SMMT的提交FDA的依沃西单抗BLA走的应是标准审评 （另附1月12日及29日公告原文及AI翻译） 260202 0040
先说结论：
SMMT的提交的依沃西单抗 (Ivonescimab)的此项BLA，应该是走的标准审评通道（Standard Review），而不是 优先审评Priority Review。SMMT提交BLA的时间较大概率是25年11月16日~30日。$Summit Therapeutics(SMMT)$ $康方生物(09926)$
以及，走标准审评，对此项BLA是很正常的，因为由于临床设计的原因，毕竟OS统计学上不显著，按照惯例，就应该走标准审评。以及，10个月的审评期，也应该有利于补充提交一些欧美的OS的后续临床进展、甚至更多来自中国的真实世界治疗数据。这些进展，不论你是不是正式提交，应该大概率都会影响FDA决策。（属于瞎猜的）
如果我查到的以下信息是正确的话，以上就有较大概率成立。
1. 反馈的时间节点
向FDA提交生物制品许可申请（BLA）后，FDA 有一个“60天立卷审查期”（60-day Filing Period）。
第 60 天（立卷决定）： FDA 的项目管理经理（RPM）通常会在第 60 天左右通过信函通知申请人：申请是否被正式受理（Filing）。是否授予**优先审评（Priority Review）**资格。
第 74 天（74-day Letter）： 如果第60天时还没明确，FDA 最迟会在第 74 天发出一封“立卷沟通函”（Filing Communication/74-day Letter）。这封信不仅会确认审评级别（标准还是优先），还会给出审评的目标日期（PDUFA Date）。
2. 反馈的内容
反馈通常是以正式信函的形式发送给申请人，主要包含：
审评分类： 明确是 Priority（优先，目标周期6个月）还是 Standard（标准，目标周期10个月）。
审评团队： 确定负责该申请的主要审评人员和项目经理。
初步缺陷： 如果在立卷审查中发现了明显的资料缺失或技术问题，FDA 也会在这封信或随后的沟通中提及。
1月12日SMMT公告翻译(AI）：
Summit Therapeutics 宣布向美国 FDA 提交生物制品许可申请 (BLA)，寻求批准依沃西单抗 (Ivonescimab) 联合化疗用于 EGFR 突变 NSCLC 患者的二线及以上治疗
2026年1月12日
该领域仍存在巨大的未满足医疗需求
美国每年有超过 14,000 名患者符合该领域的二线及以上（2L+）治疗条件
Summit 进入 2026 年时拥有约 7.1 亿美元现金储备
迈阿密——（商业资讯）—— Summit Therapeutics Inc. (NASDAQ: SMMT)（简称“Summit”、“我们”或“公司”）今日宣布，已向美国食品药品监督管理局 (FDA) 提交了生物制品许可申请 (BLA)，寻求批准其创新的首创（First-in-class）在研双特异性抗体依沃西单抗（ivonescimab）联合化疗，用于治疗表皮生长因子受体（EGFR）突变的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者的二线及以上（2L+）治疗。此次 BLA 提交是基于全球 III 期 HARMONi 试验的总体结果，并已于 2025 年第四季度完成提交。
“这次 BLA 的提交是依沃西单抗的首个申请，标志着 Summit、我们的全球临床开发计划以及众多急需更好治疗方案的 EGFR 突变 NSCLC 患者的一个关键里程碑，”Summit 联席首席执行官 Robert W. Duggan 和 Maky Zanganeh 博士表示。“随着我们通过不断扩大的全球 III 期试验和临床合作，继续支持和扩大依沃西单抗的快速开发，我们期待依沃西单抗在这种难治性疾病领域获得潜在的首个美国批准。”
HARMONi 试验评估了依沃西单抗联合铂类双药化疗，对比安慰剂联合铂类双药化疗，用于在接受第三代 EGFR 酪氨酸激酶抑制剂（TKI）治疗后进展的 EGFR 突变局部晚期或转移性 NSCLC 患者。在此类患者群体中，PD-1 单克隆抗体在此前的全球 III 期临床试验中均未能显示出无进展生存期（PFS）或总生存期（OS）的获益（这两个指标是本研究的两个主要终点）。
根据标准审查时间表，如果申请按原样被受理，我们预计 FDA 将在 2026 年第四季度做出决定。
关于当前财务状况的更新
截至 2025 年 12 月 31 日，公司初步未经审计的现金、现金等价物及短期投资余额约为 7.1 亿美元。此金额为初步数据，尚需完成财务结账程序。因此，该金额可能与公司截至 2025 年 12 月 31 日止年度的合并财务报表中反映的金额有所出入。
关于依沃西单抗 (Ivonescimab)
依沃西单抗在 Summit 的授权地区（北美、南美、欧洲、中东、非洲和日本）被称为 SMT112，在 Summit 授权地区以外被称为 AK112。它是一种创新的、潜在的首创在研双特异性抗体，将通过阻断 PD-1 产生的免疫治疗作用与阻断 VEGF 相关的抗血管生成作用结合在单个分子中。
依沃西单抗的设计使其能与每个预期靶点产生独特的协同结合：在 VEGF 存在的情况下，它与 PD-1 的结合亲和力会提高数倍。这种设计的目的是使依沃西单抗具备差异化，因为与正常组织相比，肿瘤组织和肿瘤微环境（TME）中 PD-1 和 VEGF 的表达（存在）通常更高。我们认为，依沃西单抗特有的工程化四价结构（四个结合位点）能在 TME 中实现更高的亲和力（多重结合相互作用的累积强度）。这种四价结构、创新的分子设计以及将这两个靶点整合至具有协同结合特性的单核双抗中，使其有潜力将药效引导至肿瘤组织而非健康组织。
该设计的初衷，结合其在首剂后 6 至 7 天的半衰期（在稳态给药时增加至约 10 天），是为了在疗效、副作用和安全性方面超越此前已获批的针对这些靶点的药物。
依沃西单抗由康方生物 (Akeso Inc.) 研发，目前正用于多项 III 期临床试验。根据康方生物的数据，全球已有超过 4,000 名患者在临床研究中接受了依沃西单抗治疗；若计入中国已商业化使用的病例，则有超过 60,000 名患者接受了治疗。
临床项目概况
HARMONi (Phase III): 针对经三代 EGFR TKI 治疗失败的 EGFR 突变 NSCLC。BLA 已于 2025 年 Q4 提交。
HARMONi-3 (Phase III): 评估依沃西单抗联合化疗对比帕博利珠单抗（K 药）联合化疗，用于一线转移性鳞状或非鳞状 NSCLC。
HARMONi-7 (Phase III): 评估依沃西单抗单药对比帕博利珠单抗单药，用于 PD-L1 高表达的一线转移性 NSCLC。
HARMONi-GI3 (Phase III): 评估依沃西单抗联合化疗对比贝伐珠单抗联合化疗，用于一线不可切除的转移性结直肠癌 (CRC)。
此外，康方生物最近在中国开展的三项 III 期临床试验（HARMONi-A、HARMONi-2 和 HARMONi-6）中获得了积极结果，包括 HARMONi-A 中显著的总生存期 (OS) 获益。
依沃西单抗在中国已于 2024 年 5 月获批上市。在 Summit 的授权地区（包括美国和欧洲），它仍处于在研阶段。
关于 Summit Therapeutics
Summit Therapeutics 是一家生物制药公司，专注于发现、开发和商业化对患者、医生和护理人员友好的肿瘤疗法，旨在提高生活质量、延长生命并解决严重的医疗需求。Summit 成立于 2003 年，总部位于佛罗里达州迈阿密。
1月29日SMMT公告AI翻译：
这是一篇关于生物制药公司 Summit Therapeutics 的新闻稿翻译，详细介绍了其创新药物依沃西单抗（Ivonescimab）在美国监管方面取得的重大进展。
Summit Therapeutics 宣布美国 FDA 已受理依沃西单抗（Ivonescimab）联合化疗治疗 TKI 治疗后 EGFR 突变非小细胞肺癌（NSCLC）患者的生物制品许可申请（BLA）
2026 年 1 月 29 日
BLA 提交基于 HARMONi 全球 III 期研究结果
PDUFA 目标审评日期定为 2026 年 11 月 14 日
该领域仍存在显著的未满足需求；美国每年有超过 14,000 名患者符合该疗法的治疗条件
迈阿密——（商业资讯）—— Summit Therapeutics Inc.（纳斯达克股票代码：SMMT）（以下简称“Summit”、“我们”或“公司”）今日宣布，美国食品药品监督管理局（FDA）已受理依沃西单抗联合化疗用于治疗表皮生长因子受体（EGFR）突变的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者的生物制品许可申请（BLA）。该申请针对的是在接受酪氨酸激酶抑制剂（TKI）治疗后的患者。FDA 设定的《处方药申报者付费法案》（PDUFA）目标行动日期为 2026 年 11 月 14 日。
此次 BLA 的提交是基于 III 期 HARMONi 临床试验的总体结果。该研究评估了依沃西单抗联合含铂双药化疗，对比安慰剂联合含铂双药化疗，用于治疗此前接受过第三代 EGFR TKI 治疗的 EGFR 突变、局部晚期或转移性非鳞状 NSCLC 患者。
FDA 表示，其打算根据《新药申请与生物制品许可申请良好审评管理原则与规范》草案指南，对已受理并存档的申请进行全面审评。这包括计划中的中期会议和总结会议；在不发现重大缺陷的前提下，FDA 拟于 PDUFA 日期前提出拟定说明书草案。
后面关于依沃西，SMMT,以及免责声明，略。
1月12日原文：
网页链接
Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2L+ Treatment of Patients with EGFRm NSCLC
January 12, 2026
网页链接{Download(opens in new window)}
Significant Unmet Need Remains in this Setting
Over 14,000 Patients are Eligible for 2L+ Treatment in This Setting in the United States Each Year
Summit Enters 2026 with Approximately $710 Million in Cash
MIAMI--(BUSINESS WIRE)-- Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for ivonescimab, the novel, first-in-class investigational bispecific antibody, in combination with chemotherapy in second-line or later treatment of patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The BLA submission was based on the overall results of the global Phase III HARMONi trial. The BLA was submitted during the fourth quarter of 2025.
“This BLA submission, the first for ivonescimab, marks a critical milestone for Summit, our global clinical development plan, and the many patients with EGFRm NSCLC in need of better therapeutics options,” stated Robert W. Duggan and Dr. Maky Zanganeh, Co-Chief Executive Officers of Summit. “As we continue to support and expand ivonescimab’s rapid development via our growing set of global Phase III trials and clinical collaborations, we look forward to the potential first U.S. approval for ivonescimab in this difficult to treat setting.”
HARMONi evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI). This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials in showing either a progression-free survival (PFS) or overall survival (OS) benefit, the two primary endpoints of this clinical study.
Based upon standard review timelines, if the application is accepted as submitted, we anticipate a decision from the agency by the fourth quarter of 2026.
Update Regarding Current Financial Position
As of December 31, 2025, the company’s preliminary unaudited balance of cash, cash equivalents, and short-term investments was approximately $710 million. This amount is preliminary and is subject to completion of financial closing procedures. As a result, this amount may differ from the amount that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2025.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.
This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC, 2023) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.
Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization in the fourth quarter of 2025.
HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.
HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.
In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.
HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.
HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.
HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.
Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary tract cancer, colorectal cancer, breast cancer, pancreatic cancer, small cell lung cancer, and head and neck cancer.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.
About Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol “SMMT”). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.
26年1月29日SMMT公告原文：
Summit Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) Seeking Approval for Ivonescimab in Combination with Chemotherapy in Treatment of Patients with EGFRm NSCLC Post-TKI Therapy
January 29, 2026
网页链接{Download(opens in new window)}
BLA Filing Based on HARMONi Global Phase III Study Results
PDUFA Goal Action Date of November 14, 2026
Significant Unmet Need Remains; Over 14,000 U.S. Patients Eligible for Treatment Each Year in This Setting
MIAMI--(BUSINESS WIRE)-- Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that the U.S. Food & Drug Administration (FDA) has accepted for filing Summit's Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
The BLA was submitted based on the overall results of the Phase III HARMONi trial, which evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC who were previously treated with a 3rd generation EGFR TKI.
The FDA has noted that they intend to perform a complete review of the accepted and filed application in accordance with draft guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.1 This includes planned mid-cycle and wrap-up meetings, and, subject to major deficiencies not being identified during the FDA's review, proposed labeling, prior to the PDUFA date.
________________________________
1 The most recent version of this draft guidance can be found on the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
About Ivonescimab （按摩师略）
About Summit Therapeutics （按摩师略）
Summit Forward-looking Statements（按摩师略）