Zolbetuximab

Exploratory ad hoc analyses from SPOTLIGHT and GLOW trials report quantitative differences in median progression-free survival (mPFS) and median overall survival (mOS) for patients treated with VYLOY plus chemotherapy when data from patients who discontinued early due to common adverse events were censored Effective management of adverse events remains an important component of supportive care for patients receiving treatment for advanced gastric or GEJ cancer NORTHBROOK, Ill., Jan. 8, 2026 /PRNewswire/ -- Astellas Pharma U.S., Inc. (Head of US Commercial: Mike Petroutsas, "Astellas") today announced the publication of exploratory ad hoc analyses from the combined Phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies in patients with HER2-negative, CLDN18.2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in ESMO Open, characterizing the management of adverse events on treatment adherence and efficacy of VYLOY (zolbetuximab) plus chemotherapy and evaluating strategies for managing these side effects. The exploratory analyses, which included 1,072 patients, reported higher mPFS and mOS estimates for patients treated with zolbetuximab plus chemotherapy after censoring data from patients who discontinued early or had inadequate treatment exposure due to nausea and/or vomiting.1 Pooled data from the analyses show that mPFS with zolbetuximab plus chemotherapy was 10.4 months (95% confidence interval [CI]: 8.8-12.2), and 8.2 months (95% CI: 7.7-8.4) with placebo plus chemotherapy. The hazard ratio [HR] versus placebo was 0.65 (95% CI: 0.56-0.76).1 Similarly, mOS with zolbetuximab plus chemotherapy was 17.9 months (95% CI: 16.4-19.5) and 13.7 months (95% CI: 12.4-15.3) with placebo plus chemotherapy with a HR versus placebo of 0.69 (95% CI: 0.60-0.80).1 Sam Klempner, MD, Gastrointestinal Medical Oncologist, Massachusetts General Hospital, Boston: "Nausea and vomiting are important symptoms that can affect patient comfort and treatment continuity for advanced gastric or GEJ cancer, particularly during early cycles when these symptoms are most common. Supportive care measures are therefore an important part of managing patients receiving cancer therapy." Zolbetuximab (VYLOY) is an FDA approved monoclonal antibody for patients with HER2-negative, CLDN18.2-positive advanced gastric or GEJ cancer. In combination with chemotherapy, zolbetuximab demonstrated statistically significant improvements in PFS and OS compared with placebo plus chemotherapy in the SPOTLIGHT and GLOW Phase 3 clinical trials.2,3 In SPOTLIGHT and GLOW, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared with placebo plus chemotherapy. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite.2,3 The ad-hoc analyses in these studies showed an association between nausea and vomiting and higher treatment discontinuation rates compared with placebo. Timothy Forrest, RN, BSN, Massachusetts General Hospital, Boston: "Early cycles are a critical window for supporting patients starting treatment for advanced gastric or GEJ cancer. Since we know nausea and vomiting are common in this setting, preparing patients, monitoring closely, and using guideline-aligned supportive care can make a meaningful difference to their comfort and ability to continue treatment as planned." Within the published exploratory analyses, the effect of guideline-aligned supportive care on early nausea and vomiting associated with zolbetuximab plus chemotherapy was assessed.1 Data indicate that use of a guideline-recommended three-drug antiemetic regimen was associated with a higher proportion of patients who did not experience nausea or vomiting at cycle 1 dose 1 (C1D1; 60.8% and 75.3%, respectively).1 Additionally, across the SPOTLIGHT and GLOW trials, 57.9% of patients who received steroids at C1D1 did not experience nausea (versus 49.7% without steroids) and 63.7% did not experience vomiting at C1D1 (versus 62.6% with no steroids).1 Finally, results from the combined analysis suggest that a faster initial infusion may have contributed to adverse events such as nausea and vomiting observed during the first infusion. The authors noted that infusion-rate modifications may help mitigate these symptoms.1 Exploratory ad hoc analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value. Astellas is committed to supporting patients and the oncology care community by continuing to generate insights that enhance the patient and healthcare professional experience and better understand supportive care needs and treatment experiences. About the SPOTLIGHT Phase 3 Clinical Trial SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment in patients with locally advanced, unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia. The primary endpoint was progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters. Data from the SPOTLIGHT clinical trial were presented during the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium in an oral presentation on January 19, 2023, and were subsequently published in The Lancet on April 14, 2023. The final analyses of SPOTLIGHT and GLOW, including additional supporting data in the appendix, were later published as a Letter to the Editor in the New England Journal of Medicine in 2024. For more information, please visit clinicaltrials.gov under Identifier NCT03504397. About the GLOW Phase 3 Clinical Trial GLOW is a Phase 3, global, multi-center, double-blind, randomized study assessing the efficacy and safety of zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America, and Asia, including Japan. The primary endpoint was PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints included OS, ORR, DOR, safety and tolerability, and quality-of-life parameters. Data from the GLOW study were initially presented at the March 2023 ASCO Plenary Series with an updated oral presentation at the 2023 ASCO Annual Meeting on June 3, 2023, and were subsequently published in Nature Medicine on July 31, 2023. For more information, please visit clinicaltrials.gov under Identifier NCT03653507. About VYLOY VYLOY (zolbetuximab) is a monoclonal antibody (mAb) specifically designed to target tumor cells that express claudin 18.2 (CLDN18.2), a transmembrane protein. By binding to CLDN18.2, zolbetuximab induces cancer cell death and inhibits tumor growth by activating two distinct immune system pathways - antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), as demonstrated in preclinical studies. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18.2 immunohistochemical staining. Astellas collaborated with Roche on the Ventana™ CLDN18 (43-14a) RXDX assay which, where approved, can be used by pathologists or laboratories to identify patients eligible for targeted treatment with zolbetuximab. About Astellas Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . U.S. VYLOY ( zolbetuximab-clzb) Indication and Important Safety Information INDICATION VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. Warnings and Precautions Hypersensitivity reactions, including serious anaphylaxis reactions, and serious and fatal infusion-related reactions (IRR) have been reported in clinical studies when VYLOY has been administered. Any grade hypersensitivity reactions, including anaphylactic reactions, occurring with VYLOY in combination with mFOLFOX6 or CAPOX was 18%. Severe (Grade 3 or 4) hypersensitivity reactions, including anaphylactic reactions, occurred in 2% of patients. Seven patients (1.3%) permanently discontinued VYLOY for hypersensitivity reactions, including two patients (0.4%) who permanently discontinued VYLOY due to anaphylactic reactions. Seventeen (3.2%) patients required dose interruption, and three patients (0.6%) required infusion rate reduction due to hypersensitivity reactions. All grade IRRs occurred in 3.2% in patients administered VYLOY in combination with mFOLFOX6 or CAPOX. Severe (Grade 3) IRRs occurred in 2 (0.4%) patients who received VYLOY. An IRR led to permanent discontinuation of VYLOY in 2 (0.4%) patients and dose interruption in 7 (1.3%) patients. The infusion rate was reduced for VYLOY for 2 (0.4%) patients due to an IRR. Monitor patients during infusion with VYLOY and for 2 hours after completion of infusion or longer if clinically indicated, for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice). Monitor patients for signs and symptoms of IRRs including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. If a severe or life-threatening hypersensitivity or IRR reaction occurs, discontinue VYLOY permanently, treat symptoms according to standard medical care, and monitor until symptoms resolve. For any Grade 2 hypersensitivity or IRR, interrupt the VYLOY infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion. Follow Grade 2 management for Grade 3 infusion-related nausea and vomiting. Premedicate the patient with antihistamines for the subsequent infusions, and closely monitor the patient for symptoms and signs of a hypersensitivity reaction. The infusion rate may be gradually increased as tolerated. Severe Nausea and Vomiting. VYLOY is emetogenic. Nausea and vomiting occurred more often during the first cycle of treatment. All grade nausea and vomiting occurred in 82% and 67% respectively of patients treated with VYLOY in combination with mFOLFOX6 and 69% and 66% in combination with CAPOX, respectively. Severe (Grade 3) nausea occurred in 16% and 9% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX respectively. Severe (Grade 3) vomiting occurred in 16% and 12% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX. Nausea led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 18 (3.4%) patients and dose interruption in 147 (28%) patients. Vomiting led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 20 (3.8%) patients and dose interruption in 150 (28%) patients. Pretreat with antiemetics prior to each infusion of VYLOY. Manage patients during and after infusion with antiemetics or fluid replacement. Interrupt the infusion, or permanently discontinue VYLOY based on severity. ADVERSE REACTIONS Most common adverse reactions (≥15%): Nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia. Most common laboratory abnormalities (≥15%): Decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, decreased phosphate, decreased potassium, and decreased magnesium. SPOTLIGHT Study: 279 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with mFOLFOX6 Serious adverse reactions occurred in 45% of patients treated with VYLOY in combination with mFOLFOX6; the most common serious adverse reactions (≥2%) were vomiting (8%), nausea (7%), neutropenia (2.9%), febrile neutropenia (2.9%), diarrhea (2.9%), intestinal obstruction (3.2%), pyrexia (2.5%), pneumonia (2.5%), respiratory failure (2.2%), pulmonary embolism (2.2%), decreased appetite (2.1%) and sepsis (2.0%). Fatal adverse reactions occurred in 5% of patients who received VYLOY in combination with mFOLFOX6 including sepsis (1.4%), pneumonia (1.1%), respiratory failure (1.1%), intestinal obstruction (0.7%), acute hepatic failure (0.4%), acute myocardial infarction (0.4%), death (0.4%), disseminated intravascular coagulation (0.4%), encephalopathy (0.4%), and upper gastrointestinal hemorrhage (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 20% of patients; the most common adverse reactions leading to discontinuation (≥2%) were nausea and vomiting. Dosage interruptions of VYLOY due to an adverse reaction occurred in 75% of patients; the most common adverse reactions leading to dose interruption (≥5%) were nausea, vomiting, neutropenia, abdominal pain, fatigue, and hypertension. GLOW Study: 254 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with CAPOX Serious adverse reactions occurred in 47% of patients treated with VYLOY in combination with CAPOX; the most common serious adverse reactions (≥2%) were vomiting (6%), nausea (4.3%), decreased appetite (3.9%), decreased platelet count (3.1%), upper gastrointestinal hemorrhage (2.8%), diarrhea (2.8%), pneumonia (2.4%), pulmonary embolism (2.3%), and pyrexia (2.0%). Fatal adverse reactions occurred in 8% of patients who received VYLOY in combination with CAPOX including sepsis (1.2%), pneumonia (0.4%), death (0.8%), upper gastrointestinal hemorrhage (0.8%), cerebral hemorrhage (0.8%), abdominal infection (0.4%), acute respiratory distress syndrome (0.4%), cardio-respiratory arrest (0.4%), decreased platelet count (0.4%), disseminated intravascular coagulation (0.4%), dyspnea (0.4%), gastric perforation (0.4%), hemorrhagic ascites (0.4%), procedural complication (0.4%), sudden death (0.4%), and syncope (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 19% of patients; the most common adverse reaction leading to discontinuation (≥2%) was vomiting. Dosage interruption of VYLOY due to an adverse reaction occurred in 55% of patients; the most common adverse reactions leading to dose interruption (≥2%) were nausea, vomiting, neutropenia, thrombocytopenia, anemia, fatigue, infusion-related reaction, and abdominal pain. SPECIFIC POPULATIONS Lactation Advise lactating women not to breastfeed during treatment with VYLOY and for 8 months after the last dose. Full U.S. Prescribing Information Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Shitara K, Smyth E, Lordick F, et al. Impact and effective management of nausea/vomiting on patients treated with zolbetuximab + chemotherapy: Insights from the phase 3 SPOTLIGHT and GLOW studies. ESMO Open. 2026. Available at: (25)01801-0/fulltext. Last accessed: January 2026. 2 Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet 2023;401(10389):1655-1668. Errata in: Lancet 2023;402(10398):290; Lancet 2024;403(10421):30. 3 Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med 2023;29(8):2133-2141. SOURCE Astellas Pharma Inc. 21% more press release views with Request a Demo

氨基观察-创新药组原创出品 作者 | 武月 对一家志在成为全球生物科技平台的公司而言，没有什么能比“实绩”更能验证其平台化能力的成熟度与商业模式的可行性。 新桥生物正站在这样一个关键节点上。日前，其更新的Givastomig联合疗法积极临床数据，已成为市场焦点。核心在于，Givastomig联合O药及化疗在治疗HER2阴性、CLDN18.2阳性的一线转移性胃癌患者中，进一步展现出CLDN18.2同类最优的潜力。 根据1b期临床试验剂量扩展数据，在HER2阴性一线胃癌治疗场景中，8mg/kg剂量组客观缓解率（ORR）达77%，12mg/kg剂量组ORR达73%；其中8mg/kg剂量组更创下历史纪录的16.9个月的中位无进展生存期（mPFS），且由于随访时间差异，12mg/kg数据仍在持续成熟中，目前其6个月PFS率已高达91%。 这一成果不仅刷新了CLDN18.2靶点疗法的临床纪录，更是目前一线胃癌治疗领域已观察到的最佳PFS数据——相比O药联合化疗方案7.7个月的PFS（源自CheckMate-649研究），延长幅度超一倍，因而引发市场高度关注。 并且，其疗效覆盖人群极为广泛，无论PD-L1表达水平高低，也无论CLDN18.2表达强度如何，甚至在低PD-L1与低CLDN18.2双低表达患者中，ORR仍达到了83%。 这也让市场重新审视新桥生物。 在控股股东、亚洲最大专注医疗健康的资产管理公司康桥资本的支持下，其立志成为具备全球视野的平台型玩家，推动亚洲潜力创新药物研发与高价值出海，而Givastomig积极临床数据的出炉，标志着新其战略转型迎来关键验证；结合其将继续在引进层面继续发力，印证了其独特的“中心-辐射”模式正加速落地，更验证了该模式下推进国际化临床的有效路径与实践价值。 随着新桥生物平台化能力的持续验证与模式的不断成熟，中国创新药行业长期存在的痛点可能也在迎来破解的曙光。 / 01 / mPFS潜在最佳， Givastomig刷新CLDN18.2上限 在创新药世界，临床数据是衡量价值的终极标尺。 新桥生物的核心资产Givastomig，一款靶向CLDN18.2和4-1BB的双特异性抗体，近期公布的Ib期联合疗法数据，足以让市场为之侧目。 最新临床数据显示，在8mg/kg剂量组，Givastomig联合治疗组的ORR高达77%，疾病控制率（DCR）更是达到96%；12mg/kg剂量组ORR为 73%，DCR实现100%全覆盖，且出现1例完全缓解（CR）病例。尤为值得关注的是无进展生存期，在随访10.7个月的8 mg/kg组，mPFS达到了令人瞩目的16.9个月，且仍在持续成熟中。这已经足够惊艳，正如上文提及，这是目前在一线胃癌治疗中观察到的最佳PFS数据，相比O药联合化疗7.7个月的PFS（CheckMate-649研究），延长了一倍有余。且参考过往临床研究，结合该联合治疗组突出的疗效情况，该mPFS数据应该不会出现明显回落。 12 mg/kg组因随访时间较短（6.8个月），mPFS为7.7个月，但其6个月无进展生存率达到91%，显示出积极的势头。 差异化优势是Givastomig脱颖而出的核心。在分子设计上，它通过条件性激活T细胞的独特机制，在CLDN18.2表达的肿瘤微环境中特异性启动4-1BB信号通路，既保证了抗肿瘤活性，又避免了传统4-1BB激动剂常见的脱靶毒性。临床数据显示，除出现免疫相关性胃炎，该联合疗法的安全性与现有标准治疗相当，3级以上治疗相关不良事件发生率较低，仅中性粒细胞减少等常见化疗相关不良反应发生率超过20%，且未出现剂量限制性毒性。 而新发生的胃炎，大多数病例为低级别且可控，且胃炎病例之出现与更高的缓解率及更长的生存期相关。麻省总医院医学副教授Samuel J. Klempner博士指出，免疫相关性胃炎在单药研究中未观察到，这可能与Givastomig暴露时间延长有关，这一现象在某些CLDN18.2靶向药物亦有出现。 更关键的是，其疗效覆盖人群极为广泛，无论PD-L1表达水平高低，也无论CLDN18.2表达强度如何，甚至在低PD-L1与低CLDN18.2双低表达患者中，ORR仍达到了83%。 这与仅对高表达人群有效的zolbetuximab形成鲜明对比，也意味着Givastomig潜在患者将比zolbetuximab多出几倍。 广阔的市场前景为这款潜在大单品提供了巨大的想象空间。 胃癌是全球高发恶性肿瘤，HER2阴性胃癌市场规模就达120亿美元，而CLDN18.2阳性患者约占该人群的70%-80%。根据安斯泰来预测，zolbetuximab全球峰值将达7-13 亿美元。凭借更广泛的人群覆盖，Givastomig有望冲刺几倍于zolbetuximab更高的峰值。若后续全球II期临床能够保持目前的表现，无疑会进一步增强其确定性，也将为后续的重磅BD合作奠定坚实基础。 事实上，MNC已在关注Givastomig的临床数据。比如，新桥生物已与BMS达成了合作协议，后者免费提供O药供其临床使用，同时拥有优先购买权。 不仅如此，Givastomig后续还可拓展至胰腺导管腺癌、胆管癌等其他CLDN18.2阳性的恶性肿瘤，进一步打开想象空间。 Givastomig的亮眼数据，不仅启动了其自身成为重磅炸弹的引擎，也如同一束强光，照亮了新桥生物作为其孵化平台的独特价值与能力。 / 02 / 验证全球孵化能力，确证新桥商业逻辑 新桥生物的野心，从来不止于做好一个项目。 背靠康桥资本，新桥生物立志成为具备全球视野的平台型玩家，推动亚洲潜力创新药物研发与高价值出海。而Givastomig，正是其全球化平台模式的首次硬核验证。 平台型企业并不少见，但真正有价值的平台，最终必须落实到能产出重磅产品。Givastomig最初由韩国公司ABL Bio研发，新桥生物以敏锐的眼光将其引进，凭借自身的研发实力与全球化资源，将其从早期资产快速推进至临床验证。 如今的Givastomig已成为新桥生物在新模式下孵化出的第一个潜在重磅创新药。这首先验证了其稀缺的“淘金”眼光与资产获取能力。 当然，这只是第一步。对于新桥生物这类公司，更核心的研发竞争力在于“D”（Development，开发），即如何通过深入的药物机制研究，制定差异化的全球开发策略，快速推进临床并验证价值。Givastomig则展现了新桥生物的研发实力。 新桥生物核心团队在肿瘤新药海外临床开发方面拥有丰富经验。公司CEO‌ Sean Fu博士行业经验丰富，其背景包括材料科学博士学位及工商管理硕士学位，具备跨学科管理经验，同时其曾在默沙东、绿叶制药等大药企任职多年，负责国际研发、财务、运营管理等多项工作。首席医疗官Phillip Dennis博士肿瘤免疫临床开发经验十分丰富，在赛诺菲、阿斯利康主导肺癌临床工作多年，加入新桥生物后，带领团队设计了差异化的临床路径——直接推进Givastomig与PD-1抑制剂及化疗的三联疗法用于一线治疗，而非传统的单药爬坡后再联合的路径，这一决策既凸显了药物的协同优势，又加速了临床验证进程。 全球化运作能力则是新桥生物的另一大优势。Givastomig 1b期研究在全球开展，美、中和其它区域各占三分之一，这一选择极具战略眼光。 一方面，新桥生物的团队配置具备全球化视野，核心成员均拥有跨国药企或顶尖 biotech的工作经历，借助自身美国多年本土化运营积累的临床经验和MNC资源，确保了试验的高质量与高效率； 另一方面，海外生成的临床数据，在国际上享有更高的可信度，能有效规避当前业内关于“数据可信度”的争议，使其更易获得全球监管机构的认可以及MNC的青睐。毕竟，中国临床数据是否可靠一直是市场最关心的问题。即便是2025年中国创新最大BD案，MNC早期对引进资产的临床数据持有谨慎态度，在经历了长期、极为详细的尽调之后，才打消疑虑。而在CLDN18.2领域，也有国产分子出现海外未能复制国内惊艳数据的情况。而Givastomig拥有全球入组，因此会更值得MNC信任。 除此之外，2025年7月份新桥生物通过收购BridgeHealth，获得了CLDN18.2亲本抗体在双抗、多抗及ADC领域的完整上游权利，并减少相关里程碑付款义务。这能巩固Givastomig的竞争壁垒，筑牢知识产权护城河，为后续的合作开发和商业拓展奠定更有利的基础。 可以说，全球化平台模式的资源赋能效应，在Givastomig身上得到充分体现，而这正是新桥生物“中心-辐射”模式规模化落地的预演。其通过战略合作获取中国和亚洲优质早期资产，再借助自身强大的跨境临床开发和转化医学团队进行“价值赋能”——设计最优临床路径、选择最佳适应症、执行高质量全球临床试验，最终将资产价值放大数倍后实现灵活的退出。 / 03 / 双轮驱动，“新桥飞轮”大提速 新桥生物自我强化的“飞轮效应”已然启动。Givastomig的一步步验证是其“飞轮效应”第一个推动力，它向全球证明了公司“引进-开发-增值-兑现”平台模式的有效性。这会显著提升新桥生物在MNC和资本市场中的信誉与吸引力。随之而来的，将是更多、更优质的全球合作机会与BD交易。 这些合作不仅带来资金和管线，更会反哺公司，使其全球化运营能力、临床开发经验和资源网络得到进一步进化与迭代。更强的能力，意味着能更高效地孵化出下一个、乃至更多的潜在重磅产品，从而吸引更高层次的合作，实现交易数量与质量的螺旋式上升，形成一个无限增强的正向循环。 当然，数量和质量并不是平台化模式成功与否的评判标准，更进一步的，可复制性与风险控制能力则是飞轮高速转动的基础。 参考海外成功的平台型公司如Roivant，新桥生物的未来价值兑现路径清晰、空间可期。其通过“中心-辐射”模式，建立多个专注特定资产的子公司，既保证了运营聚焦，又分散了单一管线失败的风险。转型后新桥生物成立的第一家子公司Visara，专注眼科创新药VIS-101的开发，并配置业内顶尖的团队，加速这款VEGF-A/ANG2双抗挑战百亿美元级市场。 相较于其他平台型公司，新桥生物的独特优势体现在多个维度——既有看得见的资源积累，更有“看不见”却至关重要的“人的优势”，尤其是执行董事长傅唯的深度绑定与全面赋能。这也是新桥生物成功的最大底气。 / 04 / 背靠康桥，生态协同加速进击 战略清晰（平台化模式）+能力落地（Givastomig验证）+生态协同（康桥资本及合作伙伴网络）三位一体，正共同推动一个全新的全球生物科技平台标杆加速运转。 正如前文所言，新桥生物的独特优势还在于“人”。公司核心团队兼具跨国药企经验与全球化视野，执行董事长傅唯，从投资人转型企业管理台前，年轻有为的他希望在新桥生物再造一个康桥资本这样百亿美金的神话，依托着全球化的广阔视野，其资源整合能力与执行力均处于行业领先水平，为新桥生物构筑了核心竞争壁垒。 一方面，傅唯能直接为新桥生物导入康桥资本的优质资源积淀，手握无可比拟的中国创新药资源获取渠道。依托400+项目库与百亿美元资金池，公司可高效筛选出具备全球竞争力的早期创新资产。在此基础上，新桥生物既能充分借力中国丰富的临床资源红利，实现更高效率、更低成本的临床开发；又能借助美国的临床资源与成熟监管经验，保障临床数据的全球认可度，为资产的国际化布局奠定基础。 另一方面，傅唯对新桥生物的赋能不止于管线层面。依托其在资本运作与实业运营等众多生物医药项目中积累的丰富经验，新桥生物在资产筛选、临床阶段的风险识别与战略调整上更具精准度。例如，年初公司主动开展管线优先级梳理，将Givastomig列为优先开发项目，这一决策正是其精准战略判断的有力佐证。 与此同时，傅唯的进取、开拓的魄力及其与新桥生物的深度绑定，更赋予了公司外界难以窥见的韧性与破釜沉舟的底气。这种核心管理层的坚定信念与深度投入，会渗透到团队运营的方方面面，进而凝聚成强劲的团队凝聚力与执行力，为公司的长期发展注入持续动力。 也正因此，从Givastomig的一鸣惊人，到引进平台飞轮的全面加速，新桥生物能够在短时间内改变市场对其价值认知。 更重要的是，其平台化进化，承载着超越自身的行业生态价值——致力于破解中国创新药行业长期存在的“卖青苗”和“被赚差价”的痛点，为整个行业的价值提升路径，提供一个充满希望的标杆。 在这条难而正确的道路上，新桥生物的进击之路，才刚刚开始。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。