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

Cyclobenzaprine hydrochloride, Flexiban, Flexeril

Chemical Name: 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethylpropan-1-amine hydrochloride
项目整合开发状态: Launched
项目研究机构: Merck & Co. (Originator), Vela Pharmaceuticals (Not Determined), Alza ...
参考文献标题:5-(3'-Dimethylamino-2'-methylpropyl)dibenzocycloheptenes
文献作者:Vilani,F.J.(Schering Corp.)
参考来源:US 3409640

新产品编号:1622059

Chemical Name: N-Benzyl-9-isopropyl-2-(thiomorpholin-4-yl)-9H-purin-6-amine
项目整合开发状态: Biological Testing
项目研究机构: LG Chem (Originator)
合成路线:Adenine (I) was oxidized with hydrogen peroxide in a...
参考文献标题:Synthesis and biological activities of C-2,N-9 substituted 6-benzylaminopurine derivatives as cyclin-dependent kinase inhibitor
文献作者:Woo,E.-R.; Baek,D.J.; Lee,s.-C.; Hong,C.Y.; Lee,K.-S.; Yang,B.-S.; Cho,J.-H.; Oh,C.-H.
参考来源:Arch Pharm 1999,332(6),187

新产品编号:1623641

Chemical Name: 2-(3-Benzoyl-4-cyclohexyl-1,4-dihydropyridin-1-yl)propionamide
项目整合开发状态: Preclinical
项目研究机构: University of Alberta (Originator), University of Calgary (Originator)
合成路线:Alkylat...
参考文献标题:Synthesis and analgesic activity of 2-methyl-2-[1-(3-benzoyl-4-substituted-1,4-dihydropyridyl)]acetic acid methyl esters,acetic acids,and acetamides
文献作者:Agudoawu,S.A.; et al.
参考来源:Arch Pharm 1999,332(6),213

新产品编号:1625223

Chemical Name: 4-[3-(4-Benzylpiperidin-1-yl)-1-propynyl]phenol
项目整合开发状态: Preclinical
项目研究机构: Pfizer (Originator)
合成路线:4-Benzylpiperidine (I) was alkylated with butynyl tosylate (II) to afford...
参考文献标题:Subtype-selective N-methyl-D-aspartate receptor antagonists: Synthesis and biological evaluation of 1-(arylakynyl)-4-benzylpiperidines
文献作者:Wright,J.L.; Gregory,T.F.; Bigge,C.F.; Boxer,P.A.; Serpa,K.; Meltzer,L.T.; Wise,L.D.; Cai,S.X.; Hawkinson,J,E.; Konkoy,C.S.; Whittemore,E.R.; Woodward,R.M.; Zhou,Z.L.
参考来源:J Med Chem 1999,42(13),2469

新产品编号:1626805

Chemical Name: N-Benzyl-3-[2-(dimethylamino)ethyl]-5-[2-(4,4-dimethyl-2,5-dioxoimidazolidin-1-yl)ethyl]-1H-indole-2-carboxamide
项目整合开发状态: Preclinical
项目研究机构: GlaxoSmithKline (Originator), Roche ...
参考文献标题:Synthesis and serotonergic activity of substituted 2,N-benzylcarboxamido-5-(2-ethyl-1-dioxoimidazolidinyl)-N,N-dimethyltryptamine derivatives: Novel antagonists for the vascular 5-HT1B-like receptor
文献作者:Moloney,G.P.; Martin,G.R.; Mathews,N.; Milne,A.; Hobbs,H.; Dodsworth,S.; Sang,P.Y.; Knight,C.; Williams,M.; Maxwell,M.; Glen,R.C.
参考来源:J Med Chem 1999,42(14),2504

新产品编号:1628387

Chemical Name: N-Benzyl-3-[2-(dimethylamino)ethyl]-5-[2-(2,5-dioxoimidazolidin-1-yl)ethyl]-1H-indole-2-carboxamide
项目整合开发状态: Preclinical
项目研究机构: GlaxoSmithKline (Originator), Roche Bioscience (O...
参考文献标题:Synthesis and serotonergic activity of substituted 2,N-benzylcarboxamido-5-(2-ethyl-1-dioxoimidazolidinyl)-N,N-dimethyltryptamine derivatives: Novel antagonists for the vascular 5-HT1B-like receptor
文献作者:Moloney,G.P.; Martin,G.R.; Mathews,N.; Milne,A.; Hobbs,H.; Dodsworth,S.; Sang,P.Y.; Knight,C.; Williams,M.; Maxwell,M.; Glen,R.C.
参考来源:J Med Chem 1999,42(14),2504

新产品编号:1629969

Chemical Name: (3S,10R,16S)-10-[3-Chloro-4-(dimethylamino)benzyl]-16-[2(R),3(R)-epoxy-1(R)-methyl-3-phenylpropyl]-3-isobutyl-6,6-dimethyl-1,4-dioxa-8,11-diazacyclohexadec-13(E)-ene-2,5,9,12-tetraone 参考文献标题:Novel cryptophycin antitumor agents: Synthesis and cytotoxicity of fragment "B" analogues
文献作者:Patel,V.F.; Andis,S.L.; Kennedy,J.H.; Ray,J.E.; Schultz,R.M.
参考来源:J Med Chem 1999,42(14),2588

AL-16049

Chemical Name: 7-[(1S,2R,3R,5S)-3,5-Dihydroxy-2-[2(S)-hydroxy-4-[3-(trifluoromethyl)phenyl]butoxy]cyclopentyl]-5(Z)-heptenoic acid isopropyl ester; 17-[3-(Trifluoromethyl)phenyl]-13,14-dihydro-18,19,2...
参考文献标题:13-Oxa prostaglandins for the treatment of glaucoma and ocular hypertension
文献作者:Feng,Z.; Hellberg,M.R.(Alcon Laboratories,Inc.)
参考来源:US 6232344; WO 9932441

SPH-1286

Chemical Name: (-)-(4aS,6R,8aS)-6-Hydroxy-3-methoxy-11-[3-(piperidin-1-yl)propyl]-5,6,9,10,11,12-hexahydro-4aH-benzofuro[3a,3,2-e,f][2]benzazepine
项目整合开发状态: Preclinical
项目研究机构: Sanochemia (Origi...
参考文献标题:New benzazepine derivs.,medicaments containing the same and their use to prepare medicaments
文献作者:K黣nburg,B.; Fr鰄lich,J.; Jordis,U.; Czollner,L.(Sanochemia Pharmazeutika AG)
参考来源:WO 9740049

新产品编号:1631551

Chemical Name: 1-(2-Methylalanyl-D-tryptophyl)-3-(2-pyridylmethyl)piperidine-3(S)-carboxylic acid ethyl ester
项目整合开发状态: Preclinical
项目研究机构: Merck & Co. (Originator)
合成路线:Protection of ethyl p...
参考文献标题:Thiazole-derived potent,highly bioavailable short duration growth hormone secretagogues
文献作者:Yang,L.; Morriello,G.; Leung,K.; Jacks,T.; Cheng,K.; Schleim,K.D.; Smith,R.; Patchett,A.A.
参考来源:Bioorg Med Chem Lett 1999,9(13),1761