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:1497081

Chemical Name: 3-Chloro-5,8-dimethoxy-3-(3-methoxyphenoxy)-1,4-naphthoquinone
项目整合开发状态: Biological Testing
项目研究机构: Memorial Sloan-Kettering Cancer Center (Originator)
合成路线:Friedel Crafts cond...
参考文献标题:Design of antineoplastic agents based on the "2-phenylnaphthalene-type" structural pattern.4.Synthesis and biological activity of 2-chloro-3-(substituted phenoxy)-1,4-naphthoquinones and related 5,8-dihydroxy-1,4-naphthoquinones
文献作者:Chang,H.-X.; Chou,T.C.; Savaraj,N.; Liu,L.F.; Yu,C.; Cheng,C.C.
参考来源:J Med Chem 1999,42(3),405

新产品编号:1498663

Chemical Name: 3-Chloro-5,8-dimethoxy-2-[3,5-(dimethoxy)phenoxy]-1,4-naphthoquinone
项目整合开发状态: Biological Testing
项目研究机构: Memorial Sloan-Kettering Cancer Center (Originator)
合成路线:Friedel Craft...
参考文献标题:Design of antineoplastic agents based on the "2-phenylnaphthalene-type" structural pattern.4.Synthesis and biological activity of 2-chloro-3-(substituted phenoxy)-1,4-naphthoquinones and related 5,8-dihydroxy-1,4-naphthoquinones
文献作者:Chang,H.-X.; Chou,T.C.; Savaraj,N.; Liu,L.F.; Yu,C.; Cheng,C.C.
参考来源:J Med Chem 1999,42(3),405

MBT

Chemical Name: 2-(5-tert-Butyl-1H-indol-3-yl)-N-methyl-1-ethanamine
项目整合开发状态: Biological Testing
项目研究机构: Lilly (Originator), Synaptic (Originator)
合成路线:Diazotization of 4-tert-butylaniline (I...
参考文献标题:Method for treating 5HT2B receptor related conditions
文献作者:Audia,J.E.; Cohen,M.L.; Gidda,J.S.; Nelson,D.L.G.; Baker,S.R.; Ezquerra-Carrera,J.; Lamas-Peteira,C.; Pedregal-Tercero,C.(Eli Lilly and Company)
参考来源:EP 0749313; JP 1997510216; US 5663178; WO 9524200; WO 9624351

新产品编号:1500245

Chemical Name: 2-(5-tert-Butyl-1H-indol-3-yl)-N,N-dimethyl-1-ethanamine
项目整合开发状态: Biological Testing
项目研究机构: Lilly (Originator), Synaptic (Originator)
合成路线:Diazotization of 4-tert-butylanilin...
参考文献标题:Method for treating 5HT2B receptor related conditions
文献作者:Audia,J.E.; Cohen,M.L.; Gidda,J.S.; Nelson,D.L.G.; Baker,S.R.; Ezquerra-Carrera,J.; Lamas-Peteira,C.; Pedregal-Tercero,C.(Eli Lilly and Company)
参考来源:EP 0749313; JP 1997510216; US 5663178; WO 9524200; WO 9624351

REC-15/3079

Chemical Name: N-[2-[4-(2-Methoxyphenyl)piperazin-1-yl]ethyl]-N-(2-nitrophenyl)cyclohexanecarboxamide
项目整合开发状态: Phase I
项目研究机构: Recordati (Originator)
合成路线:The condensation of 1-(2-aminoethyl...
参考文献标题:1-(N-Phenylaminoalkyl)-piperazine derivs.substd.at position 2 of the phenyl ring
文献作者:Leonardi,A.; Motta,G.; Testa,R.; Riva,C.(Recordati Industria Chimica e Farmaceutica SpA)
参考来源:EP 1000047; JP 2001512112; US 6399614; WO 9906384

新产品编号:1501827

Chemical Name: 2(S)-Amino-1-[4-[N-(4-benzyloxyphenyl)-N-(3-methyl-2-butenyl)amino]-1-piperidinyl]-4-methyl-1-pentanone
项目整合开发状态: Preclinical
项目研究机构: Elan (Originator), Pfizer (Originator)
合成路...
参考文献标题:Aniline derivs.as calcium channel blockers
文献作者:Rafferty,M.F.; Ryder,T.R.; Hu,L.-Y.(Pfizer Inc.)
参考来源:WO 9907689

新产品编号:1503409

Chemical Name: N-[1-[2(S)-Amino-4-methylpentyl]piperidin-4-yl]-N-(4-benzyloxyphenyl)-N-(3-methyl-2-butenyl)amine
项目整合开发状态: Biological Testing
项目研究机构: Pfizer (Originator)
合成路线:The reductoconde...
参考文献标题:Aniline derivs.as calcium channel blockers
文献作者:Rafferty,M.F.; Ryder,T.R.; Hu,L.-Y.(Pfizer Inc.)
参考来源:WO 9907689

新产品编号:1504991

Chemical Name: N-(Cyclopropylmethyl)-N-[2-methyl-8-(2,4,6-trimethylphenyl)quinolin-4-yl]-N-propylamine
项目整合开发状态: Preclinical
项目研究机构: Janssen (Originator), Neurocrine Biosciences (Originator)
...
参考文献标题:CRF antagonistic quino- and quinazolines
文献作者:Huang,C.; Chen,C.; McCarthy,J.R.; Haddach,M.; Wilcoxen,K.M.(Janssen Pharmaceutica NV; Neurocrine Biosciences Inc.)
参考来源:EP 0977737; WO 9847874

新产品编号:1506573

Chemical Name: 1-[3-[1-[2-(4-Iodophenyl)ethyl]piperidin-4-yl]propyl]-2-(phenoxymethyl)-4-[3-(1-piperidinyl)propoxy]-1H-benzimidazole
项目整合开发状态: Biological Testing
项目研究机构: Lilly (Originator)
合成...
参考文献标题:Structure-activity relationship of a series of diaminoalkyl substituted benzimidazole as neuropeptide Y Y1 receptor antagonists
文献作者:Zarrinmayeh,H.; Zimmerman,D.M.; Cantrell,B.E.; Schober,D.A.; Bruns,R.F.; Gackenheimer,S.L.; Ornstein,P.L.; Hipskind,P.A.; Britton,T.C.; Gehlert,D.R.
参考来源:Bioorg Med Chem Lett 1999,9(5),647

新产品编号:1508155

Chemical Name: 2-[Hydroxy(4-nitrophenyl)methyl]acrylonitrile; 3-Hydroxy-2-methylene-3-(4-nitrophenyl)propionitrile
项目整合开发状态: Preclinical
项目研究机构: Indian Institute of Technology (Originator)
合成...
参考文献标题:Antimalarial activity of 3-hydroxyalkyl-2-methylene-propionic acid derivatives
文献作者:Kundu,M.K.; Sundar,N.; Kumar,S.K.; Bhat,S.V.; Biswas,S.; Valecha,N.
参考来源:Bioorg Med Chem Lett 1999,9(5),731