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1.Prezcobix ÔÚ¼ÓÄôóÉÏÊÐÖÎÁÆ HIV
Janssen ¹«Ë¾Ö¤Êµ£¬Ã¿ÈÕ¿Ú·þÒ»´ÎµÄ HIV ¸ÐȾÖÎÁÆÒ© Prezcobix(TM)£¨´ï«ÄÇΤ/cobicistat£©ÒÑÔÚ¼ÓÄôó¿ªÊÛ£¬ÓÃÒÔͬÆäËû¿¹Äæת¼²¡¶¾Ò©ÎïÁªºÏÖÎÁÆ¡£ÒÔµ¥Æ¬ÐÎʽʹ´ï«ÄÇΤÔöЧ£¬ÕâÖÖ HIV ÖÎÁÆ·½°¸¶Ô»¼ÕßÀ´ËµÉÐÊôÊ״Ρ£2 Ïî III ÆÚÑо¿£¨ARTEMIS ºÍ ODIN£©ºÍ 1 ÏîÖ§³ÖÐÔÑо¿£¨GS-US-216-0130£©£¨ClinicalTrials.gov ±êʶºÅ NCT01440569£©Ö¤ÊµÁ˱¾Æ·µÄÁÆЧ£¨Janssen ÐÂΟ壩¡£
Janssen ¹«Ë¾µÄ¹Ì¶¨¼ÁÁ¿¸´·½Ò©È¥ÄêÏò EMA µÝ½»ÁË MAA£¬²¢ÔÚ½ñÄêÔçЩʱºòÏò FDA µÝ½»ÁË NDA£¨¼û 2013 Äê 10 Ô 15 ÈÕºÍ 2014 Äê 4 Ô 2 ÈÕ¡¶ÌÀÉ·͸ҩÎïÐÂÎÅ¡·£©¡£ Cobicistat µÄ×ÛÊö¼û Temesgen, Z. Drugs Today 2013, 49(4): 233¡£
2.Chugai Pharmaceutical ¹«Ë¾ÍƳö ALK ÒÖÖƼÁ Alecensa
Chugai Pharmaceutical ¹«Ë¾ÔÚÈÕ±¾ÍƳöÁ˼ä±äÐÔÁÜ°ÍÁöø£¨ALK£©ÒÖÖƼÁ Alecensa(R)£¨ÑÎËá alectinib£©£¬ÊÊÓ¦Ö¢ÊÇ ALK ÈںϻùÒòÑôÐԵIJ»¿ÉÇгý¡¢¸´·¢ÐÔ/ÍíÆÚ·ÇСϸ°û·Î°© (NSCLC) ¡£¸Ã¹«Ë¾ÓÚ 7 Ô·ݻñµÃÁËÈÕ±¾µÄÖÆÔìÉÏÊÐÅúÎÄ£¨¼û 2014 Äê 7 Ô 7 ÈÕ¡¶ÌÀÉ·͸ҩÎïÐÂÎÅ¡·£©¡£¸Ã²úÆ·ÔÚÅ·ÖÞºÍÃÀ¹úµÈÆäËû¹ú¼Ò/µØÇøµÄȨÀûÓÚ 2012 Äê¶ÔÍâÊÚȨ¸ø Roche ¹«Ë¾£¬Ä¿Ç°ÕýÔÚÃÀ¹ú¡¢Å·ÖÞ¼°ÆäËû¹ú¼Ò/µØÇø¿ªÕ¹ÁÙ´²ÊÔÑ飨Chugai Pharmaceutical ÐÂΟ壩¡£ ÑÎËá alectinib µÄ×ÛÊö¼û Cole, P. Drugs Fut 2013, 38(12): 799 ¡£
3.FDA Ϊ pembrolizumab ÖÎÁƺÚÉ«ËØÁö°ä·¢¿ìËÙÉóÅú
FDA Ϊ Merck & Co. ¹«Ë¾µÄ Keytruda(R) (pembrolizumab) °ä·¢ÁË¿ìËÙÉóÅú£¬ÒÔÿ 3 ÖÜ 2 mg/kg µÄ¼ÁÁ¿£¬ÖÎÁƲ»¿ÉÇгý»òתÒÆÐÔºÚÉ«ËØÁö»òÒÁƥľµ¥¿¹ÖÎÁÆ£¨»òÈôÖ×ÁöΪ BRAF V600 Í»±äÑôÐÔ£¬ÔòÓà B-raf ÒÖÖƼÁÖÎÁÆ£©ºó¼²²¡½øÕ¹µÄ»¼Õß¡£Pembrolizumab ÊÇÊ׸ö FDA Åú×¼µÄ³ÌÐòÐÔϸ°ûËÀÍöµ°°× 1£¨PD-1£©°ÐÏòÒ©Îï¡£´Ë´ÎÅú×¼¸ù¾ÝµÄÊǶÔÍíÆÚ»òתÒÆÐÔºÚÉ«ËØÁö¡¢ÉÏƤ°©»ò·ÇСϸ°û·Î°©»¼ÕßÕýÔÚ¿ªÕ¹µÄ¿ª·ÅÐÔ Ib ÆÚÑо¿ KEYNOTE-001£¨ClinicalTrials.gov ±êʶºÅ NCT01295827)£©µÄÊý¾Ý¡£ÕâÏîÊÔÑéÄÉÈëÁ˽ÓÊÜÒÁƥľµ¥¿¹ÖÎÁƵIJ»¿ÉÇгý»òתÒÆÐÔºÚÉ«ËØÁö»¼Õߣ¨ÈôÆäÖ×ÁöÊôÓÚ BRAF V600 Í»±äÑôÐÔ£¬ÔòÓà B-raf »ò MEK ÒÖÖƼÁ£©£¬ÒÔ¼°Ä©´ÎʹÓÃÒÁƥľµ¥¿¹ºó 24 ÖÜÄÚ¼²²¡½øÕ¹µÄ»¼Õ߶ÓÁС£ÕâЩ»¼Õßÿ 3 ÖܽÓÊÜ 2 mg/kg (n = 89) »ò 10 mg/kg (n = 84)£¬Ö±ÖÁ¼²²¡½øÕ¹»ò³öÏÖ²»¿É½ÓÊܶ¾ÐÔ¡£2 mg/kg ¼ÁÁ¿ÖÎÁÆ»¼ÕßÖУ¬1 Àý±íÏÖ³öÍêÈ«»º½â£¬20 Àý²¿·Ö»º½â£¬×Ü»º½âÂÊΪ 24%¡£8 Àý»¼ÕߵĻº½â³ÖÐø³¬¹ý 6 ¸öÔ¡£Õâ×éµÄ 89 Àý»¼ÕßÖУ¬6% Òò²»Á¼Ê¼þ¶øÍ£Óà pembrolizumab ÖÎÁÆ¡£Merck & Co. ¹«Ë¾Ô¤¼ÆÔÚ 1 ÖÜÖ®ÄÚÍƳö pembrolizumab¡£ÍíÆÚºÚÉ«ËØÁöµÄ II ÆÚºÍ III ÆÚÊÔÑéÕýÔÚ½øÐÐÖ®ÖУ¨Merck & Co. ÐÂΟ壻ClinicalTrials.gov ÍøÕ¾£© EMA »¹ÔÚ¶Ô¸ÃÒ©ÖÎÁÆÍíÆÚºÚÉ«ËØÁöÕ¹¿ªÆÀÉ󣨼û 2014 Äê 7 Ô 1 ÈÕ¡¶ÌÀÉ·͸ҩÎïÐÂÎÅ¡·£©¡£
4.Opdivo ÖÎÁƲ»¿ÉÇгýºÚÉ«ËØÁöÔÚÈÕ±¾ÉÏÊÐ
Ono Pharmaceutical ¹«Ë¾Ö¤Êµ¿¹ÈËÌå³ÌÐòÐÔϸ°ûËÀÍöµ°°×1 (PD-1) ¿¹Ì塪¡ªµ¥¿Ë¡¿¹Ìå Opdivo(R) (nivolumab) ¾²Âö×¢Éä¼Á¡ª¡ªÒÑÔÚÈÕ±¾¿ªÊÛ£¬ÓÃÓÚÖÎÁƲ»¿ÉÇгýºÚÉ«ËØÁö¡£¾ÝÈÏΪ£¬±¾Æ·¿É×è¶ÏÁÜ°Íϸ°ûµÄ PD-1-½éµ¼¸ºÏòµ÷¿Ø£¬´Ó¶øÔöÇ¿ÃâÒßϵͳ½«°©Ï¸°ûʶ±ðΪÒìÎï²¢½«ÆäÇå³ýµÄÄÜÁ¦¡£Opdivo ÊÇÊÀ½çÉÏÊ׸ö»ñÅúµÄ PD-1 °ÐÏòÒ©Î¼û 2014 Äê 7 Ô 7 ÈÕ¡¶ÌÀÉ·͸ҩÎïÐÂÎÅ¡·£©£¨Ono Pharmaceutical ÐÂΟ壩¡£ Nivolumab µÄ×ÛÊö¼û Moreira da Silva, R. Drugs Fut 2014, 39(1): 15¡£
5.FDA Åú×¼ Otezla ¿Ú·þÖÎÁÆ°ß¿é×´Òøм²¡
FDA Åú×¼ÁË Celgene ¹«Ë¾µÄÁ×Ëá¶þõ¥Ã¸ 4 (PDE4) ÒÖÖƼÁ Otezla(R)£¨apremilast£©£¬¿Ú·þÖÎÁƲ»ÒËÓùâÁÆ»òÈ«ÉíÐÔÖÎÁƵÄÖÐÖضȰ߿é×´Òøм²¡¡£ÕâÏîÅú×¼ÒÀ¾ÝµÄÊÇ III ÆÚÊÔÑé ESTEEM 1 ºÍ ESTEEM 2 µÄÊý¾Ý£¨ClinicalTrials.gov ±êʶºÅ·Ö±ðΪ NCT01194219 ºÍ NCT01232283£©¡£ÔÚÕâÁ½Ïο¼Á¶ÔÕÕÑо¿ÖУ¬Ö÷ÒªÖյ㶼ÊÇµÚ 16 ÖÜ¡°Òøм²¡Ãæ»ýºÍÑÏÖس̶ÈÖ¸Êý (PASI-75)¡±½Ï»ùÏßÖÁÉÙ½µµÍ 75% µÄÊÜÊÔÕß±ÈÀý£¬30 mg apremilast ÿÈÕÁ½´ÎÖÎÁƶ¼Ã÷ÏÔÌá¸ß£¨¼û 2013 Äê 1 Ô 9 ÈÕ¡¶ÌÀÉ·͸ҩÎïÐÂÎÅ¡·£©¡£FDA ÓÚ 2014 Äê 3 ÔÂÅú×¼ÁË apremilast ÖÎÁÆÒøм²¡¹Ø½ÚÑ×£¨¼û 2014 Äê 3 Ô 24 ÈÕ¡¶ÌÀÉ·͸ҩÎïÐÂÎÅ¡·£©¡£Celgene ¹«Ë¾»¹ÔÚ 2013 ÄêµÚ¶þ¼¾¶È¾ÍÖÎÁÆÒøм²¡¹Ø½ÚÑ×Ïò¼ÓÄôó±¨Åú£¬2013 ÄêµÚËļ¾¶È¾ÍÕë¶ÔÒøм²¡±¨Åú¡£¸Ã¹«Ë¾ÔÚ 2013 ÄêµÚËļ¾¶È¾ÍÖÎÁÆÁ½ÖÖÊÊÓ¦Ö¢ÏòÅ·Ã˵ݽ»ÁË MAA£¨Celgene ÐÂΟ壩¡£
6.FDA Åú×¼ Trulicity ÖÎÁÆ 2 ÐÍÌÇÄò²¡
Trulicity(TM) (dulaglutide) ÊÇ Eli Lilly ¹«Ë¾¿ª·¢µÄ¸ßѪÌÇËØÑùëÄ-1 (GLP-1) ÊÜÌ弤¶¯¼Á£¬Ã¿ÖÜÓÃÒ©Ò»´Î£¬FDA ÒÑÅú×¼Æä×÷ΪÒûʳºÍÔ˶¯µÄ¸¨ÖúÊֶΣ¬¸ÄÉÆ 2 ÐÍÌÇÄò²¡³ÉÈ˵ÄѪÌÇ¿ØÖÆ¡£ÒûʳºÍÔ˶¯¿ØÖƲ»¼ÑµÄ»¼Õߣ¬½¨Òé²»ÒªÓà dulaglutide ×÷ΪһÏßÖÎÁÆ¡£ÕâÏîÅú×¼ÊÇ dulaglutide ÔÚÈ«ÊÀ½çµÄÊ״λñÅú¡£Lilly ¹«Ë¾¼Æ»®¼Æ»®ÔÚ½ñÄêÍíЩʱºòÍƳö Trulicity 0.75 mg ºÍ 1.5 mg µ¥¼ÁÁ¿×¢Éä±Ê¡£BLA °üÀ¨ dulaglutide µ¥ÓûòÓë³£ÓÃÌÇÄò²¡´¦·½Ò©£¨°üÀ¨¶þ¼×Ë«ëÒ¡¢ßÁ¸ñÁÐͪ¡¢¸ñÁÐÃÀëå¡¢Àµ¸¬ÒȵºËØ£©ÁªÓõÄÑо¿¡£ÕâЩÑо¿°üÀ¨ AWARD£¨Assessment of Weekly AdministRation of LY-2189265 in Diabetes£¬Ã¿ÖÜʹÓÃÒ»´Î LY-2189265 ÖÎÁÆÌÇÄò²¡µÄÆÀ¹À£©¼Æ»®ÖÐµÄ 5 Ïî´óÐÍ III ÐÍÊÔÑé¡£Dulaglutide µÄÁÆЧÓë¶þ¼×Ë«ëÒ¡¢Januvia(R)£¨Á×ËáÎ÷¸ñÁÐÍ¡µ¥Ë®ºÏÎ¡¢Byetta(R)£¨°¬ÈûÄÇëÄ£©ºÍ Lantus(R)£¨¸Ê¾«ÒȵºËØ£©Ïà·Â¡£Dulaglutide µÄ˵Ã÷ÊéÖбêÓмӿò¾¯¸æ£¬³Æ¸ù¾Ý´óÊóµÄÑо¿£¬·¢Éú¼××´ÏÙ C ϸ°ûÖ×ÁöµÄ·çÏÕÉý¸ß¡£´óÊóÖÕÉúÓÃÒ©ºó£¬dulaglutide µ¼Ö¼××´ÏÙ C ϸ°ûÖ×Áö£¨ÏÙÁöºÍ°©£©·¢ÉúÂʳʼÁÁ¿Ïà¹Ø¼°ÁƳÌÒÀÀµÐÔÉý¸ß¡£ÁÙ´²»ò·ÇÁÙ´²Ñо¿ÎÞ·¨È·¶¨ÈËÌåÏà¹ØÐÔ¡£Óм××´ÏÙËèÑù°©¸öÈËÊ·»ò¼Ò×åÊ·»¼Õß¼° 2 ÐͶ෢ÐÔÄÚ·ÖÃÚÖ×Áö×ÛºÏÕ÷»¼Õß½ûÓà dulaglutide¡£ÒÑÏò EMA ¼°ÆäËûµ±¾ÖµÝ½»Á˼à¹ÜÉ걨£¨Eli Lilly ÐÂΟ壩¡£ Dulaglutide µÄ×ÛÊö¼û Amblee, A. Drugs Today 2014, 50(4): 277¡£
7.Ryzodeg ÔÚÊ×·¢¹úÉÏÊÐ
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8.FDA Åú×¼ naloxegol ÖÎÁÆÂýÐÔÌÛÍ´»¼ÕߵݢƬÓÕ·¢±ãÃØ
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9.FDA Åú×¼ Rixubis ÖÎÁÆѪÓѲ¡ B ¶ùͯ
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