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Apollomics Inc. Receives FDA Orphan Drug Designation For Vebreltinib For Treatment Of Non-Small Cell Lung Cancer With MET Genomic Tumor Aberrations
Apollomics Inc. Receives FDA Orphan Drug Designation For Vebreltinib For Treatment Of Non-Small Cell Lung Cancer With MET Genomic Tumor Aberrations
Apollomics Inc. (NASDAQ:JMAC), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination-oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to vebreltinib (APL-101) for the treatment of non-small cell lung cancer (NSCLC) with MET genomic tumor aberrations. The FDA granted the Orphan Drug Designation in August.
"While NSCLC is the most common type of lung cancer, a subset of patients will have MET genomic dysregulations in their tumors which make them more resistant to treatment, presenting an unmet medical need," said Guo-Liang Yu, PhD, co-founder, Chairman and Chief Executive Officer of Apollomics. "We are pleased to have received the Orphan Drug Designation for vebreltinib, as patients need new and better treatment options. Through genomic testing, we can identify patients who will benefit most from a targeted treatment like vebreltinib. Orphan Drug Designation brings significant developmental benefits to the vebreltinib program, most notably seven-year market exclusivity upon its approval."
Apollomics' ongoing global Phase 2 SPARTA study is evaluating vebreltinib in patients with NSCLC and other solid tumors with MET genomic dysregulation.
Dysregulation of the c-MET tyrosine kinase receptor is implicated in the development of tumor malignancy and can arise through several mechanisms, including gene fusion and amplification, overexpression of the receptor and/or its ligand hepatocyte growth factor (HGF), and the acquisition of activating mutations. One type of the activating mutations cause exon 14 to be skipped due to aberrant splicing of MET mRNA. MET exon 14 skipping occurs in approximately 3-4% of NSCLC and has been demonstrated to be an oncogenic driver. MET amplification, another potential oncogenic driver, occurs in ~3% of newly diagnosed NSCLC, as well as in some NSCLC patients treated with targeted TKI therapy, such as EGFR inhibitors, who become treatment resistant.
The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides certain benefits including assistance in the drug development process, tax credits for clinical costs, exemption from FDA Prescription Drug User Fee Act (PDUFA) fees, and seven years of post-approval exclusivity.
As previously announced on Sept. 14, 2022, Apollomics and Maxpro Capital Acquisition Corp. ("Maxpro") (NASDAQ:JMAC, JMACU, JMACW))))), announced a definitive agreement for a business combination (the "Transaction" or the "Business Combination") that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market ("Nasdaq"). The Business Combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol "APLM."
Apollomics Inc. (NASDAQ:JMAC), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination-oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to vebreltinib (APL-101) for the treatment of non-small cell lung cancer (NSCLC) with MET genomic tumor aberrations. The FDA granted the Orphan Drug Designation in August.
致力于发现和开发单一和联合肿瘤疗法的创新生物制药公司Apollomics Inc.(纳斯达克股票代码:JMAC)今天宣布,美国食品药品监督管理局(FDA)已授予用于治疗伴有MET基因组肿瘤畸变的非小细胞肺癌(NSCLC)的孤儿药称号。APL-101美国食品药品管理局于8月批准了孤儿药称号。
"While NSCLC is the most common type of lung cancer, a subset of patients will have MET genomic dysregulations in their tumors which make them more resistant to treatment, presenting an unmet medical need," said Guo-Liang Yu, PhD, co-founder, Chairman and Chief Executive Officer of Apollomics. "We are pleased to have received the Orphan Drug Designation for vebreltinib, as patients need new and better treatment options. Through genomic testing, we can identify patients who will benefit most from a targeted treatment like vebreltinib. Orphan Drug Designation brings significant developmental benefits to the vebreltinib program, most notably seven-year market exclusivity upon its approval."
Apollomics联合创始人、董事长兼首席执行官余国亮博士说:“虽然非小细胞肺癌是最常见的肺癌类型,但一部分患者的肿瘤中会出现MET基因组失调,这使他们对治疗的抵抗力更强,这表明医疗需求未得到满足。”“我们很高兴获得vebreltinib的孤儿药称号,因为患者需要新的、更好的治疗选择。通过基因组测试,我们可以确定哪些患者将从诸如vebreltinib之类的靶向治疗中受益最大。孤儿药认证为vebreltinib项目带来了显著的开发益处,最值得注意的是该项目获得批准后的七年市场独家经营权。”
Apollomics' ongoing global Phase 2 SPARTA study is evaluating vebreltinib in patients with NSCLC and other solid tumors with MET genomic dysregulation.
Apollomics正在进行的全球2期SPARTA研究正在评估非小细胞肺癌和其他伴有MET基因组失调的实体瘤患者的vebreltinib。
Dysregulation of the c-MET tyrosine kinase receptor is implicated in the development of tumor malignancy and can arise through several mechanisms, including gene fusion and amplification, overexpression of the receptor and/or its ligand hepatocyte growth factor (HGF), and the acquisition of activating mutations. One type of the activating mutations cause exon 14 to be skipped due to aberrant splicing of MET mRNA. MET exon 14 skipping occurs in approximately 3-4% of NSCLC and has been demonstrated to be an oncogenic driver. MET amplification, another potential oncogenic driver, occurs in ~3% of newly diagnosed NSCLC, as well as in some NSCLC patients treated with targeted TKI therapy, such as EGFR inhibitors, who become treatment resistant.
c-met 酪氨酸激酶受体的失调与肿瘤恶性肿瘤的发生有关,可通过多种机制引起,包括基因融合和扩增、受体和/或其配体肝细胞生长因子 (HGF) 的过度表达以及激活突变的获得。由于 MET mRNA 拼接异常,其中一种类型的激活突变会导致外显子 14 被跳过。MET 外显子 14 跳跃发生在大约 3-4% 的非小细胞肺癌中,已被证明是一种致癌驱动因素。MET扩增是另一种潜在的致癌驱动因素,在新诊断的非小细胞肺癌中,以及一些接受靶向TKI治疗(例如表皮生长因子抑制剂)治疗的NSCLC患者中,会出现耐药性。
The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides certain benefits including assistance in the drug development process, tax credits for clinical costs, exemption from FDA Prescription Drug User Fee Act (PDUFA) fees, and seven years of post-approval exclusivity.
美国食品药品管理局孤儿产品开发办公室授予用于治疗、诊断或预防罕见疾病或影响美国少于 200,000 人的疾病的药物和生物制剂认定为孤儿。孤儿药指定提供某些好处,包括药物开发过程中的协助、临床成本的税收抵免、FDA《处方药使用者费用法》(PDUFA)费的豁免以及七年的批准后独家经营权。
As previously announced on Sept. 14, 2022, Apollomics and Maxpro Capital Acquisition Corp. ("Maxpro") (NASDAQ:JMAC, JMACU, JMACW))))), announced a definitive agreement for a business combination (the "Transaction" or the "Business Combination") that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market ("Nasdaq"). The Business Combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol "APLM."
正如先前在2022年9月14日宣布的那样,Apollomics和Maxpro Capital收购公司(“Maxpro”)(纳斯达克股票代码:JMAC、JMACU、JMACW)))宣布了一项业务合并(“交易” 或 “业务合并”)的最终协议,这将使Apollomics成为纳斯达克全球市场(“纳斯达克”)的上市公司。业务合并预计将于2023年第一季度完成,Apollomics有望在纳斯达克上市,股票代码为 “APLM”。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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