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

L-826141

Chemical Name: 4-[2-[3,4-Bis(difluoromethoxy)phenyl]-2-[4-[2,2,2-trifluoro-1-hydroxy-1-(trifluoromethyl)ethyl]phenyl]ethyl]-3-methylpyridine N-oxide (enantiomer 1)
项目整合开发状态: Preclinical
项目研究机构: ...
参考文献标题:Tri-aryl ethane derivs.as PDE IV inhibitors
文献作者:Guay,D.; Ducharme,Y.; Blouin,M.; Hamel,P.; Girard,M.(Merck Frosst Canada Inc.)
参考来源:EP 0873311; JP 2000501742; US 5710170; WO 9722586

PD-0199646

Chemical Name: 6-[3(S)-Aminopyrrolidin-1-yl]-8-bromo-5-fluoro-2-hydroxy-1H-benzo[de]isoquinoline-1,3(2H)-dione
项目整合开发状态: Biological Testing
项目研究机构: Naeja (Originator), Pfizer (Originator)
合成路...
参考文献标题:The synthesis and SAR of a series of 2-hydroxyisoquinolones: New antibacterial gyrase inhibitors
文献作者:Stier,M.A.; et al.
参考来源:40th Intersci Conf Antimicrob Agents Chemother (Sept 17 2000,Toronto) 2000,Abst F-1503

新产品编号:1946369

Chemical Name: 3,5-Diamino-4-nitro-1H-pyrazole-1-carboxamidine
项目整合开发状态: Preclinical
项目研究机构: Friedrich-Schiller-Universit鋞 Jena (Originator), NIOPIK (Originator)
合成路线:The condensation of nitr...
参考文献标题:4-Nitropyrazole derivatives as new exogenic donors of nitric oxide
文献作者:Makarov,V.; et al.
参考来源:16th Int Symp Med Chem (Sept 18 2000,Bologna) 2000,Abst PA-120

AWD-34-022

Chemical Name: 6-(2-Chlorobenzyl)-3,6-dihydro-4H-pyrazolo[3,4-d][1,2,3]triazin-4-one
项目整合开发状态: Preclinical
项目研究机构: Asta Medica (Originator)
合成路线:Benzyl pyrazole derivative (III) was prepared ...
参考文献标题:Pyrazolo[3,4-d][1,2,3]triazines with anticonvulsive action and methods for producing the same
文献作者:Lankau,H.-J.; Arnold,T.; Rostock,A.; Unverferth,K.; Kronbach,T.; Bartsch,R.(Arzneimittelwerk Dresden GmbH)
参考来源:DE 19924872; WO 0073309

VRC-3375

Chemical Name: 1-[2(R)-(N-Hydroxycarbamoylmethyl)hexanoyl]-L-proline tert-butyl ester
项目整合开发状态: Preclinical
项目研究机构: Vicuron Pharmaceuticals (Originator), Novartis (Codevelopment)
合成路线:The tit...
参考文献标题:Novel succinate cpds.,compsns.and methods of use and preparation
文献作者:Patel,D.V.; Jacobs,J.W.; Yuan,Z.; Ni,Z.-J.; Jain,R.(Vicuron Pharmaceuticals Inc.)
参考来源:EP 1237862; JP 2003534239; US 2002115863; US 6797820; WO 0144179

新产品编号:1947951

Chemical Name: N-(2Ethylbutyryl)-L-prolyl-3-(2-naphthyl)-D-alanyl [2-(2-aminoacetamido)ethyl]amide hydrochloride
项目整合开发状态: Biological Testing
项目研究机构: Kaken (Originator), Molecular Research Insti...

新产品编号:1949533

Chemical Name: (3beta,17Z)-3-Hydroxypregna-5,17(20)-dien-21-al oxime; (17Z)-21-(Hydroxyimino)pregna-5,17(20)-dien-3-beta-ol
项目整合开发状态: Preclinical
项目研究机构: Universit鋞 des Saarlandes (Originator) 参考文献标题:Synthesis and evaluation of novel steroidal oxime inhibitors of P450 17 (17alpha-hydroxylase/C17-20-lyase)and 5alpha-reductase types 1 and 2
文献作者:Hartmann,R.W.; Hector,M.; Haidar,S.; Ehmer,P.B.; Reichert,W.; Jose,J.
参考来源:J Med Chem 2000,43(22),4266

D14

Chemical Name: 8-Chloro-5-oxidopyrazolo[5,1-c][1,2,4]benzotriazine-3-carboxylic acid thien-2-ylmethyl ester; 8-Chloro-3-(thien-2-ylmethoxycarbonyl)pyrazolo[5,1-c][1,2,4]benzotriazine 5-oxide
项目整合开发...
参考文献标题:Benzodiazepine receptor ligands.7.Synthesis and pharmacological evaluation of new 3-esters of the 8-chloropyrazolo[5,1-c][1,2,4]benzotriazine 5-oxide.3-(2-Thienylmethoxycarbonyl) derivative: An anxioselective agent in rodents
文献作者:Costanzo,A.; Guerrini,G.; Ciciani,G.; Bruni,F.; Costagli,C.; Selleri,S.; Besnard,F.; Costa,B.; Martini,C.; Malmberg Aiello,P.
参考来源:J Med Chem 2002,45(26),5710

MC-1060

Chemical Name: 6-[1-(2,6-Difluorophenyl)ethyl]-5-methyl-2-(methylsulfanyl)pyrimidin-4(3H)-one
项目整合开发状态: Biological Testing
项目研究机构:
合成路线:The condensation of 2-(2,6-difluorophenyl)acetic acid ...
参考文献标题:Selected non-nucleoside reverse transcriptase inhibitors (NNRTIs): the DABOs family
文献作者:Artico,M.
参考来源:Drugs Fut 2002,27(2),159

MEN-11951

Chemical Name: 7-O-[4-O-(3-Amino-2,3,6-trideoxy-alpha-L-mannopyranosyl)-2,6-dideoxy-alpha-L-galactopyranosyl]-4-demethoxyadriamycinone hydrochloride
项目整合开发状态: Preclinical
项目研究机构: Menarini (Origi...
参考文献标题:L-Arabino-disaccharides of anthracyclines,processes for their preparation,and pharmaceutical compsns.containing them
文献作者:Bigioni,M.; Cipollone,A.; Animati,F.; Maggi,C.A.; Berettoni,M.(Menarini Industrie Farma Riunite Srl)
参考来源:WO 0053615