{"id":79801,"date":"2026-04-21T00:05:19","date_gmt":"2026-04-21T00:05:19","guid":{"rendered":"https:\/\/english.saigonbiz.com\/vn\/essential-pharma-%e6%97%97%e4%b8%8b%e5%85%ac%e5%8f%b8-renaissance-pharma-limited-%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97%e9%ab%98%e5%8d%b1%e7%a5%9e%e7%bb%8f%e6%af%8d%e7%bb%86%e8%83%9e%e7%98%a4%e7%9a%84-d\/"},"modified":"2026-04-21T00:05:19","modified_gmt":"2026-04-21T00:05:19","slug":"essential-pharma-%e6%97%97%e4%b8%8b%e5%85%ac%e5%8f%b8-renaissance-pharma-limited-%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97%e9%ab%98%e5%8d%b1%e7%a5%9e%e7%bb%8f%e6%af%8d%e7%bb%86%e8%83%9e%e7%98%a4%e7%9a%84-d","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/essential-pharma-%e6%97%97%e4%b8%8b%e5%85%ac%e5%8f%b8-renaissance-pharma-limited-%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97%e9%ab%98%e5%8d%b1%e7%a5%9e%e7%bb%8f%e6%af%8d%e7%bb%86%e8%83%9e%e7%98%a4%e7%9a%84-d\/","title":{"rendered":"Essential Pharma \u65d7\u4e0b\u516c\u53f8 Renaissance Pharma Limited \u7528\u4e8e\u6cbb\u7597\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7684 Daretabart (hu1418K322A) \u83b7\u5f97 FDA \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\uff0c\u5e76\u901a\u8fc7 IND \u5ba1\u8bc4"},"content":{"rendered":"<div>\n<p align=\"center\"><\/p>\n<ul type=\"square\">\n<li style=\"margin-bottom:12pt; text-align:justify;\"><i>FDA \u6388\u4e88 Daretabart (hu1418K322A) \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\u8d44\u683c\uff0c\u4ee5\u89e3\u51b3\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u9886\u57df\u5b58\u5728\u7684\u91cd\u5927\u672a\u6ee1\u8db3\u533b\u7597\u9700\u6c42\uff0c\u5141\u8bb8\u8be5\u836f\u7269\u8fdb\u5165\u52a0\u901f\u8bc4\u5ba1\u548c\u6eda\u52a8\u5ba1\u8bc4\u6d41\u7a0b<\/i><\/li>\n<li style=\"margin-bottom:12pt; text-align:justify;\"><i>FDA \u901a\u8fc7\u65b0\u836f\u4e34\u5e8a\u7814\u7a76 (IND) \u7533\u8bf7\u540e\uff0c\u5373\u53ef\u5728\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u590d\u53d1\u53ca\u96be\u6cbb\u6027\u60a3\u8005\u4e2d\u542f\u52a8 SHINE II\/III \u671f\u4e34\u5e8a\u8bd5\u9a8c<\/i><\/li>\n<li style=\"text-align:justify;\"><i>Daretabart (hu1418K322A) \u7b2c\u4e00\u4e2a\u5546\u4e1a\u5316\u89c4\u6a21 GMP \u751f\u4ea7\u6279\u6b21\u5df2\u987a\u5229\u5b8c\u6210<\/i><\/li>\n<li style=\"margin-bottom:12pt; text-align:justify;\"><i>\u9879\u76ee\u57fa\u4e8e II \u671f\u7684\u79ef\u6781\u6570\u636e\uff0c\u60a3\u8005\u603b\u751f\u5b58\u7387\u8fbe 86.0% <\/i><\/li>\n<\/ul>\n<p align=\"justify\"><b>\u82f1\u56fd \u2013 2026 \u5e74 4 \u6708 21 \u65e5<\/b> \u2013 Essential Pharma \u65d7\u4e0b\u4e13\u6ce8\u4e8e\u7814\u53d1\u9636\u6bb5\u8d44\u4ea7\u7684\u516c\u53f8 Renaissance Pharma Limited \u4eca\u5929\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40 (FDA) \u5df2\u6388\u4e88\u5176\u65b0\u578b\u6297 GD2 \u5355\u514b\u9686\u6297\u4f53 Daretabart (hu1418K322A) \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\u8d44\u8d28\uff0c\u8fd9\u79cd\u6b63\u5728\u5f00\u53d1\u7684\u836f\u7269\u7528\u4e8e\u6cbb\u7597\u7f55\u89c1\u513f\u7ae5\u764c\u75c7 \u2014 \u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624 (HRNB)\u3002\u6b64\u9879\u8ba4\u5b9a\u65e8\u5728\u89e3\u51b3 HRNB \u9886\u57df\u5b58\u5728\u7684\u91cd\u5927\u672a\u6ee1\u8db3\u533b\u7597\u9700\u6c42\uff0c\u5c06\u6709\u52a9\u4e8e\u8be5\u516c\u53f8\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u4e0e FDA \u66f4\u9891\u7e41\u5730\u6c9f\u901a\u4e92\u52a8\uff0c\u5e76\u4f7f\u5176\u5177\u5907\u83b7\u5f97\u52a0\u901f\u5ba1\u8bc4\u548c\u6eda\u52a8\u5ba1\u8bc4\u7684\u8d44\u683c\u3002<\/p>\n<p align=\"justify\">\u516c\u53f8\u540c\u65f6\u786e\u8ba4\u5df2\u83b7\u5f97 FDA \u7684\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u8bb8\u53ef\uff0c\u5373\u5c06\u5728\u7f8e\u56fd\u542f\u52a8\u9488\u5bf9 HRNB \u590d\u53d1\u6216\u96be\u6cbb\u6027\u60a3\u513f\u7684 SHINE II\/III \u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002Daretabart (hu1418K322A) \u7528\u4e8e SHINE \u8bd5\u9a8c\u7684\u7b2c\u4e00\u4e2a\u5546\u4e1a\u5316\u89c4\u6a21\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303 (GMP) \u6279\u6b21\u7684\u751f\u6210\u4e5f\u5df2\u6210\u529f\u5b8c\u6210\u3002<\/p>\n<p align=\"justify\">Daretabart (hu1418K322A) \u7531 Renaissance Pharma \u6839\u636e\u4e0e\u5168\u7403\u513f\u7ae5\u764c\u75c7\u7814\u7a76\u4e0e\u6cbb\u7597\u9886\u5bfc\u8005 St. Jude \u513f\u7ae5\u7814\u7a76\u533b\u9662\u7684\u72ec\u5bb6\u8bb8\u53ef\u534f\u8bae\u5f00\u53d1\u3002\u8be5\u6297\u4f53\u7684\u9776\u90e8\u4f4d\u662f GD2\uff0c\u8fd9\u662f\u4e00\u79cd\u5728\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7ec6\u80de\u8868\u9762\u9ad8\u5ea6\u8868\u8fbe\u7684\u6297\u539f\u3002\u6309\u5176\u8bbe\u8ba1\uff0cDaretabart (hu1418K322A) \u901a\u8fc7\u7ed3\u5408 GD2 \u589e\u5f3a\u514d\u75ab\u4ecb\u5bfc\u7684\u80bf\u7624\u7ec6\u80de\u6740\u4f24\uff0c\u540c\u65f6\u901a\u8fc7\u65b0\u578b\u7ed3\u6784\u4fee\u9970\u6765\u63d0\u5347\u836f\u7269\u8010\u53d7\u6027\u3002<\/p>\n<p align=\"justify\">\u8be5\u9879\u76ee\u57fa\u4e8e II \u671f\u7814\u7a76\u7684\u6570\u636e\uff0c\u5bf9 Daretabart (hu1418K322A) \u4f5c\u4e3a HRNB \u60a3\u8005\u4e00\u7ebf\u6cbb\u7597\u53ca\u5de9\u56fa\u6cbb\u7597\u540e\u65b9\u6848\u7684\u7597\u6548\u8fdb\u884c\u7684\u8bc4\u4f30\u7ed3\u679c\u4ee4\u4eba\u9f13\u821e\u3002\u7814\u7a76\u663e\u793a\u4e09\u5e74\u65e0\u4e8b\u4ef6\u751f\u5b58\u7387 (EFS) \u8fbe 73.7%\uff0c\u603b\u751f\u5b58\u7387 (OS) \u8fbe 86.0%\u3002\u8fd9\u4e9b\u6210\u679c\u5df2\u4e8e 2021 \u5e74 12 \u6708\u53d1\u8868\u4e8e\u300a<i>\u4e34\u5e8a\u80bf\u7624\u5b66\u6742\u5fd7<\/i>\u300b\u3002<\/p>\n<p align=\"justify\">\u7b2c\u4e00\u4e2a\u5546\u4e1a\u5316\u89c4\u6a21 GMP \u6279\u6b21\u7684\u6210\u529f\u751f\u4ea7\u6807\u5fd7\u7740\u5173\u952e\u8fd0\u8425\u91cc\u7a0b\u7891\u7684\u5b9e\u73b0\uff0c\u5f70\u663e\u4e86 Renaissance Pharma \u5728\u9879\u76ee\u63a8\u8fdb\u8fc7\u7a0b\u4e2d\u81f4\u529b\u4e8e\u786e\u4fdd\u53ef\u9760\u3001\u9ad8\u8d28\u91cf\u4f9b\u5e94\u7684\u575a\u5b9a\u627f\u8bfa\u3002\u8fd9\u4e00\u6210\u679c\u6709\u529b\u5730\u652f\u6301\u4e86\u6301\u7eed\u4e34\u5e8a\u5f00\u53d1\uff0c\u5e76\u671d\u7740\u672a\u6765\u5546\u4e1a\u5316\u51c6\u5907\u8fc8\u51fa\u91cd\u8981\u4e00\u6b65\u3002<\/p>\n<p align=\"justify\"><b>Essential Pharma \u4e34\u65f6 CEO \u517c Renaissance Pharma Limited \u603b\u76d1 Simon Ball \u8868\u793a<\/b>\uff1a\u201c<i>Daretabart \u6709\u671b\u4e3a\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u60a3\u513f\u5e26\u6765\u5b9e\u8d28\u6027\u6539\u53d8\uff1b\u8fd9\u79cd\u75be\u75c5\u5373\u4fbf\u7ecf\u8fc7\u5f3a\u5316\u6cbb\u7597\uff0c\u9884\u540e\u4ecd\u7136\u6781\u4e0d\u7406\u60f3\u3002FDA \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\u662f\u5bf9\u8fd9\u79cd\u6f5c\u529b\u7684\u91cd\u8981\u5916\u90e8\u9a8c\u8bc1\uff0c\u518d\u52a0\u4e0a\u5df2\u83b7\u5f97\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u8bb8\u53ef\u4ee5\u53ca\u6211\u4eec\u5177\u5907\u7684\u5546\u4e1a\u5316\u89c4\u6a21\u751f\u4ea7\u80fd\u529b\uff0c\u8fd9\u4e00\u8ba4\u5b9a\u5145\u5206\u5f70\u663e\u4e86\u8be5\u9879\u76ee\u7684\u5b9e\u529b\u4e0e\u6210\u719f\u5ea6\u3002\u7ecf\u8fc7\u6570\u6708\u4ee5\u6765\u5728\u5e55\u540e\u7684\u975e\u51e1\u52aa\u529b\uff0c\u6211\u4eec\u6000\u7740\u65e0\u6bd4\u6fc0\u52a8\u7684\u5fc3\u60c5\u516c\u5e03\u8fd9\u4e00\u8fdb\u5c55\u3002\u6211\u4eec\u6b63\u5728\u7a33\u6b65\u63a8\u8fdb\uff0c\u5e76\u671f\u5f85\u968f\u7740 SHINE \u8bd5\u9a8c\u7684\u8fdb\u5c55\u5206\u4eab\u76f8\u5173\u6570\u636e\u3002\u4eca\u5929\u7684\u6d88\u606f\u8ba9\u6211\u4eec\u79bb\u5b9e\u73b0\u76ee\u6807\u66f4\u8fd1\u4e86\u4e00\u6b65\uff1a\u4e3a\u7f79\u60a3\u8fd9\u79cd\u4fb5\u88ad\u6027\u764c\u75c7\u7684\u513f\u7ae5\u63d0\u4f9b Daretabart\uff0c\u4f5c\u4e3a\u6709\u610f\u4e49\u7684\u65b0\u578b\u6cbb\u7597\u9009\u62e9\u3002\u201d<\/i><\/p>\n<p align=\"justify\"><u>\u53c2\u8003\u6587\u732e<\/u><br \/><sup>1 <\/sup>Furman WL, McCarville B, Shulkin BL, Davidoff A, Krasin M, Hsu CW, et al. Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. Journal of Clinical Oncology [Internet]. 2022 Feb 1;40(4):335\u201344. \u6765\u6e90\uff1a<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=9WRdErzNnYu8yxyVjk4JBbtbbV_Nl8h4HuDAXuTdew335_008ZUYDrAVerQwxtcS94DghjV_tA3g6JVI1ywJfukoHqPYeYHiBVmJj_yczhClpAxzbhvzFEzLzt8pOlBDlUcm0BBrR-przo47GmDD0Q==\" rel=\"nofollow\" target=\"_blank\" title=\"\">http:\/\/dx.doi.org\/10.1200\/jco.21.01375<\/a><\/p>\n<p align=\"justify\"><sup>2<\/sup> News Medical Life Sciences. European scientists target high-risk childhood cancer with liquid biopsy. \u6765\u6e90\uff1ahttps:\/\/www.news-medical.net\/news\/20240129\/European-scientists-target-high-risk-childhood-cancer-with-liquid biopsy.aspx#:~:text=Neuroblastoma%20mainly%20affects%20toddlers%20and,patients%20are%20high%2Drisk%20cases<\/p>\n<p>St. Jude \u513f\u7ae5\u7814\u7a76\u533b\u9662\u3002- <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=9WRdErzNnYu8yxyVjk4JBWNSsesRMwadtiayowxQ9D4ygetcGwa2Gb5uHRC6jQNIrMQgKaGdhtb02Xg3HEGSD43vJ8qCRfwEVdjybdcv0udOC1UkLYKClJVjdd0HbYB3_eWLpBCLM-LGX0y03pJop0GwNfiGKh_9cXnWedianRI=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/www.stjude.org\/disease\/neuroblastoma.html<\/a><\/p>\n<p align=\"justify\"><b>\u5173\u4e8e Renaissance Pharma <\/b><\/p>\n<p align=\"justify\">Renaissance Pharma Limited \u4f5c\u4e3a Essential Pharma \u65d7\u4e0b\u516c\u53f8\uff0c\u4e13\u6ce8\u4e8e\u7814\u53d1\u9636\u6bb5\u8d44\u4ea7\uff0c\u76ee\u524d\u81f4\u529b\u4e8e\u6539\u5584\u7f55\u89c1\u513f\u79d1\u75be\u75c5\u7684\u6cbb\u7597\u9009\u62e9\u3002\u00a0\u00a0 \u6838\u5fc3\u5019\u9009\u836f\u7269 Daretabart (hu1418K322A) \u4e13\u95e8\u9488\u5bf9\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7684\u6cbb\u7597\u3002<\/p>\n<p align=\"justify\"><b>\u5173\u4e8e Essential Pharma<\/b><\/p>\n<p align=\"justify\">Essential Pharma \u662f\u4e00\u5bb6\u5168\u7403\u6027\u5236\u836f\u516c\u53f8\uff0c\u81f4\u529b\u4e8e\u4e3a\u7279\u6b8a\u60a3\u8005\u7fa4\u4f53\u7814\u53d1\u548c\u4f9b\u5e94\u836f\u7269\u3002\u6211\u4eec\u4e0d\u65ad\u6269\u5927\u7684\u4ea7\u54c1\u7ec4\u5408\u5df2\u60e0\u53ca\u5927\u7ea6 70 \u4e2a\u56fd\u5bb6\/\u5730\u533a\u7684\u60a3\u8005\uff0c\u8986\u76d6\u591a\u4e2a\u6cbb\u7597\u9886\u57df\uff0c\u5c24\u5176\u5173\u6ce8\u6cbb\u7597\u7f55\u89c1\u75c5\u548c\u5fc3\u80ba\u75be\u75c5\u7684\u4e13\u79d1\u836f\u7269\u3002\u00a0\u00a0 \u901a\u8fc7\u5168\u8d44\u5b50\u516c\u53f8 Renaissance Pharma Limited \u7ba1\u7406\u7684\u7b2c\u4e00\u6b3e\u5728\u7814\u4ea7\u54c1\uff0c\u662f\u7528\u4e8e\u6cbb\u7597\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7684\u6297 GD2 \u6297\u4f53\uff0cDaretabart (hu1418K322A)\u3002\u6211\u4eec\u6253\u7834\u5e38\u89c4\uff0c\u4ee5\u66f4\u52a0\u667a\u6167\u7684\u65b9\u5f0f\u52aa\u529b\u786e\u4fdd\u5c0f\u4f17\u3001\u533b\u7597\u8d44\u6e90\u532e\u4e4f\u6216\u7f55\u89c1\u75c5\u60a3\u8005\u7fa4\u4f53\u80fd\u591f\u83b7\u5f97\u6240\u9700\u7684\u836f\u7269\u3002<\/p>\n<p align=\"justify\">\u66f4\u591a\u4fe1\u606f\u8bf7\u8bbf\u95ee <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=z5GrZqT81vcu5AbJE2wveNHUvH3AVRnk_w_dlSn5a_PTgq07_ZnQ1YDJuvJl8vbsWYtqqtJhNa7lgiSYII0l3sMSYMp2NOoXtMVms9P557NcdM63UW9JCQRY_XK7Ca-B\" rel=\"nofollow\" target=\"_blank\" title=\"www.essentialpharmagroup.com\">www.essentialpharmagroup.com<\/a><\/p>\n<p align=\"justify\"><b>\u5173\u4e8e\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624<\/b><\/p>\n<p align=\"justify\">\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u5360\u5168\u90e8\u513f\u7ae5\u764c\u75c7\u7684 7-10%\uff0c\u662f\u513f\u7ae5\u6700\u5e38\u89c1\u7684\u9885\u5916\u6076\u6027\u80bf\u7624\uff0c\u4e5f\u662f\u4e00\u5c81\u4ee5\u4e0b\u5a74\u5e7c\u513f\u6700\u5e38\u89c1\u7684\u764c\u75c7\u3002\u6b27\u6d32\u6bcf\u5e74\u65b0\u589e\u75c5\u4f8b\u8d85\u8fc7 1,500 \u4f8b\uff0c\u5728\u7f8e\u56fd\u7ea6\u4e3a 800 \u4f8b\u3002\u7ea6\u6709\u534a\u6570\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u60a3\u8005\u5c5e\u4e8e\u9ad8\u5371\u578b (HRNB)\uff0c\u5176\u4e94\u5e74\u603b\u751f\u5b58\u7387\u5927\u7ea6\u4e3a 50%\u3002\u73b0\u884c\u6807\u51c6\u6cbb\u7597\u65b9\u6848\u5f3a\u5ea6\u5927\u4e14\u9700\u591a\u6a21\u5f0f\u8054\u5408\uff0c\u5305\u62ec\u5316\u7597\u3001\u624b\u672f\u3001\u653e\u7597\u3001\u5e72\u7ec6\u80de\u79fb\u690d\u548c\u6297 GD2 \u5355\u514b\u9686\u6297\u4f53 (mAb) \u6cbb\u7597\u3002\u5c3d\u7ba1\u6709\u8fd9\u4e9b\u5e72\u9884\u63aa\u65bd\uff0cHRNB \u4ecd\u5b58\u5728\u660e\u663e\u672a\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\uff0c\u4e9f\u9700\u66f4\u6709\u6548\u4e14\u8010\u53d7\u6027\u66f4\u4f73\u7684\u6cbb\u7597\u65b9\u6848<sup>1,2<\/sup><\/p>\n<p align=\"justify\"><b>\u8054\u7cfb\u65b9\u5f0f<\/b><\/p>\n<p align=\"justify\"><b>Essential Pharma<\/b><\/p>\n<p align=\"justify\">Simon Ball<\/p>\n<p align=\"justify\">\u4e34\u65f6\u9996\u5e2d\u6267\u884c\u5b98<\/p>\n<p align=\"justify\">\u7535\u8bdd\uff1a +44 (0)1784 477 167<\/p>\n<p align=\"justify\">\u90ae\u7bb1\uff1a<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=CZuVrGJaPimSPVRmlRxRGAKaQclCYuUP8lUSYHDjNJkUcbN-kkb1cPGOzchx7ol82xDQzHgsa55Xr1I0hgAPB0LEPnlQa_BXCGpNyx3uJTV3ovHArI1bsBjxHMj7Gugo\" rel=\"nofollow\" target=\"_blank\" title=\"info@essentialpharmagroup.com\">info@essentialpharmagroup.com<\/a><\/p>\n<p align=\"justify\"><b>ICR Healthcare <\/b><\/p>\n<p align=\"justify\">Tracy Cheung\/Chris Welsh<\/p>\n<p align=\"justify\">\u90ae\u7bb1\uff1a<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=3aI_eJeiZ_tZffCgT65LINQ7EUHvhQ39Pw_nP6kSPrZTnHzPNvkkmbxCGKYJ223Tg955Q9xFEt4kL5xZ9EKFA_S2oU9GHGBXwYOENbBw9BksGKK-dKUMvL9qkOPTuoAgHauTS2wDEHxd_mtBmcoJfg==\" rel=\"nofollow\" target=\"_blank\" title=\"\"><u>Essentialpharma@icrhealthcare.com<\/u><\/a><\/p>\n<p id=\"gnw_attachments_section-header\">\n    <strong>Attachments<\/strong>\n<\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li>\n        <a target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=W3wtxjdDrpcAWKYfuEmKC3jYnQnGZ13EwLb4omX7CmafyItUDsoF8ddND-4_5H2HU6r9KEi76ycaJVY4sM6bdKEdhjIG2SH_X2f8SLONGLfUiKprZPHaUMUuYGYxa7_mi2-cB9kRyfqSbkGEFkuiFstdHBR4ZQuERLlZJxb4J-KF6_X6uBPx-0GyLCUqcIVOtnd2SiUmqxGnLcpvNPtS2A==\" title=\"Eng 260414 Essential_Pharma_Daretabart_PR_FTD FINAL\" rel=\"nofollow\">Eng 260414 Essential_Pharma_Daretabart_PR_FTD FINAL<\/a>\n      <\/li>\n<li>\n        <a target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=S6Pc3_BM3OGkzbOo1Mx1Pphme0COLcjUMj5FL370eCW2e8ABqE8cg7pqIZeiZgA989CmfC6e1QxKISLthIYSxspsFUVIXlrvHd5fkuRRMpBmFBeZIGHlxvu9dMjLljk_yS8rSFLfTOGYhUA2bHuAZhfMmRmBCRVtaYEN7NDQ7G38gh7dfa_SLa5BNR9BCGm1xuCrqY0-g0wbs_qR0qZ05Q==\" title=\"JP 260414 Essential_Pharma_Daretabart_PR_FTD FINAL_\" rel=\"nofollow\">JP 260414 Essential_Pharma_Daretabart_PR_FTD FINAL_<\/a>\n      <\/li>\n<\/ul>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/ml-eu.globenewswire.com\/media\/MjkxNGYzNmQtN2NjOS00YmRjLWE2YjMtMjA3MzIyZTdiNzk2LTcwMDAxMzYwMS0yMDI2LTA0LTIwLWVu\/tiny\/Essential-Pharma.png\" referrerpolicy=\"no-referrer-when-downgrade\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA \u6388\u4e88 Daretabart (hu1418K322A) \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\u8d44\u683c\uff0c\u4ee5\u89e3\u51b3\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u9886\u57df\u5b58\u5728\u7684\u91cd\u5927\u672a\u6ee1\u8db3\u533b\u7597\u9700\u6c42\uff0c\u5141\u8bb8\u8be5\u836f\u7269\u8fdb\u5165\u52a0\u901f\u8bc4\u5ba1\u548c\u6eda\u52a8\u5ba1\u8bc4\u6d41\u7a0b FDA \u901a\u8fc7\u65b0\u836f\u4e34\u5e8a\u7814\u7a76 (IND) \u7533\u8bf7\u540e\uff0c\u5373\u53ef\u5728\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u590d\u53d1\u53ca\u96be\u6cbb\u6027\u60a3\u8005\u4e2d\u542f\u52a8 SHINE II\/III \u671f\u4e34\u5e8a\u8bd5\u9a8c Daretabart (hu1418K322A) \u7b2c\u4e00\u4e2a\u5546\u4e1a\u5316\u89c4\u6a21 GMP \u751f\u4ea7\u6279\u6b21\u5df2\u987a\u5229\u5b8c\u6210 \u9879\u76ee\u57fa\u4e8e II \u671f\u7684\u79ef\u6781\u6570\u636e\uff0c\u60a3\u8005\u603b\u751f\u5b58\u7387\u8fbe 86.0% \u82f1\u56fd \u2013 2026 \u5e74 4 \u6708 21 \u65e5 \u2013 Essential Pharma \u65d7\u4e0b\u4e13\u6ce8\u4e8e\u7814\u53d1\u9636\u6bb5\u8d44\u4ea7\u7684\u516c\u53f8 Renaissance Pharma Limited \u4eca\u5929\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40 (FDA) \u5df2\u6388\u4e88\u5176\u65b0\u578b\u6297 GD2 \u5355\u514b\u9686\u6297\u4f53 Daretabart (hu1418K322A) \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\u8d44\u8d28\uff0c\u8fd9\u79cd\u6b63\u5728\u5f00\u53d1\u7684\u836f\u7269\u7528\u4e8e\u6cbb\u7597\u7f55\u89c1\u513f\u7ae5\u764c\u75c7 \u2014 \u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624 (HRNB)\u3002\u6b64\u9879\u8ba4\u5b9a\u65e8\u5728\u89e3\u51b3 HRNB \u9886\u57df\u5b58\u5728\u7684\u91cd\u5927\u672a\u6ee1\u8db3\u533b\u7597\u9700\u6c42\uff0c\u5c06\u6709\u52a9\u4e8e\u8be5\u516c\u53f8\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u4e0e FDA \u66f4\u9891\u7e41\u5730\u6c9f\u901a\u4e92\u52a8\uff0c\u5e76\u4f7f\u5176\u5177\u5907\u83b7\u5f97\u52a0\u901f\u5ba1\u8bc4\u548c\u6eda\u52a8\u5ba1\u8bc4\u7684\u8d44\u683c\u3002 \u516c\u53f8\u540c\u65f6\u786e\u8ba4\u5df2\u83b7\u5f97 FDA \u7684\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u8bb8\u53ef\uff0c\u5373\u5c06\u5728\u7f8e\u56fd\u542f\u52a8\u9488\u5bf9 HRNB [&#8230;]\n","protected":false},"author":1,"featured_media":79802,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-79801","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Essential Pharma \u65d7\u4e0b\u516c\u53f8 Renaissance Pharma Limited \u7528\u4e8e\u6cbb\u7597\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7684 Daretabart (hu1418K322A) \u83b7\u5f97 FDA \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\uff0c\u5e76\u901a\u8fc7 IND \u5ba1\u8bc4 - Biz and Live in Saigon<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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