Enfortumab Vedotin-ejfv

Experienced CEO brings deep oncology drug development and corporate strategy experience to Corrixr's board as the company advances CXR101 toward the clinic NEWARK, Del.--(BUSINESS WIRE)--Corrixr Therapeutics, a pre-clinical genetic medicine company targeting lung, head & neck, and esophageal squamous cell carcinomas, today announced the appointment of Nancy Whiting, PharmD, as Chair of the Board of Directors, succeeding Janice E. Nevin, M.D., MPH. The transition follows Dr. Nevin’s announcement that she will retire from ChristianaCare effective September 1, 2026. Dr. Nevin will remain on Corrixr’s board, as will Jenn Schwartz, who will succeed her as President and CEO of ChristianaCare, continuing ChristianaCare’s role as Corrixr’s founding institutional investor and partner. Dr. Whiting has served as CEO of Recludix Pharma for the past 5 years and brings an extensive track record across all phases of drug development, including over 15-years at Seagen, where she made significant contributions in her roles of Executive Vice President of Corporate Strategy and Executive Vice President of Clinical Development. She steps into the Chair role at a pivotal moment as Corrixr advances CXR101 toward IND filing and first-in-human proof-of-mechanism trials. “Nancy brings to the board the extensive oncology development and commercial experience Corrixr needs as it moves toward the clinic,” said Janice E. Nevin, M.D., MPH, President & CEO of ChristianaCare. “It has been an honor to chair Corrixr’s board as ChristianaCare’s founding institutional investor and partner, and to help guide the company from its origins at the Gene Editing Institute to this point.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “I’m thrilled to take on the Chair role at such a pivotal moment for the company,” said Nancy Whiting, PharmD. “Having spent my career bringing transformative oncology medicines through development and into the hands of patients, I see that same potential with Corrixr. I’m grateful to Janice for her leadership in building this board and look forward to working with her, Hilary, and the rest of the Corrixr team.” “Nancy’s appointment as Board Chair, strengthens Corrixr’s leadership at a pivotal moment as we advance toward the clinic,” said Hilary M. Malone, Ph.D., Chief Executive Officer of Corrixr. “I am deeply grateful to Janice Nevin for her vision, leadership and unwavering support of Corrixr, and I look forward to working with Nancy and Jenn Schwartz to build on that foundation and drive the company forward.” Corrixr is developing CXR101 to eliminate NRF2, a transcription factor consistently hyperactive in squamous cell cancers, directly at its genetic source. Unlike small-molecule approaches that attempt to inhibit NRF2 protein activity, CXR101 acts upstream, disrupting the mechanism that sustains squamous cell tumor survival without the toxicity associated with systemic exposure. Delivered locally via ionizable lipid nanoparticles, the approach collapses tumor survival, proliferation, immune evasion, and metabolic reprogramming in a single intervention. About Nancy Whiting, PharmD Nancy Whiting, PharmD, is the Chief Executive Officer of Recludix Pharma and has an established track record across all phases of drug development. Dr. Whiting is a 15-year veteran of Seagen, where she most recently served as Executive Vice President of Corporate Strategy, holding broad responsibility for corporate strategy and planning, strategic alliances and partnerships, investor relations, corporate communications, and information technologies. She previously served as Executive Vice President of Late Stage Development, Senior Vice President of Clinical Development and Medical Affairs, and Head of Experimental Medicine. During her tenure at Seagen, Dr. Whiting played a central role in the development and regulatory approval of ADCETRIS for lymphoma, PADCEV for bladder cancer, TUKYSA for breast cancer, TIVDAK for cervical cancer, and several other pipeline compounds. Prior to transitioning to the pharmaceutical industry, Dr. Whiting practiced as a Clinical Oncology Pharmacist at the Seattle Cancer Care Alliance. She completed her undergraduate training at the University of British Columbia and received her PharmD from the University of Washington and completed a residency in clinical pharmacy practice at Vancouver General Hospital. Dr. Whiting is a member of the American Society of Clinical Oncology, the American Society of Hematology, and the European Society of Medical Oncology. She serves on the Board of Directors of Caribou Biosciences, Boundless Bio, and Biocom California. About Corrixr Therapeutics Corrixr Therapeutics is a genetic medicine company developing breakthrough treatments for squamous cell carcinomas of the lung, head & neck, and esophagus, among the deadliest and treatment-resistant cancers in the world. Corrixr's lead program, CXR101, targets NRF2, a transcription factor consistently hyperactive in squamous tumors that drives tumor survival. Using a proprietary CRISPR-based gene editing approach, CXR101 ablates NRF2 directly at the genetic source, with no reliance on small molecule binding, dismantling the biological mechanism these tumors cannot live without while aiming to reduce the burden patients experience with conventional therapies. Learn more at corrixr.com . Contacts Media: Jennifer Hanley 347-819-0402

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 PART 01 周报概述 随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。 本文将深入分析2026年7月6日至2026年7月12日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。 PART 02 国内113款新药IND获批 根据摩熵医药数据库统计，2026年7月6日至2026年7月12日期间，共有100个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号78个，进口药品受理号22个。 本周共计113款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药68款，生物药44款，1款中药。 本周获批临床创新药/改良型新药部分信息速览（不含补充申请） 注：完整数据可识别“文末”二维码下载查看 PART 03 本周全球TOP10创新药研发进展 7月 6 日，安斯泰来递交了维恩妥尤单抗（enfortumab vedotin）的新适应症上市申请，用于联合帕博利珠单抗围手术期治疗无论是否适合接受顺铂化疗的肌层浸润性膀胱癌（MIBC）成人患者。2025年8月，维恩妥尤单抗联合帕博利珠单抗围手术期治疗不适合顺铂化疗MIBC的III期KEYNOTE-905（EV-303）研究取得了积极结果。 截图来源：摩熵医药全球药物研发数据库（查数据.找摩熵） 2025年12月，维恩妥尤单抗联合帕博利珠单抗围手术期治疗适合顺铂化疗MIBC的III期KEYNOTE-B15（EV-304）研究同样取得了积极结果。结果显示，与化疗组相比，维恩妥尤单抗联合帕博利珠单抗组患者的中位EFS显著延长（未达到 vs 48.5个月，HR=0.53，P<0.0001），估算EFS达到2年的患者比例更高（79.4% vs 66.2%）。此外，维恩妥尤单抗联合帕博利珠单抗组OS达到2年的患者比例更高（86.9% vs 81.3%），实现pCR的患者比例显著提高（55.8% vs 32.5%，P<0.0001）。 7月7日，正大天晴宣布，其开发的1类创新药TQB3126片获得中国国家药品监督管理局药品审评中心（CDE）的临床试验默示许可，拟开发用于晚期乳腺癌。TQB3126依托正大天晴口服蛋白降解剂技术平台开发，是一款口服、靶向雌激素受体（ER）的蛋白降解靶向嵌合体药物。作为一种异双功能分子，TQB3126通过泛素-蛋白酶体系统降解ER，阻断ER信号通路，进而抑制肿瘤生长。临床前研究表明，该产品机制明确，安全性良好，具有肿瘤组织分布高的差异化PK优势。据正大天晴新闻稿介绍，传统ER药物更多是“连接受体、阻断信号”，蛋白降解靶向嵌合体药物则是把ER蛋白“拉到”细胞自身的泛素-蛋白酶体系统中进行降解，从源头减少ER蛋白水平。这一机制的优势在于，蛋白降解靶向嵌合体可以利用细胞降解系统清除致病蛋白，减少肿瘤细胞继续依赖该通路生长的可能。从全球研发趋势看，ER蛋白降解靶向嵌合体药物已成为乳腺癌内分泌治疗耐药方向的重要创新路径。 本周全球 TOP10 创新药研发进展 截图来源：摩熵医药周报 PART 04 本周全球TOP7积极/失败临床结果 本周全球Top 7积极/失败临床进展盘点：7月7日，恒瑞医药宣布，其口服小分子GLP-1受体激动剂HRS-7535（大中华区外称KAI-7535，由Kailera Therapeutics开发）在中国成人肥胖及超重人群中的III期临床试验（HARBOR-1）取得积极顶线数据（NCT06904105）。HRS-7535所有剂量组（120mg、180mg）在治疗44周时达到了所有主要终点和关键次要终点；且继续治疗减重效果持续，第50周时180mg组平均减重可达11.1%；同时观察到了多项心血管代谢指标的改善。 截图来源：摩熵医药全球药物研发数据库（查数据.找摩熵） HRS-7535是恒瑞医药自主研发的口服小分子胰高血糖素样肽-1（GLP-1）受体激动剂，采用每日一次口服给药方式，其吸收不受进食和饮水影响，无需严格的空腹条件及服药后等待时间，服药方式灵活便捷。目前，除了体重管理（HARBOR系列试验），HRS-7535还正在中国开展多项II-III期临床研究，覆盖糖尿病（OUTSTAND系列试验）及慢性肾脏病（RENEW-CKD试验）等多项适应症领域。 本周全球 TOP10 积极/失败临床结果 截图来源：摩熵医药周报 PART 05 60款品种过评，石家庄四药等3家药企大丰收 根据摩熵医药数据库统计，2026年7月6日至2026年7月12日期间，共有76项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号71项（包括化药3类，4类，5.2类），新注册分类临床申请受理号2项，一致性评价申请3项。本周6个品种通过一致性评价（按受理号计9项），本周54个品种视同通过一致性评价（按受理号计77项）。本周1项生物类似物注册申报动态：北京博康健基因科技有限公司申报的特立帕肽注射液。 本周过评/视同过评品种主要为消化系统与代谢药物；过评/视同过评产品剂型主要为片剂。 截图来源：摩熵医药周报 本周富马酸伏诺拉生片过评/视同过评受理号最多为6个，本周富马酸伏诺拉生片和钠钾镁钙注射用浓溶液过评/视同过评企业最多均为3家；本周苏州中化药品工业有限公司和成都倍特药业股份有限公司、郑州泰丰制药有限公司企业过评/视同过评品种最多，均为2种，本周过评/视同过评企业包括广州白云山天心制药股份有限公司、回音必集团江西东亚制药有限公司、江苏宣泰药业有限公司和苏州中化药品工业有限公司等共66家。 截图来源：摩熵医药周报 本周有盐酸埃克替尼片是首次过评/视同过评品种。 截图来源：摩熵医药周报 本周卡铂注射液、依折麦布阿托伐他汀钙片(Ⅰ)2款是过评/视同过评达7家企业品种。 摩熵咨询本期周报领取方式 END 本文为原创文章，转载请留言获取授权 点击阅读原文，申请摩熵医药企业版免费试用！