浠婂ぉ鏄細

瀹為獙瀹よ祫璁綉

銆愬彂鏀瑰銆戝尰鐤楀櫒姊颁骇涓氱粨鏋勮皟鏁?娣樻卑钀藉悗鎶€鏈拰浜у搧

瀹為獙瀹よ祫璁綉鏃堕棿:2019-04-13 鐐瑰嚮: 娆?/span> 鐧惧害鎼滅储

銆愬璇汇€?/strong>4鏈?鏃ワ紝鍥藉姟闄㈠彂鏀瑰鍙戝竷銆婁骇涓氱粨鏋勮皟鏁存寚瀵肩洰褰曪紙2019骞存湰锛?寰佹眰鎰忚绋匡級銆嬩竴鏂囷紝鏂囦腑鐢?榧撳姳绫汇€侀檺鍒剁被銆佹窐姹扮被 涓変釜绫诲埆缁勬垚銆?榧撳姳绫讳富瑕佹槸瀵圭粡娴庣ぞ浼氬彂灞曟湁閲嶈淇冭繘浣滅敤锛屾湁鍒╀簬婊¤冻浜烘皯缇庡ソ鐢熸椿闇€瑕佸拰鎺ㄥ姩楂樿川閲忓彂灞曠殑鎶€鏈€佽澶囥€佷骇鍝併€佽涓氥€?闄愬埗绫讳富瑕佹槸宸ヨ壓鎶€鏈惤鍚庯紝涓嶇鍚堣涓氬噯......
TAG鏍囩锛?鍖荤枟鍣ㄦ 鍙戞敼濮?/a> 娣樻卑 浜т笟缁撴瀯璋冩暣 钀藉悗鎶€鏈?/a> 钀藉悗浜у搧
銆愬彂鏀瑰銆戝尰鐤楀櫒姊颁骇涓氱粨鏋勮皟鏁?娣樻卑钀藉悗鎶€鏈拰浜у搧

4鏈?鏃ワ紝鍥藉姟闄㈠彂鏀瑰鍙戝竷銆婁骇涓氱粨鏋勮皟鏁存寚瀵肩洰褰曪紙2019骞存湰锛?寰佹眰鎰忚绋匡級銆嬩竴鏂囷紝鏂囦腑鐢?span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">榧撳姳绫汇€侀檺鍒剁被銆佹窐姹扮被涓変釜绫诲埆缁勬垚銆?/span>榧撳姳绫讳富瑕佹槸瀵圭粡娴庣ぞ浼氬彂灞曟湁閲嶈淇冭繘浣滅敤锛屾湁鍒╀簬婊¤冻浜烘皯缇庡ソ鐢熸椿闇€瑕佸拰鎺ㄥ姩楂樿川閲忓彂灞曠殑鎶€鏈€佽澶囥€佷骇鍝併€佽涓氥€?/span>闄愬埗绫讳富瑕佹槸宸ヨ壓鎶€鏈惤鍚庯紝涓嶇鍚堣涓氬噯鍏ユ潯浠跺拰鏈夊叧瑙勫畾锛岀姝㈡柊寤烘墿寤哄拰闇€瑕佺潱淇冩敼閫犵殑鐢熶骇鑳藉姏銆佸伐鑹烘妧鏈€佽澶囧強浜у搧銆?/span>娣樻卑绫讳富瑕佹槸涓嶇鍚堟湁鍏虫硶寰嬫硶瑙勮瀹氾紝涓嶅叿澶囧畨鍏ㄧ敓浜ф潯浠讹紝涓ラ噸娴垂璧勬簮銆佹薄鏌撶幆澧冿紝闇€瑕佹窐姹扮殑钀藉悗宸ヨ壓銆佹妧鏈€佽澶囧強浜у搧銆?/span>

闇€瑕佽鏄庣殑鏄紝瀵逛笉灞炰簬榧撳姳绫汇€侀檺鍒剁被鍜屾窐姹扮被锛屼笖绗﹀悎鍥藉鏈夊叧娉曞緥銆佹硶瑙勫拰鏀跨瓥瑙勫畾鐨勶紝涓哄厑璁哥被銆?/span>鍏佽绫讳笉鍒楀叆鐩綍銆?/span>

涓庡尰鐤椾骇涓氶鍩熺浉鍏崇殑鐨勪俊鎭暣鐞嗗涓嬶細

绗竴绫伙細榧撳姳绫?/span>

鍖昏嵂鏂归潰锛?/span>

1銆佹嫢鏈夎嚜涓荤煡璇嗕骇鏉冪殑鏂拌嵂寮€鍙戝拰鐢熶骇锛屽ぉ鐒惰嵂鐗╁紑鍙戝拰鐢熶骇锛屾弧瓒虫垜鍥介噸澶с€佸鍙戞€х柧鐥呴槻娌婚渶姹傜殑閫氱敤鍚嶈嵂鐗╅娆″紑鍙戝拰鐢熶骇锛岃嵂鐗╂柊鍓傚瀷銆佹柊杈呮枡銆佸効绔ヨ嵂銆佺煭缂鸿嵂鐨勫紑鍙戝拰鐢熶骇锛岃嵂鐗╃敓浜ц繃绋嬩腑鐨勮啘鍒嗙銆佽秴涓寸晫钀冨彇銆佹柊鍨嬬粨鏅躲€佹墜鎬у悎鎴愩€侀叾淇冨悎鎴愩€佽繛缁弽搴斻€佺郴缁熸帶鍒剁瓑鎶€鏈紑鍙戜笌搴旂敤锛屽師鏂欒嵂鐢熶骇鑺傝兘闄嶈€楀噺鎺掓妧鏈€佹柊鍨嬭嵂鐗╁埗鍓傛妧鏈紑鍙戜笌搴旂敤銆?/span>

2銆侀噸澶х柧鐥呴槻娌荤柅鑻椼€佹姉浣撹嵂鐗┿€佸熀鍥犳不鐤楄嵂鐗┿€佺粏鑳炴不鐤楄嵂鐗┿€侀噸缁勮泲鐧借川鑽墿銆佹牳閰歌嵂鐗╋紝澶ц妯$粏鑳炲煿鍏诲拰绾寲鎶€鏈€佸ぇ瑙勬ā鑽敤澶氳偨鍜屾牳閰稿悎鎴愩€佹姉浣撳伓鑱斻€佹棤琛€娓呮棤铔嬬櫧鍩瑰吇鍩哄煿鍏汇€佸彂閰点€佺函鍖栨妧鏈紑鍙戝拰搴旂敤锛岄噰鐢ㄧ幇浠g敓鐗╂妧鏈敼閫犱紶缁熺敓浜у伐鑹恒€?/span>

3銆佹柊鍨嬭嵂鐢ㄥ寘瑁呮潗鏂欎笌鎶€鏈殑寮€鍙戝拰鐢熶骇(涓€х〖纭呰嵂鐢ㄧ幓鐠冿紝鍖栧绋冲畾鎬уソ銆佸彲闄嶈В锛屽叿鏈夐伩鍏夈€侀珮闃婚殧鎬х殑鍔熻兘鎬ф潗鏂欙紝姘旈浘鍓傘€佺矇闆惧墏銆佽嚜鎴戠粰鑽€侀鐏屽皝銆佽嚜鍔ㄦ贩鑽瓑鏂板瀷鍖呰缁欒嵂绯荤粺鍙婄粰鑽缃?銆?/span>

4銆佹繏鍗辩█缂鸿嵂鐢ㄥ姩妞嶇墿浜哄伐绻佽偛鎶€鏈紑鍙戯紝鍏堣繘鍐滀笟鎶€鏈湪涓嵂鏉愯鑼冨寲绉嶆銆佸吇娈栦腑鐨勫簲鐢紝涓嵂鏉愮殑鐢熸€佺妞嶄笌鐢熶骇锛屼腑鑽潗璧勬簮缁煎悎鍒╃敤鎶€鏈紝涓嵂璐ㄩ噺鎺у埗鏂版妧鏈紑鍙戝拰搴旂敤锛屼腑鑽幇浠e墏鍨嬬殑宸ヨ壓鎶€鏈€佺敓浜ц繃绋嬫帶鍒舵妧鏈紝涓嵂楗墖鐐埗鎶€鏈紶鎵夸笌鍒涙柊锛屼腑鑽粡鍏稿悕鏂圭殑寮€鍙戜笌鐢熶骇, 涓嵂鍒涙柊鑽墿鐨勭爺鍙戜笌鐢熶骇锛屼腑鎴愯嵂浜屾寮€鍙戝拰鐢熶骇锛屾皯鏃忚嵂鐗╁紑鍙戝拰鐢熶骇銆?/span>

5銆佹柊鍨嬪尰鐢ㄨ瘖鏂澶囧拰璇曞墏锛屾暟瀛楀寲鍖诲褰卞儚璁惧锛屼汉宸ユ櫤鑳借緟鍔╁尰鐤楄澶囷紝楂樼鏀惧皠娌荤枟璁惧锛屽唴绐ラ暅銆佹墜鏈満鍣ㄤ汉绛夐珮绔绉戣澶囷紝鏀灦銆佸亣浣撶瓑鏂板瀷妞嶅叆浠嬪叆璁惧涓庢潗鏂欏強澧炴潗鍒堕€犳妧鏈紑鍙戜笌搴旂敤锛屽嵄閲嶇梾鐢ㄧ敓鍛芥敮鎸佽澶囷紝绉诲姩涓庤繙绋嬭瘖鐤楄澶囷紝鏂板瀷鍩哄洜銆佽泲鐧藉拰缁嗚優璇婃柇璁惧銆?/span>

6銆佸疄楠屽姩鐗╂爣鍑嗗寲鍏绘畺鍙婂姩鐗╁疄楠屾湇鍔°€?/span>

7銆佸熀鏈嵂鐗╄川閲忓拰鐢熶骇鎶€鏈按骞虫彁鍗囧強闄嶄綆鎴愭湰銆?/span>

8銆侀珮绔埗鑽澶囧紑鍙戜笌鐢熶骇銆?/span>閫忕毊鍚告敹銆佺矇闆惧墏绛夋柊鍨嬪埗鍓傚伐鑹鸿澶囷紝澶ц妯$敓鐗╁弽搴斿櫒鍙婇檮灞炵郴缁燂紝铔嬬櫧璐ㄩ珮鏁堝垎绂诲拰绾寲璁惧锛屼腑鑽珮鏁堟彁鍙栬澶囥€佷腑鑽ギ鐗囪繛缁煍鎬х敓浜ц澶囥€佽繛缁寲鍥轰綋鍒跺墏鐢熶骇璁惧銆?/span>

绗簩绫伙細闄愬埗绫?/span>

闄愬埗绫讳富瑕佹槸宸ヨ壓鎶€鏈惤鍚庯紝涓嶇鍚堣涓氬噯鍏ユ潯浠跺拰鏈夊叧瑙勫畾锛岀姝㈡柊寤烘墿寤哄拰闇€瑕佺潱淇冩敼閫犵殑鐢熶骇鑳藉姏銆佸伐鑹烘妧鏈€佽澶囧強浜у搧銆?/span>

鍖昏嵂鏂归潰锛?/span>

1銆佹柊寤恒€佹墿寤哄彜榫欓吀鍜岀淮鐢熺礌C鍘熺矇锛堝寘鎷嵂鐢ㄣ€侀鍝佺敤鍜岄ゲ鏂欑敤銆佸寲濡嗗搧鐢級鐢熶骇瑁呯疆锛屾柊寤鸿嵂鍝併€侀鍝併€侀ゲ鏂欍€佸寲濡嗗搧绛夌敤閫旂殑缁寸敓绱燘1銆佺淮鐢熺礌B2銆佺淮鐢熺礌B12 (缁煎悎鍒╃敤闄ゅ)銆?0缁寸敓绱燛鍘熸枡鐢熶骇瑁呯疆銆?/span>

2銆佹柊寤洪潚闇夌礌宸ヤ笟鐩愩€?-姘ㄥ熀闈掗湁鐑烽吀锛?-APA锛夈€佸寲瀛︽硶鐢熶骇 7-姘ㄥ熀澶村鐑烽吀锛?-ACA锛夈€?-姘ㄥ熀-3-鍘讳箼閰版哀鍩哄ご瀛㈢兎閰革紙7-ADCA锛夈€侀潚闇夌礌V銆佹皑鑻勯潚闇夌礌銆佺緹姘ㄨ媱闈掗湁绱犮€佸ご瀛㈣弻绱燾鍙戦叺銆佸湡闇夌礌銆佸洓鐜礌銆佹隘闇夌礌銆佸畨涔冭繎銆佸涔欓叞姘ㄥ熀閰氥€佹灄鍙湁绱犮€佸簡澶ч湁绱犮€佸弻姘㈤摼闇夌礌銆佺~閰搁樋绫冲崱鏄熴€侀害杩湁绱犮€佹煴鏅剁櫧闇夌礌銆佺幆涓欐盁鍝岄吀銆佽姘熸矙鏄熴€佹盁鍡吀銆佸埄绂忓钩銆佸挅鍟″洜銆佸彲鍙眴纰辩敓浜ц缃€?/span>

3銆佹柊寤虹传鏉夐唶锛堥厤濂楃孩璞嗘潐绉嶆闄ゅ锛夈€佹鐗╂彁鍙栨硶榛勮繛绱狅紙閰嶅榛勮繛绉嶆闄ゅ锛夌敓浜ц缃€?/span>

4銆佹柊寤恒€佹敼鎵╁缓鑽敤涓佸熀姗¤兌濉炪€佷簩姝ユ硶鐢熶骇杈撴恫鐢ㄥ鏂欑摱鐢熶骇瑁呯疆銆?/span>

5銆佹柊寤哄強鏀规墿寤哄師鏂欏惈鏈夊皻鏈妯″寲绉嶆鎴栧吇娈栫殑婵掑嵄鍔ㄦ鐗╄嵂鏉愮殑浜у搧鐢熶骇瑁呯疆銆?/span>

6銆佹柊寤恒€佹敼鎵╁缓鍏呮睘寮忕幓鐠冧綋娓╄銆佽鍘嬭鐢熶骇瑁呯疆銆侀摱姹為綈榻跨鏉愭枡銆佹柊寤?浜挎敮/骞翠互涓嬩竴娆℃€ф敞灏勫櫒銆佽緭琛€鍣ㄣ€佽緭娑插櫒鐢熶骇瑁呯疆銆?/span>

绗笁绫伙細娣樻卑绫?/span>

娣樻卑绫讳富瑕佹槸涓嶇鍚堟湁鍏虫硶寰嬫硶瑙勮瀹氾紝涓嶅叿澶囧畨鍏ㄧ敓浜ф潯浠讹紝涓ラ噸娴垂璧勬簮銆佹薄鏌撶幆澧冿紝闇€瑕佹窐姹扮殑钀藉悗宸ヨ壓銆佹妧鏈€佽澶囧強浜у搧銆?/span>

娉?鏈夋窐姹拌鍒掔殑鏉$洰锛屾牴鎹鍒掕繘琛屾窐姹?鏈爣娣樻卑鏈熼檺鎴栨窐姹拌鍒掔殑鏉$洰涓哄浗瀹朵骇涓氭斂绛栧凡鏄庝护娣樻卑鎴栫珛鍗虫窐姹般€?/span>

涓€锛庡尰鑽被钀藉悗鐢熶骇宸ヨ壓瑁呭

1銆佹墜宸ヨ兌鍥婂~鍏呭伐鑹?/span>

2銆佽蒋鏈ㄥ鐑厞鍖呰鑽搧宸ヨ壓

3銆佷笉绗﹀悎GMP瑕佹眰鐨勫畨鐡挎媺涓濈亴灏佹満

4銆佸寮忛噸钂搁姘村櫒

5銆佹棤鍑€鍖栬鏂界殑鐑骞茬嚗绠?/span>

6銆佺幆澧冦€佽亴涓氬仴搴峰拰瀹夊叏涓嶈兘杈惧埌鍥藉鏍囧噯鐨勫師鏂欒嵂鐢熶骇瑁呯疆

7銆侀搧绮夎繕鍘熸硶瀵逛箼閰版皑鍩洪厷锛堟墤鐑伅鐥涳級銆佸挅鍟″洜瑁呯疆

8銆佷娇鐢ㄦ隘姘熺儍锛圕FCs锛変綔涓烘皵闆惧墏銆佹帹杩涘墏銆佹姏灏勫墏鎴栧垎鏁e墏鐨勫尰鑽敤鍝佺敓浜у伐鑹猴紙鏍规嵁鍥藉灞ヨ鍥介檯鍏害鎬讳綋璁″垝瑕佹眰杩涜娣樻卑锛?/span>

浜岋紟鍖昏嵂绫昏惤鍚庝骇鍝?/span>

1銆侀搮閿¤蒋鑶忕銆佸崟灞傝仛鐑儍杞啅绠★紙鑲涜偁銆佽厰閬撶粰鑽櫎澶栵級

2銆佸畨鐡跨亴瑁呮敞灏勭敤鏃犺弻绮夋湯

3銆佽嵂鐢ㄥぉ鐒惰兌濉?/span>

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