鐔辨晱鍌寲鍔慡A-102鍦ㄨ€愮敤鎬ц仛姘ㄩ叝杓儙涓殑鎳夌敤

1. 寮曡█

闅ㄨ憲姹借粖宸ユキ(y猫)鐨勫揩閫熺櫦(f膩)灞�锛岃吉鑳庝綔鐐烘苯杌婄殑閲嶈绲勬垚閮ㄥ垎锛屽叾鎬ц兘鐩存帴褰遍熆鍒拌粖杓涚殑瀹夊叏鎬�銆佽垝閬╂€у拰鐕冩补缍�(j墨ng)婵熸€с€傚偝绲�(t菕ng)鐨勬鑶犺吉鑳庨洊鐒跺叿鏈夎壇濂界殑褰堟€у拰鑰愮（鎬�锛屼絾鍦ㄩ珮婧�銆侀珮閫熺瓑妤电姊濅欢涓�锛屽叾鎬ц兘鏈冮’钁椾笅闄�銆傜偤浜嗘豢瓒崇従(xi脿n)浠ｆ苯杌婂皪杓儙鎬ц兘鐨勬洿楂樿姹�锛岃仛姘ㄩ叝杓儙鎳夐亱鑰岀敓銆傝仛姘ㄩ叝杓儙鍏锋湁鍎�(y艒u)鐣扮殑鑰愮（鎬�銆佹姉鎾曡鎬у拰鑰愰珮婧€ц兘锛岄€愭几鎴愮偤杓儙琛屾キ(y猫)鐨勭爺绌剁啽榛炪€�

鐒惰€�锛岃仛姘ㄩ叝杓儙鐨勭敓鐢�(ch菐n)閬庣▼涓�锛屽偓鍖栧姂鐨勯伕鐢ㄥ皪绲傜敘(ch菐n)鍝佺殑鎬ц兘鏈夎憲鑷抽棞閲嶈鐨勫奖闊�銆傜啽鏁忓偓鍖栧姂SA-102浣滅偤涓€绋珮鏁�銆佺挵(hu谩n)淇濈殑鍌寲鍔�锛屽湪鑱氭皑閰吉鑳庣殑鐢熺敘(ch菐n)涓睍鐝�(xi脿n)鍑虹崹鐗圭殑鍎�(y艒u)鍕€€傛湰鏂囧皣瑭崇窗浠嬬垂鐔辨晱鍌寲鍔慡A-102鍦ㄨ€愮敤鎬ц仛姘ㄩ叝杓儙涓殑鎳夌敤锛屽寘鎷叾鐢�(ch菐n)鍝佸弮鏁�(sh霉)銆佹噳鐢ㄥ師鐞嗐€佺敓鐢�(ch菐n)宸ヨ棟銆佹€ц兘鍎�(y艒u)鍕互鍙婂競鍫村墠鏅€�

2. 鐔辨晱鍌寲鍔慡A-102姒傝堪

2.1 鐢�(ch菐n)鍝佸弮鏁�(sh霉)

鐔辨晱鍌寲鍔慡A-102鏄竴绋珮鏁�銆佺挵(hu谩n)淇濈殑鑱氭皑閰偓鍖栧姂锛屽唬娉涙噳鐢ㄤ簬鑱氭皑閰场娌€佸綀鎬ч珨銆佹秱鏂�銆佽啝绮樺姂绛夐牁鍩熴€傚叾涓昏鍙冩暩(sh霉)濡備笅琛ㄦ墍绀猴細

2.2 鎳夌敤鍘熺悊

鐔辨晱鍌寲鍔慡A-102鍦ㄨ仛姘ㄩ叝鍙嶆噳涓捣鍒板姞閫熷弽鎳夌殑浣滅敤锛屽叾宸ヤ綔鍘熺悊鏄€氶亷闄嶄綆鍙嶆噳娲诲寲鑳�锛屼績閫茬暟姘伴吀閰垏澶氬厓閱囦箣闁撶殑鍙嶆噳锛屽緸鑰屽姞蹇仛姘ㄩ叝鐨勫浐鍖栭€熷害銆傝垏鍌崇当(t菕ng)鍌寲鍔戠浉姣旓紝SA-102鍏锋湁鐔辨晱鐗规€�锛屽嵆鍦ㄤ綆婧笅娲绘€ц純浣庯紝鑰屽湪楂樻韩涓嬫椿鎬ч’钁楀寮�銆傞€欎竴鐗规€т娇寰桽A-102鍦ㄨ仛姘ㄩ叝杓儙鐨勭敓鐢�(ch菐n)涓兘澶犲鐝�(xi脿n)绮剧⒑鎺у埗鍙嶆噳閫熷害锛岄伩鍏嶅洜鍙嶆噳閬庡揩灏庤嚧鐨勫収閮ㄦ噳鍔涢泦涓拰姘ｆ场绛夊晱椤�銆�

3. 鑱氭皑閰吉鑳庣殑鐢熺敘(ch菐n)宸ヨ棟

3.1 鍘熸潗鏂欐簴鍌�

鑱氭皑閰吉鑳庣殑鐢熺敘(ch菐n)涓昏娑夊強浠ヤ笅鍘熸潗鏂欙細

• 澶氬厓閱囷細浣滅偤鑱氭皑閰殑涓昏鎴愬垎涔嬩竴锛屽鍏冮唶鐨勭ó椤炲拰鍒嗗瓙閲忓皪绲傜敘(ch菐n)鍝佺殑鎬ц兘鏈夐噸瑕佸奖闊�銆�
• 鐣版鞍閰搁叝锛氳垏澶氬厓閱囧弽鎳夌敓鎴愯仛姘ㄩ叝锛屽父鐢ㄧ殑鐣版鞍閰搁叝鍖呮嫭MDI锛堜簩鍩虹敳鐑蜂簩鐣版鞍閰搁叝锛夊拰TDI锛堜簩鐣版鞍閰搁叝锛�銆�
• 鐔辨晱鍌寲鍔慡A-102锛氱敤浜庡姞閫熷弽鎳夛紝鎺у埗鍙嶆噳閫熷害銆�
• 濉枡鍜屽姪鍔戯細濡傜偔榛戙€佺娌圭瓑锛岀敤浜庢敼鍠勮吉鑳庣殑鑰愮（鎬�銆佹姉鎾曡鎬у拰鍔犲伐鎬ц兘銆�

3.2 鐢熺敘(ch菐n)宸ヨ棟娴佺▼

鑱氭皑閰吉鑳庣殑鐢熺敘(ch菐n)宸ヨ棟娴佺▼涓昏鍖呮嫭浠ヤ笅骞惧€嬫椹燂細

1. 閰嶆枡锛氭寜鐓ч厤鏂规瘮渚嬪皣澶氬厓閱囥€佺暟姘伴吀閰�銆佸偓鍖栧姂SA-102銆佸～鏂欏拰鍔╁姂绛夊師鏉愭枡娣峰悎鍧囧嫽銆�
2. 闋愯仛鍙嶆噳锛氬皣娣峰悎濂界殑鍘熸枡鍦ㄤ竴瀹氱殑婧害鍜屽鍔涗笅閫茶闋愯仛鍙嶆噳锛岀敓鎴愰爯鑱氶珨銆�
3. 婢嗘敞鎴愬瀷锛氬皣闋愯仛楂旀敞鍏ヨ吉鑳庢ā鍏蜂腑锛岄€氶亷鍔犵啽鍜屽姞澹撲娇鍏跺浐鍖栨垚鍨嬨€�
4. 鍚庤檿鐞�锛氬皪鎴愬瀷鍚庣殑杓儙閫茶淇暣銆佹墦纾ㄥ拰琛ㄩ潰铏曠悊锛屼互鎻愰珮鍏跺瑙€璩噺鍜屾€ц兘銆�
5. 妾㈡脯鑸囧寘瑁�锛氬皪鎴愬搧杓儙閫茶鎬ц兘妾㈡脯锛屽悎鏍煎悗閫茶鍖呰鍜屽劜瀛�銆�

3.3 宸ヨ棟鍙冩暩(sh霉)鎺у埗

鍦ㄨ仛姘ㄩ叝杓儙鐨勭敓鐢�(ch菐n)閬庣▼涓�锛屽伐钘濆弮鏁�(sh霉)鐨勬帶鍒跺皪绲傜敘(ch菐n)鍝佺殑鎬ц兘鑷抽棞閲嶈銆備互涓嬫槸涓昏宸ヨ棟鍙冩暩(sh霉)鐨勬帶鍒惰寖鍦嶏細

4. 鐔辨晱鍌寲鍔慡A-102鍦ㄨ仛姘ㄩ叝杓儙涓殑鎳夌敤鍎�(y艒u)鍕�

4.1 绮剧⒑鎺у埗鍙嶆噳閫熷害

鐔辨晱鍌寲鍔慡A-102鐨勭啽鏁忕壒鎬т娇寰楀叾鍦ㄨ仛姘ㄩ叝杓儙鐨勭敓鐢�(ch菐n)涓兘澶犲鐝�(xi脿n)绮剧⒑鎺у埗鍙嶆噳閫熷害銆傚湪浣庢韩涓�锛孲A-102鐨勬椿鎬ц純浣庯紝鍙嶆噳閫熷害杓冩參锛屾湁鍒╀簬鍘熸枡鐨勫厖鍒嗘贩鍚堝拰闋愯仛鍙嶆噳鐨勫潎鍕婚€茶銆傝€屽湪楂樻韩涓嬶紝SA-102鐨勬椿鎬ч’钁楀寮�锛屽弽鎳夐€熷害鍔犲揩锛屾湁鍒╀簬蹇€熷浐鍖栧拰鎴愬瀷銆傞€欑ó绮剧⒑鎺у埗鍙嶆噳閫熷害鐨勮兘鍔涳紝鍙互鏈夋晥閬垮厤鍥犲弽鎳夐亷蹇皫鑷寸殑鍏ч儴鎳夊姏闆嗕腑鍜屾埃娉＄瓑鍟忛锛屾彁楂樿吉鑳庣殑鍧囧嫽鎬у拰绌�(w臎n)瀹氭€�銆�

4.2 鎻愰珮杓儙鐨勮€愮（鎬у拰鎶楁挄瑁傛€�

鑱氭皑閰吉鑳庣殑鑰愮（鎬у拰鎶楁挄瑁傛€ф槸鍏堕噸瑕佺殑鎬ц兘鎸囨銆傜啽鏁忓偓鍖栧姂SA-102鍦ㄨ仛姘ㄩ叝鍙嶆噳涓兘澶犱績閫插垎瀛愰張鐨勪氦鑱�(li谩n)锛屽舰鎴愭洿鍔犺嚧瀵嗗拰鍧囧嫽鐨勭恫(w菐ng)鐙€绲愭锛屽緸鑰屾彁楂樿吉鑳庣殑鑰愮（鎬у拰鎶楁挄瑁傛€�銆傚椹楄〃鏄庯紝浣跨敤SA-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙锛屽叾鑰愮（鎬у拰鎶楁挄瑁傛€ф瘮鍌崇当(t菕ng)鍌寲鍔戠敓鐢�(ch菐n)鐨勮吉鑳庢彁楂樹簡20%浠ヤ笂銆�

4.3 鏀瑰杽杓儙鐨勮€愰珮婧€ц兘

鑱氭皑閰吉鑳庡湪楂樻韩鐠�(hu谩n)澧冧笅鐨勬€ц兘琛ㄧ従(xi脿n)鐩存帴褰遍熆鍏朵娇鐢ㄥ＝鍛藉拰瀹夊叏鎬с€傜啽鏁忓偓鍖栧姂SA-102鍦ㄩ珮婧笅娲绘€у寮�锛岃兘澶犱績閫茶仛姘ㄩ叝鍒嗗瓙閺堢殑鍏呭垎浜よ伅(li谩n)锛屽舰鎴愭洿鍔犵┅(w臎n)瀹氱殑绲愭锛屽緸鑰屾彁楂樿吉鑳庣殑鑰愰珮婧€ц兘銆傚椹楄〃鏄�锛屼娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙锛屽湪120鈩冮珮婧笅鐨勬€ц兘淇濇寔鐜囨瘮鍌崇当(t菕ng)鍌寲鍔戠敓鐢�(ch菐n)鐨勮吉鑳庢彁楂樹簡15%浠ヤ笂銆�

4.4 鐠�(hu谩n)淇濇€ц兘鍎�(y艒u)鐣�

鐔辨晱鍌寲鍔慡A-102浣滅偤涓€绋挵(hu谩n)淇濆瀷鍌寲鍔戯紝涓嶅惈鏈夊鐗╄唱锛岀鍚堢挵(hu谩n)淇濊姹�銆傚湪鑱氭皑閰吉鑳庣殑鐢熺敘(ch菐n)閬庣▼涓�锛孲A-102鐨勪娇鐢ㄤ笉鏈冪敘(ch菐n)鐢熸湁瀹虫埃楂斿拰寤㈡鐗╋紝灏嶇挵(hu谩n)澧冨弸濂�銆傛澶�锛孲A-102鐨勯珮鏁堝偓鍖栦綔鐢ㄥ彲浠ユ笡灏戝偓鍖栧姂鐨勭敤閲忥紝闄嶄綆鐢熺敘(ch菐n)鎴愭湰锛屽叿鏈夐’钁楃殑缍�(j墨ng)婵熸晥鐩娿€�

5. 鑱氭皑閰吉鑳庣殑鎬ц兘娓│鑸囪⿻鍍�

5.1 鑰愮（鎬ф脯瑭�

鑰愮（鎬ф槸琛￠噺杓儙浣跨敤澹藉懡鐨勯噸瑕佹寚妯�銆傞€氶亷Taber纾ㄨ€楄│椹楁灏嶄娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙閫茶鑰愮（鎬ф脯瑭︼紝绲愭灉濡備笅琛ㄦ墍绀猴細

寰炶〃涓彲浠ョ湅鍑�锛屼娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙鐨勭（鑰楅噺椤憲浣庝簬鍌崇当(t菕ng)鍌寲鍔戠敓鐢�(ch菐n)鐨勮吉鑳庯紝琛ㄦ槑鍏惰€愮（鎬ф洿濂�銆�

5.2 鎶楁挄瑁傛€ф脯瑭�

鎶楁挄瑁傛€ф槸琛￠噺杓儙鎶楁悕鍌疯兘鍔涚殑閲嶈鎸囨銆傞€氶亷鎾曡寮峰害瑭﹂姗熷皪浣跨敤SA-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙閫茶鎶楁挄瑁傛€ф脯瑭�锛岀祼鏋滃涓嬭〃鎵€绀猴細

寰炶〃涓彲浠ョ湅鍑�锛屼娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙鐨勬挄瑁傚挤搴﹂’钁楅珮浜庡偝绲�(t菕ng)鍌寲鍔戠敓鐢�(ch菐n)鐨勮吉鑳�锛岃〃鏄庡叾鎶楁挄瑁傛€ф洿濂姐€�

5.3 鑰愰珮婧€ц兘娓│

鑰愰珮婧€ц兘鏄　閲忚吉鑳庡湪楂樻韩鐠�(hu谩n)澧冧笅鎬ц兘淇濇寔鑳藉姏鐨勯噸瑕佹寚妯�銆傞€氶亷楂樻韩鑰佸寲瑭﹂绠卞皪浣跨敤SA-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙閫茶鑰愰珮婧€ц兘娓│锛岀祼鏋滃涓嬭〃鎵€绀猴細

寰炶〃涓彲浠ョ湅鍑�锛屼娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙鍦�120鈩冮珮婧笅鐨勬€ц兘淇濇寔鐜囬’钁楅珮浜庡偝绲�(t菕ng)鍌寲鍔戠敓鐢�(ch菐n)鐨勮吉鑳庯紝琛ㄦ槑鍏惰€愰珮婧€ц兘鏇村ソ銆�

5.4 鐠�(hu谩n)淇濇€ц兘娓│

鐠�(hu谩n)淇濇€ц兘鏄　閲忚吉鑳庣敓鐢�(ch菐n)閬庣▼涓皪鐠�(hu谩n)澧冨弸濂界▼搴︾殑閲嶈鎸囨銆傞€氶亷姘ｇ浉鑹茶瓬-璩瓬鑱�(li谩n)鐢ㄥ剙灏嶄娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙閫茶鐠�(hu谩n)淇濇€ц兘娓│锛岀祼鏋滃涓嬭〃鎵€绀猴細

寰炶〃涓彲浠ョ湅鍑�锛屼娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙鐨勬湁瀹崇墿璩惈閲忛’钁椾綆浜庡偝绲�(t菕ng)鍌寲鍔戠敓鐢�(ch菐n)鐨勮吉鑳�锛岃〃鏄庡叾鐠�(hu谩n)淇濇€ц兘鏇村ソ銆�

6. 甯傚牬鍓嶆櫙鑸囨噳鐢ㄦ渚�

6.1 甯傚牬鍓嶆櫙

闅ㄨ憲姹借粖宸ユキ(y猫)鐨勫揩閫熺櫦(f膩)灞曞拰鐠�(hu谩n)淇濊姹傜殑涓嶆柗鎻愰珮锛岃仛姘ㄩ叝杓儙浣滅偤涓€绋珮鎬ц兘銆佺挵(hu谩n)淇濆瀷杓儙锛屽叾甯傚牬闇€姹傞€愬勾澧炲姞銆傜啽鏁忓偓鍖栧姂SA-102鍦ㄨ仛姘ㄩ叝杓儙鐢熺敘(ch菐n)涓殑鍎�(y艒u)鐣拌〃鐝�(xi脿n)锛屼娇鍏跺湪甯傚牬涓婂叿鏈夊唬闂婄殑鎳夌敤鍓嶆櫙銆傞爯瑷堟湭渚嗗咕骞达紝闅ㄨ憲鑱氭皑閰吉鑳庣殑鏅強鍜孲A-102鍌寲鍔戠殑鎺ㄥ唬锛屽叾甯傚牬瑕�(gu墨)妯″皣涓嶆柗鎿村ぇ銆�

6.2 鎳夌敤妗堜緥

6.2.1 妗堜緥涓€锛氭煇鐭ュ悕姹借粖鍒堕€犲晢

鏌愮煡鍚嶆苯杌婂埗閫犲晢鍦ㄥ叾楂樼杌婂瀷涓噰鐢ㄤ簡浣跨敤SA-102鍌寲鍔戠敓鐢�(ch菐n)鐨勮仛姘ㄩ叝杓儙銆傜稉(j墨ng)閬庡闅涗娇鐢ㄦ脯瑭�锛岃┎杓儙鍦ㄨ€愮（鎬�銆佹姉鎾曡鎬у拰鑰愰珮婧€ц兘鏂归潰琛ㄧ従(xi脿n)鍑鸿壊锛屽緱鍒颁簡鐢ㄦ埗鐨勪竴鑷村ソ瑭�銆傝┎鍒堕€犲晢瑷堝妰鍦ㄦ湭渚嗘洿澶氳粖鍨嬩腑鎺ㄥ唬浣跨敤閫欑ó楂樻€ц兘杓儙銆�

6.2.2 妗堜緥浜岋細鏌愯吉鑳庣敓鐢�(ch菐n)浼佹キ(y猫)

鏌愯吉鑳庣敓鐢�(ch菐n)浼佹キ(y猫)鍦ㄥ叾鏂扮敘(ch菐n)鍝侀枊鐧�(f膩)涓噰鐢ㄤ簡SA-102鍌寲鍔戯紝鐢熺敘(ch菐n)鍑轰竴绯诲垪楂樻€ц兘鑱氭皑閰吉鑳�銆傜稉(j墨ng)閬庡競鍫存帹寤ｅ拰鐢ㄦ埗鍙嶉锛岃┎绯诲垪杓儙鍦ㄨ€愮（鎬с€佹姉鎾曡鎬у拰鐠�(hu谩n)淇濇€ц兘鏂归潰琛ㄧ従(xi脿n)鍎�(y艒u)鐣�锛岃繀閫熷崰闋樹簡甯傚牬浠介锛屾垚鐐鸿┎浼佹キ(y猫)鐨勬槑鏄熺敘(ch菐n)鍝�銆�

7. 绲愯珫

鐔辨晱鍌寲鍔慡A-102鍦ㄨ€愮敤鎬ц仛姘ㄩ叝杓儙涓殑鎳夌敤锛屽睍鐝�(xi脿n)浜嗗叾鍦ㄧ簿纰烘帶鍒跺弽鎳夐€熷害銆佹彁楂樿吉鑳庤€愮（鎬у拰鎶楁挄瑁傛€�銆佹敼鍠勮€愰珮婧€ц兘浠ュ強鐠�(hu谩n)淇濇€ц兘鏂归潰鐨勯’钁楀劒(y艒u)鍕€€傞€氶亷鍚堢悊鐨勭敓鐢�(ch菐n)宸ヨ棟鍜屽弮鏁�(sh霉)鎺у埗锛屼娇鐢⊿A-102鐢熺敘(ch菐n)鐨勮仛姘ㄩ叝杓儙鍦ㄦ€ц兘娓│涓〃鐝�(xi脿n)鍑鸿壊锛屽叿鏈夊唬闂婄殑甯傚牬鍓嶆櫙鍜屾噳鐢ㄦ經鍔涖€傞毃钁楁苯杌婂伐妤�(y猫)鐨勪笉鏂风櫦(f膩)灞曞拰鐠�(hu谩n)淇濊姹傜殑鎻愰珮锛岀啽鏁忓偓鍖栧姂SA-102灏囧湪鑱氭皑閰吉鑳庣殑鐢熺敘(ch菐n)涓櫦(f膩)鎻秺渚嗚秺閲嶈鐨勪綔鐢�锛屾帹鍕曡吉鑳庤妤�(y猫)鐨勬妧琛撻€叉鍜岀敘(ch菐n)鍝佸崌绱氥€�

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