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

BM-208

Chemical Name: 5-Chloro-N-[2-[4-[2-cyano-3-cyclohexylguanidinosulfonyl)phenyl]ethyl]-2-methoxybenzamide
项目整合开发状态: Biological Testing
项目研究机构: University of Li鑗e (Originator)
合成路线:Reaction of d...
参考文献标题:Synthesis and biological evaluation of sulfonylcyanoguanidines and sulfonamidonitroethylenes as bioisosteres of hypoglycemic sulfonylureas
文献作者:Masereel,B.; et al.
参考来源:Eur J Med Chem 1997,32(5),453-456

新产品编号:1131639

Chemical Name: (?-(2R*,5Z,9S*,10S*,16R*)-9-Acetoxy-10,2,10-(epoxymetheno)-1-benz[c]azacyclododeca-5-ene-3,7-diyne-1-carboxylic acid 4-chlorophenyl ester,mixture with (2R*,5Z,9R*,10S*,16R*)-isomer (2:1...
参考文献标题:Structure-activity relationships of cyclic enediynes related to dynemicin A-I.Synthesis and antitumor activity of 9-acetoxy enediynes equipped with aryl carbamate moieties
文献作者:Unno,R.; Michishita,H.; Inagaki,H.; Suzuki,Y.; Baba,Y.; Jomori,T.; Nishikawa,T.; Isobe,M.
参考来源:Bioorg Med Chem 1997,5(5),883

新产品编号:1133221

Chemical Name: (?-(2R*,5Z,9S*,10S*,16R*)-9-[N-[2-(1-Pyrrolidinyl)ethyl]carbamoyloxy]-10,2,10-(epoxymetheno)-1-benz[b]azacyclododeca-5-ene-3,7-diyne-1-carboxylic acid 4-chlorophenyl ester hydrochloride...
参考文献标题:Synthesis and antitumor activity of water-soluble enediyne compounds related to dynemicin A
文献作者:Unno,R.; Michishita,H.; Inagaki,H.; Suzuki,Y.; Baba,Y.; Jomori,T.; Nishikawa,T.; Isobe,M.
参考来源:Bioorg Med Chem 1997,5(5),987-999

ZK-805412(free base)

Chemical Name: (Z,Z)-2,7-Bis(4-amidinobenzylidene)cycloheptanone trifluoroacetate
项目整合开发状态: Biological Testing
项目研究机构: Berlex (Originator)
合成路线:Aldol condensation of cycloheptanone (I) with t...
参考文献标题:(Z,Z)-2,7-Bis(4-amidinobenzylidene)cycloheptan-1-one: Identification of a highly active inhibitor of blood coagulation factor Xa
文献作者:Shaw,K.J.; Guilford,W.J.; Dallas,J.L.; Koovakkaat,S.K.; McCarrick,M.A.; Liang,A.; Light,D.R.; Morrissey,M.M.
参考来源:J Med Chem 1998,41(19),3551-3556

新产品编号:1134803

Chemical Name: O-(6-Deoxy-alpha-L-galactopyranosyl)-N-(2-tetradecylhexadecanoyl)-D-seryl-L-glutamic acid 1-methylamide
项目整合开发状态: Biological Testing
项目研究机构: Kanebo (Originator)
合成路线:Condensati...
参考文献标题:A stereoselective alpha-fucosylation reaction using 1-hydroxy 2,3,4-tri-O-benzyl-L-fucose donor for the practical synthesis of selectin blocker
文献作者:Kiyoi,T.; Kondo,H.
参考来源:Bioorg Med Chem Lett 1998,8(20),2845

KR-21056

Chemical Name: (1S,5R,6S)-6-[1(R)-Hydroxyethyl]-2-[1(R)-hydroxy-2-methylpropyl]-1-methyl-1-carba-2-penem-3-carboxylic acid 1-(isopropoxycarbonyloxy)ethyl ester
项目整合开发状态: Preclinical
项目研究机构: Kore...
参考文献标题:beta-Methylcarbapenem derivs.,process for the preparation thereof and pharmaceutical compsn.comprising same
文献作者:Lee,C.H.; Lee,D.H.; Kim,K.S.; Kim,J.H.; Kim,Y.S.; Jun,Y.S.; Lim,S.S.; Bae,E.M.; Kim,B.J.(Korea Research Institute of Chemical Technology)
参考来源:EP 1019405; JP 1999500750; US 5869477; WO 9720844

新产品编号:1136385

Chemical Name: N-[3-[3-Fluoro-4-[4-(3-pyridazinyl)piperazin-1-yl]phenyl]-2-oxooxazolidin-5(S)-ylmethyl]acetamide
项目整合开发状态: Biological Testing
项目研究机构: Pfizer (Originator)
合成路线:The condensation...
参考文献标题:Synthesis and antibacterial activity of U-100592 and U-100766,two oxazolidinone antibacterial agents for the potential treatment of multidrug-resistant Gram-positive bacterial infections
文献作者:Hutchinson,D.K.; Brickner,S.J.; Barbachyn,M.R.; Manninen,P.R.; Ulanowicz,D.A.; Garmon,S.A.; Grega,K.C.; Hendges,S.K.; Toops,D.S.; Ford,C.W.; Zurenko,G.E.
参考来源:J Med Chem 1996,39(3),673

新产品编号:1137967

Chemical Name: N-[3-[3-Fluoro-4-[4-(6-methylpyridazin-3-yl)piperazin-1-yl]phenyl]-2-oxooxazolidin-5(S)-ylmethyl]acetamide
项目整合开发状态: Biological Testing
项目研究机构: Pfizer (Originator)
合成路线:The con...
参考文献标题:Synthesis and antibacterial activity of U-100592 and U-100766,two oxazolidinone antibacterial agents for the potential treatment of multidrug-resistant Gram-positive bacterial infections
文献作者:Hutchinson,D.K.; Brickner,S.J.; Barbachyn,M.R.; Manninen,P.R.; Ulanowicz,D.A.; Garmon,S.A.; Grega,K.C.; Hendges,S.K.; Toops,D.S.; Ford,C.W.; Zurenko,G.E.
参考来源:J Med Chem 1996,39(3),673

BMOV

Chemical Name: Bis(maltolato)oxovanadium(IV)
项目整合开发状态: Phase II
项目研究机构: Kinetek (Originator), University of British Columbia (Originator), Gho Pharma (Not Determined)
合成路线:Bis(maltolato)oxova...
参考文献标题:Complexed vanadium for the treatment of diabetes mellitus
文献作者:McNeill,J.H.; Hoveyda,H.R.; Orvig,C.(University of British Columbia)
参考来源:JP 1994511244; US 5300496; WO 9306811

CGS-33090A

Chemical Name: 2(R)-[4-Ethoxy-N-(4-pyridylmethyl)phenylsulfonamido]-2-(trans-4-propoxycyclohexyl)acetohydroxamic acid hydrochloride
项目整合开发状态: Preclinical
项目研究机构: Novartis (Originator)
合成路线:Hy...
参考文献标题:alpha-Substd.arylsulphonamido hydroxamic acids as TNF-alpha and matrix metalloproteinase inhibitors
文献作者:Parker,D.T.(Novartis AG)
参考来源:EP 0873312; JP 2000502088; US 5770624; WO 9722587