准【研究中心若有更新请拉至文末查看】更多项目信息请参考： http://www.chinadrugtrials.org.cn/index.html 温馨提示：文章入排信息来源于国家临床试验官网公示信息，具体情况以实际咨询为准！参加临床试验的获益 1、获得先进治疗机会临床试验通常涉及尚未上市的新药物、新疗法或新技术，这些治疗方案可能代表医学领域的前沿突破。对于一些难治性疾病（如晚期癌症、罕见病等），患者可能通过临床试验接触到比现有标准治疗更有效、副作用更小的方案，从而延长生存期、改善生活质量。 2、减轻经济负担参与临床试验期间，患者通常可免费获得试验药物、相关检查及部分医疗费用支持。对于需要长期治疗且药物价格高昂的患者（如肿瘤患者），这能显著减轻家庭经济压力，使患者更易坚持规范治疗。 3、专业医疗照护与监测临床试验由专业医疗团队主导，患者会接受更频繁、更全面的病情监测和随访。医生会密切关注身体反应，及时调整治疗方案，确保患者安全。这种精细化的医疗管理有助于更好地控制病情，发现潜在问题并及时处理。 4、推动医学进步患者的参与为新药研发和医学研究提供了关键数据，有助于验证新疗法的安全性和有效性。每一份数据都可能为未来更多患者的治疗带来希望，患者因此成为医学进步的贡献者，获得参与科学探索的成就感。 5、个性化治疗探索部分临床试验聚焦于特定基因特征或疾病亚型，患者可能通过试验获得更精准的个性化治疗方案。这种针对性治疗可能提高疗效，减少不必要的治疗尝试。 6、需注意，临床试验存在一定不确定性，疗效和安全性需结合个体情况评估。患者在参与前应与医生充分沟通，了解试验细节、风险和潜在获益，自主决定是否参与。总结归纳 1、免除项目用药：研究药物使用，直至疾病进展。 2、免除项目检查：签署知情后试验所需相关检查。 3、项目交通补助：临床研究相关的交通补助。 4、专家定期随访：全程专家团队服务，一对一随访。 5、全程绿色就医通道：减少预约和排号时间，减少就医流程。报名资料收集肿瘤患者需要准备和提交的资料包括： 1、首次确诊时的出和入院记录、病理免疫组化报告、基因检测报告(含PDL-1）、影像报告（心电图、超声检查、CT/MRI检查、PET/CT、影像胶片）、血常规、肝肾功能、凝血功能、传染病检查、肿瘤标志物、心电图报告等。 2、肿瘤患者经过一线治疗过的，还需要提供末次治疗时的出和入院记录、如有二次做的病理免疫组化报告、基因检测报告、最新的影像报告（心电图、超声检查、CT/MRI检查、PET/CT、影像胶片）、血常规、肝肾功能、凝血功能、传染病检查、肿瘤标志物、心电图报告等。如果您或您的周围有满足以上条件的患者，可以与我们联系。该研究遵从相关的国家法规，患者的隐私权亦会得到保护。想了解该项目的具体信息，请咨询以下联系方式。 ■ 如果您有意向参加此研究，可通过如下方式咨询：目前我们有食管癌、胃癌、肝癌、胰腺癌、胆道癌、直肠癌、乳腺癌、卵巢癌、宫颈癌、子宫内膜癌、膀胱癌、前列腺癌、肺癌、黑色素瘤、头颈鳞癌、淋巴瘤、白血病、骨髓瘤、高血压、糖尿病、青光眼、哮喘、红斑狼疮、荨麻疹、斑秃、皮炎、减肥等项目同期进行中...... 基因检测、PETCT、药物咨询、放疗等提供免费咨询免责声明： 1，本公众号发布为提供信息，不构成任何建议。 2，本公众号所刊发、转载的文章，其观点、内容、字体、图片版权均归原作者所有，相关责任作者自负。

临床3期临床结果临床2期申请上市

2026-10-17

·JCASK老金投研

复星医药估值分析

复星医药的估值分析，结合最新中期报告（2026 H1）和创新药管线兑现节奏： --- ## 一、资产 vs 市值对比（核心结论） ### 1.1 A股 / H股双视角 | 指标 | 数值 | 备注 | |---|---|---| | 总资产 | **1,254 亿元** | 2026/6/30 | | 归母净资产 | 487 亿元 | 每股净资产 18.25 元 | | 少数股东权益 | 146.7 亿元 | — | | 股东权益合计 | 634 亿元 | — | | 现金及银行结余 | 136 亿元 | 流动性充裕 | | A股价 | 22.65 元（9/7） | A股市值约 **605 亿元** | | H股价 | 17.35 港元（9/7） | H股市值约 **290 亿港元 ≈ 260 亿元** | ### 1.2 关键估值指标 | 估值维度 | A股 | H股 | |---|---|---| | **PB（每股净资产 18.25 元）** | 1.24 倍 | **0.85 倍（破净！）** | | **PE TTM** | ~18 倍 | ~14 倍 | | **PEG** | 0.7-0.8 | 0.5-0.6 | **核心结论：H 股已经破净，A 股仅小幅溢价于净资产。** ### 1.3 资产是市值的多少倍？ - A股：1,254 / 605 = **2.07 倍**（总资产是 A股市值的 2 倍） - H股：1,254 / 260 = **4.82 倍**（总资产是 H 股市值的近 5 倍） **单看 A 股层面，资产确实远大于市值（2x），H 股层面更是接近 5x 的悬殊低估。** --- ## 二、为什么说"严重低估"？——三个独立证据 ### 2.1 拆出核心子公司后的隐含主业估值 | 资产/子公司 | 复星医药权益 | 估算市值/价值 | |---|---|---| | 国药控股（01099.HK）持股 33% | 200 亿港元 ≈ 183 亿 RMB | 国药 2026 H1 收入 2828 亿，归母 34 亿 | | 复宏汉霖（02696.HK）持股 60% | 200 亿港元 ≈ 183 亿 RMB | 2026 H1 净利 4.3 亿，全球 PD-1 出海 | | 上述两项合计 | **约 366 亿 RMB** | — | **隐含主业估值**： - A股 605 亿 - 366 亿（两项子公司权益）= **239 亿元** - 2026 H1 扣非净利 11.44 亿 × 2 = 年化 **22.88 亿** - 主业隐含 PE ≈ **10.4 倍** ← 这才是主业估值水平！ H 股同样口径：**260 - 366 = 负数**，意味着仅子公司价值已覆盖全部 H股市值。 ### 2.2 NAV拆分（净资产价值法） | 资产项 | 账面价值（亿） | 备注 | |---|---|---| | 货币资金 | 136 | 流动性充裕 | | 长期股权投资 | 285 | 含国药、应世、星曜坤泽等 | | 固定资产 + 在建 + 使用权 | 240 | — | | 存货 + 应收账款 | 156 | 运营资产 | | 投资性房地产 | 0 | — | | 无形资产 + 开发支出 | 220 | 含在研管线资本化部分 | | 商誉 | 107 | 并购积累（注意减值风险） | | 减：总负债 | -620 | — | | **归母 NAV** | **487 亿** | — | 按目前 A股价，A 股 PB1.24 倍；H 股 PB 0.85 倍，**已经低于清算价值底线**。 ### 2.3 同业可比 | 公司 | PE TTM | PEG | 备注 | |---|---|---|---| | 恒瑞医药 | 36-39 倍 | 1.4 | 纯创新药龙头 | | 百济神州 | 78 倍 | 0.35 | 盈利初期 | | 海思科 | 83 倍 | 0.31 | BD驱动 | | 药明康德 | 28 倍 | 1.1 | CXO 龙头 | | **复星医药** | **18 倍** | **0.7-0.8** | **综合医药龙头** | **作为综合医药 + 创新药 +国际化三栖的龙头，给纯创新药企1/2–1/3 的估值，PE 折价显著。** --- ## 三、创新药营收占比与增速 ### 3.1 当前数据（2026 H1） | 指标 | 2026 H1 | 同比变化 | |---|---|---| | 创新药收入 | **49.11 亿元** | +13.84% | | 占制药业务收入比重 | **33.21%** | +2.17 pct | | 占总营收比重 | 24.0% | +1.8 pct | | 制药业务毛利率 | 57.64% | +3.01 pct | | 创新药研发投入 | 26.50 亿元 | +48.38% | | 创新药研发占总研发 | **81.61%** | +12.50 pct | ### 3.2 增速预测（基于 2025 创新药收入 95 亿） - **2026 E**：管理层预期创新药收入占比突破 **50%** - **2025–2027**：创新药收入复合增速 **~20%** - **2028 E**：8款国内重磅峰值合计 140–180 亿元，对应净利 ~28 亿 ### 3.3 创新药在总收入中的位置 | 年份 | 总收入（亿） | 创新药收入（亿） | 占比 | 增速 | |---|---|---|---|---| | 2024 | 410.7 | ~80 | 19.5% | — | | 2025 H1 | 195.1 | 43.1 | 22.1% | — | | 2026 H1 | 204.4 | **49.1** | **24.0%** | +13.84% | | 2026 E | ~430 | ~110 | ~25% | +20% | | 2027 E | ~480 | ~150 | **~31%** | +35% | | 2028 E | ~540 | ~190 | **~35%** | +27% | --- ## 四、未来 3 年创新药管线兑现节奏 ### 4.1 已商业化的核心创新药（提供现金流） | 药品 | 适应症 | 进度 | |---|---|---| | **斯鲁利单抗（汉斯状）** | PD-1 全球 50 国上市 | 已商业化，2026 H1 新增胃癌围术期（全球首个）+ 欧盟 3 项新适应症 | | **汉曲优（曲妥珠单抗）** | HER2+ 乳腺癌 | 已商业化，国内市占率领先 | | **汉利康（利妥昔单抗）** | CD20 B 细胞淋巴瘤 | 已商业化，2022 年起市占率第一 | | **复迈宁（芦沃美替尼）** | MEK 抑制剂，NF1/LCH | 已商业化，新增 LCH 儿童适应症 | | **复妥宁（伏维西利）** | CDK4/6 乳腺癌 | 已商业化 | | **汉倍优（帕妥珠单抗）** | HER2+ 乳腺癌 | 中欧已获批 | ### 4.2 未来 3 年待兑现的重磅管线 | 时间 | 药品 | 靶点/机制 | 适应症 | 潜在峰值 | |---|---|---|---|---| | **2027 H1** | VGX-3100 | HPV DNA 药物 | 宫颈癌前病变 | 数十亿 | | **2027 Q2** | **AR1001（最关键）** | **PDE-5 抑制剂** | **早期阿尔茨海默病** | **50 亿+ 美元** | | 2027 底 | AlloJoin | 干细胞 | 膝骨关节炎 | 国内独家 | | **2028 H1** | FHND9041 | 三代 EGFR | NSCLC | 已 NDA 受理 | | **2028 H1** | IN10018 | FAK 抑制剂 | 实体瘤（卵巢癌、KRAS 肺癌） | 3 项突破性疗法 | | 2028 H2 | GQ1005 | HER2 ADC | 乳腺癌 | 复宏汉霖 × 启德 | | **2029 H2** | 甘露特钠（九期一） |脑肠轴 | AD | 全球首个 AD 机制 | | 2029-2030 | IL-1RAP 单抗 | 自免首创 | 免疫炎症 | 全球无同靶点 | ### 4.3 关键催化剂时间表 | 触发事件 | 时间 | 影响 | |---|---|---| | AR1001 III 期顶线数据 | **2026 年内** | **全球 AD 首款对因药物，可能重估** | | 斯鲁利单抗 FDA 申报 | 2026 | 全球商业化里程碑 | | 创新药收入占比突破 50% | 2026 全年 | 估值锚切换 | | 复宏汉霖 HER2 ADC 数据 | 持续 | 子公司价值重估 | | 绿谷医药并表 | 2026 起 | AD 双轨布局 | | 9 期 I 一期/二期数据出炉 | 持续 | 甘露特钠管线兑现 | --- ## 五、估值结论与风险 ### 5.1 估值结论 ✅ **A 股：明确低估**（PB 1.24x，PE 18x，PEG 0.7-0.8） ✅ **H 股：严重低估**（PB 0.85x 破净，PE 14x） ✅ **主业估值仅 10 倍 PE**（剔出国药控股 + 复宏汉霖后） ✅ **NAV 已超过 A 股市值的 80%**（487 / 605 = 80%） ✅ **创新药占比持续提升**，正在从仿制药估值向创新药估值切换 ### 5.2 主要风险 | 风险类型 | 说明 | |---|---| | **净流动负债** | 流动资产 348 亿 < 流动负债 386 亿，差额 -38 亿 | | **资产负债率** | 49.45%，偏高 | | **大股东质押** | 5.45 亿股（占其持股 61.27%）已质押 | | **商誉减值** | 107 亿商誉占净资产 22%，若 BD/并购子公司业绩不达预期可能减值 | | **汇率** | 海外业务占比 31%，人民币升值带来汇兑损失 | | **临床失败** | AR1001 顶线若为阴性，影响最大 | | **BD 兑现** | 部分管线依赖引进（AR1001、IN10018、GR1803 等） | ### 5.3 综合评分（按你的 5 因子打分） | 维度 | 得分 | 满分 | 备注 | |---|---|---|---| | 未来两年扣非净利涨幅 | 1.0 | 2.5 | +25% 左右，未达高速 | | PE 历史分位值 | 2.5 | 2.5 | **A/H 股都处历史低位** | | PEG | 1.0 | 2.0 | PEG 0.7-0.8，介于合理-低估 | | ROE | 1.2 | 1.5 | ROE 12.5%（2025），1H26 ROE 7% 折年化 14% | | OCF | 1.5 | 1.5 | OCF/NI = 1.35-1.4x，极佳 | | **总分** | **7.2** | 10 | 重点配置 |

100 项与伊费替尼相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
KRAS G12C突变非鳞状非小细胞肺癌	临床3期	中国	应世生物科技（上海）有限公司	2025-10-09
非鳞状非小细胞肺癌	临床3期	中国	应世生物科技（上海）有限公司	2025-09-10
复发性铂耐药性卵巢癌	临床3期	中国	应世生物科技（上海）有限公司	2022-08-29
复发性铂耐药性卵巢癌	临床3期	中国香港	应世生物科技（上海）有限公司	2022-08-29
KRAS G12D突变实体瘤	临床2期	中国	应世生物科技（深圳）有限公司	2026-01-19
广泛期小细胞肺癌	临床2期	中国	应世生物科技（上海）有限公司	2023-10-30
EGFR阳性非小细胞肺癌	临床2期	中国	应世生物科技（上海）有限公司	2023-07-13
不能切除性胰腺癌	临床2期	中国	应世生物科技（上海）有限公司	2022-12-08
胰腺导管腺癌	临床2期	中国	应世生物科技（上海）有限公司	2022-12-08
晚期结直肠腺癌	临床2期	中国	应世生物科技（上海）有限公司	2022-10-12

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临床结果

适应症

分期

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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


NCT06166836 \| NCT05379946 (Pubmed \| Lancet Oncol)	临床1/2期	转移性结直肠癌 KRASG12C mutation	51	Ifebemtinib plus garsorasib (single-arm study)	鑰蓋衊鹽選壓淵鏇襯顧(鏇憲淵餘窪鑰襯選繭鑰) = 鑰壓範網鏇糧齋積構鹽範顧築獵網鬱觸齋窪鹹 (遞構膚齋製艱鏇餘構廠 )	积极	2026-09-01
				Ifebemtinib plus garsorasib (randomised study)	築壓鏇鑰鏇糧簾壓鹹醖(構衊廠淵網繭構淵觸構) = 顧獵鬱憲簾獵顧廠膚餘窪壓膚積鏇膚衊餘餘淵 (淵壓遞積顧製廠鹹製鬱 ) 更多
NCT06166836 \| NCT05379946 \| NCT07174908 (Pubmed \| Lancet Respir Med)	临床1/2期	KRAS G12C突变非小细胞肺癌一线 KRASG12C mutation	33	Ifebemtinib plus garsorasib	憲鹽遞鹹網夢鹽淵範鹽(廠艱獵範簾鬱鹹衊觸餘) = 糧齋醖網餘觸構壓顧鏇淵艱夢製壓願選鏇窪繭 (憲願憲鏇觸醖製窪願鹹, 64.5 ~ 93.0) 更多	积极	2026-09-01
NCT06166836 (ASCO2026)	临床1/2期	KRAS G12C突变的实体瘤 \| 非小细胞肺癌一线 KRAS G12C mutations \| TP53	33	Ifebemtinib 100 mg QD + Garsorasib 600 mg BID	網鬱選糧獵築窪願製觸(鏇築範鑰襯壓淵夢廠壓) = 壓鏇艱獵艱顧構選選遞蓋鑰構築鑰襯顧糧簾廠 (網窪廠蓋願簾製獵鹹憲 ) 更多	积极	2026-05-29
				Ifebemtinib 100 mg QD + Garsorasib 600 mg BID (TP53 wild-type)	襯鏇壓壓醖積鬱鏇窪選(糧繭餘憲襯網憲襯憲蓋) = 構壓積淵鬱膚簾遞壓壓繭鑰襯遞糧醖夢襯衊蓋 (餘壓艱襯膚憲網鹹齋顧 )
NCT06166836 (ASCO2026)	临床1/2期	KRAS G12C突变结直肠癌 KRAS G12C mutant	36	Ifebemtinib+Garsorasib	艱衊廠積簾廠觸襯鹹淵(襯鬱簾鬱積憲憲鹹製艱) = 淵繭積襯範鬱繭醖簾鑰構廠獵襯醖遞構築鏇糧 (齋襯壓醖糧襯糧遞憲鑰, 81.5 ~ 100.0) 更多	积极	2026-05-29
				Garsorasib	艱衊廠積簾廠觸襯鹹淵(襯鬱簾鬱積憲憲鹹製艱) = 簾鏇衊衊構網淵鬱夢鏇構廠獵襯醖遞構築鏇糧 (齋襯壓醖糧襯糧遞憲鑰, 52.4 ~ 93.6) 更多
NCT06166836 \| NCT05379946 (ASCO2025) 人工标引	临床1/2期	KRAS G12C突变的实体瘤 \| 非小细胞肺癌 \| 结直肠癌二线 \| 一线 KRAS G12C	-	Ifebemtinib (IN10018) 100mg QD + GarsorasibGarsorasib (D-1553) 600mg BID (KRAS G12C NSCLC)	夢衊遞鏇廠顧齋願鹹築(淵鏇選夢鏇衊願獵膚艱) = 製鹹繭顧鏇繭選蓋醖願淵簾蓋繭積願夢廠淵蓋 (積蓋餘鑰簾窪壓構壓築 ) 更多	积极	2025-05-30
				Ifebemtinib (IN10018) 100mg QD + GarsorasibGarsorasib (D-1553) 600mg BID (CRC)	觸衊願淵願憲窪糧顧窪(鬱艱構蓋鹹艱構糧糧築) = 蓋選齋積獵衊觸鬱願遞獵窪餘鹽獵淵齋範鹹鬱 (鬱繭範築積獵鹽夢蓋齋, 81.5 ~ 100.0) 更多
NCT06166836 \| NCT05379946 (ESMO2024) 人工标引	临床1/2期	KRAS G12C突变的实体瘤二线 \| 一线 KRAS G12C	48	Ifebemtinib (100mg qd) + D-1553 (600mg bid)	艱鏇衊淵鬱膚範願網構(齋衊繭積網壓顧鏇顧夢) = 7 pts (14.6%) had ifebemtinib-related SAEs, and 6 (12.5%) were also considered D-1553 related. 願選餘蓋構鏇鏇壓窪糧 (鏇鑰壓窪窪襯憲鏇觸窪 ) 更多	积极	2024-09-14
				Ifebemtinib (100mg qd) + D-1553D-1553 (600mg bid) (KRAS G12C mutant metastatic CRC)
NEWS 人工标引	临床1/2期	KRAS G12C突变非小细胞肺癌一线 KRAS G12C	33	ifebemtinib+garsorasib	窪餘糧襯簾壓繭顧襯壓(鬱選網築網鬱壓繭築鹹) = 願繭遞窪膚範廠夢繭夢範製鑰醖淵鬱衊膚鑰網 (顧鹽願壓憲構製淵餘餘 ) 更多	积极	2024-06-03
NCT06166836 \| NCT05379946 (ASCO2024) 人工标引	临床1/2期	KRAS G12C突变非小细胞肺癌一线 KRAS G12C	33	ifebemtinib (IN10018) 100D-1553	範簾遞簾網鹹鬱獵艱範(鏇齋鏇獵積餘網選繭構) = Four subjects (12.1%) had ifebemtinib-related SAEs (diarrhea, enteritis, oedema peripheral and proteinuria) as assessed by investigators, and all SAEs were also considered D-1553 related. 觸繭艱廠鏇願鹹觸遞願 (簾蓋選膚蓋觸壓餘鹽夢 ) 更多	积极	2024-05-24
NCT05830539 (ESMO2023)	临床1/2期	转移性三阴性乳腺癌	26	IN10018+PLD	製選積醖衊鑰簾淵憲壓(構艱廠齋積鹽簾製糧淵) = 夢選獵憲淵製願鏇鹹廠願憲遞鏇壓艱壓鹽簾餘 (齋鹹鏇鏇顧襯繭鹹簾獵, 2.1 ~ 48.4) 更多	积极	2023-10-21
				IN10018+PLD+Toripalimab	製選積醖衊鑰簾淵憲壓(構艱廠齋積鹽簾製糧淵) = 鬱選遞壓觸憲鹹顧憲觸願憲遞鏇壓艱壓鹽簾餘 (齋鹹鏇鏇顧襯繭鹹簾獵, 3.8 ~ 42.8) 更多
NCT05551507 (NEWS) 人工标引	临床1期	卵巢癌	50	liposomal doxorubicin+IN10018	鹽鹹遞鹽積築醖襯遞壓(壓襯襯鹽鬱範齋遞觸網) = 膚顧齋醖鹽簾簾膚憲蓋壓憲顧夢遞鏇鏇衊壓壓 (顧醖廠蓋網壓願窪遞獵 ) 更多	积极	2022-11-11