{"id":96551,"date":"2023-10-05T06:25:00","date_gmt":"2023-10-04T23:25:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2023100506250096551"},"modified":"2023-10-08T16:18:40","modified_gmt":"2023-10-08T08:18:40","slug":"%e4%ba%91%e9%a1%b6%e6%96%b0%e8%80%80%e5%90%88%e4%bd%9c%e4%bc%99%e4%bc%b4-calliditas-%e5%9c%a8-%e4%b8%9c%e4%ba%ac%e7%ac%ac-17-%e5%b1%8a-iga-%e8%82%be%e7%97%85%e5%9b%bd%e9%99%85%e7%a0%94%e8%ae%a8","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2023100506250096551","title":{"rendered":"\u4e91\u9876\u65b0\u8000\u5408\u4f5c\u4f19\u4f34 Calliditas \u5728 \u4e1c\u4eac\u7b2c 17 \u5c4a IgA \u80be\u75c5\u56fd\u9645\u7814\u8ba8\u4f1a\u4e0a\u516c\u5e03 NefIgArd 3 \u671f\u8bd5\u9a8c\u751f\u7269\u6807\u8bb0\u7269\u548c\u4e9a\u7ec4\u5206\u6790\u6570\u636e"},"content":{"rendered":"

\u4e0a\u6d77<\/span>2023\u5e7410\u67085\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u4e91\u9876\u65b0\u8000\uff08HKEX 1952.HK\uff09\u5408\u4f5c\u4f19\u4f34 Calliditas Therapeutics AB \uff08\u7eb3\u65af\u8fbe\u514b\u80a1\u7968\u4ee3\u7801\uff1aCALT\uff0c\u7eb3\u65af\u8fbe\u514b\u65af\u5fb7\u54e5\u5c14\u6469\u80a1\u7968\u4ee3\u7801\uff1aCALTX\uff09\uff08\u4ee5\u4e0b\u7b80\u79f0"Calliditas"\uff09\u5728\u65e5\u672c\u4e1c\u4eac\u4e3e\u884c\u7684\u7b2c 17 \u5c4a IgA \u80be\u75c5\u56fd\u9645\u7814\u8ba8\u4f1a\u4e0a\uff0c\u4ee5\u6d77\u62a5\u548c\u53e3\u5934\u62a5\u544a\u5f62\u5f0f\u516c\u5e03\u4e86 \u8010\u8d4b\u5eb7®<\/sup> 3 \u671f NefIgArd \u7814\u7a76\u7684\u751f\u7269\u6807\u8bb0\u7269\u548c\u4e9a\u7ec4\u5206\u6790\u6570\u636e\u3002<\/p>\n

\u4e91\u9876\u65b0\u8000\u9996\u5e2d\u6267\u884c\u5b98\u7f57\u6c38\u5e86\u8868\u793a\uff1a" NefIgArd 3 \u671f\u7814\u7a76\u7684\u751f\u7269\u6807\u8bb0\u7269\u548c\u60a3\u8005\u4e9a\u7ec4\u5206\u6790\u8fdb\u4e00\u6b65\u8bc1\u5b9e\u4e86\u8010\u8d4b\u5eb7<\/b>®<\/b><\/sup>\u901a\u8fc7\u80a0\u9053\u9ecf\u819c\u514d\u75ab\u8c03\u8282\u673a\u5236\u6765\u4f5c\u7528\u4e8eIgA<\/b>\u80be\u75c5\u7684\u53d1\u75c5\u6e90\u5934\uff0c\u5b9e\u73b0\u5bf9\u56e0\u6cbb\u7597\u4ee5\u8fbe\u5230\u5ef6\u7f13\u80be\u529f\u80fd\u8870\u9000\u7684\u7597\u6548\uff0c\u5e76\u5728\u4e9a\u6d32\u4eba\u7fa4\u4e2d\u663e\u793a\u4e86\u975e\u5e38\u79ef\u6781\u7684\u7ed3\u679c\u3002<\/b>\u4e2d\u56fd\u53c2\u4e0e\u4e86NefIgArd 3\u671f\u7814\u7a76\uff0c\u4e91\u9876\u65b0\u8000\u8ba1\u5212\u5c06\u5728\u672a\u6765\u7684\u5b66\u672f\u4f1a\u8bae\u4e0a\u53d1\u5e03\u8010\u8d4b\u5eb7®<\/sup>\u5728\u4e2d\u56fd\u4e9a\u7ec4\u4eba\u7fa4\u7684\u4e34\u5e8a\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u7531\u4e8e\u4e9a\u6d32 IgA\u80be\u75c5\u60a3\u75c5\u7387\u8fdc\u9ad8\u4e8e\u4e16\u754c\u5176\u4ed6\u5730\u533a\uff0c\u6211\u4eec\u671f\u5f85\u80fd\u5c3d\u5feb\u5c06\u8fd9\u6b3e\u75be\u75c5\u9996\u521b\uff0c\u80fd\u9488\u5bf9\u75be\u75c5\u6e90\u5934\u3001\u6539\u53d8\u75be\u75c5\u8fdb\u5c55\u7684\u6cbb\u7597\u65b9\u6848\u5e26\u7ed9\u4e2d\u56fd\u548c\u66f4\u591a\u4e9a\u6d32\u60a3\u8005\uff0c\u4ee5\u6ee1\u8db3\u8feb\u5207\u7684\u4e34\u5e8a\u9700\u6c42\u3002"<\/p>\n

NefIgArd\u662f\u4e00\u9879\u5168\u7403\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u76843\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5728\u76ee\u524d\u5305\u62ec\u4f18\u5316RAS\u6291\u5236\u5242\u5728\u5185\u7684\u6807\u51c6\u652f\u6301\u6cbb\u7597\u57fa\u7840\u4e0a\u8054\u5408\u53e3\u670d\u8010\u8d4b\u5eb7®<\/sup>\uff0816 mg\/d\uff09\u6216\u5b89\u6170\u5242\u6cbb\u7597\u3002NefIgArd\u7814\u7a76\u5206\u4e3aA\u3001B\u4e24\u90e8\u5206\uff1aA\u90e8\u5206\u5305\u62ec9\u4e2a\u6708\u6cbb\u7597\u671f\u548c3\u4e2a\u6708\u505c\u836f\u968f\u8bbf\u671f\uff1bB\u90e8\u5206\u5219\u5305\u62ec\u518d\u5ef6\u7eed12\u4e2a\u6708\u7684\u505c\u836f\u968f\u8bbf\u671f\u3002\u7f3a\u9677\u578bIgA1\u5206\u5b50\uff08Gd-IgA1\uff09\u662f\u5bfc\u81f4IgA\u80be\u75c5\u7684\u5173\u952e\u56e0\u7d20\uff0c\u8d8a\u6765\u8d8a\u591a\u7684\u8bc1\u636e\u652f\u6301\u80a0\u9053\u9ecf\u819c\u76f8\u5173\u6dcb\u5df4\u7ec4\u7ec7\uff08GALT\uff09\u662fGd-IgA1\u7684\u4e3b\u8981\u6765\u6e90\u3002\u4f5c\u4e3aGALT\u4e2dIgA\u5408\u6210\u7684\u5173\u952e\u7ec6\u80de\u56e0\u5b50\uff0cB\u7ec6\u80de\u6d3b\u5316\u56e0\u5b50\uff08BAFF\uff09\u3001\u589e\u6b96\u8bf1\u5bfc\u914d\u4f53\uff08APRIL\uff09\u4e0e\u7279\u5b9a\u7684\u7ec6\u80de\u8868\u9762\u53d7\u4f53BCMA\uff08B\u7ec6\u80de\u6210\u719f\u6297\u539f\uff09\u7b49\u76f8\u7ed3\u5408\u53d1\u6325\u4f5c\u7528\u3002\u56e0\u6b64\u7f3a\u9677\u578bIgA1\u5206\u5b50\uff08Gd-IgA1\uff09\u3001\u5faa\u73afIgA\u514d\u75ab\u590d\u5408\u7269\uff08IgA-IC\uff09\u3001B\u7ec6\u80de\u6d3b\u5316\u56e0\u5b50\uff08BAFF\uff09\u3001\u589e\u6b96\u8bf1\u5bfc\u914d\u4f53\uff08APRIL\uff09\u53ca\u53ef\u6eb6\u6027BCMA\uff08B\u7ec6\u80de\u6210\u719f\u6297\u539f\uff09\u7b49\u4f5c\u4e3a\u53c2\u4e0eIgA\u80be\u75c5\u53d1\u75c5\u7684\u91cd\u8981\u6307\u6807\u3002<\/p>\n

\u542b\u6709 IgA \u7684\u514d\u75ab\u590d\u5408\u7269 (IgA-IC)\u5df2\u88ab\u8bc1\u660e\u4f1a\u5728\u80be\u7ec4\u7ec7\u4e2d\u79ef\u805a\uff0c\u4ece\u800c\u5f15\u53d1\u80be\u5c0f\u7403\u708e\u75c7\u3002\u57283\u671f\u7814\u7a76A\u90e8\u5206\uff0c\u5171\u6709160\u4f8b\u60a3\u8005\u6d4b\u5b9a\u4e86\u8840\u6e05IgA-IC\u6c34\u5e73\u3002\u7ed3\u679c\u663e\u793a\uff0c\u8010\u8d4b\u5eb7®<\/sup>\u6cbb\u7597\u7ec4\u5728\u6cbb\u75973\u4e2a\u6708\uff08P=0.0055\uff09\u30016\u4e2a\u6708\uff08P=0.047\uff09\u548c9\u4e2a\u6708\uff08P=0.0169\uff09\u65f6\uff0c\u8840\u6e05IgA-IC\u6c34\u5e73\u8f83\u5b89\u6170\u5242\u7ec4\u8868\u73b0\u51fa\u7edf\u8ba1\u5b66\u4e0a\u7684\u663e\u8457\u4e0b\u964d\u3002\u7ed3\u5408\u4e4b\u524d\u53d1\u8868\u7684<\/b>3<\/b>\u671f\u7814\u7a76A<\/b>\u90e8\u5206\u4e2d\u964d\u4f4e\u5faa\u73af\u4e2dGd-IgA1<\/b>\u6c34\u5e73\u7684\u7ed3\u679c\uff0834%<\/b>\uff09\uff0c\u8fdb\u4e00\u6b65\u652f\u6301\u8010\u8d4b\u5eb7®<\/sup><\/b>\u53ef\u9488\u5bf9IgA<\/b>\u80be\u75c5\u7684\u53d1\u75c5\u673a\u5236\u6765\u6539\u5584\u75be\u75c5\u8fdb\u5c55\u3002<\/b><\/p>\n

\u5bf9\u53c2\u52a0 3 \u671f NefIgArd \u4e34\u5e8a\u7814\u7a76 A \u90e8\u5206\u7684 160 \u540d\u60a3\u8005\u8fd8\u8fdb\u884c\u4e86\u989d\u5916\u5206\u6790\uff0c\u4ee5\u8bc4\u4f30\u5df2\u77e5\u8c03\u8282\u80a0\u9053\u9ecf\u819c\u76f8\u5173\u6dcb\u5df4\u7ec4\u7ec7 (GALT) \u4e2d\u7684 BAFF\u3001APRIL \u548c \u53ef\u6eb6\u6027BCMA \u8fd9\u4e09\u79cd\u5173\u952e\u7ec6\u80de\u56e0\u5b50\u7684\u6c34\u5e73\u3002\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u5b89\u6170\u5242\u7ec4\u76f8\u6bd4\uff0c\u8010\u8d4b\u5eb7<\/b>®<\/b><\/sup>\u6cbb\u7597\u7b2c 3<\/b>\u4e2a\u6708\u30016<\/b>\u4e2a\u6708 <\/b>\u548c 9 <\/b>\u4e2a\u6708\u5747\u68c0\u6d4b\u5230\u4e86BAFF <\/b>\u6c34\u5e73\u7684\u4e0b\u964d\u3002 <\/b>\u8010\u8d4b\u5eb7®<\/sup><\/b>\u6cbb\u7597\u7b2c3 <\/b>\u4e2a\u6708\u548c 6 <\/b>\u4e2a\u6708\u68c0\u6d4b\u5230APRIL <\/b>\u6c34\u5e73\u7684\u663e\u8457\u964d\u4f4e\uff0c\u540c\u65f6\u4e5f\u68c0\u6d4b\u5230\u53ef\u6eb6\u6027BCMA <\/b>\u6c34\u5e73\u5728\u7b2c 6 <\/b>\u4e2a\u6708\u65f6\u964d\u4f4e\u3002\u8fd9\u4e9b\u6570\u636e\u8fdb\u4e00\u6b65\u652f\u6301\u8010\u8d4b\u5eb7®<\/sup><\/b>\u662f\u9776\u5411IgA<\/b>\u80be\u75c5\u6e90\u5934\u7684\u5bf9\u56e0\u6cbb\u7597\u836f\u7269\uff0c\u5e76\u5f3a\u5316\u4e86\u80a0-<\/b>\u80be\u8f74\u5728 IgA<\/b>\u80be\u75c5\u53d1\u75c5\u673a\u5236\u4e2d\u7684\u6838\u5fc3\u4f5c\u7528\u3002<\/b><\/p>\n

\u8010\u8d4b\u5eb7®<\/sup>\u53ef\u663e\u8457\u964d\u4f4e\u5faa\u73af\u4e2dGd-IgA1\u53caIgA\u514d\u75ab\u590d\u5408\u7269\u7684\u6c34\u5e73\uff0c\u800c\u8fd9\u4e9b\u53d8\u5316\u4e0e\u8d8b\u5316\u56e0\u5b50\u548c\u7ec6\u80de\u56e0\u5b50\u7684\u8c03\u8282\u6a21\u5f0f\u6539\u53d8\u76f8\u5173\u3002NefIGard\u7814\u7a76 A\u90e8\u5206\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u8010\u8d4b\u5eb7®<\/sup> 16 mg\/d\u6cbb\u7597\u53ef\u663e\u8457\u964d\u4f4eCXCL5\u6c34\u5e73\uff083\u4e2a\u6708P=0.009\uff0c6\u4e2a\u6708P=0.001\uff0c9\u4e2a\u6708P=0.0128\uff09\u548cCCL13\u6c34\u5e73\uff083\u4e2a\u6708P=0.022\uff0c6\u4e2a\u6708P=0.0004\uff0c9\u4e2a\u6708P=0.04\uff09\uff1b\u540c\u65f6\u589e\u52a0CCL11\u6c34\u5e73\uff083\u4e2a\u6708P=0.003\uff0c6\u4e2a\u6708P=0.0037\uff0c9\u4e2a\u6708P=0.0004\uff09\u3002\u8fd9\u4e9b\u6570\u636e\u8fdb\u4e00\u6b65\u652f\u6301\u8010\u8d4b\u5eb7<\/b>®<\/b><\/sup>\u901a\u8fc7\u80a0\u9053\u9ecf\u819c\u514d\u75ab\u8c03\u8282\u673a\u5236\u4f5c\u7528\u4e8eIgA<\/b>\u80be\u75c5\u7684\u53d1\u75c5\u6e90\u5934\uff0c\u4ece\u800c\u8fdb\u4e00\u6b65\u8c03\u8282\u4e0b\u6e38\u66f4\u591a\u7ec6\u80de\u56e0\u5b50\u3001\u8d8b\u5316\u56e0\u5b50\uff0c\u5ef6\u7f13\u75be\u75c5\u7684\u53d1\u751f\u53d1\u5c55\u3002<\/b><\/p>\n

NefIgArd 3 \u671f\u7814\u7a76\u7684\u5b8c\u6574\u7ed3\u679c\u5df2\u4e8e\u4eca\u5e748\u6708\u53d1\u8868\u5728\u5168\u7403\u9876\u7ea7\u533b\u5b66\u671f\u520a\u300a\u67f3\u53f6\u5200\u300b\u3002\u8be5\u6570\u636e\u663e\u793a\uff0c\u5728\u4e24\u5e74\u7814\u7a76\u671f\u95f4\uff0c\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u8010\u8d4b\u5eb7<\/b>®<\/b><\/sup>\u5728 eGFR (<\/b>\u4f30\u7b97\u80be\u5c0f\u7403\u6ee4\u8fc7\u7387) <\/b>\u4e0a\u663e\u793a\u51fa\u5177\u6709\u7edf\u8ba1\u5b66\u663e\u8457\u6027\u548c\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u83b7\u76ca\u3002<\/b>\u4e24\u5e74\u7814\u7a76\u671f\u7ed3\u675f\u65f6\uff0c\u8010\u8d4b\u5eb7®<\/sup>\u6cbb\u7597\u7ec4eGFR\u81ea\u57fa\u7ebf\u4e0b\u964d6.11 ml\/min\/1.73m2\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u81ea\u57fa\u7ebf\u4e0b\u964d12.00 ml\/min\/1.73m2\uff0c\u5bf9\u5e94\u4e8e\u4e24\u5e74<\/b>eGFR <\/b>\u603b\u659c\u7387\u7684\u7ec4\u95f4\u5dee\u5f02\u4e3a\u6bcf\u5e742.95 mL\/min\/1.73m2 (p<0<\/b>·0001)<\/b>\u3002\u8010\u8d4b\u5eb7®<\/sup> <\/b>\u6cbb\u7597\u7ec4\u8fd8\u89c2\u5bdf\u5230\u6301\u4e45\u7684UPCR<\/b>\uff08\u5c3f\u86cb\u767d\u4e0e\u808c\u9150\u6bd4\uff09\u4e0b\u964d\u4f5c\u7528\uff0c\u5728\u6cbb\u7597\u671f\u7ed3\u675f\u540e\u768415 <\/b>\u4e2a\u6708\u7684\u505c\u836f\u968f\u8bbf\u671f\u95f4\u4f9d\u7136\u4fdd\u6301\u6301\u4e45\u7684\u6cbb\u7597\u6548\u679c\u3002\u572815<\/b>\u4e2a\u6708\u7684\u505c\u836f\u968f\u8bbf\u671f\uff0c\u8010\u8d4b\u5eb7®<\/sup><\/b>\u6cbb\u7597\u7ec4\u7684UPCR<\/b>\u4e0b\u964d\u5e45\u5ea6\u572830% <\/b>\u4ee5\u4e0a\uff0c\u5176\u95f4\u5728\u7b2c12<\/b>\u4e2a\u6708\u65f6\uff08\u505c\u836f\u540e\u7b2c3<\/b>\u4e2a\u6708\uff09\u89c2\u5bdf\u5230UPCR <\/b>\u4e0b\u964d 50% <\/b>\u4ee5\u4e0a\u3002\u540c\u65f6\u8fd8\u89c2\u5bdf\u5230\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u955c\u4e0b\u8840\u5c3f\u60a3\u8005\u6bd4\u4f8b\u663e\u8457\u4e0b\u964d\u3002<\/b>\u8010\u8d4b\u5eb7®<\/sup>\u6cbb\u7597\u7ec4\u955c\u4e0b\u8840\u5c3f\u7684\u60a3\u8005\u6bd4\u4f8b\u4ece\u57fa\u7ebf\u768466.5%\u964d\u81f340.5%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4ece\u57fa\u7ebf\u768467.8%\u964d\u81f361.2%\u3002\u955c\u4e0b\u8840\u5c3f\u60a3\u8005\u6bd4\u4f8b\u5728\u4e24\u7ec4\u95f4\u7684\u6bd4\u503c\u6bd4\u4e3a<\/b>0.4<\/b>\uff08OR[95% CI]<\/b>\uff1a0.4 [0.2-0.6], p=0.0001<\/b>\uff09\uff0c\u5373\u955c\u4e0b\u8840\u5c3f\u98ce\u9669\u51cf\u5c1160%<\/b>\u3002<\/b><\/p>\n

\u672c\u6b21\u53d1\u5e03\u7684NefIgArd\u7814\u7a76\uff08n=364 \u75c5\u4eba)\u7684\u5b8c\u65742\u5e74\u6570\u636e\u8fdb\u4e00\u6b65\u5206\u6790\u4e86\u4e9a\u6d32\u4eba\uff08n=83\uff09\u6216\u767d\u4eba\uff08n=275\uff09\u8840\u7edf\u5bf9 \u8010\u8d4b\u5eb7®<\/sup> \u6cbb\u7597\u53cd\u5e94\u7684\u6f5c\u5728\u5dee\u5f02\u3002\u7ed3\u679c\u8868\u660e\uff0c\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u65e0\u8bba\u4e9a\u6d32\u4eba\u8fd8\u662f\u767d\u79cd\u4eba\uff0c\u8010\u8d4b\u5eb7<\/b>®<\/b><\/sup>\u6cbb\u75979<\/b>\u4e2a\u6708\u5747\u53ef\u663e\u8457\u6301\u7eed\u5ef6\u7f13 eGFR<\/b>\u4e0b\u964d\uff0c\u4fdd\u62a4\u80be\u529f\u80fd\uff0c\u5e76\u5e26\u6765\u6301\u4e45\u7684\u86cb\u767d\u5c3f\u4e0b\u964d\u548c\u51cf\u5c11\u955c\u4e0b\u8840\u5c3f\u98ce\u9669\u3002<\/b><\/p>\n

\u8010\u8d4b\u5eb7®<\/sup>\u5df2\u76f8\u7ee7\u5728\u7f8e\u56fd\u548c\u6b27\u76df\u83b7\u6279\u4e0a\u5e02\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u5df2\u63a5\u53d7\u5408\u4f5c\u4f19\u4f34 Calliditas Therapeutics AB\u63d0\u4ea4\u7684\u8010\u8d4b\u5eb7®<\/sup>\u6cbb\u7597 IgA \u80be\u75c5\u7684\u8865\u5145\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7 (sNDA) \u5e76\u6388\u4e88\u4f18\u5148\u5ba1\u8bc4\uff0c\u9884\u8ba1\u5c06\u4e8e2023 \u5e74 12\u670820\u65e5\u524d\u505a\u51fa\u5ba1\u8bc4\u51b3\u5b9a\u3002\u6b64\u5916\uff0c\u8010\u8d4b\u5eb7®<\/sup>\u65b0\u836f\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u5df2\u88ab\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7eb3\u5165\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269\u7a0b\u5e8f\uff0c\u5e76\u6388\u4e88\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff0c\u9884\u8ba1\u5c06\u4e8e\u4eca\u5e74\u4e0b\u534a\u5e74\u83b7\u5f97\u6279\u51c6\u3002\u81ea2023\u5e744\u6708\u8d77\uff0c\u8010\u8d4b\u5eb7®<\/sup>\u5df2\u901a\u8fc7\u65e9\u671f\u51c6\u5165\u9879\u76ee\u5728\u4e0a\u6d77\u4ea4\u901a\u5927\u5b66\u533b\u5b66\u9662\u9644\u5c5e\u745e\u91d1\u533b\u9662\u6d77\u5357\u533b\u9662\u5e94\u7528\u4e8e\u4e34\u5e8a\u4f7f\u7528\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u4e0a\u6d772023\u5e7410\u67085\u65e5 \/\u7f8e\u901a\u793e\/ — \u4e91\u9876\u65b0\u8000\uff08HKEX 1952.HK\uff09\u5408\u4f5c\u4f19\u4f34 Calliditas Therapeutics AB \uff08\u7eb3\u65af\u8fbe\u514b\u80a1\u7968\u4ee3\u7801\uff1aCALT\uff0c\u7eb3\u65af\u8fbe\u514b\u65af\u5fb7\u54e5\u5c14\u6469\u80a1\u7968\u4ee3\u7801\uff1aCALTX\uff09\uff08\u4ee5\u4e0b\u7b80\u79f0"Calliditas"\uff09\u5728\u65e5\u672c\u4e1c\u4eac\u4e3e\u884c\u7684\u7b2c 17 \u5c4a IgA \u80be\u75c5\u56fd\u9645\u7814\u8ba8\u4f1a\u4e0a\uff0c\u4ee5\u6d77\u62a5\u548c\u53e3\u5934\u62a5\u544a\u5f62\u5f0f\u516c\u5e03\u4e86 \u8010\u8d4b\u5eb7® 3 \u671f NefIgArd \u7814\u7a76\u7684\u751f\u7269\u6807\u8bb0\u7269\u548c\u4e9a\u7ec4\u5206\u6790\u6570\u636e\u3002 \u4e91\u9876\u65b0\u8000\u9996\u5e2d\u6267\u884c\u5b98\u7f57\u6c38\u5e86\u8868\u793a\uff1a" NefIgArd 3 \u671f\u7814\u7a76\u7684\u751f\u7269\u6807\u8bb0\u7269\u548c\u60a3\u8005\u4e9a\u7ec4\u5206\u6790\u8fdb\u4e00\u6b65\u8bc1\u5b9e\u4e86\u8010\u8d4b\u5eb7®\u901a\u8fc7\u80a0\u9053\u9ecf\u819c\u514d\u75ab\u8c03\u8282\u673a\u5236\u6765\u4f5c\u7528\u4e8eIgA\u80be\u75c5\u7684\u53d1\u75c5\u6e90\u5934\uff0c\u5b9e\u73b0\u5bf9\u56e0\u6cbb\u7597\u4ee5\u8fbe\u5230\u5ef6\u7f13\u80be\u529f\u80fd\u8870\u9000\u7684\u7597\u6548\uff0c\u5e76\u5728\u4e9a\u6d32\u4eba\u7fa4\u4e2d\u663e\u793a\u4e86\u975e\u5e38\u79ef\u6781\u7684\u7ed3\u679c\u3002\u4e2d\u56fd\u53c2\u4e0e\u4e86NefIgArd 3\u671f\u7814\u7a76\uff0c\u4e91\u9876\u65b0\u8000\u8ba1\u5212\u5c06\u5728\u672a\u6765\u7684\u5b66\u672f\u4f1a\u8bae\u4e0a\u53d1\u5e03\u8010\u8d4b\u5eb7®\u5728\u4e2d\u56fd\u4e9a\u7ec4\u4eba\u7fa4\u7684\u4e34\u5e8a\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u7531\u4e8e\u4e9a\u6d32 IgA\u80be\u75c5\u60a3\u75c5\u7387\u8fdc\u9ad8\u4e8e\u4e16\u754c\u5176\u4ed6\u5730\u533a\uff0c\u6211\u4eec\u671f\u5f85\u80fd\u5c3d\u5feb\u5c06\u8fd9\u6b3e\u75be\u75c5\u9996\u521b\uff0c\u80fd\u9488\u5bf9\u75be\u75c5\u6e90\u5934\u3001\u6539\u53d8\u75be\u75c5\u8fdb\u5c55\u7684\u6cbb\u7597\u65b9\u6848\u5e26\u7ed9\u4e2d\u56fd\u548c\u66f4\u591a\u4e9a\u6d32\u60a3\u8005\uff0c\u4ee5\u6ee1\u8db3\u8feb\u5207\u7684\u4e34\u5e8a\u9700\u6c42\u3002" NefIgArd\u662f\u4e00\u9879\u5168\u7403\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u76843\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5728\u76ee\u524d\u5305\u62ec\u4f18\u5316RAS\u6291\u5236\u5242\u5728\u5185\u7684\u6807\u51c6\u652f\u6301\u6cbb\u7597\u57fa\u7840\u4e0a\u8054\u5408\u53e3\u670d\u8010\u8d4b\u5eb7®\uff0816 mg\/d\uff09\u6216\u5b89\u6170\u5242\u6cbb\u7597\u3002NefIgArd\u7814\u7a76\u5206\u4e3aA\u3001B\u4e24\u90e8\u5206\uff1aA\u90e8\u5206\u5305\u62ec9\u4e2a\u6708\u6cbb\u7597\u671f\u548c3\u4e2a\u6708\u505c\u836f\u968f\u8bbf\u671f\uff1bB\u90e8\u5206\u5219\u5305\u62ec\u518d\u5ef6\u7eed12\u4e2a\u6708\u7684\u505c\u836f\u968f\u8bbf\u671f\u3002\u7f3a\u9677\u578bIgA1\u5206\u5b50\uff08Gd-IgA1\uff09\u662f\u5bfc\u81f4IgA\u80be\u75c5\u7684\u5173\u952e\u56e0\u7d20\uff0c\u8d8a\u6765\u8d8a\u591a\u7684\u8bc1\u636e\u652f\u6301\u80a0\u9053\u9ecf\u819c\u76f8\u5173\u6dcb\u5df4\u7ec4\u7ec7\uff08GALT\uff09\u662fGd-IgA1\u7684\u4e3b\u8981\u6765\u6e90\u3002\u4f5c\u4e3aGALT\u4e2dIgA\u5408\u6210\u7684\u5173\u952e\u7ec6\u80de\u56e0\u5b50\uff0cB\u7ec6\u80de\u6d3b\u5316\u56e0\u5b50\uff08BAFF\uff09\u3001\u589e\u6b96\u8bf1\u5bfc\u914d\u4f53\uff08APRIL\uff09\u4e0e\u7279\u5b9a\u7684\u7ec6\u80de\u8868\u9762\u53d7\u4f53BCMA\uff08B\u7ec6\u80de\u6210\u719f\u6297\u539f\uff09\u7b49\u76f8\u7ed3\u5408\u53d1\u6325\u4f5c\u7528\u3002\u56e0\u6b64\u7f3a\u9677\u578bIgA1\u5206\u5b50\uff08Gd-IgA1\uff09\u3001\u5faa\u73afIgA\u514d\u75ab\u590d\u5408\u7269\uff08IgA-IC\uff09\u3001B\u7ec6\u80de\u6d3b\u5316\u56e0\u5b50\uff08BAFF\uff09\u3001\u589e\u6b96\u8bf1\u5bfc\u914d\u4f53\uff08APRIL\uff09\u53ca\u53ef\u6eb6\u6027BCMA\uff08B\u7ec6\u80de\u6210\u719f\u6297\u539f\uff09\u7b49\u4f5c\u4e3a\u53c2\u4e0eIgA\u80be\u75c5\u53d1\u75c5\u7684\u91cd\u8981\u6307\u6807\u3002 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(IgA-IC)\u5df2\u88ab\u8bc1\u660e\u4f1a\u5728\u80be\u7ec4\u7ec7\u4e2d\u79ef\u805a\uff0c\u4ece\u800c\u5f15\u53d1\u80be\u5c0f\u7403\u708e\u75c7\u3002\u57283\u671f\u7814\u7a76A\u90e8\u5206\uff0c\u5171\u6709160\u4f8b\u60a3\u8005\u6d4b\u5b9a\u4e86\u8840\u6e05IgA-IC\u6c34\u5e73\u3002\u7ed3\u679c\u663e\u793a\uff0c\u8010\u8d4b\u5eb7®\u6cbb\u7597\u7ec4\u5728\u6cbb\u75973\u4e2a\u6708\uff08P=0.0055\uff09\u30016\u4e2a\u6708\uff08P=0.047\uff09\u548c9\u4e2a\u6708\uff08P=0.0169\uff09\u65f6\uff0c\u8840\u6e05IgA-IC\u6c34\u5e73\u8f83\u5b89\u6170\u5242\u7ec4\u8868\u73b0\u51fa\u7edf\u8ba1\u5b66\u4e0a\u7684\u663e\u8457\u4e0b\u964d\u3002\u7ed3\u5408\u4e4b\u524d\u53d1\u8868\u76843\u671f\u7814\u7a76A\u90e8\u5206\u4e2d\u964d\u4f4e\u5faa\u73af\u4e2dGd-IgA1\u6c34\u5e73\u7684\u7ed3\u679c\uff0834%\uff09\uff0c\u8fdb\u4e00\u6b65\u652f\u6301\u8010\u8d4b\u5eb7®\u53ef\u9488\u5bf9IgA\u80be\u75c5\u7684\u53d1\u75c5\u673a\u5236\u6765\u6539\u5584\u75be\u75c5\u8fdb\u5c55\u3002 \u5bf9\u53c2\u52a0 3 \u671f NefIgArd 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