Mabwell Therapeutics, Inc.

8月26日，迈威生物发布公告，其自主研发的创新药9MW2821联合特瑞普利单抗对比标准化疗一线治疗局部晚期或转移性尿路上皮癌患者的随机、对照、开放、多中心Ⅲ期临床研究的方案获得CDE批准，迈威生物已启动9MW2821联合PD-1单抗一线治疗尿路上皮癌的Ⅲ期临床研究，目前处于入组阶段。 9MW2821为迈威生物靶向Nectin-4的定点偶联ADC新药。9MW2821注射入体内后，可与肿瘤细胞表面的Nectin-4结合并进入细胞，通过酶解作用，定向释放细胞毒素，从而实现对肿瘤的精准杀伤。迈威生物正在针对尿路上皮癌、宫颈癌、食管癌、乳腺癌等多个适应症开展多项临床研究，截至目前，已有超过400例受试者入组。 9MW2821是国内同靶点药物中首个开展临床试验的品种，亦是全球同靶点药物中首个在宫颈癌、食管癌以及乳腺癌适应症披露临床有效性数据的品种。 9MW2821于2024年获得美国FDA授予的多项审评资质：“快速通道认定”（FTD）分别用于治疗晚期、复发或转移性食管鳞癌（ESCC），既往接受过含铂化疗方案治疗失败的复发或转移性宫颈癌（CC）和局部晚期或转移性Nectin-4阳性三阴性乳腺癌（TNBC）；“孤儿药资格认定”（ODD）用于治疗食管癌（EC）。9MW2821于2024年8月被CDE纳入突破性治疗品种名单，用于治疗既往铂类化疗和PD-(L)1抑制剂治疗失败的局部晚期或转移性尿路上皮癌。 内容来源于网络，如有侵权，请联系删除。

迈威生物（688062.SH），一家全产业链布局的创新型生物制药公司，宣布其自主研发的靶向 Nectin-4 ADC 创新药（研发代号：9MW2821）已被国家药品监督管理局（NMPA）药品审评中心（CDE）纳入突破性治疗品种名单，用于治疗既往铂类化疗和 PD-(L)1 抑制剂治疗失败的局部晚期或转移性尿路上皮癌。 突破性治疗品种的认定旨在加快严重疾病新药的开发进程，获纳入的新药在早期临床试验中已显示出与现有疗法相比的显著疗效或安全性优势。 对于被纳入突破性疗法清单的新药，CDE 将优先分配资源处理沟通交流、提供指导促进药物开发，具有加速临床开发进度、上市审评审批速度的双重作用。这将有助于加速 9MW2821 开发进程，尽快满足中国患者的未满足临床需求。 9MW2821 为迈威生物靶向 Nectin-4 的定点偶联 ADC 新药，为公司利用 ADC 药物开发平台开发的创新品种，是国内同靶点药物中首个开展临床试验的品种，亦是全球同靶点药物中首个在宫颈癌、食管癌以及乳腺癌适应症披露临床有效性数据的品种。于 2024 年获得美国 FDA 授予的多项审评资质：“快速通道认定”（FTD）分别用于治疗晚期、复发或转移性食管鳞癌，既往接受过含铂化疗方案治疗失败的复发或转移性宫颈癌和局部晚期或转移性 Nectin-4 阳性三阴性乳腺癌；“孤儿药资格认定”（ODD）用于治疗食管癌。并被中国国家药品监督管理局药品审评中心纳入突破性治疗品种名单。 该品种通过具有自主知识产权的偶联技术连接子及优化的 ADC 偶联工艺，实现抗体的定点修饰。9MW2821 注射入体内后，可与肿瘤细胞表面的 Nectin-4 结合并进入细胞，通过酶解作用，定向释放细胞毒素，从而实现对肿瘤的精准杀伤。 迈威生物 (688062.SH) 是一家全产业链布局的创新型生物制药公司，始终秉承“让创新从梦想变成现实”的愿景，践行“探索生命，惠及健康”的使命，通过源头创新，为患者提供疗效更好、可及性更强的生物创新药，满足全球未被满足的临床需求。2017 年成立以来，迈威生物构建了以抗体药物靶点发现与分子发现为起点，覆盖成药性研究、临床前研究、临床研究和生产转化等药品研发全周期的创新体系，实现集研发、生产、营销于一体的全产业链布局。我们专注于肿瘤和年龄相关疾病，涉及肿瘤、自身免疫、代谢、眼科、感染等治疗领域，凭借国际领先的特色技术平台和研发创新能力，建立了丰富且具有竞争力的管线。现有 14 个品种处于不同阶段，包括 10 个创新品种和 4 个生物类似药，其中 3 个品种上市，1 个品种药品上市许可申请已获受理，3 个品种处于关键注册临床试验阶段。并独立承担 1 项国家“重大新药创制”重大科技专项、2 项国家重点研发计划和多个省市级科技创新项目。迈威生物以创新为本，注重产业转化，符合中国 NMPA、美国 FDA、欧盟 EMA GMP标准的抗体和重组蛋白药物产业化基地已在江苏泰州投入使用，并已通过欧盟 QP 审计，位于上海金山和江苏泰州的大规模商业化生产基地正在建设中。欲了解更多信息，请访问：www.mabwell.com。 内容来源于网络，如有侵权，请联系删除。

Mabwell (stock code: 688062.SH), as an innovative company in the field of bioparmaceuticals, has announced an important news: its development of Nectin-4 targeted antibody drug conjugate (ADC) innovative drug product (R&D code: 9MW2821) has received approval from the National Medical Products Administration (NMPA) to conduct a phase II clinical trial in triple-negative breast cancer (TNBC), which will evaluate the efficacy and safety of 9MW2821 as monotherapy or in combination with PD-1 inhibitors. The approval of the phase II clinical trials will be divided into two research queue, to delve into 9 mw2821 in different groups of patients with therapeutic effect. Queue will include those who have received A yew class/anthracycline-based chemotherapy and to topoisomerase inhibitors as the carrier of the antibody coupling drug treatment, but still progression in patients with locally advanced or metastatic TNBC, patients will receive 9 mw2821 monotherapy. Cohort B will include patients with locally advanced or metastatic TNBC who have not received previous systemic therapy and who will receive 9MW2821 in combination with a PD-1 inhibitor. Notably, early clinical study results of 9MW2821 were presented at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO), showing an overall response rate of 50.0% and a disease control rate of 80.0% in 20 evaluable TNBC patients. Median progression-free survival reached 5.9 months. One of these patients achieved a complete response and maintained progression-free status for an impressive 20 months. In addition, 9MW2821 was recently granted a breakthrough therapy designation by the Food and Drug Administration (FDA) - an innovative agent for the treatment of locally advanced or metastatic Nectin-4-positive TNBC. 9 mw2821 is using its Mabwell company independent research and development of ADC platform and high flux hybridoma antibodies detection technology, the development of the targets of antibodies against Nectin - 4 coupling drugs. It is not only the first Nectin-4 targeted drug to enter the clinical stage in China, but also the first Nectin-4 targeted drug to show clinical efficacy in multiple indications such as cervical cancer, esophageal cancer and breast cancer worldwide. The clinical trial has been approved, for Mabwell company, is in the tumor treatment is an important milestone in the history of the pipeline, also marks the company in the field of difficult to treat cancer for TNBC, innovative therapy on the development of new breakthrough. The company's commitment to 9MW2821, a Nectin-4 ADC, reflects its commitment to improving the quality of life of cancer patients.