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

PD-150714

Chemical Name: 1-Ethyl-4-phenyl-1,2,3,6-tetrahydropyridine-3-carboxylic acid hexyl ester oxalate
项目整合开发状态: Preclinical
项目研究机构: Pfizer (Originator)
合成路线:Treatment of oxazolylpyridine (I) with ...
参考文献标题:Identification and characterization of m1 selective muscarinic receptor antagonists
文献作者:Augelli-Szafran,C.E.; Blankley,C.J.; Jaen,J.C.; Moreland,D.W.; Nelson,C.B.; Penvose-Yi,J.R.; Schwarz,R.D.; Thomas,A.J.
参考来源:J Med Chem 1999,42(3),356

新产品编号:1038301

Chemical Name: (6R,7R)-7-[2-(2-Aminothiazol-4-yl)-2(Z)-[1-carboxy-1-(5-cyano-3,4-dihydroxythien-2-yl)methoxyimino]acetamido]-3-[3-quinolinio-1(E)-propenyl]-3-cephem-4-carboxylate
项目整合开发状态: Biologic...
参考文献标题:Cephalosporins having in position 7 as substd.axymino radical,intermediates,processes for their preparation and their use as medicaments
文献作者:Aszodi,J.; Dini,C.; Fauveau,P.(Aventis Pharma SA)
参考来源:CA 2111164; EP 0628562; JP 1994345776

OPB-3206

Chemical Name: 3(R)-Isobutyl-4-[1-methoxy-2-oxo-1,2,3,4-tetrahydroquinolin-3(S)-ylamino]-4-oxobutyrohydroxamic acid
项目整合开发状态: Preclinical
项目研究机构: Otsuka (Originator)
合成路线:The protection of th...
参考文献标题:Carbostyril derivs.as matrix metalloproteinases inhibitors
文献作者:Sakamoto,M.; Imaoka,T.; Motoyama,M.; Yamamoto,Y.; Takasu,H.(Otsuka Pharmaceutical Co.,Ltd.)
参考来源:EP 0641323; JP 1995157470; WO 9421612

新产品编号:1039883

Chemical Name: 4-[2-[1-(4,4'-Dipropylbenzhydryl)indole-5-carboxamido]phenoxy]butyric acid
项目整合开发状态: Biological Testing
项目研究机构: Kyowa Hakko (Originator)
合成路线:The target compound has been obtai...
参考文献标题:Indole and benzimidazole derivatives as steroid 5alpha-reductase inhibitors in the rat prostate
文献作者:Takami,H.; Kishibayashi,N.; Ishii,A.; Kumazawa,T.
参考来源:Bioorg Med Chem 1998,6(12),2441

新产品编号:1041465

Chemical Name: (+)-6-Fluoro-1(R)-(fluoromethyl)-7-(4-methylpiperazin-1-yl)-4-oxo-4H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic acid
项目整合开发状态: Preclinical
项目研究机构: Nippon Shinyaku (Originator)
...
参考文献标题:Quinolinecarboxylic acid deriv.and process for producing the same
文献作者:Segawa,J.; Matsuoka,M.; Tomii,Y.(Nippon Shinyaku Co.,Ltd.)
参考来源:EP 0675127; WO 9414819

新产品编号:1043047

Chemical Name: (-)-6-Fluoro-1(S)-(fluoromethyl)-7-(4-methylpiperazin-1-yl)-4-oxo-4H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic acid
项目整合开发状态: Preclinical
项目研究机构: Nippon Shinyaku (Originator)
...
参考文献标题:Quinolinecarboxylic acid deriv.and process for producing the same
文献作者:Segawa,J.; Matsuoka,M.; Tomii,Y.(Nippon Shinyaku Co.,Ltd.)
参考来源:EP 0675127; WO 9414819

AZD-4407, ZD-4407

Chemical Name: (2S,4R)-5-[4-(4-Hydroxy-2-methyltetrahydropyran-4-yl)thien-2-ylsulfanyl]-1-methyl-2,3-dihydro-1H-indol-2-one
项目整合开发状态: Discontinued
项目研究机构: AstraZeneca (Originator)
合成路线:This c...
参考文献标题:Use of titanium thienyl anion and a simple procedure for introducing a thiol group into thiophene in the development of a manufacturing route to the 5-lipoxygenase inhibitor ZD4407
文献作者:Hutton,J.; et al.
参考来源:Org Process Res Dev 1997,1(1),61

TAN-67

Chemical Name: (-)-(4aS*,12aR*)-4a-(3-Hydroxyphenyl)-2-methyl-1,2,3,4,4a,5,12,12a-octahydropyrido[3,4-b]acridine
项目整合开发状态: Preclinical
项目研究机构: Toray (Originator)
合成路线:The cyclization of perhy...
参考文献标题:Rational drug design and synthesis of a highly selective nonpeptide delt-opioid agonist,(4aS*,12aR*)-4a-(3-hydroxyphenyl)-2-methyl-1,2,3,4,4a,5,12,12a-octrahydropyrido[3,4-b]acridine (TAN-67)
文献作者:Nagase,H.; Kawai,K.; Hayakawa,J.; Wakita,H.; Mizusuna,A.; Matsuura,H.; Tajima,C.; Takezawa,Y.; Endoh,T.
参考来源:Chem Pharm Bull 1998,46(11),1695

新产品编号:1044629

Chemical Name: 2-(3,4-Dimethoxyphenyl)-7-(6,7-dimethoxy-1,2,3,4-tetrahydroisoquinolin-2-yl)-2-(4-methylphenylsulfanyl)heptanenitrile
项目整合开发状态: Preclinical
项目研究机构: Wyeth Pharmaceuticals (Originat...
参考文献标题:Novel multidrug resistance reversal agents
文献作者:Berger,D.; Citarella,R.; Dutia,M.; Greenberger,L.; Hallett,W.; Paul,R.; Powell,D.
参考来源:J Med Chem 1999,42(12),2145

SR-10204

Chemical Name: 6-Amino[1]benzothieno[3,2-h]isoquinoline
项目整合开发状态: Biological Testing
项目研究机构: SRI (Originator)
合成路线:3-(Chloromethyl)benzothiophene (II) was prepared by condensation of benzothi...
参考文献标题:Novel benzothiophene analogs as antiviral agents
文献作者:Reist,E.J.(SRI International)
参考来源:EP 0712404; JP 1997500386; US 5424315; WO 9504059