Gemcitabine Hydrochloride

Long-term OS follow-up analysis of JUPITER-02 demonstrates significantly better and clinically meaningful improvement with toripalimab plus chemotherapy as 1st-line treatment for R/M NPC, achieving mOS of 64.8 months and a 5-year OS rate of 52.3%. Torpalimab plus chemotherapy has been approved in over 40 countries, representing the new standard of care for the 1st line treatment of R/M NPC. The final OS analysis of JUPITER-06 confirms the sustained survival benefit with toripalimab plus chemotherapy in advanced ESCC, showing a mOS of 17.7 months and a 3-year OS rate of 29.7%. Results from JUPITER-02 and JUPITER-06 were orally presented at ESMO Asia 2025. Dec. 05, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced new and promising long-term survival results from JUPITER-02 (NCT03581786) and JUPITER-06 (NCT03829969) at the European Society for Medical Oncology (ESMO) ASIA Congress 2025. JUPITER-02 and JUPITER-06 evaluated toripalimab, an anti-PD-1 antibody developed by Junshi Biosciences, in combination with chemotherapy as first-line treatment for recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) in JUPITER-02 and advanced or metastatic esophageal squamous cell carcinoma (ESCC) in JUPITER-06. Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences and TopAlliance Biosciences, said: "At ESMO ASIA, we were excited to share the latest long-term survival follow-up data from the Phase 3 JUPITER-02 and JUPITER-06 trials. These remarkable results set new records for the longest survival benefit achieved with immuno-oncology (I-O) therapy in certain NPC and ESCC populations, further cementing toripalimab's global leadership in immunotherapy for advanced NPC and ESCC. It’s so encouraging to see toripalimab now approved in over 40 countries and regions worldwide, giving more patients access to the new standard of care. We extend our deepest gratitude to the patients, their families, investigators and the R&D teams who made these landmark studies possible." JUPITER-02, the first global multicenter, double-blind, randomized Phase 3 trial in immunotherapy for NPC, has reported breakthrough results at multiple international congresses. Its interim and final overall survival (OS) analyses were published in Nature Medicine and the Journal of the American Medical Association (JAMA), respectively, making it the first NPC immunotherapy study featured in JAMA. The JUPITER-02 5-year OS follow-up data was presented at the ESMO Asia 2025, and it demonstrated sustained clinical benefits of toripalimab plus chemotherapy in R/M NPC. The JUPITER-02 trial enrolled 289 chemotherapy-naïve patients with R/M NPC, randomizing them 1:1 to receive either toripalimab 240 mg (n=146) or placebo (n=143) combined with gemcitabine/cisplatin (GP) chemotherapy every 3 weeks (Q3W) for ≤6 cycles, followed by toripalimab or placebo monotherapy (Q3W) until disease progression, unacceptable toxicity, or 2-year treatment completion. Stratification factors included baseline ECOG status (0 vs. 1) and disease extent (recurrent vs. primary metastatic). The primary endpoint was Blinded Independent Review Committee (BIRC)-assessed progression-free survival (PFS) per RECIST v1.1 in the intent-to-treat (ITT) population. The secondary endpoints included OS (key secondary), investigator-assessed PFS, objective response rate (ORR), safety, etc. By the data cut-off date, June 24, 2025, the toripalimab arm had demonstrated consistently significant survival improvements with the final OS analysis. Patients on toripalimab achieved a median OS (mOS) of 64.8 months compared to the 33.7 months seen with placebo. This 31.1-month extension in median survival also meant a 39% reduction in death risk (HR=0.62; 95%CI: 0.45-0.85; p=0.0027), with a 5-year OS rate of 52.3% vs. 33.9%. PD-L1 expression subgroup analyses revealed consistent OS improvements regardless of PD-L1 status. As the first trial to confirm survival benefits with first-line immunotherapy for NPC, JUPITER-02 has now established a transformative global standard for R/M NPC treatment. Toripalimab plus GP chemotherapy is now approved in over 40 countries and endorsed by 3 major international guidelines (CSCO, NCCN, and ESMO), establishing a new benchmark for first-line R/M NPC therapy worldwide. JUPITER-06 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of toripalimab combined with TP (paclitaxel + cisplatin) chemotherapy versus placebo plus TP chemotherapy as first-line treatment for advanced or metastatic ESCC. The findings from JUPITER-06 have been presented at major international congresses and published in top-tier journals, including Cancer Cell and the Journal of Clinical Oncology (JCO). Results from the JUPITER-06 final analysis and biomarker evaluation were presented at the ESMO ASIA 2025. The JUPITER-06 trial enrolled 514 systemic treatment-naïve patients with advanced or metastatic ESCC, randomly assigning 1:1 to receive either toripalimab 240 mg plus TP chemotherapy (n=257) or placebo plus TP chemotherapy (n=257) Q3W for ≤6 cycles, followed by toripalimab or placebo monotherapy Q3W. With stratification by baseline ECOG status (0 vs. 1) and prior radiotherapy history (yes vs. no), the study featured dual primary endpoints of PFS and OS assessed by BICR per RECIST v1.1, alongside secondary endpoints including investigator-assessed PFS, ORR, safety, etc. By the data cut-off date, February 23, 2023 (median follow-up: 14.2 months), the pre-specified final OS analysis of JUPITER-06 demonstrated that according to the BICR, the toripalimab arm achieved a mOS of 17.7 months versus 12.9 months in the placebo arm, with a 28% reduction in death risk (HR=0.72, 95% CI: 0.58–0.88; P=0.002). The 2-year and 3-year OS rates are 39.1% vs. 27.1% and 29.7% vs. 19.9%, respectively. Key subgroup analyses showed consistent OS benefits with toripalimab plus chemotherapy across all subgroups. Specifically, the PD-L1 expression subgroup analysis revealed improved OS in the toripalimab arm regardless of PD-L1 expression status. Long-term follow-up revealed no new safety signals. Treatment-emergent adverse events (TEAEs) related to study treatment were comparable between the toripalimab arm and the placebo arm, with both groups showing a 97.3% incidence rate. Furthermore, the investigators conducted translational research that, for the very first time, systematically identified predictive biomarkers for the "anti-PD-1 antibody + chemotherapy" combination. The results helped establish the world's first Esophageal Genomic Immunophenotype Classification (EGIC). This new framework prospectively pinpoints potential precision-targeted strategies for patients who respond poorly to chemo-immunotherapy, paving a practice-changing path for guiding more individualized clinical therapy and developing future combination approaches. Up till now, toripalimab has gained approval for first-line treatment of advanced ESCC in China, EU, and multiple countries. Notably, it stands as Europe's first anti-PD-1 antibody approved for 1L advanced ESCC regardless of PD-L1 expression status. Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are twelve approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy; recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy; locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC; in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC); in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC); in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC; in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC); in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC); in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients; first-line treatment for unresectable or metastatic melanoma. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. Toripalimab for the treatment of advanced NPC and ESCC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore, United Arab Emirates, Kuwait, Pakistan, Canada and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe. Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). The content above comes from the network. if any infringement, please contact us to modify.

整理：肿瘤资讯 来源：肿瘤资讯 国家药品监督管理局（NMPA）已正式公布2025年国家医保目录，恒瑞医药在肿瘤治疗领域的多款创新药物成功纳入新版目录。作为中国医药创新的核心力量，恒瑞医药在肿瘤治疗领域的成果尤为值得期待。恒瑞肿瘤事业部历经三十余年深耕，已构建起一个深度覆盖多种高发肿瘤、涵盖免疫治疗、靶向治疗、抗体偶联药物（ADC）等前沿作用机制的差异化产品矩阵。依托全方位的技术平台，恒瑞肿瘤在实体瘤领域实现了跨瘤种、多阶段的系统化布局，并致力于为患者提供覆盖疾病全周期的“一站式”治疗与管理方案。 本次医保目录调整中，恒瑞肿瘤共有11款产品成功纳入，包括5款首次纳入国家医保目录的创新产品，3款创新药的关键新适应症，以及3款重点产品的目录内续约。这些产品的成功纳入，将极大提升我国肿瘤患者对前沿、高效治疗方案的可及性与可负担性。 5 款首次纳入国家医保目录的创新药产品 注射用瑞康曲妥珠单抗（商品名：艾维达®） 该药用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。基于关键性HORIZON-Lung研究结果[1]，瑞康曲妥珠单抗于2025年5月获NMPA批准用于治疗HER2突变NSCLC患者，该药也是国内首个获批用于HER2突变NSCLC的中国自主研发ADC药物。目前，瑞康曲妥珠单抗已有9项适应症被国家药监局药品审评中心（CDE）纳入突破性治疗品种名单，覆盖非小细胞肺癌、乳腺癌、胃癌、结直肠癌等多个瘤种，瑞康曲妥珠单抗联合阿得贝利单抗和化疗用于胃癌或胃食管结合部腺癌的适应症也已获得美国食品药品监督管理局（FDA）孤儿药资格认定，展现出广阔的应用前景。 注射用磷罗拉匹坦帕洛诺司琼（商品名：瑞坦宁®） 该药是中国首个超长效、原研双靶点止吐针剂，于2025年5月正式在中国获批上市，用于预防成人高度致吐性化疗（HEC）引起的恶心和呕吐。关键Ⅲ期PROFIT研究证实，在接受以顺铂为基础的HEC的患者中，磷罗拉匹坦帕洛诺司琼方案展现出优异的疗效，且每周期仅需给药一次，显著提升了患者的治疗依从性和生活质量[2]。 苹果酸法米替尼胶囊（商品名：艾比特®） 该药是恒瑞自主研发的多靶点酪氨酸激酶受体（RTK）抑制剂。法米替尼于2025年5月获得国内上市许可，其适应症为联合注射用卡瑞利珠单抗用于既往接受含铂化疗失败但未接受过贝伐珠单抗治疗的复发/转移性宫颈癌患者。该疗法在关键II期临床研究中展现出良好的疗效[3]。 醋酸阿比特龙片（II）（商品名：艾瑞吉®） 作为中国首个醋酸阿比特龙纳米晶制剂，该药于2023年12月获NMPA批准上市，联合泼尼松或泼尼松龙可用于治疗转移性去势抵抗性前列腺癌（mCRPC），以及新诊断的高危转移性内分泌治疗敏感性前列腺癌（mHSPC），包括未接受过内分泌治疗或接受内分泌治疗最长不超过3个月的患者。其创新的纳米晶技术优化了药物吸收，为前列腺癌患者提供了更便捷、高效的治疗方案。 盐酸伊立替康脂质体注射液（II）（商品名：越优力®） 该药于2023年12月在国内获批，适应症为联合氟尿嘧啶（5-FU）和亚叶酸钙（LV），用于既往经吉西他滨为基础的化疗失败的不可切除的局部晚期或转移性胰腺癌患者。基于中国人群的III期Pan-Heroic-1研究显示，对比常规化疗，伊立替康脂质体联合方案可有效延长患者的生存期，有望突破该类胰腺癌患者二线治疗的困境[4]。 3 款创新药产品的新增适应症纳入医保 氟唑帕利胶囊（商品名：艾瑞颐®） 该药是中国首个自主研发的聚腺苷二磷酸核糖聚合酶（PARP）抑制剂，近几年已在国内依次获批用于复发性卵巢癌、输卵管癌或原发性腹膜癌，以及乳腺癌的相关治疗。氟唑帕利今年纳入医保的新适应症为：单药或联合甲磺酸阿帕替尼用于伴有胚系BRCA突变（gBRCAm）的人表皮生长因子受体2（HER2）阴性转移性乳腺癌成年患者，其中激素受体（HR）阳性患者需接受过内分泌治疗或不适合内分泌治疗。FABULOUS研究显示，氟唑帕利联合阿帕替尼有望为伴有gBRCAm的HER2阴性转移性乳腺癌患者带来更优的靶向治疗策略[5]。至此，该产品已上市适应症均已纳入医保目录。 注射用卡瑞利珠单抗（商品名：艾瑞卡®） 该药是恒瑞自主研发并具有知识产权的人源化PD-1单克隆抗体，已在肺癌、肝癌、食管癌、鼻咽癌以及宫颈癌等瘤种中获批多项适应症。基于CLOVER研究的积极结果[3]，卡瑞利珠单抗联合苹果酸法米替尼用于复发/转移性宫颈癌的新适应症纳入医保，将进一步巩固其在妇科肿瘤领域的地位，惠及更多晚期宫颈癌患者。至此，该产品已上市适应症均已纳入医保目录。 甲磺酸阿帕替尼片（商品名：艾坦®） 该药是恒瑞研发的靶向VEGFR的小分子酪氨酸激酶抑制剂，已在胃癌、肝癌、乳腺癌获批4项适应症。阿帕替尼联合氟唑帕利用于新辅助、辅助或转移阶段接受过化疗治疗的伴有gBRCAm的HER2阴性转移性乳腺癌成年患者的新适应症，是“抗血管+PARP抑制剂”协同作用的成功实践。基于FABULOUS研究的有力数据[5]，该项医保新增适应症将使更多乳腺癌患者从精准联合治疗中获益。至此，该产品已上市适应症均已纳入医保目录。 3 款产品在医保目录内续约 马来酸吡咯替尼片（艾瑞妮®） 该药是恒瑞自主研发且具有知识产权的口服HER1/HER2/HER4酪氨酸激酶抑制剂。马来酸吡咯替尼于2018年获NMPA批准上市，并于2020年首次被纳入国家医保目录。本次医保目录更新后，吡咯替尼已获批的3项乳腺癌适应症均成功续约，分别为：1、本品联合卡培他滨，适用于治疗表皮生长因子受体2（HER2）阳性、既往未接受或接受过曲妥珠单抗的复发或转移性乳腺癌患者。使用本品前 患者应接受过蒽环类或紫杉类化疗。2、本品与曲妥珠单抗和多西他赛联合，适用于治疗表皮生长因子受体2（HER2）阳性、晚期阶段未接受过抗HER2治疗的复发或转移性乳腺癌患者。早期或局部晚期乳腺癌。3、本品与曲妥珠单抗和多西他赛联合，适用于表皮生长因子受体2（HER2）阳性早期或局部晚期乳腺癌患者的新辅助治疗。 海曲泊帕乙醇胺片（恒曲®） 作为恒瑞自主研发的新一代口服血小板生成素受体激动剂（TPO-RA），海曲泊帕乙醇胺片于2021年6月获NMPA批准上市，并于2022年首次纳入国家医保目录。该药续约成功并保留在国家医保目录的适应症包括：1.既往对糖皮质激素、免疫球蛋白等治疗反应不佳的慢性原发免疫性血小板减少症（ITP）成人患者；2.对免疫抑制治疗（IST）疗效不佳的重型再生障碍性贫血（SAA）成人患者。海曲泊帕乙醇胺片作为口服药物，极大提升了患者用药的便利性。本次成功续约，将进一步保障该药物的可及性与可负担性。  硫培非格司亭注射液（艾多®） 该药作为恒瑞自主研发的创新长效重组人粒细胞刺激因子（G-CSF），于2018年5月在中国获批上市，并于2020年首次纳入国家医保目录。硫培非格司亭注射液在国家医保目录的成功续约，将继续用于成年非髓性恶性肿瘤患者在接受易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染的发生率。 以创新为驱动，践行民族药企担当 近年来，在国家医保政策的战略引导下，中国原研药的创新价值正得到日益充分的体现。2025年医保目录首次确立的“双轨制”评审，为创新药提供了更多元的准入路径。这不仅呼应了患者的迫切需求，也激励着本土药企在创新之路上坚定前行。 长期以来，恒瑞医药积极响应国家号召，以“科技为本，为人类创造健康生活”为使命，致力于解决未被满足的临床需求。公司已构建起从基础研究到临床应用的全链条创新能力，力求将每一款药物都打造成精品。恒瑞肿瘤共16款已上市创新药中（14款1类新药，2款2类新药），已有14款纳入国家医保目录，实现了创新成果近全线的医保覆盖，让前沿治疗更大范围地惠及患者。 未来，恒瑞医药将继续坚守初心，聚焦临床价值，加快研制出更多新药、好药，并积极配合国家医保工作，提升创新药物的可及性与可负担性，让更多患者和家庭切实受益，为“健康中国2030”宏伟蓝图的实现贡献更多力量。 参考文献 [1] Li Z, Wang Y, Sun Y, et al. Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025 Apr;26(4):437-446.[2] Zhou H, Zhao Y, Zhang M, et al. Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. J Clin Oncol. 2025 Mar 20;43(9):1123-1136.[3] Xia L, Zhang K, Tang Y, et al. Camrelizumab Plus Famitinib versus Camrelizumab Alone and Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer: A Randomized, Phase II Study. J Clin Oncol. 2025 Aug 20;43(24):2720-2733.[4] Cui J, Qin S, Zhou Y, et al. Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. Signal Transduct Target Ther. 2024 Sep 19;9(1):248.[5] Liu Y, Wang W, Yin R, et al. A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis. BMC Med. 2023 Sep 29;21(1):376. 责任编辑：肿瘤资讯-Grady 排版编辑：肿瘤资讯-Fan 版权声明 本文专供医学专业人士参考，未经著作人许可，不可出版发行。同时，欢迎个人转发分享，其他任何媒体、网站如需转载或引用本网版权所有内容，须获得授权，且在醒目位置处注明"转自：良医汇-肿瘤医生APP"。