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Median overall survival not yet reached with projected improvement of more than one year versus osimertinib RARITAN, NJ, USA I March 26, 2025 I Johnson & Johnson (NYSE: JNJ ) today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT ® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor ( EGFR ) exon 19 deletions (ex19del) or L858R substitution mutations. Median OS is projected to exceed one year beyond the median of three years observed with osimertinib and has not yet been reached. This is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib. New compelling data were presented during a proffered paper session at the 2025 European Lung Cancer Congress (ELCC) (Abstract #4O). 1 “The survival curve tells a clear story. RYBREVANT plus LAZCLUZE helps patients live longer, and the benefit keeps growing over time,” said trial investigator Professor Nicolas Girard*, M.D., Ph.D., Head of Medical Oncology, Institut Curie, and Professor of Thoracic Oncology and Respiratory Medicine at the Paris-Saclay University, France. “We see the gap between the survival curves continue to widen, which is exactly what we want to see in lung cancer treatment to improve outcomes for patients. These results reinforce that we are entering a new era for EGFR -mutated non-small cell lung cancer; with this evidence in hand, we need to ensure every patient gets the most effective treatment in the first line for the best possible chance at longer survival.” Unlike progression-free survival (PFS), which tracks the time a treatment keeps a patient’s cancer from progressing, OS helps patients understand the impact therapy could have on the ability to live longer from the start of treatment. Extending life expectancy is the most meaningful indicator of a treatment’s impact. At a median follow-up of 37.8 months, patients treated with the chemotherapy-free regimen of first-line RYBREVANT ® plus LAZCLUZE™ had a significantly longer OS compared to those receiving osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92; nominal P<0.005). Median OS for RYBREVANT ® plus LAZCLUZE™ has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period (not reached [NR]; 95 percent CI, 42.9-NR). Comparatively, median OS for osimertinib-treated patients was 36.7 months (95 percent CI, 33.4-41.0) and consistent with prior studies with osimertinib. Fifty-six percent of patients treated with RYBREVANT ® and LAZCLUZE™ were alive at three and a half years compared to 44 percent of patients on osimertinib. Projections based on survival data suggest RYBREVANT ® plus LAZCLUZE™ could extend median OS by at least 12 months compared to osimertinib. 1 The RYBREVANT ® combination also prolonged multiple secondary endpoints vs osimertinib, including intracranial PFS, intracranial duration of response (DOR) and intracranial overall response rate (ORR). Notably, RYBREVANT ® plus LAZCLUZE™ prolonged time to symptomatic progression (TTSP) – the time from treatment randomization to the onset of lung cancer symptoms – by more than 14 months compared to osimertinib (43.6 months vs 29.3 months; HR, 0.69; 95 percent CI, 0.57–0.83; nominal P<0.001). This is a key patient-centered measure, highlighting how long quality of life can be preserved before lung cancer symptoms emerge. 1 “Right now, only twenty percent of patients with EGFR- positive NSCLC survive beyond five years. These MARIPOSA results suggest that RYBREVANT plus LAZCLUZE can change this dire statistic that has been stagnant for far too long,” said Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “This regimen isn’t just extending survival, it’s offering hope. By using RYBREVANT plus LAZCLUZE first, we’re delaying the need for chemotherapy and giving patients and their families more time.” The safety profile of RYBREVANT ® plus LAZCLUZE™ was consistent with the primary analysis, with adverse event (AE) rates comparable to other RYBREVANT ® regimens. No new safety signals were identified with the additional longer-term follow-up. Most AEs occurred early during RYBREVANT ® and LAZCLUZE™ treatment. 1 RYBREVANT ® research findings suggest that implementing prophylactic measures during the first four months of RYBREVANT ® and LAZCLUZE™ treatment may significantly reduce the risk of skin reactions, infusion-related reactions and venous thromboembolic events. 2,3,4 The MARIPOSA study met its primary endpoint in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib. RYBREVANT ® plus LAZCLUZE™ is approved in the United States, Europe and other markets around the world for patients with first-line EGFR -mutated NSCLC. These OS results will be shared with health authorities globally. About the MARIPOSA Study MARIPOSA ( NCT04487080 ), which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating RYBREVANT ® in combination with LAZCLUZE™ versus osimertinib and versus LAZCLUZE™ alone in first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations. The primary endpoint of the study is PFS (using RECIST v1.1 guidelines**) as assessed by BICR. Secondary endpoints include OS, ORR, DOR, PFS2 and intracranial PFS. 5 About RYBREVANT ® RYBREVANT ® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S. , Europe and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. 6 RYBREVANT ® is approved in the U.S. , Europe and other markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. RYBREVANT ® is approved in the U.S., Europe and other markets around the world in combination with LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. RYBREVANT ® is approved in the U.S. , Europe and other markets around the world in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR TKI. In February 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of SC amivantamab and LAZCLUZE™ in Europe for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. The National Comprehensive Cancer Network ® (NCCN ® ) Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for NSCLC § prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Guidelines include: In addition to the Phase 3 MARIPOSA Study, RYBREVANT ® is being studied in multiple clinical trials in NSCLC, including: For more information, visit: https://www.RYBREVANT.com . About LAZCLUZE™ In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (marketed as LECLAZA in South Korea). LAZCLUZE™ is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR . An analysis of the efficacy and safety of LAZCLUZE™ from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023. 21 About Non-Small Cell Lung Cancer Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. 22,23 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. 24 Among the most common driver mutations in NSCLC are alterations in EGFR , which is a receptor tyrosine kinase controlling cell growth and division. 25 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients. 22,23,26,27,28,29 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations. 30 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent. 31,32 EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation. 33 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent. 34 Please read full Prescribing Information for RYBREVANT ® . Please read full Prescribing Information for LAZCLUZE™. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com or at http://www.innovativemedicine.jnj.com/ . Follow us at @JNJInnovMed . Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen-Cilag, S.A. are Johnson & Johnson companies. *Nicolas Girard, M.D., Ph.D., has served as a consultant to Johnson & Johnson; he has not been paid for any media work. **RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger. †See the NCCN Guidelines for detailed recommendations, including other treatment options. ‡The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories. §The NCCN Content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 1 Yang J, et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line (1L) EGFR-mutant (EGFRm) Advanced NSCLC: Final Overall Survival (OS) from the Phase 3 MARIPOSA Study. 2025 European Lung Cancer Congress. March 26, 2025. 2 Johnson & Johnson. COCOON study meets primary endpoint demonstrating statistically significant and clinically meaningful reduction in dermatologic reactions with easy-to-use prophylactic regimen for patients with EGFR-mutated NSCLC. January 14, 2025. Accessed February 13, 2025. 3 Spira AI, et al. J Thorac Oncol. 2025. In press. 4 Leighl N, et al. J Clin Oncol. 2024;42(30):3593-3605. 5 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). https://classic.clinicaltrials.gov/ct2/show/NCT04487080. Accessed March 2025. 6 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 7 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2025 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed March 2025. 8 ClinicalTrials.gov. A Study of Amivantamab and LAZCLUZE™ in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2). Available at: https://classic.clinicaltrials.gov/ct2/show/study/NCT04988295. Accessed March 2025. 9 ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON). Available at: https://clinicaltrials.gov/ct2/show/NCT04538664. Accessed March 2025. 10 ClinicalTrials.gov. A Study of LAZCLUZE™ With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). https://clinicaltrials.gov/ct2/show/NCT05388669. Accessed March 2025. 11 ClinicalTrials.gov. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PALOMA-2). https://clinicaltrials.gov/ct2/show/NCT05498428. Accessed March 2025. 12 ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (PALOMA). Available at: https://clinicaltrials.gov/study/NCT04606381. Accessed March 2025. 13 ClinicalTrials.gov. A Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS). https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed March 2025. 14 ClinicalTrials.gov. A Study of LAZCLUZE™ as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (CHRYSALIS-2). https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed March 2025. 15 ClinicalTrials.gov. A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer (METalmark). https://clinicaltrials.gov/ct2/show/NCT05488314. Accessed March 2025. 16 ClinicalTrials.gov. A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer (swalloWTail). https://www.clinicaltrials.gov/study/NCT06532032. Accessed March 2025. 17 ClinicalTrials.gov. A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (PolyDamas). https://www.clinicaltrials.gov/study/NCT05908734. Accessed March 2025. 18 ClinicalTrials.gov. Premedication to Reduce Amivantamab Associated Infusion Related Reactions (SKIPPirr). https://classic.clinicaltrials.gov/ct2/show/NCT05663866. Accessed March 2025. 19 ClinicalTrials.gov. A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS). https://www.clinicaltrials.gov/study/NCT06667076. Accessed March 2025. 20 ClinicalTrials.gov. Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (COCOON). https://www.clinicaltrials.gov/study/NCT06120140. Accessed March 2025. 21 Cho BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217. 22 The World Health Organization. Cancer. https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/cancer. Accessed March 2025. 23 American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed March 2025. 24 Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.10 25 Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 26 Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 37:97-104. 27 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 28 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993. 29 Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911. 30 American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed March 2025. 31 Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site. 32 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65. 33 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9. 34 Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 35 LAZCLUZE™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. SOURCE: Johnson & Johnson

上海 2025年3月26日 /美通社/ -- 君实生物（1877.HK，688180.SH）宣布，由公司自主研发的抗PD-1单抗药物特瑞普利单抗（新加坡商品名：LOQTORZI ® ）联合顺铂和吉西他滨用于复发、不能手术或放疗的，或转移性鼻咽癌成人患者的一线治疗的上市许可申请获得新加坡卫生科学局（HSA）批准。特瑞普利单抗成为新加坡 首个且唯一 获批用于鼻咽癌的肿瘤免疫治疗药物。 鼻咽癌是一种发生于鼻咽部黏膜上皮的恶性肿瘤，是常见的头颈部恶性肿瘤之一。 报告指出 ，2022年鼻咽癌在全球范围内确诊的新发病例数超过12万 [1] 。特瑞普利单抗是《美国国家综合癌症网络（NCCN）头颈部肿瘤临床实践指南2025.V1》中推荐用于复发/转移性鼻咽癌全线治疗的 唯一首选 药物 [2] 。 本次鼻咽癌适应症的获批主要基于JUPITER-02（一项针对一线治疗鼻咽癌的随机、双盲、安慰剂对照、国际多中心Ⅲ期临床研究，NCT03581786）的研究结果。JUPITER-02研究是鼻咽癌免疫治疗领域首个国际多中心、样本量最大的双盲、随机对照III期临床研究，也是全球首个鼻咽癌一线免疫联合化疗对比单纯化疗将总生存期（OS）预设有统计学检验（一类错误控制）并确证具有生存获益的Ⅲ期临床研究。该研究结果曾以口头报告形式亮相2021年美国临床肿瘤学会（ASCO）年会全体大会（ #LBA2 ），随后荣登《自然-医学》（ Nature Medicine ）杂志封面，并获得《美国医学会杂志》（ Journal of the American Medical Association，JAMA ）全文发表。 研究结果显示，与单纯化疗相比，特瑞普利单抗联合化疗使患者的疾病进展风险降低48%，死亡风险降低37%。特瑞普利单抗联合化疗组的中位无进展生存期（PFS）对比单纯化疗延长了13.2个月，从8.2个月提升至21.4个月。此外，接受该联合疗法治疗的患者可获得更高的客观缓解率（ORR）和更长的持续缓解时间（DoR），完全缓解（CR）率达到26.7%，且未发现新的安全性信号。长期生存随访数据在2024年ASCO年会展示，特瑞普利单抗治疗组5年生存率达到52%。 君实生物总经理兼首席执行官邹建军博士 表示："特瑞普利单抗在新加坡获批标志着我们正式登陆东南亚市场。东南亚是鼻咽癌的高发地区之一，我们很高兴能够将鼻咽癌领域具有划时代意义的创新疗法带给东南亚患者，以改变当地的治疗格局。目前，特瑞普利单抗已成功在全球四个大洲的超过35个国家和地区获批上市。我们将继续深化‘立足中国，布局全球'的国际化战略，推动中国创新药造福世界患者。" 此次上市许可申请的递交是通过 奥比斯项目（ Project Orbis） 。该项目由美国食品药品监督管理局（FDA）肿瘤学卓越中心（OCE）发起和倡导，为FDA和其它国家及地区的监管机构搭建合作机制和框架，允许不同监管机构共同审评肿瘤药品的注册申请。特瑞普利单抗治疗是首个被纳入奥比斯项目的国产肿瘤药，此前君实生物通过奥比斯项目向澳大利亚药品管理局（TGA）递交的特瑞普利单抗鼻咽癌适应症的2项上市许可申请已获得TGA批准。 【参考文献】 1. https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/4-nasopharynx-fact-sheet.pdf. 2. 2025NCCN 临床实践指南：头颈部肿瘤（2025.V1） 1. 本材料旨在传递前沿信息，无意向您做任何产品的推广，不作为临床用药指导。 2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导。 关于特瑞普利单抗注射液（拓益 ® ） 特瑞普利单抗注射液（拓益 ® ）作为我国批准上市的首个国产以PD-1为靶点的单抗药物，获得国家科技重大专项项目支持，并荣膺国家专利领域最高奖项"中国专利金奖"。 特瑞普利单抗至今已在全球（包括中国、美国、欧洲及东南亚等地）开展了覆盖超过15个适应症的40多项由公司发起的临床研究。正在进行或已完成的关键注册临床研究在多个瘤种范围内评估特瑞普利单抗的安全性及疗效，包括肺癌、鼻咽癌、食管癌、胃癌、膀胱癌、乳腺癌、肝癌、肾癌及皮肤癌等。 截至目前，特瑞普利单抗已在中国内地获批11项适应症：用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗（2018年12月）；用于既往接受过二线及以上系统治疗失败的复发/转移性鼻咽癌患者的治疗（2021年2月）；用于含铂化疗失败包括新辅助或辅助化疗12个月内进展的局部晚期或转移性尿路上皮癌的治疗（2021年4月）；联合顺铂和吉西他滨用于局部复发或转移性鼻咽癌患者的一线治疗（2021年11月）；联合紫杉醇和顺铂用于不可切除局部晚期/复发或远处转移性食管鳞癌患者的一线治疗（2022年5月）；联合培美曲塞和铂类用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌的一线治疗（2022年9月）；联合化疗围手术期治疗，继之本品单药作为辅助治疗，用于可切除IIIA-IIIB期非小细胞肺癌的成人患者（2023年12月）；联合阿昔替尼用于中高危的不可切除或转移性肾细胞癌患者的一线治疗（2024年4月）；联合依托泊苷和铂类用于广泛期小细胞肺癌一线治疗（2024年6月）；联合注射用紫杉醇（白蛋白结合型）用于经充分验证的检测评估PD-L1阳性（CPS≥1）的复发或转移性三阴性乳腺癌的一线治疗（2024年6月）；联合贝伐珠单抗用于不可切除或转移性肝细胞癌患者的一线治疗（2025年3月）。2020年12月，特瑞普利单抗首次通过国家医保谈判，目前已有10项获批适应症纳入《国家医保目录（2024年）》，是目录中唯一用于黑色素瘤、非小细胞肺癌围手术期、肾癌、三阴性乳腺癌治疗的抗PD-1单抗药物。2024年10月，特瑞普利单抗用于复发/转移性鼻咽癌治疗的适应症在中国香港获批。 在国际化布局方面，特瑞普利单抗目前已在美国、欧盟、印度、英国、约旦、澳大利亚、新加坡等国家和地区获得批准上市，并在全球多个国家或地区接受上市审评。 关于君实生物 君实生物（688180.SH，1877.HK）成立于2012年12月，是一家以创新为驱动，致力于创新疗法的发现、开发和商业化的生物制药公司。依托全球一体化源头创新研发能力，公司已构建起涵盖超过50款创新药物的多层次产品管线，覆盖恶性肿瘤、自身免疫、慢性代谢类、神经系统、感染性疾病五大治疗领域，已有5款产品在国内或海外上市，包括我国首个自主研发、在中美欧等地超过35个国家和地区获批上市的PD-1抑制剂特瑞普利单抗（拓益 ® ）。疫情期间，君实生物还参与开发了埃特司韦单抗、民得维 ® 等多款预防和治疗新冠的创新药物，积极承担本土创新药企的责任。 君实生物以"用世界一流、值得信赖的创新药普惠患者"为使命，立足中国，布局全球。目前，公司在全球拥有约2500名员工，分布在美国旧金山和马里兰，中国上海、苏州、北京、广州等。 官方网站： www.junshipharma.com 官方微信：君实生物