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

PNU-172576

Chemical Name: N-[3-[4-(4-Cyano-1H-pyrazol-1-yl)-3-fluorophenyl]-2-oxo-1,3-oxazolidin-5(S)-ylmethyl]acetamide
项目整合开发状态: Preclinical
项目研究机构: Pfizer (Originator)
合成路线:Treatment of 3,4-difluoron...
参考文献标题:Substituent effects on the antibacterial activity of novel highly potent nitrogen-bound azolylphenyl oxazolidinones
文献作者:Genin,M.J.; et al.
参考来源:38th Intersci Conf Antimicrob Agents Chemother (Sept 24 1998,San Diego) 1998,Abst F-138

J-111347

Chemical Name: (1R,5S,6S)-2-[5(R)-[4-(Aminomethyl)phenyl]pyrrolidinyl-3(S)-ylsulfanyl]-6-[1(R)-hydroxyethyl]-1-methyl-1-carbapen-2-em-3-carboxylic acid hydrochloride
项目整合开发状态: Preclinical
项目研究机构...
参考文献标题:Carbapenem derivs.
文献作者:Ushijima,R.; Sugimoto,Y.; Shimizu,A.; Kiyonaga,H.; Nagano,R.; Nakagawa,S.; Sakuraba,S.; Sato,H.; Hashizume,T.; Nakano,M.; Imamura,H.; Fukatsu,H.(Banyu Pharmaceutical Co.,Ltd.)
参考来源:EP 1048669; JP 2000143512; WO 9931106

A-170568(free base), A-170568.1

Chemical Name: 1-Cyclopropyl-7-fluoro-9-methyl-8-[7(S)-(methylamino)-5-azaspiro[2.4]hept-5-yl]-4-oxo-4H-quinolizine-3-carboxylic acid hydrochloride
项目整合开发状态: Preclinical
项目研究机构: Abbott (Originat...
参考文献标题:Pyridone antibiotic with improved safety profile
文献作者:Or,Y.S.; Armiger,Y.-L.; Fung,A.(Abbott Laboratories Inc.)
参考来源:US 5977133; WO 0010998

ONO-8713

Chemical Name: 3-[4-[2-[N-(2-Furylsulfonyl)-N-isobutylamino]-5-(trifluoromethyl)phenoxymethyl]phenyl]-2(E)-propenoic acid
项目整合开发状态: Preclinical
项目研究机构: Ono (Originator)
合成路线:The condensation ...
参考文献标题:Sulfonamide and carboxamide derivs.and drugs containing the same as the active ingredient
文献作者:Nagao,Y.; Ohuchida,S.(Ono Pharmaceutical Co.,Ltd.)
参考来源:EP 0947500; WO 9827053

J-111225

Chemical Name: (1R,5S,6S)-2-[5(R)-[4-(Methylaminomethyl)phenyl]pyrrolidinyl-3(S)-ylsulfanyl]-6-[1(R)-hydroxyethyl]-1-methyl-1-carbapen-2-em-3-carboxylic acid dihydrochloride
项目整合开发状态: Preclinical 参考文献标题:Carbapenem derivs.
文献作者:Ushijima,R.; Sugimoto,Y.; Shimizu,A.; Kiyonaga,H.; Nagano,R.; Nakagawa,S.; Sakuraba,S.; Sato,H.; Hashizume,T.; Nakano,M.; Imamura,H.; Fukatsu,H.(Banyu Pharmaceutical Co.,Ltd.)
参考来源:EP 1048669; JP 2000143512; WO 9931106

J-114870

Chemical Name: (1R,5S,6S)-2-[5(R)-[4-[1(S),3-Diamino-3-oxopropyl]phenyl]pyrrolidin-3(S)-ylsulfanyl]-6-[1(R)-hydroxyethyl]-1-methyl-1-carbapen-2-em-3-carboxylic acid hydrochloride
项目整合开发状态: Preclini...
参考文献标题:Carbapenem derivs.
文献作者:Ushijima,R.; Sugimoto,Y.; Shimizu,A.; Kiyonaga,H.; Nagano,R.; Nakagawa,S.; Sakuraba,S.; Sato,H.; Hashizume,T.; Nakano,M.; Imamura,H.; Fukatsu,H.(Banyu Pharmaceutical Co.,Ltd.)
参考来源:EP 1048669; JP 2000143512; WO 9931106

J-114871

Chemical Name: (1R,5S,6S)-2-[5(R)-[4-[1(R),3-Diamino-3-oxopropyl]phenyl]pyrrolidin-3(S)-ylsulfanyl]-6-[1(R)-hydroxyethyl]-1-methyl-1-carbapen-2-em-3-carboxylic acid hydrochloride
项目整合开发状态: Preclini...
参考文献标题:Carbapenem derivs.
文献作者:Ushijima,R.; Sugimoto,Y.; Shimizu,A.; Kiyonaga,H.; Nagano,R.; Nakagawa,S.; Sakuraba,S.; Sato,H.; Hashizume,T.; Nakano,M.; Imamura,H.; Fukatsu,H.(Banyu Pharmaceutical Co.,Ltd.)
参考来源:EP 1048669; JP 2000143512; WO 9931106

BAL-5788, Ro-65-5788/001, Ro-65-5788

Chemical Name: (6R,7R)-7-[2-(5-Amino-1,2,4-thiadiazol-3-yl)-2(Z)-(hydroxyimino)acetamido]-3-[(E)-1-[1-(5-methyl-2-oxo-1,3-dioxol-4-ylmethoxycarbonyl)pyrrolidin-3(R)-yl]-2-oxopyrrolidin-3-ylidenemethyl...
参考文献标题:Vinyl pyrrolidine cephalosporins with basic substitutents
文献作者:Page,M.; Hebeisen,P.; Angehrn,P.; Heinze-Krauss,I.; Runtz,V.(F.Hoffmann-La Roche AG)
参考来源:EP 0849269; US 5981519

2F-TE-802, A-241550

Chemical Name: 11-Amino-9-deoxo-11-deoxy-3-des(cladinosyloxy)-2-fluoro-9-N,11-N-ethylene-9-imino-6-O-methyl-3-oxoerythromicin A 11-N,12-O-cyclic carbamate
项目整合开发状态: Preclinical
项目研究机构: Abbott (O...
参考文献标题:2-Substituted tricyclic ketolides: New antibacterial macrolides - Synthesis and biological activity
文献作者:Phan,L.T.; Blair,K.; Bergeron,J.; et al.
参考来源:38th Intersci Conf Antimicrob Agents Chemother (Sept 24 1998,San Diego) 1998,Abst F-127

PNU-171933

Chemical Name: N-[3-[4-(4-Cyano-1H-pyrrol-1-yl)-3-fluorophenyl]-2-oxooxazolidin-5(S)-ylmethyl]acetamide
项目整合开发状态: Preclinical
项目研究机构: Pfizer (Originator)
合成路线:Treatment of 3,4-difluoronitrobe...
参考文献标题:Substituent effects on the antibacterial activity of novel highly potent nitrogen-bound azolylphenyl oxazolidinones
文献作者:Genin,M.J.; et al.
参考来源:38th Intersci Conf Antimicrob Agents Chemother (Sept 24 1998,San Diego) 1998,Abst F-138