新项目精选

近年来，药物发现已从传统的小分子化药拓展至更多元的分子类型，这些新型API在项目整合中呈现出独特的开发范式：PROTAC/分子胶降解剂：通过诱导靶蛋白泛素化降解发挥作用，而非传统“占位驱动”抑制。这类分子的项目整合需要同时考量靶点配体、E3连接酶配体及连接子的三元复合物优化，临床前到临床的转化难度显著增加。多肽/环肽药物：介于小分子与生物制品之间，兼具高选择性与口服可用性潜力。项目整合中需重点解决稳定性、递送及生产工艺放大问题。抗体-药物偶联物（ADC）：作为“生物导弹”，ADC的项目整合涉及抗体、连接子、有效载荷三部分的协同优化，需要跨学科团队的深度整合。小核酸药物（siRNA/ASO）：通过基因沉默机制发挥作用，项目整合的核心挑战在于递送系统的设计与肝外靶向能力的突破。展望未来，新型API项目的整合将呈现以下趋势：第一，AI贯穿全链条。从靶点发现、分子优化到临床开发、上市后监测，AI将成为贯穿API全生命周期的核心工具。第二，数据资产化。临床研究数据和真实世界数据将从“辅助工具”升级为“核心资产”，数据驱动的决策将成为项目整合的标准范式。第三，开放整合生态。API经济的成熟正在推动制药企业从“封闭研发”走向“开放协作”，通过API接口与外部数据源、技术平台、CRO/CDMO实现无缝对接. 而API技术——无论是数据接口还是组织协作的“应用程序接口”——正成为支撑这一整合的核心基础设施。
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新项目整合精选

新产品编号:1025645

Chemical Name: 8-(Difluoromethoxy)-6-fluoro-1-methyl-4-oxo-7-[4-(2-pyrimidinyl)piperazin-1-yl]-1,4-dihydroquinoline-3-carboxylic acid
项目整合开发状态: Biological Testing
项目研究机构: Ube (Originator)
合成路...
参考文献标题:Synthesis and anti-HIV activity of arylpiperazinyl fluoroquinolones: A new class of anti-HIV agents
文献作者:Hagihara,M.; Kashiwase,H.; Katsube,T.; Kimura,T.; Komai,T.; Momota,K.; Ohmine,T.; Nishigaki,T.; Kimura,S.; Shimada,K.
参考来源:Bioorg Med Chem Lett 1999,9(21),3063

K-12

Chemical Name: 8-(Difluoromethoxy)-1-ethyl-6-fluoro-7-[4-(2-methoxyphenyl)piperazin-1-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
项目整合开发状态: Biological Testing
项目研究机构: Daiichi Pharmaceutical...
参考文献标题:Synthesis and anti-HIV activity of arylpiperazinyl fluoroquinolones: A new class of anti-HIV agents
文献作者:Hagihara,M.; Kashiwase,H.; Katsube,T.; Kimura,T.; Komai,T.; Momota,K.; Ohmine,T.; Nishigaki,T.; Kimura,S.; Shimada,K.
参考来源:Bioorg Med Chem Lett 1999,9(21),3063

PST-2107

Chemical Name: 17beta-(3-Furyl)-3beta-(2-guanidinoethoxy)-5beta-androstan-14beta-ol nitrate
项目整合开发状态: Preclinical
项目研究机构: Sigma-Tau (Originator)
合成路线:Reaction of furylandrostanediol (I) (J Ch...
参考文献标题:Cyclopentanperhydrophenanthren-17beta-(3-furyl)-3-derivs.and pharmaceutical compsns.comprising same for the treatment of cardiovascular disorders
文献作者:Quadri,L.; Bernardi,L.; Ferrari,P.; Gobbini,M.; Melloni,P.; Valentino,L.(Sigma-Tau Industrie Farmaceutiche Riunite SpA)
参考来源:EP 0576915; JP 1994065284; US 5432169

Gypsetin

Chemical Name: (5aR*,7aS*,8aR*,13aS*,15aS*,16aS*)-5a,13a-Bis(1,1-dimethyl-2-propenyl)-8a,16a-dihydroxy-5,5a,7,7a,8,8a,13,13a,15,15a,16,16a-dodecahydropyrazino[1'',2'':1,5; 4'',5'':1',5']dipyrrolo[2,3-...
参考文献标题:Total synthesis of gypsetin,deoxybrevianamide E,brevianamide E,and tryprostatin B: Novel constructions of 2,3-disubstituted indoles
文献作者:Schkeryantz,J.M.; et al.
参考来源:J Am Chem Soc 1999,121(51),11964

737004, SB-737004, S-0139, 97-139

Chemical Name: [4aS-(4abeta,6aalpha,6bbeta,12abeta,14bbeta]-6a-[3-[2-(3-Carboxy-2(E)-propenamido)-5-hydroxyphenyl]-2(E)-propenoyloxymethyl]-2,2,6b,9,9.12a-hexamethyl-10-oxo-1,2,3,4,4a,5,6,6a,6b,7,8,8a...
参考文献标题:Practical large-scala synthesis of endothelin receptor antagonist S-0139
文献作者:Konoike,T.; et al.
参考来源:Org Process Res Dev 1999,3(5),347

新产品编号:1027227

Chemical Name: 2-[2-(Dimethylamino)ethyl]-5-[2-(dimethylamino)ethylamino]indazolo[4,3-gh]isoquinolin-6(2H)-one
项目整合开发状态: Biological Testing
项目研究机构: Roche (Originator), University of Vermont (Ori...
参考文献标题:Synthesis and antitumor evalution of 2,5-disubstituted-indazolo[4,3-gh]isoquinoline-6(2H)-ones (9-aza-anthrapyrazoles)
文献作者:Menta,E.; et al.
参考来源:211th ACS Natl Meet (March 24-28,New Orleans) 1996,Abst MEDI 076

新产品编号:1028809

Chemical Name: 2-(2-Aminoethyl)-5-[2-(dimethylamino9ethylamino]indazolo[4,3-gh]isoquinolin-6(2H)-one
项目整合开发状态: Biological Testing
项目研究机构: Roche (Originator), University of Vermont (Originator) 参考文献标题:Synthesis and antitumor evalution of 2,5-disubstituted-indazolo[4,3-gh]isoquinoline-6(2H)-ones (9-aza-anthrapyrazoles)
文献作者:Menta,E.; et al.
参考来源:211th ACS Natl Meet (March 24-28,New Orleans) 1996,Abst MEDI 076

新产品编号:1030391

Chemical Name: 5-(2-Aminoethylamino)-2-[2-(dimethylamino)ethyl]indazolo[4,3-gh]isoquinolin-6(2H)-one
项目整合开发状态: Biological Testing
项目研究机构: Roche (Originator), University of Vermont (Originator) 参考文献标题:Synthesis and antitumor evalution of 2,5-disubstituted-indazolo[4,3-gh]isoquinoline-6(2H)-ones (9-aza-anthrapyrazoles)
文献作者:Menta,E.; et al.
参考来源:211th ACS Natl Meet (March 24-28,New Orleans) 1996,Abst MEDI 076

BTS-71091

Chemical Name: 5-(4-Chlorophenyl)-1-azaspiro[5.5]undec-4-ene hydrochloride
项目整合开发状态: Preclinical
项目研究机构: Abbott (Originator)
合成路线:Fischer esterification of 1-aminocyclohexanecarboxylic acid (...
参考文献标题:Aza spiro alkanes derivs.as therapeutic agents
文献作者:Harris,P.J.; Kerrigan,F.(The Boots Company plc)
参考来源:EP 0667860; JP 1996502985; US 5610161; WO 9411346

新产品编号:1031973

Chemical Name: N-[4-[N-(2-Methyl-4-oxo-3,4,7,8-tetrahydro-6H-cyclopenta[g]quinazolin-6(S)-yl)-N-(2-propynyl)amino]benzoyl]-L-glutamic
项目整合开发状态: Biological Testing
项目研究机构: AstraZeneca (Originato...
参考文献标题:Chemoenzymatic preparation of the novel antifolate thymidylate synthase inhibitor N-(4-{N-[(6S)-2-methyl-4-oxo-3,4,7,8-tetrahydro-6H-cyclopenta[g]quinazolin-6-yl]-N-(prop-2-ynyl)amino}-benzoyl)-L-glutamic acid and its glutamyl cleavage product
文献作者:Bavetsias,V.; Matusiak,Z.; Melin,C.; Neidle,S.; Marriott,J.H.; Boyle,F.T.; Jackman,A.L.
参考来源:J Chem Soc - Perkins Trans I 1999,(11),1495