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

NO-prednisolone, NCX-1015

Chemical Name: 11beta,17alpha-Dihydroxy-21-[4-(nitrooxymethyl)benzoyloxy]pregna-1,4-diene-3,20-dione
项目整合开发状态: Phase I
项目研究机构: NicOx (Originator), William Harvey Research Institute (Originator)<...
参考文献标题:New corticosteroids
文献作者:Del Soldato,P.; Ongini,E.(NicOx SA)
参考来源:WO 0364443

MLN-576, XR-11576

Chemical Name: N-[2-(Dimethylamino)-1(R)-methylethyl]-4-methoxybenzo[a]phenazine-11-carboxamide
项目整合开发状态: Phase I
项目研究机构: Xenova (Originator), Millennium (Licensee)
合成路线:The oxidation of 5-me...
参考文献标题:Benzo[a]phenazin-11-carboxamide derivs.and their use as joint inhibitors of topomerase I and II
文献作者:Vicker,N.; Folkes,A.J.; Wang,S.; Milton,J.; Denny,W.A.(Xenova Group plc)
参考来源:WO 0146157

FDPCICM

Chemical Name: 21-Chloro-9alpha-fluoro-11beta-hydroxy-3,20-dioxo-1,4-pregnadiene-16alpha-carboxylic acid methyl ester
项目整合开发状态: Preclinical
项目研究机构: Florida A&M University (Originator)
合成路线:Th...
参考文献标题:New steroidal anti-inflammatory antedrugs: methyl 21-desoxy-21-chloro-11beta,17alpha-dihydroxy-3,20-dioxo-1,4-pregnadiene-16alpha-carboxylate,methyl 21-desoxy-21-chloro-11beta-hydroxy-3,20-dioxo-1,4-pregnadiene-16alpha-carboxylate,and their 9alpha-fluor
文献作者:Ko,D.H.; Heiman,A.S.; Chen,M.; Lee,H.J.
参考来源:Steroids 2000,65(4),210

新产品编号:1846703

Chemical Name: N-[4-(2-Oxo-2,3-dihydro-1H-benzimidazol-1-yl)piperidin-1-ylcarbonyl]-D-(benzo[b]thiophen-3-yl)alanyl-L-lysine tert-butyl ester hydrochloride
项目整合开发状态: Biological Testing
项目研究机构: M...
参考文献标题:Novel isoxazoline and isoxazole fibrinogen receptor antagonists
文献作者:Wityak,J.; Xue,C.-B.; Sielecki-Dzurdz,T.M.; Olson,R.E.; Degrado,W.F.; Cain,G.A.(DuPont Pharmaceuticals Co.)
参考来源:EP 0730590; EP 0832076; JP 1997505590; JP 1999504651; US 5849736; WO 9514683; WO 9638426

BPDZ-83

Chemical Name: 7-Chloro-3-(1,2,2-trimethylpropylamino)-4H-pyrido[2,3-e][1,2,4]thiadiazine 1,1-dioxide
项目整合开发状态: Preclinical
项目研究机构: Universit?Libre de Bruxelles (Originator), University of Li鑗e ...
参考文献标题:3-Alkylamino-4H-pyrido[2,3-e]-1,2,4-thiadiazine 1,1-dioxides structurally related to diazoxide and pinacidil as potassium channel openers acting on vascular smooth muscle cells: Design,synthesis,and pharmacological evaluation
文献作者:Pirotte,B.; Quedraogo,R.; de Tullio,P.; Khelili,S.; Somers,F.; Boverie,S.; Dupont,L.; Fontaine,J.; Damas,J.; Lebrun,P.
参考来源:J Med Chem 2000,43(8),1456

新产品编号:1848285

Chemical Name: 2-(6-Methoxy-2-naphthyl)propionic acid 2-[2-(4-methyl-1-piperazinyl)acetoxy]ethyl ester
项目整合开发状态: Preclinical
项目研究机构: University of Kuopio (Originator)
合成路线:The hydroxyethyl es...
参考文献标题:Synthesis and in vitro evaluation of novel morpholinyl- and methylpiperazinylacyloxyalkyl prodrugs of 2-(6-methoxy-2-naphthyl)propionic acid (naproxen) for topical drug delivery
文献作者:Rautio,J.; Nevalainen,T.; Taipale,H.; Vepsalainen,J.; Gynther,J.; Laine,K.; Jarvinen,T.
参考来源:J Med Chem 2000,43(8),1489

新产品编号:1849867

Chemical Name: 4-[2-Amino-1(R)-hydroxyethyl]-3-fluorobenzene-1,2-diol oxalate
项目整合开发状态: Biological Testing
项目研究机构: National Institutes of Health (Originator), Westf鋖ische Wilhelms-Univ. M黱ster (...
参考文献标题:Syntheses of (R)- an (S)-2- and 6-fluoronorepinephrine and (R)- and (S)-2- and 6-fluoroepinephrine: Effect of stereochemistry on fluorine-induced adrenergic selectivities
文献作者:Lu,S.; Herbert,B.; Haufe,G.; Wilhelm Laue,K.; Padgett,W.L.; Oskunleti,O.; Daly,J.W.; Kirk,K.L.
参考来源:J Med Chem 2000,43(8),1611

新产品编号:1851449

Chemical Name: 4-[2-Amino-1(S)-hydroxyethyl]-3-fluorobenzene-1,2-diol oxalate
项目整合开发状态: Biological Testing
项目研究机构: National Institutes of Health (Originator), Westf鋖ische Wilhelms-Univ. M黱ster (...
参考文献标题:Syntheses of (R)- an (S)-2- and 6-fluoronorepinephrine and (R)- and (S)-2- and 6-fluoroepinephrine: Effect of stereochemistry on fluorine-induced adrenergic selectivities
文献作者:Lu,S.; Herbert,B.; Haufe,G.; Wilhelm Laue,K.; Padgett,W.L.; Oskunleti,O.; Daly,J.W.; Kirk,K.L.
参考来源:J Med Chem 2000,43(8),1611

新产品编号:1853031

Chemical Name: 4-[2-Amino-1(R)-hydroxyethyl]-5-fluorobenzene-1,2-diol oxalate
项目整合开发状态: Biological Testing
项目研究机构: National Institutes of Health (Originator), Westf鋖ische Wilhelms-Univ. M黱ster (...
参考文献标题:Syntheses of (R)- an (S)-2- and 6-fluoronorepinephrine and (R)- and (S)-2- and 6-fluoroepinephrine: Effect of stereochemistry on fluorine-induced adrenergic selectivities
文献作者:Lu,S.; Herbert,B.; Haufe,G.; Wilhelm Laue,K.; Padgett,W.L.; Oskunleti,O.; Daly,J.W.; Kirk,K.L.
参考来源:J Med Chem 2000,43(8),1611

新产品编号:1854613

Chemical Name: 4-[2-Amino-1(S)-hydroxyethyl]-5-fluorobenzene-1,2-diol oxalate
项目整合开发状态: Biological Testing
项目研究机构: National Institutes of Health (Originator), Westf鋖ische Wilhelms-Univ. M黱ster (...
参考文献标题:Syntheses of (R)- an (S)-2- and 6-fluoronorepinephrine and (R)- and (S)-2- and 6-fluoroepinephrine: Effect of stereochemistry on fluorine-induced adrenergic selectivities
文献作者:Lu,S.; Herbert,B.; Haufe,G.; Wilhelm Laue,K.; Padgett,W.L.; Oskunleti,O.; Daly,J.W.; Kirk,K.L.
参考来源:J Med Chem 2000,43(8),1611