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

DF-1

Chemical Name: 3-[(3R,9S,9aR)-9-Hydroxy-4,4-dimethyl-2-oxoperhydroquinolizin-3-yl]quinazolin-4(3H)-one
项目整合开发状态: Preclinical
项目研究机构: Okayama University (Originator), Tohoku College of Pharmacy (...
参考文献标题:New type of febrifugine analogues,bearing a quinolizidine moiety,show potent antimalarial activity against Plasmodium malaria parasite
文献作者:Takaya,Y.; Tasaka,H.; Chiba,T.; Uwai,K.; Tanitsu,M.; Kim,H.S.; Wataya,Y.; Miura,M.; Takeshita,M.; Oshima,Y.
参考来源:J Med Chem 1999,42(16),3163

DF-2

Chemical Name: 3-[(3S,9S,9aS)-9-Hydroxy-4,4-dimethyl-2-oxoperhydroquinolizin-3-yl]quinazolin-4(3H)-one
项目整合开发状态: Preclinical
项目研究机构: Okayama University (Originator), Tohoku College of Pharmacy (...
参考文献标题:New type of febrifugine analogues,bearing a quinolizidine moiety,show potent antimalarial activity against Plasmodium malaria parasite
文献作者:Takaya,Y.; Tasaka,H.; Chiba,T.; Uwai,K.; Tanitsu,M.; Kim,H.S.; Wataya,Y.; Miura,M.; Takeshita,M.; Oshima,Y.
参考来源:J Med Chem 1999,42(16),3163

MRS-1595

Chemical Name: N-(3,4-Dimethyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)-2-[4-(2,6-dioxo-1,3-dipropyl-2,3,6,7-tetrahydro-1H-purin-8-yl)phenoxy]acetamide
项目整合开发状态: Preclinical
项目研究机构: National Instit...
参考文献标题:Acyl-hydrazide derivatives of a xanthine carboxylic congener (XCC) as selective antagonists at human A2B adenosine receptors
文献作者:Karton,Y.; Melman,N.; Ji,X.-D.; Jacobson,K.A.; Linden,J.; Kim,Y.-C.
参考来源:Drug Dev Res 1999,47(4),178

A-205804

Chemical Name: 4-(4-Methylphenylsulfanyl)thieno[2,3-c]pyridine-2-carboxamide
项目整合开发状态: Preclinical
项目研究机构: Abbott (Originator), Icos (Codevelopment)
合成路线:The formylation of 3,5-dichloropyridi...
参考文献标题:Cell adhesion-inhibiting antiinflammatory cpds.
文献作者:Lartey,K.; Gunawardana,I.W.; Stout,D.M.; Bhatia,P.; Patel,M.V.; Staeger,M.A.; Boyd,S.A.; Mort,N.A.; Zhu,G.-D.; McCarty,C.M.; Stewart,A.O.; Arendsen,D.L.; Condroski,K.R.; Freeman,J.C.(Abbott Laboratories Inc.)
参考来源:WO 9962908

NMI-377

Chemical Name: 2-[2-(2,6-Dichlorophenylamino)phenyl]acetic acid 3-[N-methyl-N-[1-(nitrososulfanyl)cyclohexylmethyl]amino]propyl ester
项目整合开发状态: Preclinical
项目研究机构: NitroMed (Originator)
合成路线:...
参考文献标题:NMI-377,a nitric oxide-donating diclofenac derivative with gastroprotective properties
文献作者:Bandarage,U.K.; et al.
参考来源:217th ACS Natl Meet (March 21 1999,Anaheim) 1999,Abst MEDI 81

PD-188669

Chemical Name: 4-Benzyl-1-[4-(4-imidazolyl)-3-butynyl]piperidine
项目整合开发状态: Preclinical
项目研究机构: CoCensys (Originator), Pfizer (Originator)
合成路线:Coupling of 3-butyn-1-ol (I) with 4-iodo-1-pheny...
参考文献标题:Novel series of 4-benzyl-N-(4-imidazole-1-alkynyl)piperidines as potent subtype selective NMDA receptor antagonists
文献作者:Boxer,P.A.; Woodward,R.M.; Meltzer,L.T.; D'Wise,L.; Gregory,T.F.
参考来源:218th ACS Natl Meet (Aug 22 1999,New Orleans) 1999,Abst MEDI 94

IDD-598

Chemical Name: 2-[5-Fluoro-2-[N-(3-nitrobenzyl)thiocarbamoyl]phenoxy]acetic acid
项目整合开发状态: Preclinical
项目研究机构: Institute for Diabetes Discovery (Originator)
合成路线:Treatment of 2,4-difluorophen...
参考文献标题:Design and synthesis of novel inhibitors of aldose reductase for the treatment of diabetic complications
文献作者:Van Zandt,M.C.; Sibley,E.O.; Combs,K.J.; et al.
参考来源:218th ACS Natl Meet (Aug 22 1999,New Orleans) 1999,Abst MEDI 137

PD-176078

Chemical Name: N-[4,4-Bis(4-fluorophenyl)butyl]-4-methyl-2(S)-(methylamino)pentanamide hydrochloride; N1-[4,4-Bis(4-fluorophenyl)butyl]-N2-methyl-L-leucinamide hydrochloride
项目整合开发状态: Preclinical 参考文献标题:Substd.diarylalkyl amides as calcium channel antagonists
文献作者:Song,Y.; Rafferty,M.F.; Ryder,T.R.; Sercel,A.D.; Connor,D.T.; Malone,T.C.; Hu,L.-Y.; Roth,B.D.(Pfizer Inc.)
参考来源:WO 9955688

Ro-65-7674

Chemical Name: 2-(Methylsulfanyl)-3-(phenylsulfonyl)-8-(piperazin-1-yl)-6,7-dihydro-5H-cyclopenta[d]pyrazolo[1,5-a]pyrimidine
项目整合开发状态: Preclinical
项目研究机构: Roche (Originator)
合成路线:Condensatio...
参考文献标题:Pyrazolopyrimidines and pyrazolotriazines with 5-HT6 receptor affinity
文献作者:Stadler,H.; Boes,M.; Riemer,C.(F.Hoffmann-La Roche AG)
参考来源:EP 0941994; JP 2000186090

新产品编号:1647371

Chemical Name: 1-(2,4-Dichlorophenyl)-1-[4-[N-methyl-N-(1-naphthylmethyl)aminomethyl]phenyl]methanone
项目整合开发状态: Biological Testing
项目研究机构: Second Military Medical University (Originator)
合成路线...
参考文献标题:The synthesis and antifungal activity of the substituted naphthalenemethanamines
文献作者:Zhou,Y.; Zhang,W.; Li,K.; Jiang,Y.; Li,Y.; Wang,X.
参考来源:Chin Journal of Medicinal Chemistry 1999,9(7),7