Uliledlimab

Givastomig, a CLDN18.2 x 4-1BB bispecific antibody, continues to show robust efficacy when combined with nivolumab and chemotherapy (mFOLFOX6) in 1L HER2-negative, metastatic gastric cancer patients, with 77% ORR observed at 8 mg/kg and 73% ORR observed at 12 mg/kg, across a wide range of PD-L1 and CLDN18.2 expression levels The median PFS was 16.9 months at 8 mg/kg; 12 mg/kg is immature with approximately 4-month shorter median follow-up; data will be updated in 2026 Six-month landmark PFS was 73% for 8 mg/kg, and 91% for 12 mg/kg cohorts Combination was well tolerated; safety is comparable to the current standard of care treatment Data demonstrate that givastomig is a potential best-in-class CLDN18.2 asset when added to 1L standard of care NovaBridge is on track to initiate enrollment in a global, randomized Phase 2 study, evaluating both doses against standard of care, in Q1 2026 Detailed Phase 1b dose expansion data are expected to be presented at a medical conference later in 2026 ROCKVILLE, Md., Jan. 06, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, today announced positive updated results from the Phase 1b combination study of givastomig, a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy (mFOLFOX6) in patients with HER2-negative, first line (1L) metastatic gastric cancer. The results combine data from patients in the Phase 1b dose escalation and expansion cohorts treated with 8 mg/kg or 12 mg/kg of givastomig. An ORR of 77% (20/26) at the 8 mg/kg dose, and 73% (19/26) at the 12 mg/kg dose, confirms and extends positive signals observed in the dose escalation cohorts. Responses continue to be rapid and deepen over time, and were observed across all levels of CLDN18.2 and PD-L1 expression levels. The safety pro the combination was similar to earlier observations, except for the emergence of immune-related gastritis, which correlated with improved clinical outcomes. These data, outlined in detail below, position givastomig as a potential best-in-class CLDN18.2-directed therapy for gastric cancer, a potential $12 billion market opportunity by 2030. The full data are intended to be presented at a medical meeting later in 2026. The Phase 1b study (NCT04900818) is evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig, used in combination with nivolumab and mFOLFOX6, as 1L therapy in patients with CLDN18.2-positive gastric cancer (GC) (≥1+ immunohistochemistry (IHC) intensity in ≥1% of cells), and any level of PD-L1 expression. The primary endpoint is safety. Secondary endpoints include progression free survival (PFS). The study enrolled only patients in the U.S. “The dose expansion data reinforce the strong signals we observed in dose escalation. The efficacy is clear at 8 mg/kg, with robust ORRs, including in subgroups defined by low PD-L1 and/or CLDN18.2 expression. The PFS data are very promising and continue to mature. Emerging efficacy data at 12 mg/kg are also strong and similar in terms of ORR. The 12 mg/kg cohort was enrolled after the 8 mg/kg cohort, so follow-up is shorter and PFS is less mature. We expect to report these data later in 2026. We remain enthusiastic about the 12 mg/kg dose because exposure analysis shows higher exposure is consistently associated with a higher probability of response, without a higher probability of toxicity,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge . “I continue to be encouraged by givastomig’s high response rate across a wide range of Claudin 18.2 and PD-L1 expression levels, and the depth and duration of responses achieved with combination therapy. The development of gastritis was not predicted by the monotherapy study, and may be related to longer givastomig exposure duration, something that has been seen with some CLDN18.2-directed agents. Most gastritis cases were low grade and manageable, and interestingly appear to be associated with higher response rates and longer survival,” said Samuel J. Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital . “Givastomig’s favorable benefit-risk balance has the potential to offer real world benefit to patients and is planned to be investigated in a randomized trial.” “Givastomig is a core program for NovaBridge,” said Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge . “The compelling Phase 1b data presented today have the potential to establish givastomig as the leading CLDN18.2-directed therapy for 1L gastric cancer, where the unmet medical need remains high and the commercial opportunity is significant.” Topline Data from the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer 54 advanced metastatic gastric cancer patients (metastatic gastric, esophageal or gastroesophageal adenocarcinomas) were enrolled in cohorts across the 8 mg/kg (n=27), and 12 mg/kg (n=27) dose levels as of the December 2, 2025 data cutoff. 52 patients were efficacy evaluable Demographics show characteristics typical of metastatic gastric cancer in patients All patients were HER2-negative, CLDN18.2-positive (defined as ≥1+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels Enrolled at sites only within the United States Biomarker expression consistent with prevalence, noting that in efficacy evaluable patients: 8 mg/kg cohort was over-represented with tumors expressing CLDN18.2 >75% (63%) 12 mg/kg cohort was over-represented with tumors expressing PD-L1 10% of patients in either dose): nausea, vomiting, and fatigue, all of which had a Grade 3 incidence of ≤11% Immune-related gastritis was observed in 33% of patients in each cohort (Grade 3 in 4% of patients dosed at 8 mg/kg and 15% of patients dosed at 12 mg/kg): Gastritis was not observed in the monotherapy Phase 1 study of givastomig and infrequently observed with nivolumab and chemotherapy Most commonly occurred after several cycles of therapy, was documented via endoscopy, and was managed with medications and treatment interruption Patients developing gastritis were observed to have improved ORR, PFS and OS compared to patients who did not develop gastritis Only Grade 4 TRAE was neutropenia (4% at 8 mg/kg and 7% at 12 mg/kg) No Grade 5 TRAEs were reported Business Update with Leerink Partners Leerink Partners (Leerink) will host a NovaBridge Business Update on Tuesday, January 6, 2026 at 8:30 AM ET. Interested investors should contact their Leerink representative to join. Business Update with CITIC Securities CITIC Securities (CITICS) will host a NovaBridge Business Update (in Chinese) on Wednesday, January 7, 2026 at 9:00 AM HKT. Interested investors should contact their CITICS representative to join. About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio. About NovaBridge NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, Claudin 18.2 x 4-1BB bispecific antibody, and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer. VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a large, randomized, dose-ranging Phase 2 study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia. For more information, please visit and follow us on LinkedIn. Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the strategy, clinical development, plans, results, safety and efficacy of givastomig and VIS-101 and its other drug candidates; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, ragistomig, uliledlimab, and VIS-101; anticipated clinical milestones and results, and related timing. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. NovaBridge Investor & Media Contacts PJ Kelleher LifeSci Advisors +1-617-430-7579 pkelleher@lifesciadvisors.com NovaBridge Biosciences +1-240-745-6330 IR@novabridge.com

哪些是MNC补位需求迫切的赛道？ 撰文丨拿铁 中国创新药BD交易2025年最新数据出炉。出海授权全年交易总金额达到1356.55亿美元，较2024年的519亿美元大幅增长161%；首付款70亿美元；交易总数量达到157起，较去年94起交易大幅增长67%[1]。 这背后的原因，离不开众多MNC在未来几年将遭遇核心产品专利悬崖压力。预计截至2037年，将有超25款重磅药物面临专利悬崖，合计潜在损失金额超2300亿美元。其中包括辉瑞的阿哌沙班、默沙东的K药、BMS的O药、诺和诺德的司美格鲁肽、艾伯维的利生奇珠单抗、礼来的替尔泊肽等。我们以近年来BD较为活跃的赛诺菲、辉瑞、诺和诺德为例，分析它们如何创造未来BD机遇。这个机会窗口中，中国药企将扮演怎样的角色，2026年还可以有哪些BD交易期待？ 赛诺菲：罕见病、自免领域 赛诺菲的度普利尤单抗核心专利（美国）将于2031年到期，该药物曾是赛诺菲“Play to Win”战略的核心产品，为了打造第二增长曲线，赛诺菲通过多次对外合作以打破困局。 2025年11月19日，赛诺菲对Lifordi公司进行投资，Lifordi的核心产品LFD-200是一款靶向VISTA的自免ADC药物，作用机制为通过高度内化的细胞表面膜蛋白——VISTA，将高效糖皮质激素精准递送至靶细胞，实现持久、局部的免疫抑制效果，在保证疗效的同时，降低脱靶毒性风险。 VISTA具有快速内化和细胞内积累的独特生物学特性，该优势使其成为ADC疗法的理想选择。临床前研究表明，LFD-200具有血清半衰期短、免疫细胞内停留时间长的特点，并且能够在这些细胞内长期发挥免疫抑制功能。在2025年美国风湿病学会（ACR）年会上公布的数据显示，每周皮下注射一次LFD-200，持续13周，可在免疫细胞中维持糖皮质激素暴露，且未见系统性毒性的证据，LFD-200有望解决过去75年来限制糖皮质激素广泛长期使用的问题。 未来，VISTA靶向ADC或许是自免领域下一个待爆方向。近年来，赛诺菲一直在紧密追踪前沿医学动态，前瞻性地锁定未来的合作伙伴，及时充实自身产品管线，应对即将到来的专利悬崖。 2024年1月，赛诺菲与临床阶段生物制药上市公司Inhibrx达成22亿美元的并购协议，强化在罕见病、炎症免疫领域的地位。 2024年5月，赛诺菲与生物制药公司Fulcrum就后者在研新药Losmapimod达成合作，赛诺菲获得Losmapimod在美国以外所有地区的独家商业化权益，Fulcrum保留Losmapimod在美国的商业化权益，并将获得8000万美元首付款等。Losmapimod是一种选择性p38α/β丝裂原活化蛋白激酶（MAPK）抑制剂，针对面肩肱型肌营养不良症（FSHD），曾有望成为全球首个获批的FSHD治疗药物。但在2024年9月公布的III期临床结果中，Losmapimod治疗FSHD未能达到主要终点，赛诺菲终止合作。 2024年9月，赛诺菲与天境生物合作，以不超过20亿人民币，获得天境生物的CD73单抗——尤莱利单抗（uliledimab）在大中华区的开发与商业化权益。 可以看出，赛诺菲正在努力通过对外合作来提升自己在罕见病和自免等领域的实力，以期寻找到下一个具有差异化优势的重磅产品。 辉瑞：肿瘤、代谢领域 辉瑞在疫情期间凭借新冠疫苗赚得盆满钵满。如今业界传出辉瑞计划出售所持新冠疫苗合伙人——BioNTech的455万股存托凭证，这意味着曾经的疫情红利不再，辉瑞失去了一个强大的利润引擎。 更让辉瑞“揪心”的是，核心产品阿哌沙班将在2026年专利到期，这款由辉瑞/BMS共同开发的口服Xa因子抑制剂，自上市以来销售额不断增长，2024年达到206亿美元，2025年上半年销售超110亿美元，是小分子药物销量王者。 面对失去的新冠疫苗红利和核心产品的专利悬崖，辉瑞迫切需要找到下一个增长引擎。于是，在短短两年内，我们就看到辉瑞发起了多个百亿美元并购案。 最近一次是关注度极高的Metsera并购案。这家公司布局了极具差异化的代谢管线，其核心资产MET-097i是一款每月仅需注射一次的超长效GLP-1受体激动剂（GLP-1RA），在2025美国肥胖周（Obesity Week 2025）上，MET-097i用于减肥适应症的两项IIb期临床试验（VESPER-1和VESPER-3）取得积极结果，疗效与礼来公司的“当家花旦”Zepbound相当。治疗28周时，MET-097i相较于安慰剂的平均减重幅度最高达14.1%，部分受试者减重比例甚至高达26.5%，而且具有出色的耐受性。 这些积极结果引得诺和诺德前来竞争，最终在公平贸易委员会（FTC）的介入下，辉瑞以近100亿美元将Metsera收入囊中。对于在GLP-1领域自研产品遇到较多挫折的辉瑞来说，Metsera或将为其带来翻身机会。 在肿瘤领域，2025年5月，辉瑞与三生制药合作，以首付款12.5亿美元、里程碑款最高可达48亿美元的价格，获得后者PD-1/VEGF双抗——SSGJ-707（PF-08634404）在中国大陆以外全球范围的独家开发、生产及商业化权利。 在近期举办的投资者活动上，辉瑞明确表示了对PF-08634404的重视，宣布即将启动PF-08634404相关的7项近期临床，包括一线非小细胞肺癌（NSCLC）和一线结直肠癌的两项全球多中心III期临床试验，以及其他5项研究。 在NSCLC方面，辉瑞将开展PF-08634404联合化疗头对头Keytruda联合化疗，在一线治疗NSCLC上的研究。并且将计划探索PF-08634404与公司内部vedotin ADC的联用，以及探索PF-08634404在新辅助和辅助治疗阶段的应用等。 除了非小细胞肺癌、结直肠癌，辉瑞还将开展PF-08634404在广泛期小细胞肺癌、肝癌、尿路上皮癌和肾癌的应用。辉瑞预计，2026年底PF-08634404的全球多中心临床数量将超过20个，力图将其打造成管线网络中的基石产品。 更早之前，辉瑞还以430亿美元收购ADC领头羊Seagen，将Padcev、Adcetris等核心资产收入囊中，一跃成为ADC领域龙头。 辉瑞凭借“钞能力”和高效的执行效率，立志在肿瘤和代谢领域迎头赶上。 诺和诺德：减重、降糖及相关并发症 丹麦制药巨头诺和诺德凭借GLP-1RA——司美格鲁肽（Ozempic、Rybelsus、Wegovy），曾经富可敌国，然而随着礼来替尔泊肽的后来居上、诺和诺德下一代减肥药CagriSema疗效未达预期，以及美国本土市场仿制药挤压，诺和诺德的股价出现下滑。更紧迫的是，司美格鲁肽的美国专利将在2032年到期，诺和诺德亟需下一个接棒产品。 为了快速开启新篇章，诺和诺德采取了相对激进的措施。首先在2025年5月，前CEO周赋德（Lars Fruergaard Jørgensen）因市场表现不佳而离职，由公司内部人员杜麦克（Maziar Mike Doustdar）接任。接着，杜麦克在上任后迅速推出了大规模重组计划，包括在全球范围内裁员约9000人，以削减成本并重新聚焦业务。 变动之际，诺和诺德也从原来依赖内部研发，转向更开放的姿态。2024年2月，诺和诺德与Neomorph合作，共同发现、开发和商业化多个分子胶降解剂，潜在交易总价值高达14.6亿美元。2025年3月，诺和诺德以最高20亿美元，获得联拓生物的GLP-1/GIP/GCG三重受体激动剂Ubt-251除中国以外的独家权益。2025年10月，诺和诺德以高达52亿美元的总额，收购Akero Therapeutics，用于开发与肥胖相关的肝病MASH的治疗药物。2025年11月，诺和诺德与辉瑞竞购Metsera。 同时，围绕司美格鲁肽，诺和诺德还在推进多个适应症的临床试验，包括糖尿病相关的慢性肾病、心血管疾病以及阿尔茨海默症等。 总的来说，诺和诺德聚焦的仍是降糖、减重这一代谢领域，未来能否走出新的篇章，值得期待。 中国创新药企的机会 药品专利悬崖是各大药企都绕不过的关键挑战之一，而中国药企可能会在未来全球创新生态中扮演重要角色。主要源于三方面原因：首先，自从中国在2017年加入ICH后，国内临床数据的完整性、临床试验的质量得到显著改善，逐步获得海外同行认可。这一变化在近两年不断发生的出海交易中得到体现。 临床质量提高之外，国内药企越来越注重创新质量。在过去十年，中国构建了与FDA类似的创新政策体系，创新药企从以前的改进型、BIC型创新逐步过渡到源头创新。这些创新正在被MNC看见，一年多来，在对外授权交易中，国产ADC引领风潮，双抗成为BD新宠，而独特的NewCo和Co-Co模式也正在改写国际化合作路径。 成本优势也是MNC在中国加大“扫货”力度的主要原因之一。据摩根士丹利推算，中国临床III期受试者的直接成本为2.5万美元/人，美国为6.9万美元/人，药物研发平均回报率（IRR）约8.5%，是美国纯本土研发（3.6%）的2.4倍。 一系列因素驱动下，MNC开始与中国创新药产业深度绑定，并在国内新建多个研发中心，中国的创新药资产正向全球创新舞台中央走去。从近期密集发生的交易情况来看，自免、代谢、肿瘤、罕见病或是MNC补位需求迫切的赛道，短短数年内行业市场格局或将迎来变革性重塑。而中国药企如何抓住这波风口，MNC如何妥当处理专利悬崖，2026年值得继续期待。 数据来源：【1】医药魔方数据库 END 往期精彩内容 中国创新药“华山奖”奖杯样本出炉 自免双抗成“吸金之王” 原恒瑞医药董事长周云曙，出任先声药业总裁