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

VRC-4219

Chemical Name: 2-[2-[3(S),6-Diamino-5(R)-fluorohexanoyl]-1-methylhydrazino]acetic acid; 3(S),6-Diamino-5(R)-fluorohexanoic acid 2-(carboxymethyl)-2-methylhydrazide
项目整合开发状态: Preclinical
项目研究机构:...
参考文献标题:Fluorinated deoxynegamycin analogs: Synthesis and antimicrobial properties
文献作者:Raju,B.; Anandan,S.K.; Gu,S.; et al.
参考来源:42nd Intersci Conf Antimicrob Agents Chemother (Sept 27 2002,San Diego) 2002,Abst F-1686

RWJ-415667

Chemical Name: 11-Amino-13-deethyl-11-deoxy-3-des(hexopyranosyloxy)-3-oxo-13-propyl-6-O-[3-(6-quinoxalinyl)-2(E)-propenyl]erythromycin A 11-N,12-O-cyclic carbamate
项目整合开发状态: Preclinical
项目研究机构: ...
参考文献标题:Structure-antibacterial activty relationships of ketolides derived from 15-methylerythromycin A
文献作者:Macielag,M.; et al.
参考来源:41st Intersci Conf Antimicrob Agents Chemother (Dec 16 2001,Chicago) 2001,Abst F-1174

NVP-ABE-171

Chemical Name: 4-[8-(2,1,3-Benzoxadiazol-5-yl)-1,7-naphthyridin-6-yl]benzoic acid
项目整合开发状态: Preclinical
项目研究机构: Novartis (Originator)
合成路线:Reaction of 3-(cyanomethyl)pyridine-N-oxide (I) with...
参考文献标题:Naphtyridine derivs.
文献作者:Hersperger,R.(Novartis AG)
参考来源:EP 0934320; US 6136821; WO 9818796

新产品编号:2125135

Chemical Name: 3beta-(3-Carboxy-3-methylbutyryloxy)oleanan-28-oic acid
项目整合开发状态: Biological Testing
项目研究机构: Biotech Research Laboratories (Originator), Chinese Academy of Sciences (Originator), ...
参考文献标题:Synthesis and anti-HIV activity of oleanolic acid derivatives
文献作者:Zhu,Y.-M.; Shen,J.-K.; Wang,H.-K.; Cosentino,L.M.; Lee,K.-H.
参考来源:Bioorg Med Chem Lett 2001,11(24),3115

SM-197436

Chemical Name: (1R,5S,6S)-2-[4-(2,5-Dihydro-1H-pyrrol-3-yl)thiazol-2-ylsulfanyl]-6-[1(R)-hydroxyethyl]-1-methyl-1-carba-2-penem-3-carboxylic acid
项目整合开发状态: Preclinical
项目研究机构: Roche (Originator)...
参考文献标题:New anti-MRSA and anti-VRE carbapenems; synthesis and structure-activity relationships of 1beta-methyl-2-(thiazol-2-ylthio)carbapenems
文献作者:Sunagawa,M.; Itoh,M.; Kubota,K.; Sasaki,A.; Ueda,Y.; Angehrn,P.; Bourson,A.; Goetschi,E.; Hebeisen,P.; Then,R.L.
参考来源:J.Antibiot.2002,55(8),722

新产品编号:2126717

Chemical Name: 2,3-Dimethoxy-6-propyl-12H-[1,3]dioxolo[5,6]indeno[1,2-c]isoquinolin-6-ium chloride
项目整合开发状态: Preclinical
项目研究机构: National Cancer Institute (Originator), Purdue University (Origin...
参考文献标题:Synthesis of new dihydroindeno[1,2-c]isoquinoline and indenoisoquinolinium chloride topoisomerase I inhibitor having high in vivo anticancer activity in the hollow fiber animal model
文献作者:Jayaraman,M.; Fox,B.M.; Hollingshead,M.; Kohlhagen,G.; Pommier,Y.; Cushman,M.
参考来源:J Med Chem 2002,45(1),242

新产品编号:2128299

Chemical Name: 5-[3-(2,4-Diaminopyrimidin-5-ylmethyl)-4-methoxyphenoxy]pentanoic acid
项目整合开发状态: Biological Testing
项目研究机构: Harvard Medical School (Originator)
合成路线:Protection of 4-methoxyphen...
参考文献标题:Inhibition of Pneumocystis carinii,Toxoplasma gondii,and Mycobacterium avium dihydrofolate reductases by 2,4-diamino-5-[2-methoxy-5-(omega-carboxyalkyloxy)benzyl]pyrimidines: Marked improvement in potency relative to trimethoprim and species selectivity
文献作者:Rosowsky,A.; Forsch,R.A.; Queener,S.F.
参考来源:J Med Chem 2002,45(1),233

新产品编号:2129881

Chemical Name: (-)-2-[1(S)-(Biphenyl-2-yloxy)ethyl]-4,5-dihydro-1H-imidazole oxalate
项目整合开发状态: Preclinical
项目研究机构: Universit?degli Studi di Bari (Originator), Universit?degli Studi di Camerino (...
参考文献标题:alpha-Adrenoceptors profile modulation and high antinociceptive activity of (S)-(-)-2-[1-(biphenyl-2-yloxy)ethyl]-4,5-dihydro-1H-imidazole
文献作者:Gentili,F.; Bousquet,P.; Brasili,L.; Caretto,M.; Carrieri,A.; Dontenwill,M.; Giannella,M.; Marucci,G.; Perfumi,M.; Piergentili,A.; Quaglia,W.; Rascente,C.; Pigini,M.
参考来源:J Med Chem 2002,45(1),32

新产品编号:2131463

Chemical Name: 6-(2,6-Difluorobenzyl)-2-(isopropylamino)-5-methylpyrimidin-4(3H)-one
项目整合开发状态: Biological Testing
项目研究机构:
合成路线:The condensation of 2-(2,6-difluorophenyl)acetic acid (I) with ...
参考文献标题:Selected non-nucleoside reverse transcriptase inhibitors (NNRTIs): the DABOs family
文献作者:Artico,M.
参考来源:Drugs Fut 2002,27(2),159

新产品编号:2133045

Chemical Name: 6-(2,6-Difluorobenzyl)-2-(N-isopropyl-N-methylamino)-5-methylpyrimidin-4(3H)-one
项目整合开发状态: Biological Testing
项目研究机构:
合成路线:The condensation of 2-(2,6-difluorophenyl)acetic aci...
参考文献标题:Selected non-nucleoside reverse transcriptase inhibitors (NNRTIs): the DABOs family
文献作者:Artico,M.
参考来源:Drugs Fut 2002,27(2),159