鐛甸牠瑕栬锛氱窗(x矛)鑳炴不鐧傞牁(l菒ng)鍩熺殑楂樼浜烘墠闇�姹傝垏钖叕
鐧�(f膩)甯冩檪(sh铆)闁擄細2025-07-15
绱�(x矛)鑳炴不鐧傦紙Cell Therapy锛夋槸鐣�(d膩ng)鍓嶇敓鐗╅啱(y墨)钘ラ牁(l菒ng)鍩熸渶鍓嶆部鐨勮辰閬撲箣涓�锛岄毃钁�CAR-T銆�iPSC銆�NK绱�(x矛)鑳炵瓑鎶�琛�(sh霉)蹇�熺櫦(f膩)灞�锛屼互鍙婂湅(gu贸)鍏�(n猫i)鐪惧鍓�(chu脿ng)鏂颁紒妤�(y猫)鍔犻�熻嚚搴婃帹閫�(j矛n)锛屽皪(du矛)楂樼浜烘墠鐨勯渶姹備笉鏂蜂笂鍗�銆備互涓嬫槸灏�(du矛)绱�(x矛)鑳炴不鐧傞牁(l菒ng)鍩熼珮绔汉鎵嶇殑鏍稿績闇�姹傝垏钖叕鎯呮硜鐨勭郴绲�(t菕ng)鍒嗘瀽锛�
涓�銆佺窗(x矛)鑳炴不鐧傞牁(l菒ng)鍩熼珮绔汉鎵嶉渶姹傚湒璀滐紙2025锛�
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宕椾綅鏂瑰悜
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浠ｈ〃宕椾綅
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鏍稿績鑳藉姏瑕佹眰
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鍏稿瀷闆囦富
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鐮旂櫦(f膩)绉戝(xu茅)瀹�
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CAR-T/iPSC/NK/TCR鐮旂櫦(f膩)绉戝(xu茅)瀹剁窗(x矛)鑳炵法杓妧琛�(sh霉)灏堝
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鐔熸倝绱�(x矛)鑳炲煿椁�(y菐ng)銆佽綁(zhu菐n)鏌撱�佸熀鍥犵法杓紙CRISPR/Cas9锛夊叿鍌欒嚚搴婂墠闋�(xi脿ng)鐩稉(j墨ng)椹�(y脿n)
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钘ヤ紒銆佺敓鐗╂妧琛�(sh霉)鍏徃绉戠爺姗�(j墨)妲�(g貌u)锛堝涓闄�/鐢熺墿鎵�锛�
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鐢熺敘(ch菐n)鑸囪唱(zh矛)閲�
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绱�(x矛)鑳炲埗鍌欒矤(f霉)璨�(z茅)浜�GMP鐢熺敘(ch菐n)璨�(f霉)璨�(z茅)浜�QA/QC璨�(f霉)璨�(z茅)浜�
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鐔熸倝GMP妯�(bi膩o)婧�(zh菙n)銆佺劇鑿屽伐钘濆叿鍌欏伐钘濇斁澶ц垏鎶�琛�(sh霉)杞�(zhu菐n)绉荤稉(j墨ng)椹�(y脿n)
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CDMO浼佹キ(y猫)銆佺窗(x矛)鑳炴不鐧傚伐寤�
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鑷ㄥ簥杞�(zhu菐n)鍖�
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鑷ㄥ簥鐮旂┒缍�(j墨ng)鐞�/绺界洠(ji膩n)钘ョ墿璀︽垝璨�(f霉)璨�(z茅)浜猴紙PV锛�
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鐔熸倝IND鐢冲牨(b脿o)銆佸�悊娴佺▼銆佽嚚搴婅│椹�(y脿n)绠＄悊鑳藉崝(xi茅)瑾�(di脿o)CRO銆侀啱(y墨)闄㈣硣婧�
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鏂拌棩浼佹キ(y猫)銆佹敞鍐�(c猫)鐢冲牨(b脿o)鍏徃
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娉ㄥ唺(c猫)鑸囧悎瑕�(gu墨)
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娉ㄥ唺(c猫)鐢冲牨(b脿o)绺界洠(ji膩n)CMC鍚堣(gu墨)璨�(f霉)璨�(z茅)浜�
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鐔熸倝NMPA/FDA绱�(x矛)鑳炴不鐧傚鎵规祦绋嬫帉鎻�CMC鎶�琛�(sh霉)璩囨枡鎾板
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涓ぇ鍨嬬敓鐗╅啱(y墨)钘ュ叕鍙�
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鎴�(zh脿n)鐣ヨ垏鍟嗘キ(y猫)
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BD璨�(f霉)璨�(z茅)浜猴紙鍦�(gu贸)鍏�(n猫i)澶栵級鑱�(li谩n)鍚堝壍(chu脿ng)濮嬩汉/CSO绱�(j铆)鍒�
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鍏峰倷寮�(qi谩ng)瀛�(xu茅)琛�(sh霉)鑳屾櫙+琛屾キ(y猫)璩囨簮鎳傝瀺璩囥�佸钩鑷�(t谩i)妲�(g貌u)寤哄拰鍦�(gu贸)闅涘悎浣�
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鍓�(chu脿ng)鏂板垵鍓�(chu脿ng)鍏徃/璩囨湰鏂�
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浜�銆佺窗(x矛)鑳炴不鐧傞牁(l菒ng)鍩熸牳蹇冨礂浣嶈柂閰弮鑰冿紙鍖椾笂寤ｆ繁锛屽柈浣嶏細浜烘皯骞�/骞磋柂锛�
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宕椾綅
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3-5骞寸稉(j墨ng)椹�(y脿n)
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5-10骞寸稉(j墨ng)椹�(y脿n)
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楂樼绱�(j铆)鍒ワ紙10骞翠互涓婏級
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绱�(x矛)鑳炴不鐧傜爺鐧�(f膩)绉戝(xu茅)瀹�
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45-80钀�
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80-150钀�
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200-300钀�+鏈熸瑠(qu谩n)
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GMP鐢熺敘(ch菐n)璨�(f霉)璨�(z茅)浜�
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40-70钀�
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70-120钀�
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150-250钀�
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鑷ㄥ簥鐮旂┒绺界洠(ji膩n)
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50-90钀�
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90-160钀�
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180-300钀�
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娉ㄥ唺(c猫)鐢冲牨(b脿o)璨�(f霉)璨�(z茅)浜�
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60-100钀�
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100-180钀�
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180-300钀�
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BD/CSO/鍚堜紮浜�
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70-120钀�
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150-250钀�
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300-500钀�+鑲℃瑠(qu谩n)婵�鍕�(l矛)
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钖叕婧㈠児(ji脿)瑾槑锛�
· CAR-T/iPSC绛夌绶氶��(j矛n)灞曞埌鑷ㄥ簥II鏈熶互涓�锛屾牳蹇冪爺鐧�(f膩)/娉ㄥ唺(c猫)宕椾綅钖叕鍙笂娴�20-30%锛�
· 鍚屾闁嬪睍缇庡湅(gu贸)IND/FDA鑷ㄥ簥瑭﹂(y脿n)鐨勪紒妤�(y猫)锛屽皪(du矛)澶栬硣鑳屾櫙浜烘墠鎰挎剰婧㈠児(ji脿)40-50%锛�
· 鍒濆壍(chu脿ng)鍏徃楂樿柂鍚稿紩BD/CSO绱�(j铆)鑱�(li谩n)鍚堝壍(chu脿ng)濮嬩汉锛岄�氬父閰嶄互5%-10%鏈熸瑠(qu谩n)銆�
涓�銆佷汉鎵嶇穵缂虹殑涓昏鍘熷洜鍒嗘瀽
1. 鎶�琛�(sh霉)璺ㄧ晫闁�妾婚珮锛氶渶瑕佹帉鎻＄窗(x矛)鑳炵敓鐗╁(xu茅)銆佸垎瀛愮敓鐗╁(xu茅)銆佸厤鐤(xu茅)绛夊瀛�(xu茅)绉戠煡璀�(sh铆)锛�
2. 鐢�(ch菐n)妤�(y猫)鐧�(f膩)灞曞揩銆佹(bi膩o)婧�(zh菙n)灏氭湭绲�(t菕ng)涓�锛氬緢澶氭柊骞宠嚭(t谩i)铏曚簬鎺㈢储闅庢锛屾垚鐔熶汉鎵嶄緵绲︽湁闄�锛�
3. 娴峰缍�(j墨ng)椹�(y脿n)浜烘墠绋�缂�锛氬叿鍌�FDA IND鐢冲牨(b脿o)缍�(j墨ng)椹�(y脿n)鐨�“鍥炲湅(gu贸)浜烘墠”妤靛害绶婄己锛�
4. 鐢�(ch菐n)妤�(y猫)閺堝崝(xi茅)浣滃京(f霉)闆�锛氬緸鐮旂櫦(f膩)銆佺敓鐢�(ch菐n)銆佽嚚搴婂埌鍚堣(gu墨)锛岀挵(hu谩n)绡�(ji茅)澶�锛岄渶瑕佸ぇ閲忓皥妤�(y猫)鍨嬩腑楂樼浜烘墠锛�
5. 璩囨湰鎺ㄥ嫊(d貌ng)闋�(xi脿ng)鐩簳鍣�锛�2023-2025骞村ぇ閲�CAR-T/NK绱�(x矛)鑳炰紒妤�(y猫)鐛茶瀺璩�锛屼汉鎵嶉渶姹傜垎鐧�(f膩)銆�
鍥�銆佺嵉闋缓璀�
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寤鸿鏂瑰悜
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鍏�(n猫i)瀹�
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浜烘墠渚嗘簮鎷撳睍
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寰炴瓙缇庛�佹棩闊撶鐮旀(j墨)妲�(g貌u)寮曞叆鍗氬＋鍚�/鍓爺绌跺摗锛屾垨閹栧畾娓境鍦板崁(q奴)绱�(x矛)鑳炴不鐧備汉鎵�
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浼佹キ(y猫)鍋�(c猫)鍎�(y艒u)鍖�
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鍒濆壍(chu脿ng)鍏徃閫氶亷“鑲℃瑠(qu谩n)+闈堟椿杈﹀叕”鍚稿紩涓珮绔妧琛�(sh霉)浜烘墠鍔犵洘
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鎷涜仒绛栫暐
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鑱氱劍“鐢�(ch菐n)瀛�(xu茅)鐮�”铻嶅悎浜烘墠锛屾湁鎶�琛�(sh霉)鑳屾櫙鍙堟噦杞�(zhu菐n)鍖栫殑浜ゅ弶鍨嬩汉鎵�
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钖叕绛栫暐
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灏�(du矛)娉ㄥ唺(c猫)銆�CMC銆�IND鐩搁棞(gu膩n)宕椾綅瑷�(sh猫)缃珮浜庡競鍫�(ch菐ng)20%鐨勬孩鍍�(ji脿)绛栫暐
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