AN INTERVENTIONAL PHASE 3, OPEN LABEL, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH ADVANCED OR RECURRENT MISMATCH REPAIR PROFICIENT ENDOMETRIAL CANCER

This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy. Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing.
Our bodies have a built-in DNA "spell-checker," called the mismatch repair (MMR) system, that fixes genetic mistakes. In most endometrial cancers, this system works normally, and these cancers are called MMR-proficient (pMMR). However, pMMR tumors are harder for the immune system to recognize and attack. When endometrial cancer has spread beyond the uterus or comes back after previous treatment, it is called advanced or recurrent endometrial cancer. This study is for adults with mismatch repair-pMMR advanced or recurrent endometrial cancer.
Participants must meet key criteria, including:
* Women who are 18 years or older, and not pregnant at the time of joining the study
* pMMR endometrial cancer only
* Measurable Stage III disease, Stage IV disease (with or without measurable disease) per FIGO staging, a system doctors use to describe how far cancer has spread in the body, or recurrent (with or without measurable disease) endometrial cancer
* Has not received chemotherapy except for chemotherapy given after the main surgery and more than 6 months before relapse
* Be in good enough health to receive study treatment. Approximately 600 adult women will be enrolled. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups, with about half in each group. The study is open, meaning both the doctors and participants know what treatment is being given. Participants will receive their assigned treatment through intravenous infusions (medicine is given directly into a vein). The treatment will be given in cycles.
Experimental Group will receive new study medicine called PF-08634404 plus chemotherapy. It will be followed by PF 08634404 alone for up to 2 years (35 cycles).
Control Group will receive an approved medicine called pembrolizumab plus chemotherapy. It will be followed by pembrolizumab alone for up to 2 years (20 cycles).
The study will include regular visits for:
* Participants will have regular visits to the study site for treatment, health checks, and tests.
* After stopping treatment, participants will come for a final visit within a month to check their health and review any reactions.
* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records. This helps check health and any new treatments.
* Tests will be done every 9 weeks during the first 104 weeks to see how the cancer is responding. After that, tests will be done every 12 weeks.

开始日期2026-10-14

申办/合作机构

Pfizer Inc.

[+2]

NCT07476287

/ Recruiting临床2期

A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER

This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.
To join the study, participants must meet the following conditions:
* Are aged 18 years or older
* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)
* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)
* Have healthy organs based on medical tests and are in good physical condition
After joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.

开始日期2026-07-02

申办/合作机构

Pfizer Inc.

NCT07489066

/ Recruiting临床2期

AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER

This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.
The study is seeking participants who:
* Are aged 18 years or older
* Have either:
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.
* Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.
* Be in good physical condition and have healthy organs based on medical tests.
* Do not have known actionable changes in DNA
The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:
* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.
* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.
* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.
All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.

开始日期2026-06-30

申办/合作机构

Pfizer Inc.

100 项与 SSGJ-707 相关的临床结果

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100 项与 SSGJ-707 相关的转化医学

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100 项与 SSGJ-707 相关的专利（医药）

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项与 SSGJ-707 相关的文献（医药）

2026-09-01·Oncology and Therapy

Podcast on the Emerging Role of PD-(L)1/VEGF Bispecific Antibodies in the Evolving Advanced Renal Cell Carcinoma Treatment Landscape

作者: Garmezy, Benjamin ; Rini, Brian I

Combinations of an immune checkpoint inhibitor (ICI) + anti-programmed cell death 1 protein (PD-1) or anti-programmed cell death ligand 1 (PD-L1) or an ICI + tyrosine kinase inhibitor (TKI; anti-vascular endothelial growth factor [VEGF]) are the current standard first-line treatments for advanced renal cell carcinoma (RCC). However, novel therapies are needed as treatments for RCC have relied on the same mechanisms for decades, with only modest advancements made in the field compared with other genitourinary diseases. Therefore, a considerable unmet need remains for additional treatment options with enhanced activity and minimal toxicity for patients with advanced RCC. Simultaneous bispecific targeting of PD-1 and VEGF may improve efficacy and safety compared with combination therapy of PD-1- and VEGF-targeting single agents. In this podcast, authors discuss the evolving treatment landscape for patients with RCC and describe how bispecific antibodies, as monotherapy or combination therapy, have the potential to transform the treatment of these patients. Preclinical evidence shows that bispecific co-targeting of PD-(L)1 and VEGF may result in cooperative binding, which can enhance both PD-1 binding affinity and anti-angiogenic activity. Bispecific targeting can also potentially confer safety advantages owing to a reduction in immune-related adverse events. PD-(L)1/VEGF bispecifics under development include PF-08634404, ivonescimab, and BNT327, all of which have distinct structural configurations and mechanistic differences. These bispecific antibodies, among others, are being evaluated for the treatment of patients with advanced RCC. The authors discuss existing clinical evidence with bispecific antibodies in other cancers and explore the rationale for evaluating the antitumor activity of PD-(L)1/VEGF bispecifics, either as monotherapy or in conjunction with other treatments in patients with RCC.Podcast and Infographic available for this article. Podcast (MP4 107526 KB) Infographic.

1,605

项与 SSGJ-707 相关的新闻（医药）

2026-10-29

·ioncology

瞭望ESMO·智耀东方丨邬麟教授：Tivunatamig联合化疗一线治疗晚期NSCLCⅡ期研究更新

编者按 2026年10月23日～27日，备受瞩目的2026年欧洲肿瘤内科学会（ESMO）年会在西班牙马德里盛大召开。作为全球肿瘤学领域最具影响力的学术会议之一，本届大会汇聚全球顶尖专家学者，集中呈现肿瘤诊疗领域的前沿突破与未来图景。本届大会，来自湖南省肿瘤医院邬麟教授团队一项“PD-1/VEGF双特异性抗体Tivunatamig（PF-08634404/SSGJ-707）联合化疗治疗晚期非小细胞肺癌的Ⅱ期临床研究”发布了更新结果。《肿瘤瞭望》特邀邬麟教授就该研究结果进行深度剖析。研究介绍摘要号：2660P 英文标题: Phase 2 trial of the PD-1/VEGF bispecific antibody, PF-08634404 (SSGJ-707), plus chemotherapy (chemo) in advanced NSCLC: Updated results 中文标题：PD-1/VEGF双特异性抗体Tivunatamig（PF-08634404 / SSGJ-707）联合化疗治疗晚期非小细胞肺癌的II期临床研究更新结果讲者：邬麟教授（湖南省肿瘤医院）研究背景 Tivunatamig（PF-08634404 / SSGJ-707，简称PF’4404）是一种可同时靶向PD-1和VEGF的全人源IgG4型双特异性抗体。前期研究（NCT06412471）结果显示，无论PD-L1表达水平如何，Tivunatamig联合含铂化疗作为非小细胞肺癌（NSCLC）的一线治疗方案均展现出良好的抗肿瘤活性，且安全性可控。本次报告更新了Tivunatamig联合化疗一线治疗晚期NSCLC的长期随访数据。研究方法本项开放标签、随机Ⅱ期临床试验旨在评估Tivunatamig或替雷利珠单抗联合含铂化疗方案一线治疗NSCLC的疗效与安全性。研究分为两部分：Part 1纳入初治的晚期非鳞状NSCLC（nsq-NSCLC），随机接受Tivunatamig（5/10/20 mg/kg, Q3W）或替雷利珠单抗联合卡铂和培美曲塞治疗；Part 2纳入初治的晚期鳞状NSCLC（sq-NSCLC），队列A评估Tivunatamig（5/10 mg/kg, Q3W）联合卡铂和紫杉醇的不同剂量方案，队列B比较Tivunatamig或替雷利珠单抗联合化疗的不同治疗方案。本研究主要终点为评估患者安全性和初步抗肿瘤活性。疗效分析采用推荐的Ⅲ期临床试验剂量（10 mg/kg, Q3W）的数据，安全性及循环肿瘤DNA（ctDNA）分析则纳入所有接受不同剂量治疗的患者。研究结果截至2026年8月6日，共入组122例nsq-NSCLC和139例sq-NSCLC患者接受Tivunatamig或替雷利珠单抗联合化疗治疗。有效性：Tivunatamig（10 mg/kg, Q3W）和替雷利珠单抗联合化疗组中位随访时间分别为16.2和18.6个月。在nsq-NSCLC中，Tivunatamig（10 mg/kg, Q3W）联合化疗组的确认客观缓解率（cORR）为77.5%，替雷利珠单抗联合化疗组为44.7%，两组中位无进展生存期（mPFS）分别为13.8和9.7个月。在sq-NSCLC中，Tivunatamig（10 mg/kg, Q3W）联合卡铂和紫杉醇组的cORR为80.7%，替雷利珠单抗联合化疗组的cORR为67.7%，mPFS分别为13.6和8.3个月。安全性：Tivunatamig联合化疗组与替雷利珠单抗联合化疗组≥3级治疗相关不良事件（TRAE）发生率分别为55.8%和49.3%。Tivunatamig（10 mg/kg, Q3W）联合化疗剂量水平组的≥3级TRAE发生率为59.0%，nsq-NSCLC和sq-NSCLC安全性相当；最常见的TRAE为贫血（55%）、白细胞计数降低（43%）和中性粒细胞计数降低（40%）。该剂量组的VEGF相关不良事件（AE）发生率为56.4%，≥3级为12.0%，其中≥3级出血和咯血事件在nsq-NSCLC和sq-NSCLC中的发生率总体较低。免疫相关不良事件（irAE）发生率为16.2%，≥3级为6.8%。 ctDNA结果：在126例接受Tivunatamig联合化疗、基线ctDNA可检出且于第3周期第1天（C3D1）有配对样本的患者中，C3D1 ctDNA清除率为61.9%。C3D1 ctDNA清除与未清除患者的mPFS分别为16.4和9.6个月。研究结论随着随访时间延长，Tivunatamig联合化疗对比替雷利珠单抗联合化疗，无论患者的组织学类型及PD-L1表达水平如何，均持续展现出具有临床意义的抗肿瘤活性。Tivunatamig联合化疗安全性良好，该方案在鳞状和非鳞状NSCLC患者中均表现出可控且一致的安全性。探索性分析显示，治疗后ctDNA清除与较长PFS相关。上述结果支持目前正在开展的5项Symbiotic肺癌系列研究，包括在Ⅲ期Symbiotic-Lung-01研究（NCT07222566）中进一步评估Tivunatamig（10 mg/kg, Q3W）联合化疗的疗效与安全性。研究者说免疫联合化疗已成为驱动基因阴性晚期NSCLC一线治疗的重要选择，显著改善了患者的生存结局。然而，仍有部分患者初始治疗应答不佳或较早出现疾病进展，长期生存仍有较大提升空间。近年来，随着我国创新药物研发不断取得进展，以PD-1/VEGF双特异性抗体为代表的新型药物展现出良好的临床应用潜力，为进一步提高晚期NSCLC一线治疗疗效提供了新的探索方向。 Tivunatamig（PF-08634404/SSGJ-707）是一种具有独特分子结构设计的全人源IgG4型PD-1/VEGF双特异性抗体。该药采用共同轻链设计，将抗PD-1抗体Fab片段的重链部分通过连接肽融合至抗VEGF抗体重链的N端，形成具有两个PD-1结合位点和两个VEGF结合位点的“2+2”对称四价结构。 Tivunatamig联合化疗一线治疗晚期NSCLC的临床数据于2025 SITC年会首次公布，本次2026 ESMO年会进一步更新了长期随访数据。疗效方面，在nsq-NSCLC患者中，Tivunatamig（10 mg/kg, Q3W）联合化疗组和替雷利珠单抗联合化疗组的mPFS分别为13.8和9.7个月；在sq-NSCLC患者中，两组的mPFS分别为13.6和8.3个月。随着随访时间延长，Tivunatamig联合化疗在不同组织学类型的NSCLC患者中均展现出较好的抗肿瘤活性和持续的疗效获益趋势。安全性方面，Tivunatamig联合化疗的整体安全性可管理，其整体TRAE发生率与替雷利珠单抗相当，VEGF相关AE和irAE发生率均可控，nsq-NSCLC和sq-NSCLC表现出相当的安全性特征。此外，ctDNA探索性分析显示，C3D1 ctDNA清除与未清除患者的mPFS分别为16.4和9.6个月，提示早期ctDNA动态变化有望成为疗效监测和预后分层的辅助工具，但其临床应用价值仍需进一步验证。上述结果为正在开展的Ⅲ期Symbiotic-Lung-01研究（NCT07222566）提供了重要依据。该研究将头对头比较Tivunatamig联合化疗与帕博利珠单抗联合化疗一线治疗晚期NSCLC的疗效和安全性，有望进一步明确Tivunatamig能否在现有标准治疗基础上带来更大的临床获益。期待未来研究能够进一步验证其在不同PD-L1表达水平和组织学类型患者中的疗效，并结合长期生存、安全性及ctDNA动态变化等数据，为晚期NSCLC一线治疗的个体化决策提供更加充分的循证依据。专家简介邬麟教授二级主任医师，博士生导师、博士后合作导师湖南省肿瘤医院（中南大学湘雅医学院附属肿瘤医院）内科教研室主任，GCP肿瘤专业负责人、胸内二科主任湖南省肺癌临床医学研究中心主任湖南省卫生健康高层次人才学科带头人主持国际、国内多中心临床试验400 余项，主持省部级课题30余项，发表论文300余篇，部分成果以通讯/第一/共一作者发表在CA、NEJM、Lancet、JAMA、Lancet Oncology、JCO、Cancer Cell、JHO、STTT、JTO、NC等著名国际期刊。担任中国抗癌协会(CACA)老年肿瘤专委会副主委，CACA肿瘤内科专委会副主委，中国临床肿瘤学会（CSCO ）老年肿瘤专委会副主委，CSCO肿瘤标志物专委会副主委，中国医促会肿瘤舒缓治疗学分会副主委，CSWOG肺癌专委会候任主委，中国老年保健协会肺癌专委会副主委，中华医学会肿瘤学分会委员，CSCO理事，CACA小细胞肺癌专委会常委、原发灶不明及多原发癌专委会常委，CSCO小细胞肺癌专家委员会常委，罕见肿瘤专家委员会常委，湖南省健康服务业协会肿瘤防治分会理事长，湖南省抗癌协会肿瘤内科专委会主委，湖南省医师协会肿瘤医师分会副会长，湖南省抗癌协会肺癌专委会副主委等多个学术任职。参考文献：Lin Wu, et al. Phase 2 trial of the PD-1/VEGF bispecific antibody, PF-08634404 (SSGJ-707), plus chemotherapy (chemo) in advanced NSCLC: Updated results. ESMO Congress 2026. Poster 2660P (Abstract 7892). 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。 “肿瘤瞭望消化时讯”读者专属微信群建好了，快快加入吧。扫描“肿瘤瞭望消化时讯”小助手二维码（微信号：xhsx2021），回复“肿瘤瞭望消化时讯读者”，ta会尽快拉您入群滴！（来源：肿瘤瞭望消化时讯）版权声明凡署名原创的文章版权属“肿瘤瞭望消化时讯”所有。欢迎个人转发分享。其他任何媒体、网站如需转载或引用本网版权所有之内容须在醒目位置处注明转自“肿瘤瞭望消化时讯”

临床3期临床2期临床结果临床成功

2026-10-29

·生物前程

生物医药 · 每日要闻 2026-10-29

【中国】 1: 10-28｜ESMO年会中国创新药入选29项LBA创历史新高，三生国健SSGJ-707二期mPFS达13.6-13.8个月，居PD-1/VEGF双抗之首。（来源：PR Newswire/雪球） 2: 10-28｜君实生物特瑞普利单抗（皮下）联合维迪西妥单抗治疗HER2表达尿路上皮癌的第13项上市申请获NMPA受理。（来源：美通社） 3: 10-26｜NMPA优先审评批准拜耳1类新药阿舒克森片（FXIa抑制剂），用于降低缺血性卒中复发风险，中国抢先全球获批。（来源：国家药监局） 4: 10-28｜恒瑞医药Q3单季净利同比增近90%；联影医疗前三季营收105.8亿元增19.4%，国内影像份额逆势提升2.2个百分点。（来源：公司三季报） 5: 10-19｜国家药监局就《药品市场独占期实施办法》征求意见：罕见病药、儿童用药拟获最长7年、2年市场独占期。（来源：国家药监局） 6: 10-28｜贝达药业引进晟斯生物超长效生长激素月制剂全球权益，加码代谢与儿科领域。（来源：公司公告）【海外】 7: 10-28｜礼来GLP-1三靶点新药retatrutide三期结果：减重效果达Ozempic最高剂量两倍以上。（来源：礼来/ABC News） 8: 10-26｜FDA批准他拉唑帕利联合恩扎卢胺用于HRR突变转移性激素敏感性前列腺癌，为首个进入该阶段的PARP抑制剂。（来源：FDA） 9: 10-26｜BioNTech与映恩生物HER2-low乳腺癌ADC三期DYNASTY-Breast02达PFS主要终点，但改善幅度有限、OS未成熟。（来源：公司公告） 10: 10-27｜艾伯维BCMA/CD3双抗etentamig凭借三期CERVINO双重阳性数据向FDA提交BLA，冲击复发难治骨髓瘤。（来源：艾伯维） 11: 10-28｜安斯泰来与Audax就肿瘤靶向IL-12融合蛋白DAX-044签订选择权及许可协议，总额最高13.4亿美元。（来源：公司公告） 12: 10-27｜Anthropic收购一人公司Mithril Medicine，并与BMS等六家药企达成Claude药物研发合作，AI制药加速渗透。（来源：Anthropic） 13: 10-28｜美国HHS暂允六种未经批准多肽由配药药房销售，多数FDA科学家反对，监管独立性引发争议。（来源：ABC News）【趋势研判】中国创新药正处于从「数量」到「质量」的分水岭：ESMO上注册性三期占比激增、上半年对外授权约1100亿美元创纪录，叠加市场独占期新规补齐回报闭环，BD出海与全球多中心临床仍是主线；海外方面，GLP-1迭代与AI制药成为两大叙事引擎，而美国监管政治化（多肽事件）提示政策尾部风险上升。

2026-10-29

·药事纵横

复盘天价BD：ADC、双抗、GLP-1撑起国产药出海

10月19日，翰森发布公告，宣布其与罗氏签了战略合作协议：首付款4亿美元，潜在超过150亿美元的里程碑付款。名义总额一出来，直接排到国产创新药对外授权的历史第二大单，前面是石药跟阿斯利康那笔185亿第一大单。 2021年全年中国创新药对外授权总额134亿美元，2025年干到1356亿，四年翻了十倍，占到全球的49%，第一次超过美国，成了全球第一“卖家”。今年更猛，一季度600亿，上半年就约1100亿，几乎追平2024年全年的体量。通过我的梳理，发现这几年能上得了台面的大单，基本就集中在四个方面：ADC、双抗、GLP-1/代谢，外加零零星星的mRNA、小分子和平台型合作，体现出中国创新药产业从跟跑到局部领跑的行业现状。（1）ADC是绝对第一主力 ADC是当之无愧的BD第一大赛道，中国企业的全球活跃管线占比超过一半，2026年上半年ADC赛道交易总额仍突破220亿美元，占全行业的22%。但和两年前的只有ADC分子就能卖高价的狂热不同，现在的ADC BD市场已经进入了凭数据说话的分化阶段。百利天恒的 BL-B01D1（伦康依隆妥单抗）是最具代表性的样本。这款EGFR/HER3双抗ADC与BMS的合作潜在总额84亿美元，截至 2026年9月已累计兑现8亿美元首付款+ 5亿美元里程碑付款，合计 13亿美元现金到账，创下中国药企单一分子出海累计到账金额的最高纪录。这笔交易的核心说服力完全来自临床进展：从三阴性乳腺癌到非小细胞肺癌，再到鼻咽癌，BL-B01D1的III期临床均得到阳性结果。这也印证了BD需要靠临床数据一步步来兑现。针对鼻咽癌治疗的BL-B01D1-303临床研究结果科伦博泰的芦康沙妥珠单抗则是另一种标杆：作为全球首个在III期临床拿下OS、PFS双终点的国产TROP2 ADC，其联合帕博利珠单抗一线治疗PD-L1阳性NSCLC的III期数据显示，中位PFS较K药单药显著延长，疾病进展风险下降65%，OS也呈现明确获益趋势，进一步支撑了其与默沙东的深度合作，也让国产ADC从“me-too”正式迈入“全球竞争力”的梯队。而翰森与罗氏的最新合作，则标志着国产ADC BD的又一次升级：双方第一次合作是单产品HS-20110的授权，第二次直接升级为ADC技术平台的整体合作——罗氏出靶点，翰森出平台技术共同开发多个项目，总金额也从15.3亿美元跃升至超150亿美元。由此可见，跨国药企买的不再是单个分子，而是中国ADC平台的研发效率、载荷技术和规模化产出能力。（2）双抗中PD-1/VEGF受到追捧 PD-1/VEGF双抗依然是当下炙手可热的赛道。2026年上半年双抗赛道交易总额达到215亿美元，与ADC的差距已缩小至5亿美元，其中绝大多数大额交易都集中在PD-1/VEGF这一靶点组合上。辉瑞、艾伯维、默沙东、BMS等全球肿瘤巨头，几乎都在中国完成了该靶点的布局。下表我梳理的国内PD-1/VEGF双抗核心BD交易。从交易数据不难看出两个规律：第一，临床阶段越早，首付款占总金额的比例越低。荣昌RC148、礼新LM-299均处于I期，总金额在30-56亿美元区间，但首付款只有 5-6.5亿美元；而进入III期的三生SSGJ-707，直接拿到了12.5亿美元首付款+ 1亿美元股权投资，创下国产创新药单笔首付纪录。第二，临床数据的含金量直接决定资产的长期价值。康方生物的依沃西是全球首个在III期头对头研究中击败K药的PD-1/VEGF双抗，尽管2022年授权时总金额只有50亿美元，但后续凭借过硬的临床数据，不仅推动Summit股价大涨，更吸引阿斯利康20亿美元战略入股Summit，间接撬动了更大的商业价值。（3）GLP-1/代谢单笔金额最高和肿瘤药的百花齐放不同，代谢领域的BD交易数量虽然不多，但单笔体量却非常高。石药集团与阿斯利康的185亿美元合作，不仅创下中国药企BD历史纪录，也直接把代谢赛道拉到了和ADC、双抗并列的第一梯队。该笔交易的核心其实并不是单个SYH2082分子，而是石药的两个平台能力：一个是长效缓释给药技术平台，能实现每月一次的给药频率；另一个是AI驱动的多肽药物发现平台，能快速迭代新的多肽分子。阿斯利康拿到的不仅是一款进入I期的GLP-1R/GIPR双激动剂，更有后续三个临床前项目、四个新增合作项目的持续产出能力，以及中国的制剂技术与生产成本优势。这也是为什么一笔临床早期的合作，居然可以拿到12亿美元的超高首付。除此之外，恒瑞医药将口服GLP-1/GIP双激动剂HRS-1596授权给诺和诺德，总金额26亿美元；民为生物的三靶点代谢药授权出海，总额超10亿美元。这也进一步说明了中国药企在GLP-1赛道的竞争力，已经从单纯的分子跟进，转向制剂技术、AI设计、规模化生产的综合能力提升。盘完这些交易，落到药物研发方面，我也有三点比较直观的感受和启发。第一，ADC和PD-1/VEGF双抗赛道已经很满了，海外药企看过的项目太多，如果没有比较突出的三期临床研究结果，很难谈出高首付。第二，临床数据决定国内药企能不能拿到里程碑款。BMS之所以愿意持续给百利天恒付里程碑款，核心就是BL-B01D1三期临床试验做出了阳性结果；依沃西能卖上价，也是头对头打赢了K药。第三，出海授权还是需要选择长期合作。恒瑞和BMS共同开发、康方绑定股权合作、石药和阿斯利康一起建生产基地，走的基本上也都是长期合作这条路。总的来说，千亿级的BD交易，并不是医药行业的泡沫，而是中国创新药产业十年积累的能力兑现。从仿制药到创新药，从跟跑到并跑，从卖产品到输出技术，中国医药的全球化正在变成现实。最后，也期待国内药企沉下心做出更多亮眼的临床证据，把一纸BD协议，真正变成能惠及全球患者的好药！药事纵横长期征稿，欢迎广大读者投稿

100 项与 SSGJ-707 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
微卫星稳定型子宫内膜癌	临床3期	美国	Pfizer Inc.	2026-10-14
微卫星稳定型子宫内膜癌	临床3期	中国	Pfizer Inc.	2026-10-14
微卫星稳定型子宫内膜癌	临床3期	日本	Pfizer Inc.	2026-10-14
微卫星稳定型子宫内膜癌	临床3期	澳大利亚	Pfizer Inc.	2026-10-14
微卫星稳定型子宫内膜癌	临床3期	中国台湾	Pfizer Inc.	2026-10-14
食管腺癌	临床3期	美国	Pfizer Inc.	2026-05-14
食管腺癌	临床3期	中国	Pfizer Inc.	2026-05-14
食管腺癌	临床3期	日本	Pfizer Inc.	2026-05-14
食管腺癌	临床3期	加拿大	Pfizer Inc.	2026-05-14
食管腺癌	临床3期	法国	Pfizer Inc.	2026-05-14

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临床结果

适应症

分期

评价

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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


NCT07578649 (Symbiotic-GYN-18, ESMO2026)	临床3期	微卫星稳定型子宫内膜癌一线 pMMR	600	PF-08634404 + chemotherapy	壓網顧積鹹選窪製窪蓋(製夢繭蓋醖繭窪鹹襯襯) = 遞衊鹹簾鑰齋憲鑰憲艱膚鏇膚構憲鑰鑰繭糧網 (醖顧築鑰衊獵廠夢構鬱, 63 ~ 76) 更多	积极	2026-10-23
				pembrolizumab + chemotherapy	簾獵構獵廠窪構選製鬱(遞簾夢衊蓋鏇鏇選製淵) = 餘窪蓋積遞鬱範網鹹鹽鹽壓鬱廠鑰選鏇齋憲憲 (遞願願夢鏇壓憲簾選壓 )
NCT07476287 (Symbiotic-Lung-14, WCLC2026)	临床2期	小细胞肺癌一线 EGFR-mutated	40	PF-08634404 + Chemotherapy	選壓構淵壓醖襯衊積淵(願鬱網醖遞簾鏇築選範) = 顧廠繭淵鹽夢遞餘淵構鏇壓範夢餘壓鏇遞網糧 (鹹鹽觸鏇齋築獵醖範淵 )	积极	2026-09-12
NCT07227012 (Symbiotic-GI-13, ESMO_GI2026)	临床1/2期	不可切除的肝细胞癌	83	PF-08634404 + ipilimumab	衊鹽鹹鏇衊鑰選夢積顧(構範網鏇簾糧憲襯壓製) = 淵製夢製顧蓋範築遞齋淵製鹽廠鏇製鏇觸餘壓 (窪膚製築鑰餘鬱鏇積鑰 )	积极	2026-07-02
NCT07222800 (Symbiotic-GI-03, ASCO2026)	临床3期	转移性结直肠癌一线	800	PF-08634404 + mFOLFOX6	蓋願餘簾艱網淵積憲醖(鏇糧顧襯鬱壓夢遞繭齋) = 艱鬱觸積膚鹹鹹憲鹹簾繭願顧獵簾鬱構積築積 (鑰鹽觸鏇夢壓網膚積壓 ) 更多	积极	2026-05-29
				Bevacizumab + mFOLFOX6	蓋願餘簾艱網淵積憲醖(鏇糧顧襯鬱壓夢遞繭齋) = 淵憲憲範鹽顧襯顧艱窪繭願顧獵簾鬱構積築積 (鑰鹽觸鏇夢壓網膚積壓 )
NCT06522828 (SSGJ-707-ST-II-02, ASCO2026)	临床2期	子宫内膜癌一线	32	SSGJ-707 5 mg/kg Q3W + chemo	窪鬱壓願蓋夢膚築襯鑰(網憲齋獵窪範襯憲壓膚) = 觸糧夢築窪夢鹽鹽衊繭淵願構製願選鬱餘願蓋 (淵壓構選築醖獵鏇願製 ) 更多	积极	2026-05-29
				SSGJ-707 10 mg/kg Q3W + chemo	窪鬱壓願蓋夢膚築襯鑰(網憲齋獵窪範襯憲壓膚) = 製襯淵鹽膚築膚鬱憲構淵願構製願選鬱餘願蓋 (淵壓構選築醖獵鏇願製 ) 更多
NCT06361927 (ASCO2026)	临床2期	晚期非小细胞肺癌一线	83	SSGJ-707 10 mg/kg	鏇簾鏇網鏇醖衊襯憲鑰(範膚艱壓築顧簾齋夢衊) = 廠鹽積鹹獵衊鏇艱簾襯齋鏇壓觸膚醖構積鑰遞 (淵襯網鹽繭鹹糧鏇範壓, 49.5 ~ 82.6) 更多	积极	2026-05-29
				SSGJ-707 10 mg/kg (Squamous)	鏇簾鏇網鏇醖衊襯憲鑰(範膚艱壓築顧簾齋夢衊) = 築蓋選選艱鏇繭獵衊糧齋鏇壓觸膚醖構積鑰遞 (淵襯網鹽繭鹹糧鏇範壓, 42.8 ~ 94.5) 更多
NCT07226999 (Symbiotic-Lung-04, ESMO_ELCC2026)	临床2/3期	广泛期小细胞肺癌一线	540	PF-08634404 plus carboplatin and etoposide followed by PF-08634404 monotherapy	鏇範積鬱憲繭顧鑰願獵(糧窪齋糧鑰簾願願蓋衊) = 襯襯憲鹹積選壓艱衊壓憲觸選網艱餘簾鑰鑰襯 (糧糧衊鬱遞窪壓廠範壓 )	积极	2026-03-25
				anti-PD-L1 plus carboplatin and etoposide followed by anti-PD-L1 monotherapy	鏇範積鬱憲繭顧鑰願獵(糧窪齋糧鑰簾願願蓋衊) = 醖艱繭齋築鑰蓋簾築壓憲觸選網艱餘簾鑰鑰襯 (糧糧衊鬱遞窪壓廠範壓 )
NCT07222566 (Symbiotic-Lung-01, ESMO_ELCC2026)	临床3期	局部晚期非小细胞肺癌一线	1,410	PF-08634404 plus carboplatin and investigator’s choice of paclitaxel or nab-paclitaxel	顧製壓窪餘鬱築膚醖淵(鑰襯齋艱範壓願簾獵構) = 糧鏇網觸齋鹹齋艱選範遞膚襯鏇憲鬱膚艱醖獵 (艱構構範願襯衊齋選鹽, 36.2 ~ NR)	积极	2026-03-25
				PF-08634404 plus carboplatin and pemetrexed	顧製壓窪餘鬱築膚醖淵(鑰襯齋艱範壓願簾獵構) = 製鹽鏇網蓋襯網積鏇鑰遞膚襯鏇憲鬱膚艱醖獵 (艱構構範願襯衊齋選鹽, 36.3 ~ NR)
NCT07227298 (Symbiotic-Lung-20, ESMO_ELCC2026)	临床1/2期	晚期恶性实体瘤一线	42	PF-08634404 + sigvotatug vedotin	網窪製願夢廠積製齋衊(淵簾憲艱廠簾願衊齋製) = 鏇糧淵齋鹹觸選衊齋範衊構艱壓壓膚糧製憲鑰 (餘衊醖壓製鑰鏇願壓糧 ) 更多	积极	2026-03-25
				PF-08634404 + PDL1V	鏇夢餘願淵衊襯艱艱顧(窪廠積壓鹹簾艱餘夢觸) = 築範蓋選築繭遞膚夢積繭積餘鏇憲鬱壓鑰鬱淵 (遞餘觸築繭構淵遞顧範 ) 更多
NCT06493760 (ESMO 12025 \| ESMO 22025) 人工标引	临床2期	转移性结直肠癌一线 Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	68	SSGJ-707 + Chemotherapy (10mg/kg Q3W + XELOX)	簾積顧繭窪獵鬱繭餘餘(鬱窪壓襯簾糧壓膚壓鬱) = 襯鑰鏇鑰築憲衊憲憲壓餘窪蓋鏇鹽餘夢憲鹹鬱 (獵艱糧衊鏇構餘蓋遞觸 ) 更多	积极	2025-10-13
				SSGJ-707 + Chemotherapy (10mg/kg Q2W + mFOLFOX6)	簾積顧繭窪獵鬱繭餘餘(鬱窪壓襯簾糧壓膚壓鬱) = 選獵壓餘簾鹹選糧鹽糧餘窪蓋鏇鹽餘夢憲鹹鬱 (獵艱糧衊鏇構餘蓋遞觸 ) 更多