Ñз¢¶¯Ì¬
-
- 2023-09-06
ÁãÍ»ÆÆ£¡¿Ê±AGµÇ¼Èë¿Ú¹ðÁÖÄÏÒ©Ê׸ö¿Ú·þÖƼÁ»ñÃÀ¹úFDAÅú×¼ÉÏÊÐ
8ÔÂ31ºÅ£¬¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©³ÉÔ±ÆóÒµ¹ðÁÖÄÏÒ©¹É·ÝÓÐÏÞ¹«Ë¾³Ð½ÓÉú²úµÄ¹ãÆ׿¹¾úÒ©»Ç°·¼×‡fßò¼×ÑõÜÐà¤Æ¬800mg/160mg¹æ¸ñ»ñÃÀ¹úFDAÅú×¼ÉÏÊУ¬ÊµÏÖÁË¿Ú·þÖƼÁÉú²úÏßÆ·ÖÖ»ñµÃFDAÅú×¼ÉÏÊеÄÁãÍ»ÆÆ¡£¶Ô¹ðÁÖÄÏÒ©À©Õ¹ÍâÑóÊг¡ºÍ¹ú¼Ê»¯ÄÜÁ¦ÌáÉý¾ßÓÐÖØ´óÒâÒå¡£
-
- 2023-07-25
¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©×ÔÑÐMEK1/2ÒÖÖƼÁFCN-159Ƭ»ñµÚ¶þÏîÍ»ÆÆÐÔÁÆ·¨È϶¨
£¨2023Äê7ÔÂ25ÈÕ£¬ÖйúÉϺ££©7ÔÂ25ÈÕ£¬Ö²¸ùÖйú¡¢Á¢ÒìÇý¶¯µÄÈ«Çò»¯Ò½Ò©¿µ½¡¹¤Òµ¼¯ÍÅÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©£¨¼¯ÍÅ£©¹É·ÝÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¡±£¬¹ÉƱ´úÂ룺600196.SH£»02196.HK£©Ðû²¼£¬¿Ø¹É×Ó¹«Ë¾ÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤ÒµÉú³¤ÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤Òµ¡±£© ×ÔÖ÷Ñз¢µÄMEK1/2ÒÖÖƼÁFCN-159Ƭ£¨¡°¸ÃÐÂÒ©¡±£©ÓÃÓÚÖÎÁÆÎÞ·¨ÊÖÊõ»òÊõºó²ÐÁô/¸´·¢µÄ NF1£¨¼´IÐÍÉñ¾ÏËάÁö£©Ïà¹ØµÄ´Ô×´Éñ¾ÏËάÁö³ÉÈË»¼ÕßÒѱ»¹ú¼ÒÒ©Æ·¼àÊÓÖÎÀí¾Ö£¨NMPA£©Ò©Æ·ÆÀÉóÖÐÑ루CDE£©ÄÉÈëÍ»ÆÆÐÔÖÎÁÆÆ·ÖÖ¡£ÕâÊǼ̽ñÄê4Ô£¬FCN-159ƬÕë¶Ô×é֯ϸ°ûÖ×ÁöµÄ˳Ӧ֢֮ºó£¬µÚ¶þ¸ö˳Ӧ֢±»ÄÉÈëÍ»ÆÆÐÔÁÆ·¨È϶¨¡£
-
- 2023-07-12
¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©Á¢ÒìÒ©ÑÎËáÌæÄÉÅÁŵƬ?»ñÉÏÊÐÉêÇëÊÜÀí ÓÃÓÚÖÎÁÆÂýÐÔÉöÔಡѪ͸»¼Õ߸ßÁ×Ѫ֢
£¨2023Äê7ÔÂ12ÈÕ£¬ÖйúÉϺ££©7ÔÂ12ÈÕ£¬ÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©£¨¼¯ÍÅ£©¹É·ÝÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¡±£¬¹ÉƱ´úÂ룺600196.SH£»02196.HK£©Ðû²¼£¬¿Ø¹É×Ó¹«Ë¾ÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤ÒµÉú³¤ÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤Òµ¡±£©»ñÔÊÐíÁ¢ÒìÒ©TenapanorƬ£¨ÑÎËáÌæÄÉÅÁŵƬ£¬¡°¸ÃÐÂÒ©¡±£©ÓÃÓÚ¿ØÖÆÕýÔÚ½ÓÊÜѪҺ͸ÎöÖÎÁƵÄÂýÐÔÉöÔಡ£¨CKD£©³ÉÈË»¼ÕߵĸßÁ×Ѫ֢µÄÒ©Æ·×¢²áÉêÇëÓÚ¿ËÈÕ»ñ¹ú¼ÒÒ©Æ·¼àÊÓÖÎÀí¾Ö£¨¡°¹ú¼ÒÒ©¼à¾Ö¡±£©ÉóÆÀÊÜÀí¡£TenapanorƬÊǿʱAGµÇ¼Èë¿ÚÒ½Ò©´ÓArdelyxÔÊÐí
-
- 2023-07-06
¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©Á¢ÒìÐÍÈⶾËزúÆ·RT002ÖÎÁÆ˳Ӧ֢ÉÏÊÐÉêÇë»ñÊÜÀí
£¨2023Äê7ÔÂ6ÈÕ£¬ÖйúÉϺ££©7ÔÂ6ÈÕ£¬Á¢ÒìÇý¶¯µÄÈ«Çò»¯Ò½Ò©¿µ½¡¹¤Òµ¼¯ÍÅÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©£¨¼¯ÍÅ£©¹É·ÝÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¡±£¬¹ÉƱ´úÂ룺600196.SH¡¢02196.HK£©Ðû²¼£¬¿Ø¹É×Ó¹«Ë¾ÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤ÒµÉú³¤ÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤Òµ¡±£©ÔÊÐíÒý½øµÄRT002£¨¼´DaxibotulinumtoxinAÐÍÈⶾ¸Ë¾ú¶¾ËØ£©ÓÃÓÚÖÎÁƳÉÈ˾±²¿¼¡ÕÅÁ¦ÕÏ°µÄÒ©Æ·×¢²áÉêÇëÓÚ¿ËÈÕ»ñ¹ú¼ÒÒ©Æ·¼àÊÓÖÎÀí¾Ö£¨¡°¹ú¼ÒÒ©¼à¾Ö¡±£©ÉóÆÀÊÜÀí¡£
-
- 2023-07-01
ÐÂÒ»´ú³¤Ð§Éý°×Ò©£¬«˜½ð®£¨ÍØÅà·Ç¸ñ˾ͤ£©Õýʽ»ñÅúÉÏÊУ¡
6ÔÂ30ÈÕ£¬¹ú¼ÒÒ©Æ·¼àÊÓÖÎÀí¾ÖÕýʽÅú×¼Ìر¦ÉúÎïÑз¢µÄ¢ñÀàÐÂÒ©¡¢ÐÂÒ»´ú³¤Ð§ÖØ×éÈËÁ£Ï¸°û¼¯Âä´Ì¼¤Òò×Ó¡°ÍØÅà·Ç¸ñ˾ͤעÉäÒº¡±£¨ÉÌÆ·Ãû¡°«˜½ð®¡±£©ÉÏÊС£´ËÇ°£¬¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¿Ø¹É×Ó¹«Ë¾½ËտʱAGµÇ¼Èë¿ÚÒ½Ò©ÏúÊÛÓÐÏÞ¹«Ë¾ÒÑÓëÌر¦ÉúÎïÇ©Ê𡶹ØÓÚÍØÅà·Ç¸ñ˾ͤעÉäÒº£¨«˜½ð®£©µÄ¶À¼ÒÉÌÒµ»¯ÐÒé¡·£¬½ËտʱAGµÇ¼Èë¿ÚÒÑ»ñµÃÍØÅà·Ç¸ñ˾ͤעÉäÒºÔÚÖйú´ó½µØÇø£¨Ïã¸ÛÌØÊâÐÐÕþÇø¡¢°ÄÃÅÌØÊâÐÐÕþÇøºĮ́ÍåµØÇø³ýÍ⣩µÄ¶À¼ÒÍƹ㼰ÏúÊÛȨÁ¦¡£
-
- 2023-06-26
ÖйúÊ׿¿Ê±AGµÇ¼Èë¿Ú¿ÌØCAR-T²úÆ·ÞÈ¿´ï®ÐÂÔö»ñÅú¶þÏß˳Ӧ֢
2023Äê6ÔÂ26ÈÕ£¬ÖйúÉϺ££©6ÔÂ26ÈÕ£¬Á¢ÒìÇý¶¯µÄÈ«Çò»¯Ò½Ò©¿µ½¡¹¤Òµ¼¯ÍÅÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©£¨¼¯ÍÅ£©¹É·ÝÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¡±£¬¹ÉƱ´úÂ룺600196.SH¡¢02196.HK£©Ðû²¼£¬ºÏÓª¹«Ë¾¿Ê±AGµÇ¼Èë¿Ú¿ÌØÉúÎï¿Æ¼¼ÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿Ú¿ÌØ¡±£©µÄ°¢»ùÂØÈü×¢ÉäÒº£¨ÉÌÆ·Ãû£ºÞÈ¿´ï®£»ÒÔϼò³Æ¡°¸Ã²úÆ·¡±£©ÓÃÓÚÖÎÁÆÒ»ÏßÃâÒß»¯ÁÆÎÞЧ»òÔÚÒ»ÏßÃâÒß»¯Áƺó12¸öÔÂÄÚ¸´·¢µÄ³ÉÈË´óBϸ°ûÁÜ°ÍÁö£¨r/r LBCL£©£¨¡°±¾´ÎÐÂÔö˳Ӧ֢¡±£©µÄÉÏÊÐ×¢²áÉêÇëÓÚ¿ËÈÕ»ñ¹ú¼ÒÒ©Æ·¼àÊÓÖÎÀí¾Ö £¨¡°¹ú¼ÒÒ©¼à¾Ö¡±£©¸½Ìõ¼þÅú×¼¡£ÕâÒ²±ê¼Ç×ÅÞÈ¿´ï®¶þÏß˳Ӧ֢ÕýʽÉÏÊС£
-
- 2023-05-17
¸´ºêººÁØÁ¢ÒìÐÍ¿¹HER2µ¥¿¹HLX22 IÆÚÑо¿Ð§¹û½ÒÏþÓÚInvestigational New Drugs
¿ËÈÕ£¬¸´ºêººÁØHLX22£¨Á¢ÒìÐÍ¿¹HER2µ¥¿¹£©Õë¶ÔHER2¹ý±í´ïµÄÍíÆÚʵÌåÁöµÄIÆÚÁÙ´²Ñо¿Êý¾Ý½ÒÏþÓÚÆÚ¿¯Investigational New Drugs¡£Ñо¿Ð§¹ûÏÔʾ£¬HLX22ÔÚHER2¹ý±í´ïµÄÍíÆÚʵÌåÁö»¼ÕßÖоßÓÐÓÅÒìµÄÇå¾²ÐÔºÍÄÍÊÜÐÔ£¬ÎªHLX22ÓëÇúÍ×Öéµ¥¿¹µÈ²úÆ·ÍŽáÁÆ·¨µÄ¿ªÕ¹µÓÚ¨ÁË»ù´¡¡£
-
- 2023-05-10
ÐÂÐÍÄâ¸Æ¼ÁÒÀÌØ¿¨ëÄ»ñÅúÉÏÊУ¬ÖйúCKD°éSHPT»¼ÕßÓÀ´ÐÂÏ£Íû
5ÔÂ6ÈÕ£¬¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©Ðû²¼ÆäÓë°²½øÏàÖú»ñ¶À¼ÒÉÌÒµ»¯ÊÚȨµÄÐÂÐÍ×¢Éä¼ÁÐÍÄâ¸Æ¼ÁÒÀÌØ¿¨ëÄ£¨ÉÌÆ·Ãû£ºÅԱظ£®£©»ñ¹ú¼ÒÒ©Æ·¼àÊÓÖÎÀí¾Ö£¨NMPA£©Åú×¼ÉÏÊС£ÓÃÓÚÖÎÁÆÂýÐÔÉöÔಡ£¨CKD£©½ÓÊÜѪҺ͸ÎöµÄ³ÉÈË»¼Õߵļ̷¢ÐÔ¼××´ÅÔÏÙ¹¦Ð§¿º½øÖ¢£¨SHPT£©¡£
-
- 2023-04-21
¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¿¹Ö×ÁöÐÂÒ©FCN-159Ƭ»ñCDEÍ»ÆÆÐÔÁÆ·¨È϶¨
£¨2023Äê4ÔÂ21ÈÕ£¬ÖйúÉϺ££©4ÔÂ21ÈÕ£¬Ö²¸ùÖйú¡¢Á¢ÒìÇý¶¯µÄÈ«Çò»¯Ò½Ò©¿µ½¡¹¤Òµ¼¯ÍÅÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©£¨¼¯ÍÅ£©¹É·ÝÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¡±£¬¹ÉƱ´úÂ룺600196.SH£»02196.HK£©Ðû²¼£¬¿Ø¹É×Ó¹«Ë¾ÉϺ£¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤ÒµÉú³¤ÓÐÏÞ¹«Ë¾£¨¡°¿Ê±AGµÇ¼Èë¿ÚÒ½Ò©¹¤Òµ¡±£©ÔÚÑÐÐÂÒ©FCN-159Ƭ£¨¡°¸ÃÐÂÒ©¡±£©±»¹ú¼ÒÒ©Æ·¼àÊÓÖÎÀí¾Ö£¨NMPA£©Ò©Æ·ÆÀÉóÖÐÑ루CDE£©È϶¨ÎªÍ»ÆÆÐÔÖÎÁÆÆ·ÖÖ£¬ÄâÓÃÓÚÖÎÁÆ×é֯ϸ°ûÖ×Áö¡£CDE½«¶ÔÄÉÈëÍ»ÆÆÐÔÖÎÁÆÒ©Îï³ÌÐòµÄÒ©ÎïÓÅÏÈÉèÖÃ×ÊÔ´¾ÙÐÐÏàͬ½»Á÷£¬ÔöÇ¿Ö¸µ¼²¢Ôö½øÒ©ÎïÑз¢£¬ÓÐÍû½øÒ»²½Ëõ¶ÌÒ©ÎïÁÙ´²Ñз¢ÖÜÆÚ¡£