Trastuzumab-PKRB(Celltrion)

医学内容仅供参考，并不能视作专业意见。如需获取医疗帮助或意见，请咨询专业人士 韩国Celltrion（赛尔群）是全球生物类似药领域的标杆头部企业，自研原料药全部聚焦重组单抗生物类似药、下一代ADC、多靶点代谢创新药三大核心赛道‌，依托其韩国松岛、美国新泽西自有cGMP生物生产基地的独家高表达CHO/Sp2/0细胞株构建、连续流生物反应器纯化自研技术平台打造，是全球抗体类自研原料药供应链自主可控程度最高的韩国药企。 1、已商业化核心自研生物类似药原料药 英夫利昔单抗（Remsima）自研原料药‌：全球首款获批上市的单抗生物类似药自研原料药，通过独家Sp2/0细胞株构建工艺实现高纯度量产，完全符合EMA、FDA超严苛生物类似药质控标准，与原研药的氨基酸序列、高级结构、体内药代动力学表现100%匹配，用于类风湿关节炎、克罗恩病等自身免疫性疾病治疗，目前已在全球超110个国家获批上市 。 曲妥珠单抗（Herzuma）自研原料药‌：全球乳腺癌领域的标杆自研生物类似药原料药，依托其独家CHO高表达细胞株工艺实现高活性稳定量产，在日本市场市占率已达78%，欧洲市场市占率突破30%，是全球曲妥珠单抗生物类似药领域的核心自研供应品种 。 阿达木单抗（Yuflyma）/贝伐珠单抗（Vegzelma）/利妥昔单抗（Truxima）全系列自研原料药‌：覆盖全球TOP5重磅自身免疫、肿瘤类单抗生物类似药，所有自研原料药全链条自主可控，配套其自有皮下注射剂型制剂，在欧盟五大市场阿达木单抗市占率已稳居头部位置 。 乌司奴单抗/奥马珠单抗自研原料药‌：2026年新获批上市的新一代自身免疫类单抗自研原料药，其中乌司奴单抗已在日本获批新增适应症，奥马珠单抗300mg规格已在欧洲核心国家上市，进一步完善其自研生物类似药管线布局 。 2、下一代ADC自研原料药管线 CT-P70（cMET靶向ADC）自研原料药‌：获美国FDA快速通道资格，依托其独家喜树碱类新型载荷自研工艺，完全区别于传统MMAE类微管抑制剂，通过强效旁观者效应精准杀伤cMET高表达的非小细胞肺癌等实体瘤细胞，目前已推进至I期临床给药阶段 。 CT-P71（Nectin-4靶向ADC）/CT-P73（TF靶向ADC）自研原料药‌：两款自研ADC原料药均已获FDA快速通道资格，分别针对尿路上皮癌、宫颈癌/结直肠癌等实体瘤，2026年底将完成I期临床第一阶段，2027年上半年将公布初步临床数据 。 下一代双表位ADC/双载荷ADC自研原料药‌：Celltrion自研的新一代ADC技术平台，可同时靶向肿瘤细胞两个不同抗原，或在单个抗体上偶联两种不同作用机制的细胞毒药物，计划2028年前累计提交9款ADC自研原料药的IND申请 。 3、代谢与创新药领域核心自研原料药 CT-G32全球首创四靶点肥胖症自研原料药‌：全球首个同时靶向4个代谢相关靶点的GLP-1类自研多肽原料药，在临床前研究中展现出比现有三靶点激动剂更优异的减重效果，同时可有效保护肌肉等瘦体重不流失，目前正在开展非人灵长类毒理试验，计划2027年2月提交IND申请，2027年第二季度启动I期临床 。 多特异性抗体/微生物组治疗自研原料药‌：Celltrion自研的多特异性抗体原料药针对难治性实体瘤，同时布局肠道菌群相关治疗自研原料药，覆盖肠易激综合征、特应性皮炎、多重耐药菌感染等多个未满足临床需求的适应症 。 核心自研特色 Celltrion拥有全球最大规模的抗体类自研原料药生产集群，韩国松岛基地现有25万升生物反应器产能，正在建设的4号、5号工厂将新增18万升产能，美国新泽西基地总产能已扩展至14.1万升，所有生产设施全部通过FDA、EMA双重cGMP认证，依托其8~9个月即可完成高表达细胞株构建的独家自研技术，实现从细胞株开发、上游连续流培养、下游多步层析纯化到最终制剂灌装的全链条垂直整合，是全球少数掌握全系列重组单抗、下一代ADC全链条自研量产能力的头部生物药企，计划2030年前将自研生物类似药管线扩展至18款，2038年达到41款的规模 。

New data show favorable outcomes with subcutaneous infliximab following intravenous infliximab interruption, regardless of prior antibody status, in adult patients with moderate to severely active Crohn's disease and ulcerative colitis Late-breaking analysis shows significantly higher rates of clinical remission and improved endoscopic outcomes with subcutaneous versus intravenous infliximab in patients with ileum-dominant Crohn's disease Oct. 11, 2026 -- Celltrion USA, Inc. today announced that two analyses evaluating ZYMFENTRA® (infliximab-dyyb) will be presented in oral presentations on Oct. 13 and 14 at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee. The data include a late-breaking pooled and propensity score-matched analysis comparing subcutaneous (SC) and intravenous (IV) infliximab in patients with ileum-dominant Crohn's disease, as well as a post hoc analysis from the Phase 3 LIBERTY-CD and LIBERTY-UC studies assessing the impact of prior anti-drug antibody (ADA) status on clinical outcomes following SC infliximab 240 mg initiation after interruption of IV infliximab treatment. [1,2] "People living with inflammatory bowel disease (IBD) can have varied disease characteristics, presentations, and treatment histories that may shape a unique care pathway, and clinicians need evidence that reflects the range of patients they see," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "We're pleased to share new analyses at ACG that provide additional information about subcutaneous infliximab in Crohn's disease and ulcerative colitis and reflect Celltrion's commitment to advancing clinically meaningful research for the IBD community." Presentation Details Both analyses will be presented by Marla Dubinsky, M.D., Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine, Mount Sinai, New York. Post Hoc Analysis of LIBERTY-CD and -UC Studies Following an IV Infliximab Treatment Interruption Date: Tuesday, Oct. 13, from 2:45-2:55 p.m. CT Room: Karl F. Dean Grand Ballroom A, Level 4 Abstract Title: "Impact of Prior Anti-drug Antibody Status on Clinical Outcomes Following Subcutaneous Infliximab Initiation After Intravenous Infliximab Interruption: A Post Hoc Analysis of LIBERTY-CD and -UC Studies" Session: Plenary Session 3A: IBD Presentation: 40 A separate post hoc analysis evaluated efficacy, serum infliximab concentrations, and immunogenicity among patients from the placebo arms of the Phase 3 LIBERTY-CD and LIBERTY-UC studies who initiated SC infliximab 240 mg every two weeks following an interruption in IV infliximab treatment. Patients were assessed according to whether anti-drug antibodies (ADAs) had been detected before they began SC infliximab.[2] Among patients who initiated SC infliximab 240 mg, 72.5% (37 of 51) of patients with Crohn's disease and 92.2% (71 of 77) of patients with ulcerative colitis had prior ADA positivity. The median interval between the last IV infliximab infusion and initiation of SC infliximab was 16 weeks in ADA-positive and ADA-negative patients in both the Crohn's disease and ulcerative colitis groups.[2] Across Crohn's disease and ulcerative colitis populations, the analysis found clinical outcomes were generally similar regardless of whether patients had ADAs before starting SC infliximab, with clinical response in Crohn's disease and partial clinical response in ulcerative colitis observed by 8±2 weeks and sustained through 78 to 80 weeks. Serum infliximab concentrations increased after initiation of SC infliximab and were generally comparable over time across ADA-status groups. Levels of fecal calprotectin and C-reactive protein decreased at the first assessment after treatment began and remained lower through the final assessment. ADA positivity declined among patients with pre-existing ADAs, while new ADA development was uncommon in patients without prior ADAs. "Anti-drug antibodies to intravenous infliximab can compromise infliximab reinitiation after treatment interruption. Data on subcutaneous infliximab initiation after a drug holiday are limited, particularly regarding the impact of prior ADA status on clinical outcomes," said Marla Dubinsky, M.D., Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine, Mount Sinai, New York. "These post hoc findings suggest that prior ADA status did not appear to compromise clinical outcomes after initiating subcutaneous infliximab following drug holiday after intravenous infliximab induction." Date: Wednesday, Oct. 14, from 9:30-9:40 a.m. CT. Late-Breaking Abstract Title: "Comparative Efficacy of Subcutaneous Versus Intravenous Infliximab in Ileum-Dominant Crohn's Disease: A Pooled Analysis and Propensity Score-Matched Analysis of Infliximab Registrational Studies" Session: Plenary Session 4B: Liver, Esophagus, CRC, IBD Presentation: 72 The late-breaking abstract reports a pooled analysis of individual patient data from four infliximab registrational studies. The analysis included patients with ileal or ileocolonic Crohn's disease who received standard maintenance treatment with SC infliximab 120 mg every two weeks or IV infliximab 5 mg/kg every eight weeks. Of 884 patients across the studies, 200 met the eligibility criteria; a 1:1 propensity score-matched analysis included 70 patients in each treatment group.[1]In the matched population at Week 54, patients receiving SC infliximab had higher rates of clinical remission, endoscopic response, and endoscopic remission than those receiving IV infliximab:[1] Clinical remission: 71.4% vs. 51.4% (P = 0.023) Endoscopic response: 65.7% vs. 27.1% (P < 0.001) Endoscopic remission: 41.4% vs. 17.1% (P = 0.003) The analysis also found that, in both treatment groups, endoscopic responders had significantly higher serum infliximab concentrations than nonresponders. ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. The American College of Gastroenterology (ACG) is a recognized leader in educating GI professionals and the general public about digestive disorders. ACG's mission is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation, and advocacy in the areas of scientific investigation, education, prevention, and treatment. The 2026 ACG Annual Scientific Meeting & Postgraduate Course will convene in Nashville, Tennessee, from October 9 to 14, 2026. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, endocrinology and ophthalmology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), EGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO ® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. The content above comes from the network. if any infringement, please contact us to modify.