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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：外國發行人報告
美股sec公告 ·  04/25 20:35
牛牛AI助理已提取核心訊息
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，臨床階段的生物製藥公司Apollomics Inc. 宣佈，其中國合作伙伴阿維斯通生物技術有限公司。Ltd. 獲得了中國國家藥品監督管理局（NMPA）的批准，該藥物vebreltinib用於治療具有MET融合基因的神經膠質瘤。該批准基於一項2/3期試驗的結果，標誌着vebreltinib成爲首個獲准用於具有c-Met改變的中樞神經系統（CNS）腫瘤的c-Met抑制劑。該藥物適用於先前治療失敗的特定類型星形細胞瘤或膠質母細胞瘤的成年患者。該批准是在國家藥監局先前批准維佈雷替尼治療非小細胞肺癌（NSCLC）之後獲得的。Apollomics Inc.還在進行一項名爲SPARTA的全球2期研究，以研究vebreltinib對包括非小細胞肺癌在內的各種癌症的療效和安全性。該公司有九種候選藥物在線，其中六種正在臨床開發中。新聞稿還包括有關公司臨床試驗、業務計劃和目標的前瞻性陳述。
2024年4月25日，臨床階段的生物製藥公司Apollomics Inc. 宣佈，其中國合作伙伴阿維斯通生物技術有限公司。Ltd. 獲得了中國國家藥品監督管理局（NMPA）的批准，該藥物vebreltinib用於治療具有MET融合基因的神經膠質瘤。該批准基於一項2/3期試驗的結果，標誌着vebreltinib成爲首個獲准用於具有c-Met改變的中樞神經系統（CNS）腫瘤的c-Met抑制劑。該藥物適用於先前治療失敗的特定類型星形細胞瘤或膠質母細胞瘤的成年患者。該批准是在國家藥監局先前批准維佈雷替尼治療非小細胞肺癌（NSCLC）之後獲得的。Apollomics Inc.還在進行一項名爲SPARTA的全球2期研究，以研究vebreltinib對包括非小細胞肺癌在內的各種癌症的療效和安全性。該公司有九種候選藥物在線，其中六種正在臨床開發中。新聞稿還包括有關公司臨床試驗、業務計劃和目標的前瞻性陳述。
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