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

VML-530, ABT-080

Chemical Name: 4,4-Bis[4-(quinolin-2-ylmethoxy)phenyl]pentanoic acid sodium salt
项目整合开发状态: Phase I
项目研究机构: Abbott (Originator), Vernalis (Licensee)
合成路线:Esterification of 4,4-bis(4-hydroxyphe...
参考文献标题:Symmetrical bis-heteroarylmethoxyphenylalkyl carboxylates as inhibitors of leukotriene biosynthesis
文献作者:Brooks,C.D.W.; Bhatia,P.; Kolasa,T.; Stewart,A.O.; Gunn,D.E.; Craig,R.A.(Abbott Laboratories Inc.)
参考来源:EP 0862557; US 5795900; WO 9712867

L-750667-[125I], [125I]-L-750667, L-750667

Chemical Name: 3-[4-(4-[125I]-Iodophenyl)piperazin-1-ylmethyl]-1H-pyrrolo[2,3-b]pyridine
项目整合开发状态: Biological Testing
项目研究机构: Merck Sharp & Dohme (Originator)
合成路线:L-750667 is prepared by con...
参考文献标题:Pyrrolo-pyridine derivs.
文献作者:Baker,R.; Curtis,N.R.; Kulagowski,J.J.; Leeson,P.D.; Ridgill,M.P.; Smith,A.L.(Merck Sharp & Dohme Ltd.)
参考来源:CA 2116213; EP 0623618; JP 1994279442; US 5432177; US 5622950; WO 9420497

ONO-PM-123

Chemical Name: Prostaglandin E1 2-(dodecanoyloxy)ethyl ester
项目整合开发状态: Preclinical
项目研究机构: Ono (Originator)
合成路线:Lauroyl chloride (I) was condensed with ethylene glycol in the presence of pyr...
参考文献标题:Prostaglandin derivs.
文献作者:Nishiura,A.; Seko,T.; Matsumoto,R.; Hamano,S.(Ono Pharmaceutical Co.,Ltd.)
参考来源:EP 0758645; JP 1997110828; US 5690957

HS-1141

Chemical Name: 4-[4-(3-Aminobenzoisoxazol-6-yloxy)butoxy]-N,N-diisopropyl-3-methoxybenzamide
项目整合开发状态: Biological Testing
项目研究机构: Dong-Wha (Originator), Pusan National University (Originator) 参考文献标题:3-Amino-1,2-benzisoxazoles: A new family of potent inhibitors of LTB4 binding to the human neutrophils
文献作者:Suh,H.; et al.
参考来源:Bioorg Med Chem Lett 1997,7(4),389

RPR-110993

Chemical Name: N-Methyl-N-(3-methylphenyl)-N-(1H-pyrazolo[3,4-d]pyrimidin-4-yl)amine
项目整合开发状态: Biological Testing
项目研究机构: Aventis Pharma (Originator)
合成路线:The title compound is prepared by co...
参考文献标题:The synthesis and SAR of new 4-(N-alkyl-N-phenyl)amino-6,7-dimethoxyquinazolines and 4-(N-alkyl-N-phenyl)amino-pyrazolo[3,4-d]pyrimidines,inhibitors of CSF-1R tyrosine kinase activity
文献作者:Spada,A.P.; Setzer,N.N.; Myers,M.R.; et al.
参考来源:Bioorg Med Chem Lett 1997,7(4),421

TA-0201, T-0201

Chemical Name: N-[6-[2-(5-Bromopyridin-2-yloxy)ethoxy]-5-(4-methylphenyl)pyrimidin-4-yl]-4-(2-hydroxy-1,1-dimethylethyl)benzenesulfonamide monosodium salt sesquihydrate
项目整合开发状态: Clinical
项目研究机构...
参考文献标题:Benzenesulfonamide deriv.and process for preparing thereof
文献作者:Yamada,K.; Yasuda,K.; Kikkawa,K.; Kohno,R.(Tanabe Seiyaku Co.,Ltd.)
参考来源:CA 2137953; EP 0658548; JP 1996099961; US 5589478; US 5728706

SM-20550

Chemical Name: N''-(1,4-Dimethyl-1H-indol-2-ylcarbonyl)guanidine mesylate
项目整合开发状态: Preclinical
项目研究机构: Sumitomo Pharmaceuticals (Originator)
合成路线:The methylaion of 4-methyl-1H-indole-2-carbo...
参考文献标题:Indoloylguanidine derivs.as inhibitors of sodium-hydrogen exchange
文献作者:Kojima,A.; Kitano,M.; Miyagishi,A.; Noguchi,T.; Yagi,H.; Nakano,K.; Ohashi,N.(Sumitomo Pharmaceuticals Co.,Ltd.)
参考来源:CA 2121391; EP 0622356; JP 1995010839

AS-8112, AD-8112

Chemical Name: (-)-5-Bromo-N-[1-ethyl-4-methylperhydro-1,4-diazepin-6(R)-yl]-2-methoxy-6-(methylamino)pyridine-3-carboxamide difumarate
项目整合开发状态: Preclinical
项目研究机构: Dainippon Pharmaceutical (Or...
参考文献标题:(R)-5-Bromo-N-(1-ethyl-4-methylhexahydro-1H-1,4-diazepin-6-yl)-2-methoxy-6-methylamino-3-pyridine-carboxamide,process for producing the same and medicinal compsn.containing the same
文献作者:Kato,S.; Hirokawa,Y.; Morie,T.; Harada,H.; Yoshida,N.(Dainippon Pharmaceutical Co.,Ltd.)
参考来源:EP 0855397; JP 1997100276; JP 1997118669; US 5945415; WO 9705129

新产品编号:1115819

Chemical Name: (6R,8aS)-6-Hydroxy-3-methoxy-11-(10-phthalimidodecyl)-5,6,9,10-tetrahydro-4aH-benzofuro[3a,3,2-ef][2]benzazepinium bromide
项目整合开发状态: Biological Testing
项目研究机构: SCRAS (Originator)<...
参考文献标题:Potent acetylcholinesterase inhibitors: Design,synthesis,and structure-activity relationships of bis-interacting ligands in the galanthamine series
文献作者:Mary,A.; Renko,D.Z.; Guillou,C.; Thal,C.
参考来源:Bioorg Med Chem 1998,6(10),1835

新产品编号:1117401

Chemical Name: 2,4-Diamino-6-[N-(3,4,5-trimethoxyphenyl)-N-methylaminomethyl]pyrido[2,3-d]pyrimidine
项目整合开发状态: Biological Testing
项目研究机构: Duquesne University (Originator), Indiana University (Or...
参考文献标题:Derivs.of pyrido [2,3-d] and [3,2-d] pyrimidine and methods of using these derivs.
文献作者:Gangjee,A.(Duquesne University)
参考来源:US 5508281