2026-10-20 22:01:16 网络 阅读（55）
汉达(6620-TW)旗下505(b)(2)新药HND-039 OMCAZIO正式获得美国FDA核发的最终核准(FA)，FDA也同步否决并驳回原厂今年4月提出的公民诉愿，且确认OMCAZIO的现有科学数据，足以支持安全性及有效性，并可随餐或空腹服用，激励汉达今(7)日跳空开高后，亮灯涨停锁住118元。
汉达今天早盘以114.5元跳空开高后，盘中直奔涨停板锁住118元，站稳所有均线，排队委买单约500张，成交量则超过5000张。三大法人也持续敲进汉达，连续3个交易日买超，上周合计买超1358张。
汉达于7月30日公告该产品取得FDA暂时性许可(TA)，原先预估1个季度完成取得FA相关程序，不过随着相关限制条件解除，公司顺利取得最终核准，代表该产品已具备在美国上市销售的资格。
商业化布局上，汉达指出，仍采取双轨并行策略，除持续进行自主销售产品的准备作业，也不排除授权潜在合作伙伴的选项，公司将加速推进最终商业化方案的评估与决策。
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"title": "〈焦点股〉汉达癌症新药获美国FDA核发最终核准 强攻涨停",
"shortTitle": "〈焦点股〉汉达癌症新药获美国FDA核发最终核准 强攻涨停",
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"description": "汉达(6620-TW)旗下505(b)(2)新药HND-039 OMCAZIO正式获得美国FDA核发的最终核准(FA)，FDA也同步否决并驳回原厂今年4月提出的公民诉愿，激励汉达今日跳空开高后，亮灯涨停锁住118元。",
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"content": "<p>汉达(6620-TW)旗下505(b)(2)新药HND-039 OMCAZIO正式获得美国FDA核发的最终核准(FA)，FDA也同步否决并驳回原厂今年4月提出的公民诉愿，且确认OMCAZIO的现有科学数据，足以支持安全性及有效性，并可随餐或空腹服用，激励汉达今(7)日跳空开高后，亮灯涨停锁住118元。 </p>\n<p style=\"text-align:center;\"><img src=\"https://cimg.cnyes.cool/prod/news/6599143/l/082536266ccc021978013c30dd763ba8.jpg\" alt=\"〈焦点股〉汉达癌症新药获美国FDA核发最终核准 强攻涨停\" style=\"width:50%;height:auto;border-radius:6px;margin:15px auto;display:block;\"></p>\n\n\n<p>汉达今天早盘以114.5元跳空开高后，盘中直奔涨停板锁住118元，站稳所有均线，排队委买单约500张，成交量则超过5000张。三大法人也持续敲进汉达，连续3个交易日买超，上周合计买超1358张。 </p>\n\n<p>汉达于7月30日公告该产品取得FDA暂时性许可(TA)，原先预估1个季度完成取得FA相关程序，不过随着相关限制条件解除，公司顺利取得最终核准，代表该产品已具备在美国上市销售的资格。 </p>\n\n<p>商业化布局上，汉达指出，仍采取双轨并行策略，除持续进行自主销售产品的准备作业，也不排除授权潜在合作伙伴的选项，公司将加速推进最终商业化方案的评估与决策。</p><div class=\"related-articles seo-links\">\n <h4>相关阅读</h4>\n <ul>\n <li><a href=\"/new/tw/article-11715.html\" title=\"敬鹏汽车板出货接单回稳 全年营收营运预估将翻扬走高\">敬鹏汽车板出货接单回稳 全年营收营运预估将翻扬走高</a></li>\n <li><a href=\"/new/tw/article-12592.html\" title=\"〈富邦金法说〉韩蔚廷：北富银上半年AI、半导体放款增逾2成 荣景看至明年H1\">〈富邦金法说〉韩蔚廷：北富银上半年AI、半导体放款增逾2成 荣景看至明年H1</a></li>\n <li><a href=\"/new/tw/article-10232.html\" title=\"金宝集团许介立：企业永续不是成本 而是叠加竞争力的关键价值\">金宝集团许介立：企业永续不是成本 而是叠加竞争力的关键价值</a></li>\n <li><a href=\"/new/tw/article-15175.html\" title=\"创控科技8月营收创同期新高 估下半年旺季可期\">创控科技8月营收创同期新高 估下半年旺季可期</a></li>\n <li><a href=\"/new/tw/article-12881.html\" title=\"泰金-KY上半年净利2.48亿元年增3.36倍EPS 6.46元追平去年全年\">泰金-KY上半年净利2.48亿元年增3.36倍EPS 6.46元追平去年全年</a></li>\n <li><a href=\"/new/tw/article-14463.html\" title=\"营收速报 - 威润(6465)8月营收3,312万元年增率高达128.67％\">营收速报 - 威润(6465)8月营收3,312万元年增率高达128.67％</a></li>\n </ul>\n</div>",
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