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:1444875

Chemical Name: endo-1-Isopropyl-N-(8-methyl-8-azabicyclo[3.2.1]oct-3-yl)benzimidazole-2-carboxamide fumarate
项目整合开发状态: Preclinical
项目研究机构: FAES (Originator)
合成路线:The reaction of 8-methyl-8-az...
参考文献标题:Benzimidazole-2-carboxylic acid amides and esters: A new structural class of 5-HT3 ligands
文献作者:Labeaga,L.; Alonso-Cires,L.; Tapia,I.; Mosquera,R.; Orjales,A.; L髉ez-Tudanca,P.
参考来源:Eur J Med Chem 1999,34(5),415

新产品编号:1446457

Chemical Name: 7-Methyl-5-methoxy-7H-pyrido[4,3-c]carbazole
项目整合开发状态: Biological Testing
项目研究机构: Biotech Research Laboratories (Originator)
合成路线:The reaction of 2-methoxy-9-methylcarbazole-3-...
参考文献标题:Substituted 7H-pyrido[4,3-c]carbazoles with potent anti-HIV activity
文献作者:Hirata,K.; Ito,C.; Furukawa,H.; Itoigawa,M.; Cosentino,L.M.; Lee,K.H.
参考来源:Bioorg Med Chem Lett 1999,9(2),119

ALS-007

Chemical Name: 12-(beta-D-Glucopyranosyl)-3,9-dihydroxy-6,7,12,13-tetrahydro-5H-indolo[2,3-a]pyrrolo[3,4-c]carbazole-5,7-dione
项目整合开发状态: Biological Testing
项目研究机构: Advanced Life Sciences (Origin...
参考文献标题:Indolocarbazole poisons of human topoisomerase I: Regioisomeric analogues of ED-110
文献作者:Zembower,D.E.; Zhang,H.; Lineswala,J.P.; Kuffel,M.J.; Aytes,S.A.; Ames,M.M.
参考来源:Bioorg Med Chem Lett 1999,9(2),145

新产品编号:1448039

Chemical Name: 3-(Diphenylmethylene)-1-[4-[4-(4-fluorophenyl)-1-piperazinyl]butyl]-2,5-pyrrolidinedione dihydrochloride
项目整合开发状态: Biological Testing
项目研究机构: Universidad Complutense de Madrid (Or...
参考文献标题:New imidapiperazine derivs.
文献作者:K.Rovat,T.; Oesanz Mu�? L.M.; Fern醤dez Velando,E.; L髉ez Rodr韌uez,M.L.; Rosado Samitier,M.L.; Morcillo Ortega,M.J.(Universidad Complutense de Madrid)
参考来源:ES 2094690

新产品编号:1449621

Chemical Name: 3-[2-Amino-3-(isopropylsulfanyl)imidazo[1,2-a]pyridin-6-yl]-N-methyl-3-phenyl-2(E)-propenamide
项目整合开发状态: Biological Testing
项目研究机构: Lilly (Originator)
合成路线:Friedel-Crafts acyla...
参考文献标题:2-Amino-3-substituted-6-[(E)-1-phenyl-2-(N-methylcarbamoyl)vinyl]imidazo[1,2-a]pyridines as a novel class of inhibitors of human rhinovirus: Stereospecific synthesis and antiviral activity
文献作者:Hamdouchi,C.; de Blas,J.; del Prado,M.; Gruber,J.; Heinz,B.A.; Vance,L.
参考来源:J Med Chem 1999,42(1),50

TR-9109

Chemical Name: N-[3(R)-Carboxy-2,2,3-trimethylcyclopent-1(S)-ylcarbonyl]-4-(2,6-dichlorobenzamido)-L-phenylalanine
项目整合开发状态: Preclinical
项目研究机构: Pfizer (Originator), Tanabe Seiyaku (Originator)<...
参考文献标题:Inhibitors of alpha4beta1 mediated cell adhesion
文献作者:Rishton,G.; Chrusciel,R.A.; Yamagishi,M.; Polinsky,A.; Thomas,E.W.; Lobl,T.J.; Tanis,S.P.; Teegarden,B.; Fisher,J.F.(Pharmacia Corp.; Tanabe Seiyaku Co.,Ltd.)
参考来源:EP 0991619; WO 9858902

新产品编号:1451203

Chemical Name: 3'-Deoxy-2',3'-didehydro-5'-O-[[O-(2-naphthylmethyl)-L-alanino](phenoxy)phosphoryl]thymidine
项目整合开发状态: Biological Testing
项目研究机构: Rega Institute for Medical Research (Originator)<...
参考文献标题:Synthesis,anti-human immunodeficiency virus activity and esterase lability of some novel carboxylic ester-modified phosphoramidate derivatives of stavudine (d4T)
文献作者:McGuigan,C.; Sutton,P.W.; Cahard,D.; Turner,K.; O'Leary,G.; Wang,Y.; Gumbleton,M.; De Clercq,E.; Balzarini,J.
参考来源:Antivir Chem Chemother 1998,9(6),473

新产品编号:1452785

Chemical Name: 3'-Deoxy-2',3'-didehydro-5'-O-[(O-phenyl-L-alanino)(phenoxy)phosphoryl]thymidine
项目整合开发状态: Biological Testing
项目研究机构: Rega Institute for Medical Research (Originator)
合成路线:Titl...
参考文献标题:Synthesis,anti-human immunodeficiency virus activity and esterase lability of some novel carboxylic ester-modified phosphoramidate derivatives of stavudine (d4T)
文献作者:McGuigan,C.; Sutton,P.W.; Cahard,D.; Turner,K.; O'Leary,G.; Wang,Y.; Gumbleton,M.; De Clercq,E.; Balzarini,J.
参考来源:Antivir Chem Chemother 1998,9(6),473

新产品编号:1454367

Chemical Name: 3'-Deoxy-2',3'-didehydro-5'-O-[[O-(1-naphthylmethyl)-L-alanino](phenoxy)phosphoryl]thymidine
项目整合开发状态: Biological Testing
项目研究机构: Rega Institute for Medical Research (Originator)<...
参考文献标题:Synthesis,anti-human immunodeficiency virus activity and esterase lability of some novel carboxylic ester-modified phosphoramidate derivatives of stavudine (d4T)
文献作者:McGuigan,C.; Sutton,P.W.; Cahard,D.; Turner,K.; O'Leary,G.; Wang,Y.; Gumbleton,M.; De Clercq,E.; Balzarini,J.
参考来源:Antivir Chem Chemother 1998,9(6),473

新产品编号:1455949

Chemical Name: 3-(3-Amidinobenzamido)-4-(4-tert-butylbenzamido)benzoic acid hydrochloride
项目整合开发状态: Preclinical
项目研究机构: Lilly (Originator)
合成路线:Regioselective coupling of methyl 3,4-diaminobe...
参考文献标题:Structure-based design of potent,amidine-derived inhibitors of factor Xa: Evaluation of selectivity,anticoagulant activity,and antithrombotic activity
文献作者:Wiley,M.R.; Weir,L.C.; Briggs,S.; Bryan,N.A.; Buben,J.; Campbell,C.; Chirgadze,N.Y.; Conrad,R.C.; Craft,T.J.; Ficorilli,J.V.; Franciskovich,J.B.; Froelich,L.L.; Gifford-Moore,D.S.; Goodson,T.Jr.; Herron,D.K.; Klimkowski,V.J.; et al.
参考来源:J Med Chem 2000,43(5),883