share_log

Apollomics | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Apollomics | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Apollomics | 6-K:外国发行人报告
美股sec公告 ·  04/25 08:35
Moomoo AI 已提取核心信息
On April 25, 2024, Apollomics Inc., a clinical-stage biopharmaceutical company, announced that its Chinese partner, Avistone Biotechnology Co. Ltd., received approval from the National Medical Products Administration (NMPA) of China for the drug vebreltinib as a treatment for gliomas with MET fusion gene. This approval, based on the results of a Phase 2/3 trial, marks vebreltinib as the first c-Met inhibitor approved for Central Nervous System (CNS) tumors with c-Met alteration. The drug is indicated for adult patients with specific types of astrocytoma or glioblastoma who have failed previous treatments. The approval follows a previous NMPA approval for vebreltinib in treating non-small cell lung cancer (NSCLC). Apollomics Inc. is also conducting a global Phase 2 study, SPARTA, to investigate the efficacy and safety of vebreltinib in various cancers, including NSCLC. The company has a pipeline of nine drug candidates, with six in clinical development. The press release also includes forward-looking statements regarding the company's clinical trials, business plans, and objectives.
On April 25, 2024, Apollomics Inc., a clinical-stage biopharmaceutical company, announced that its Chinese partner, Avistone Biotechnology Co. Ltd., received approval from the National Medical Products Administration (NMPA) of China for the drug vebreltinib as a treatment for gliomas with MET fusion gene. This approval, based on the results of a Phase 2/3 trial, marks vebreltinib as the first c-Met inhibitor approved for Central Nervous System (CNS) tumors with c-Met alteration. The drug is indicated for adult patients with specific types of astrocytoma or glioblastoma who have failed previous treatments. The approval follows a previous NMPA approval for vebreltinib in treating non-small cell lung cancer (NSCLC). Apollomics Inc. is also conducting a global Phase 2 study, SPARTA, to investigate the efficacy and safety of vebreltinib in various cancers, including NSCLC. The company has a pipeline of nine drug candidates, with six in clinical development. The press release also includes forward-looking statements regarding the company's clinical trials, business plans, and objectives.
2024年4月25日,临床阶段的生物制药公司Apollomics Inc. 宣布,其中国合作伙伴阿维斯通生物技术有限公司。Ltd. 获得了中国国家药品监督管理局(NMPA)的批准,该药物vebreltinib用于治疗具有MET融合基因的神经胶质瘤。该批准基于一项2/3期试验的结果,标志着vebreltinib成为首个获准用于具有c-Met改变的中枢神经系统(CNS)肿瘤的c-Met抑制剂。该药物适用于先前治疗失败的特定类型星形细胞瘤或胶质母细胞瘤的成年患者。该批准是在国家药监局先前批准维布雷替尼治疗非小细胞肺癌(NSCLC)之后获得的。Apollomics Inc.还在进行一项名为SPARTA的全球2期研究,以研究vebreltinib对包括非小细胞肺癌在内的各种癌症的疗效和安全性。该公司有九种候选药物在线,其中六种正在临床开发中。新闻稿还包括有关公司临床试验、业务计划和目标的前瞻性陈述。
2024年4月25日,临床阶段的生物制药公司Apollomics Inc. 宣布,其中国合作伙伴阿维斯通生物技术有限公司。Ltd. 获得了中国国家药品监督管理局(NMPA)的批准,该药物vebreltinib用于治疗具有MET融合基因的神经胶质瘤。该批准基于一项2/3期试验的结果,标志着vebreltinib成为首个获准用于具有c-Met改变的中枢神经系统(CNS)肿瘤的c-Met抑制剂。该药物适用于先前治疗失败的特定类型星形细胞瘤或胶质母细胞瘤的成年患者。该批准是在国家药监局先前批准维布雷替尼治疗非小细胞肺癌(NSCLC)之后获得的。Apollomics Inc.还在进行一项名为SPARTA的全球2期研究,以研究vebreltinib对包括非小细胞肺癌在内的各种癌症的疗效和安全性。该公司有九种候选药物在线,其中六种正在临床开发中。新闻稿还包括有关公司临床试验、业务计划和目标的前瞻性陈述。
声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息