SSGJ-707

News 2026年5月，三生制药（01530.HK）宣布，公司PD-1/VEGF双特异性抗体SSGJ-707(PF-08634404)两项入选2026年美国临床肿瘤学会（ASCO）年会的临床研究的摘要已于ASCO官网公布。此次入选的研究中，一项获快速口头报告、一项获壁报展示。 三生制药入选2026ASCO年会的摘要核心信息如下： 快速口头报告 Updated results from a phase 2 trial of SSGJ-707 (PF-08634404), a PD-1/VEGF bispecific antibody, as monotherapy in patients with advanced non-small cell lung cancer (NSCLC). PD-1/VEGF双特异性抗体SSGJ-707 (PF-08634404)单药治疗晚期非小细胞肺癌(NSCLC)患者的2期临床研究最新结果 摘要编号：8514 展会形式：快速口头报告（Rapid Oral Abstract Session） 分会场标题：肺癌-非小细胞肺癌（Lung Cancer—Non-Small Cell Metastatic） 报告时间： 2026年5月30日 13:27 - 14:33（美国中部时间） 2026年5月31日 凌晨2:27 - 3:33（北京时间） 第一作者：邬麟教授，湖南省肿瘤医院 核心要点：这是一项在中国开展的多中心、开放标签二期临床研究，共纳入83例既往未接受系统治疗的驱动基因阴性且PD-L1 TPS≥1%的局部晚期或转移性非小细胞肺癌（NSCLC）患者。截至2025年11月28日，SSGJ-707（10 mg/kg Q3W）中位随访时间为15.2个月，确认ORR为67.6%，中位PFS达到12.4个月，中位OS尚未达到。 壁报展示 A phase 2 study evaluating PF-08634404 (SSGJ-707), a PD-1/VEGF bispecific antibody, + chemotherapy in patients with first-line advanced/recurrent endometrial cancer. 评估PD-1/VEGF双特异性抗体PF-08634404 （SSGJ-707）联合化疗一线治疗晚期/复发子宫内膜癌患者的二期临床研究 摘要编号：5627 分会场标题：妇科肿瘤（Gynecologic Cancer） 报告时间： 2026年6月1日 09:00 - 12:00（美国中部时间） 2026年6月1日 22:00 – 次日凌晨01:00（北京时间） 第一作者：周琦教授，重庆市肿瘤医院 核心要点：SSGJ-707联合化疗一线治疗晚期/复发子宫内膜癌患者的二期研究初步结果显示，SSGJ-707在不同剂量组中均具有良好的疗效，安全性良好。对于pMMR子宫内膜癌患者，考虑新增1位患者于12月确认CR/PR，SSGJ-707 10 mg/kg剂量组的确认ORR为90.9%，DCR为100%，这一令人鼓舞的初步疗效结果支持辉瑞在该人群中开展确证性临床研究（Symbiotic-GYN-18）。 关于PF-08634404/SSGJ-707 SSGJ-707是三生制药基于CLF2专利平台开发的靶向PD-1/VEGF双特异性抗体，可同时抑制PD-1和VEGF双靶点。2025年5月和7月，三生制药（01530.HK）及附属子公司沈阳三生、三生国健与辉瑞签署协议，向辉瑞独家授予SSGJ-707在全球以及中国内地的开发、生产、商业化权利，三生制药成为SSGJ-707在中国内地的首选药品生产商，以及向中美以外地区供应SSGJ-707的药品生产商之一。 关于三生制药 三生制药（股票代码：01530.HK）是一家集研发、生产和销售为一体的生物制药领军企业，致力于以高品质的药品提高患者生存质量，为人类健康造福。目前，公司拥有190余项国家发明专利授权，近40种上市产品，27种在研产品，覆盖肾科、肿瘤科、自身免疫性疾病、眼科及皮肤科等多种治疗领域。公司拥有抗体药物国家工程研究中心以及生物药和化药双平台的6大研发基地，4大生产基地及4大CDMO基地。未来，三生制药将继续秉持“珍爱生命、关注生存、创造生活”的理念，全力打造全球领先的中国生物制药企业。请访问www.3sbio.com获取更多信息。 About 3S Bio 警示说明及前瞻性陈述 本新闻稿包含前瞻性陈述，例如涉及业务和产品前景,或公司的意图、计划、认知、预期及策略。该等前瞻性陈述是根据本公司现有的资料，并按本新闻稿发布时的展望陈述。该等前瞻性陈述基于若干预测、假设及前提，其中一些是主观性的或不受我们控制。该等前瞻性陈述可能被证明是不正确的，或将来可能无法实现。就任何新产品或产品的新适应症, 我们无法确保其将能成功开发或最终上市销售。该等前瞻性陈述受各种风险及不明朗因素影响。我们的其他公开披露文件可能提供该等风险及不明朗因素的更多信息。所涉及之科学信息可能只是初步的和研究性的。本公司股东及潜在投资者在买卖本公司股份时，请务必谨慎行事。

As investors search for clues about whether the PD-(L)1/VEGF bispecific class can live up to the hype that was sparked by Akeso and Summit Therapeutics' ivonescimab two years ago, newly released abstracts ahead of the upcoming American Society of Clinical Oncology (ASCO) meeting shed some light on a pair of fast followers (see – Spotlight On: Lung cancer bispecifics poised to take centre stage at ASCO this year).BioNTech and Bristol Myers Squibb offered the first substantial look at their contender, pumitamig (BNT327), in a setting comparable to ivonescimab's HARMONi-3 and HARMONi-6 studies — the latter a China-only trial due to report overall survival (OS) data at ASCO — while Pfizer released updated data for its own PD-1/VEGF bispecific, PF-08634404.Investors appeared encouraged by the pumitamig data in particular, with BioNTech's stock jumping about 6% in after-hours trading Thursday. On the other hand, shares in Summit, which recently reported some disappointing data from HARMONi-3, slid about 8% (see – KOL Views Preview: What interim PFS miss means for ivonescimab, PD-1/VEGF bispecifics in NSCLC).The pumitamig results are drawn from the Phase II portion of the ROSETTA Lung-02 trial, testing the bispecific plus chemotherapy in previously untreated advanced non–small-cell lung cancer (NSCLC) patients, regardless of PD-L1 status. The study enrolled patients with both squamous and non-squamous tumours.70% response rateAmong 40 evaluable patients, pumitamig plus chemotherapy achieved a 70% objective response rate (ORR), including two complete responses (CR) and 26 partial responses (PR). Disease control reached 100%, while tumour shrinkage appeared broadly similar across squamous (73.7%) and non-squamous disease (66.7%), with activity across PD-L1 levels. The lower 1400-mg dose numerically outperformed the higher-dose arm, with response rates of 81.8% in squamous disease and 72.7% in non-squamous disease.However, the data are still early. The confirmed response rate fell to 52.5% after excluding five pending confirmations, and duration-of-response data weren't mature yet at the November 2025 cutoff. Median treatment duration was 4.5 months and nearly 70% of patients remained on treatment at the time of analysis.Meanwhile, grade 3 or higher treatment-related adverse events (TRAEs) in ROSETTA Lung-02 occurred in 19 patients (44.2%), though only 8 cases (18.6%) were deemed directly related to pumitamig. Two patients (4.7%) discontinued treatment due to pumitamig-related TRAEs. Bleeding events were reported in 7 patients (16.3%), with only one grade 3 event, while severe immune-related toxicities were relatively uncommon.Pfizer's contenderMeanwhile, Pfizer's abstract offered an updated glimpse at a potential PD-(L)1/VEGF challenger. Pfizer acquired rights to PF-08634404, also known as SSGJ-707, from 3SBio last year in a deal worth $1.25 billion upfront (see – Spotlight On: Pfizer calls out differentiating features of newly in-licensed bispecific antibody).Unlike pumitamig, Pfizer's Phase II study evaluated the drug as a monotherapy in previously untreated patients with PD-L1–positive advanced NSCLC.At the FDA-aligned 10 mg/kg dose in 34 evaluable patients, the drug achieved a confirmed ORR of 67.6%, with median progression-free survival reaching 12.4 months for non-squamous patients and 8.9 months for squamous patients after a little over 15 months of follow-up. Median duration of response and OS had not yet been reached.The most common side effects were pneumonia (8.4%), hypertension (7.2%) and haemoptysis (6%), though discontinuation rates remained relatively low. Pfizer recently advanced its drug as a combination with chemotherapy for first-line patients in the Phase III Symbiotic-Lung-01 study.