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:2300737

Chemical Name: N-[4-[3-(1-Methyl-1H-pyrrol-2-yl)-1-(2-phenoxybutyryl)-4,5-dihydro-1H-pyrazol-5-yl]phenyl]acetamide
项目整合开发状态: Preclinical
项目研究机构: AstraZeneca (Originator)
合成路线:Aldol condensati...
参考文献标题:N-Substituted 2-pyrazolines are opioid receptor ligands
文献作者:Semple,G.; et al.
参考来源:223rd ACS Natl Meet (April 7 2002,Orlando) 2002,Abst MEDI 43

新产品编号:2302319

Chemical Name: N-(Benzyloxycarbonyl)-L-valyl-N1-[4-[4-[(5R,5aR,8aR,9S)-9-[(2R,4aR,6R,7R,8R,8aS)-7,8-dihydroxy-2-methylperhydropyrano[3,2-d][1,3]dioxin-6-yloxy]-6-oxo-5,5a,6,8,8a,9-hexahydrofuro[3',4':...
参考文献标题:Protease-mediated fragmentation of p-amidobenzyl ethers: A new strategy for the activation of anticancer prodrugs
文献作者:Toki,B.E.; Cerveny,C.G.; Wahl,A.F.; Senter,P.D.
参考来源:J Org Chem 2002,67(6),1866

AMCPy

Chemical Name: 1-Acetoxy-2,2,5,5-tetramethylpyrrolidine-3-carboxylic acid methyl ester
项目整合开发状态: Preclinical
项目研究机构: National Institutes of Health (Originator)
合成路线:Bubbling dry HCl through a...
参考文献标题:Acyl-protected hydroxylamines as spin label generators for EPR brain imaging
文献作者:Yordanov,A.T.; Yamada,K.-i.; Krishna,M.C.; Russo,A.; Yoo,J.; English,S.; Mitchell,J.B.; Brechbiel,M.W.
参考来源:J Med Chem 2002,45(11),2283

新产品编号:2303901

Chemical Name: N-[4-[2-(2-Amino-4-ethyl-7H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid
项目整合开发状态: Biological Testing
项目研究机构: Duquesne University (Originator), Tufts University (Or...
参考文献标题:Design,synthesis,and biological activities of classical N-[4-[2-(2-amino-4-ethylpyrrolo[2,3-d]pyrimidin-5-yl)ethyl] benzoyl]-L-glutamic acid and its 6-methyl derivative as potential dual inhibitors of thymidylate synthase and dihydrofolate reductase and
文献作者:Gangjee,A.; Yu,J.; Kisliuk,R.L.; Haile,W.H.; Sobrero,G.; McGuire,J.J.
参考来源:J Med Chem 2003,46(4),591

新产品编号:2305483

Chemical Name: 3-(O-Methylpolyethyleneglycol)propionic acid 3-(1-methyl-1H-indol-3-yl)-4-(1-methyl-6-nitro-1H-indol-3-yl)-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-ylmethyl ester
项目整合开发状态: Preclinical
项...
参考文献标题:A water soluble prodrug for Ro 31-7453 suitable for both oral delivery and continuous infusion
文献作者:Liu,E.A.; et al.
参考来源:Proc Am Assoc Cancer Res 2002,43Abst 1040

新产品编号:2307065

Chemical Name: 1-[N-[2(R)-(N-Hydroxycarbamoylmethyl)heptanoyl]-L-valylamino]-L-proline methyl ester
项目整合开发状态: Biological Testing
项目研究机构: Memorial Sloan-Kettering Cancer Center (Originator)
合成...
参考文献标题:Asymmetric solid phase and solution parallel synthesis and antitumor properties of actinonin analogs
文献作者:Borella,C.; et al.
参考来源:Proc Am Assoc Cancer Res 2002,43

新产品编号:2308647

Chemical Name: 3-(2-Benzyl-10-hydroxy-5-oxo-2,3,4,5-tetrahydro-1H-1-benzopyran[4,3-c]pyridin-8-yl)butyric acid ethyl ester
项目整合开发状态: Preclinical
项目研究机构: Kos Pharmaceuticals (Originator), Univers...
参考文献标题:Soft cannabinoid analogues as potential anti-glaucoma agents
文献作者:Buchwald,A.; Derendorf,H.; Ji,F.; Nagaraja,N.Y.; Wu,W.M.; Bodor,N.
参考来源:Pharmazie 2002,57(2),108

NOBEX-AA-004, NAA-004, APAZA

Chemical Name: 5-[4-(Carboxymethyl)phenyldiazenyl]-2-hydroxybenzoic acid
项目整合开发状态: Phase I
项目研究机构: Nobex (Originator)
合成路线:The diazotization of 2-(4-aminophenyl)acetic acid (I) by means of Na...
参考文献标题:Immunoregulatory cpds.and derivs.and methods of treating diseases therewith
文献作者:Ekwuribe,N.N.; Riggs-Sauthier,J.(Nobex Corp.)
参考来源:WO 0218324

新产品编号:2310229

Chemical Name: trans,trans-1-[1-Phenyl-3-(1H-pyrrol-1-yl)-2,3-dihydro-1H-inden-2-yl]-1-(pyrrolidin-1-yl)methanone
项目整合开发状态: Preclinical
项目研究机构: Sanofi-Synth閘abo (Originator)
合成路线:3-Phenylinda...
参考文献标题:Synthesis of a novel class of non-peptide NK-2 receptor ligand,derived from 1-phenyl-3-pyrrol-1-ylidan-2-carboxamides
文献作者:Guillon,J.; Dallemagne,P.; L間er,J.-M.; Sopkova,J.; Bovy,P.R.; Jarry,C.; Rault,S.
参考来源:Bioorg Med Chem 2002,10(4),1043

新产品编号:2311811

Chemical Name: 2,2-Dimethylpropionic acid 3-[2-[4-(2-aminoethoxy)-3-methoxyphenyl]acetamido]-2-(3,4-dimethylbenzyl)propyl ester
项目整合开发状态: Preclinical
项目研究机构: AmorePacific (Originator), National ...
参考文献标题:Phenolic modification as an approach to improve the pharmacology of the 3-acyloxy-2-benzylpropyl homovanillic amides and thioureas,a promising class of vanilloid receptor agonists and analgesics
文献作者:Lee,J.; Kang,M.-S.; Kim,K.-P.; Chung,S.-J.; Blumberg,P.M.; Yi,J.-B.; Park,Y.H.
参考来源:Bioorg Med Chem 2002,10(4),1171