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:2091913

Chemical Name: 5-(2-Bromo-9H-fluoren-9-ylamino)-2-(3,4-dimethoxyphenyl)-2-isopropylpentanenitrile hydrochloride
项目整合开发状态: Biological Testing
项目研究机构: Universit?degli Studi di Bologna (Originator)...
参考文献标题:Design,synthesis,and in vitro activity of catamphiphilic reverters of multidrug resistance: Discovery of a selective,highly efficacious chemosensitizer with potency in the nanomolar range
文献作者:Teodori,E.; Dei,S.; Quidu,P.; Budriesi,R.; Chiarini,A.; Garnier-Suillerot,A.; Gualtieri,F.; Manetti,D.; Romanelli,M.N.; Scapecchi,S.
参考来源:J Med Chem 1999,42(10),1687

新产品编号:2093495

Chemical Name: 1-Acetyl-3-benzyl-5-methyl-2-thioxoimidazolidin-4-one
项目整合开发状态: Preclinical
项目研究机构: National Institutes of Health (Originator), University of Houston (Originator), University of N...
参考文献标题:Functionalized amino acid anticonvulsants: Synthesis and pharmacological evaluation of conformationally restricted analogues
文献作者:Le Tiran,A.; Stables,J.P.; Kohn,H.
参考来源:Bioorg Med Chem 2001,9(10),2693

AGN-195183

Chemical Name: 4-(4-Chloro-3-hydroxy-5,5,8,8-tetramethyl-5,6,7,8-tetrahydronaphthalen-2-ylcarboxamido)-2,6-difluorobenzoic acid
项目整合开发状态: Phase I/II
项目研究机构: Allergan (Originator)

PS-26

Chemical Name: 1-[3-(3,4-Dichlorophenoxy)propoxy]-5-isopropylbiguanide dihydrochloride
项目整合开发状态: Preclinical
项目研究机构: Jacobus (Originator)
合成路线:The reaction of 3,4-dichlorophenol (I) with 1,3-...
参考文献标题:Phenoxypropoxybiguanides,prodrugs of DHFR-inhibiting diaminotriazine antimalarials
文献作者:Jensen,N.P.; Ager,A.L.; Bliss,R.A.; Canfield,C.J.; Kotecka,B.M.; Rieckmann,K.H.; Terpinski,J.; Jacobus,D.P.
参考来源:J Med Chem 2001,44(23),3925

新产品编号:2095077

Chemical Name: 4-(6-Chloropyridazin-3-yl)-1,1-dimethylpiperazin-1-ium iodide
项目整合开发状态: Preclinical
项目研究机构: Universit?degli Studi di Firenze (Originator), Universit?di Ferrara (Originator)
合成路...
参考文献标题:Structure-affinity relationships of a unique nicotinic ligand: N1-dimethyl-N4-phenylpiperazinium iodide (DMPP)
文献作者:Romanelli,M.N.; Manetti,D.; Scapecchi,S.; Borea,P.A.; Dei,S.; Bartolini,A.; Ghelardini,C.; Gualtieri,F.; Guandalini,L.; Varani,K.
参考来源:J Med Chem 2001,44(23),3946

新产品编号:2096659

Chemical Name: (1S,2R,6S,11aS,13S,14aR)-1,13-Dihydroxy-2-[2(S)-hydroxypropyl-[S(S)]-sulfinyl]-6-methyl-2,3,4,6,7,8,9,11a,12,13,14,14a-dodecahydro-1H-cyclopenta[f]oxacyclotridecin-4-one
项目整合开发状态: Bi...
参考文献标题:Preparation and evaluation of sulfide derivatives of the antibiotic brefeldin A as potential prodrug candidates with enhanced aqueous solubilities
文献作者:Fox,B.M.; Vroman,J.A.; Fanwick,P.E.; Cushman,M.
参考来源:J Med Chem 2001,44(23),3915

DDE-934

Chemical Name: N-[2-(5-Bromothien-2-yl)ethyl]-N'-(5-chloropyridin-2-yl)thiourea
项目整合开发状态: Biological Testing
项目研究机构: Parker Hughes Institute (Originator)
合成路线:2-(2-Thienyl)ethylamine (I) was ...
参考文献标题:Regiospecific synthesis,X-ray crystal structure and biological activities of 5-bromothiophenethyl thioureas
文献作者:Uckun,F.M.; Sudbeck,E.A.; Venkatachalam,T.K.
参考来源:Tetrahedron Lett 2001,42(38),6629

SPI-339, NEO-339

Chemical Name: 4-[3-(4-Oxo-4,5,6,7-tetrahydro-1H-indol-1-yl)propionamido]benzoic acid ethyl ester
项目整合开发状态: Preclinical
项目研究机构: Spectrum Pharmaceuticals (Originator)
合成路线:The reaction of 4-am...
参考文献标题:Synthesis and methods of use of tetrahydroisoindolone analogues and derivs.
文献作者:Foreman,M.M.; Glasky,A.J.; Fick,D.B.(Spectrum Pharmaceuticals,Inc.)
参考来源:EP 1383742; WO 0285856

新产品编号:2098241

Chemical Name: 5-[2-[4-(1H-Imidazol-1-ylmethyl)phenoxy]ethoxy]-2,3-diphenylpyrazine
项目整合开发状态: Preclinical
项目研究机构: SSP (Originator)
合成路线:Alkylation of 5,6-diphenyl-2-pyrazinol (I) with mesylat...
参考文献标题:Imidazole derivs.or salts thereof and drugs containing the derivs.or the salts
文献作者:Takeda,S.; Sato,S.; Takahashi,Y.; Nagao,Y.; Konno,F.; Ohtsuka,M.; Isomae,K.; Honda,H.; Hirota,H.; Kawamoto,N.; Ishii,F.(SSP Co.,Ltd.)
参考来源:EP 1295880; WO 0200648

新产品编号:2099823

Chemical Name: 6-Amino-9-benzyl-2-butyl-9H-purin-8-ol
项目整合开发状态: Preclinical
项目研究机构: Japan Energy (Originator), Sumitomo Pharmaceuticals (Originator)
合成路线:The alkylation of 5-amino-1H-imidazol...
参考文献标题:Synthesis and structure-activity relationship of IFN inducer,8-hydroxyadenine - Optimization of 2-substituted groups of adenine
文献作者:Ogita,H.; et al.
参考来源:21st Symp Med Chem (Nov 28 2001,Kyoto) 2001,Abst 1P-11