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:1058867

Chemical Name: 3(R)-[N-[1(S)-(N-tert-Butylcarbamoyl)-2,2-dimethylpropyl]carbamoyl]-2(S)-hydroxy-5-methylhexanohydroxamic acid
项目整合开发状态: Biological Testing
项目研究机构: British Biotech (Originator) 参考文献标题:Pentafluorobenzenesulfonamides and analogs
文献作者:Flygare,J.; Medina,J.; Shan,B.; Clark,D.; Rosen,T.(Tularik Inc.)
参考来源:EP 0939627; WO 9805315

新产品编号:1060449

Chemical Name: 3-[2-(2-Phenylethyl)morpholin-4-ylmethyl]-1H-indole oxalate
项目整合开发状态: Biological Testing
项目研究机构: Merck Sharp & Dohme (Originator)
合成路线:Condensation of 2,6-diamino-4-hydroxypyri...
参考文献标题:Synthesis of classical and a nonclassical 2-amino-4-oxo-6-methyl-5-substituted Pyrrolo[2,3-d]pyrimidine antifolate inhibitors of thymidylate synthase1
文献作者:Gangjee,A.; Mavandadi,F.; Kisliuk,R.L.; Queener,S.F.
参考来源:J Med Chem 1999,42(12),2272

FR-166124

Chemical Name: 2-[2-[6-Oxo-3-(2-phenylpyrazolo[1,5-a]pyridin-3-yl)-1,6-dihydropyridazin-1-yl]-1-cyclohexenyl]acetic acid
项目整合开发状态: Preclinical
项目研究机构: Fujisawa (Originator)
合成路线:This compound...
参考文献标题:Pyrazolopyridine adenosine antagonists
文献作者:Akahane,A.; Nishimura,S.; Itani,H.; Durkin,K.P.M.(Fujisawa Pharmaceutical Co.,Ltd.)
参考来源:EP 0737193; JP 1997507485; US 5773530; WO 9518128

Q-85 HCl

Chemical Name: 7-Chloro-3-(3-dimethylaminopropylamino)quinoxaline-2-carbonitrile 1,4-dioxide hydrochloride
项目整合开发状态: Biological Testing
项目研究机构: AstraZeneca (Originator), Universidad de Navarra (...
参考文献标题:Hypoxia-selective agents derived from 2-quinoxalinecarbonitrile 1,4-di-N-oxides.2
文献作者:Monge,A.; Martinez-Crespo,F.J.; Lopez de Cerain,A.; Palop,J.A.; Narro,S.; Senador,V.; Marin,A.; Sainz,Y.; Gonzalez,M.D.; Hamilton,E.; et al.
参考来源:J Med Chem 1995,38(22),4488

Combretastatin A-4, CA-4

Chemical Name: (Z)-3'-Hydroxy-3,4,4,',5-tetramethoxy stilbene; (Z)-1-(3,4,5-Trimethoxyphenyl)-2-(3-hydroxy-4-methoxyphenyl)ethene
项目整合开发状态: Phase I/II
项目研究机构: Arizona State University (Originato...
参考文献标题:Substd.diphenylethylenes and analogues or derivs.thereof
文献作者:Rathbone,D.L.; Slack,J.A.; Griffin,R.J.; Quarterman,C.P.(Aston Molecules Ltd.)
参考来源:WO 9216486

HMR-3004, CP-426027, RU-64004, RU-004

Chemical Name: 11,12-(Aminocarbonyloxy)-11,12-dideoxy-3-des(hexopyranosyloxy)-6-O-methyl-3-oxo-N11-[3-(4-quinolyl)propylamino]erythromycin A
项目整合开发状态: Preclinical
项目研究机构: Aventis Pharma (Origina...
参考文献标题:Synthesis and antibacterial activity of ketolides (6-O-methyl-3-oxoerythromycin derivatives): A new class of antibacterials highly potent against macrolide-resistant and -susceptible respiratory pathogens
文献作者:Agouridas,C.; Denis,A.; Auger,J.M.; Benedetti,Y.; Bonnefoy,A.; Bretin,F.; Chantot,J.F.; Dussarat,A.; Fromentin,C.; D'Ambrieres,S.G.; Lachaud,S.; Laurin,P.; Le Martret,O.; Loyau,V.; Tessot,N.
参考来源:J Med Chem 1998,41(21),4080

NPS-846.HCl

Chemical Name: 3,3-Bis(3-fluorophenyl)propylamine hydrochloride
项目整合开发状态: Preclinical
项目研究机构: NPS Pharmaceuticals (Originator)
合成路线:This compound has been obtained by two related ways:1) The ...
参考文献标题:Cpds.active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases
文献作者:Barmore,R.M.; DelMar,E.G.; Balandrin,M.F.; VanWagenen,B.C.; Artman,L.D.; Mueller,A.L.; Moe,S.T.(NPS Pharmaceuticals,Inc.)
参考来源:US 6071970

新产品编号:1062031

Chemical Name: 3,5-Dimethyl-4-(nitromethylsulfonyl)phenyl ester
项目整合开发状态: Biological Testing
项目研究机构: University of Tennessee System (Originator)
合成路线:The acetylation of 3,5-dimethylaniline (I...
参考文献标题:Phenylsulfonylnitromethasanes as potent irreversible inhibitors of aldose reductase
文献作者:Rodriguez,L.; Miller,D.D.; Kador,P.F.; Saab,N.H.; Donkor,I.O.
参考来源:Eur J Med Chem 1999,34(9),745

Macrosphelide A

Chemical Name: (4S,9R,10S,15R,16S)-9,15-dihydroxy-4,10,16-trimethyl-1,5,11-trioxa-7(E),13(E)-cyclohexadecadiene-2,6,12-trione
项目整合开发状态: Biological Testing
项目研究机构: Kitasato Institute (Originator)...
参考文献标题:Total synthesis of macrosphelides B and A
文献作者:Kobayashi,Y.; et al.
参考来源:Tetrahedron Lett 2000,41(10),1559

Macrosphelide B

Chemical Name: (4S,9R,10S,16S)-9-hydroxy-4,10,16-trimethyl-1,5,11-trioxa-7(E),13(E)-cyclohexadecadiene-2,6,12,15-tetrone
项目整合开发状态: Biological Testing
项目研究机构: Kitasato Institute (Originator), Nih...
参考文献标题:Total synthesis of macrosphelides B and A
文献作者:Kobayashi,Y.; et al.
参考来源:Tetrahedron Lett 2000,41(10),1559