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

BH-1625(NOMe)TB-2

Chemical Name: (+)-1alpha-Hydroxy-26-(methoxyimino)-26,26,26-trimethyl-27-norvitamin D3
项目整合开发状态: Preclinical
项目研究机构: Johns Hopkins University (Originator), M.D. Anderson Cancer Center (Originat...
参考文献标题:Conceptually new low-calcemic oxime analogues of the hormone 1alpha,25-dihydroxyvitamin D3: Synthesis and biological testing
文献作者:Posner,G.H.; Halford,B.A.; Peleg,S.; Dolan,P.; Kensler,T.W.
参考来源:J Med Chem 2002,45(8),1723

新产品编号:2294409

Chemical Name: N-[3-(4-Chlorophenyl)-3-(2-pyridyl)propyl]-4-(1H-imidazol-4-ylmethyl)benzamidine
项目整合开发状态: Preclinical
项目研究机构: Schering-Plough (Originator)
合成路线:The unsaturated nitrile (III) i...
参考文献标题:Design and synthesis of novel dual histamine H1/H3 receptor antagonists based on the H1 receptor antagonist chlorpheniramine
文献作者:Tom,W.; Aslanian,R.; West,R.; Shih,N.-Y.; Piwinski,J.J.; She,S.; Williams,S.M.
参考来源:223rd ACS Natl Meet (April 7 2002,Orlando) 2002,Abst MEDI 63

新产品编号:2295991

Chemical Name: N-[4-[(6aS)-2-Chloro-5,6,6a,7,8,9,10,12-octahydro-7,10-methanopyrido[2,1-c][1,4]benzodiazepin-5-ylcarbonyl]phenyl]-4'-methylbiphenyl-2-carboxamide
项目整合开发状态: Preclinical
项目研究机构: Jo...
参考文献标题:Structurally novel V2-selective and dual V1A/V2 vasopressin receptor antagonists
文献作者:Dyatkin,A.B.; Demarest,K.; Look,R.; Maryanoff,B.E.; Hoekstra,W.J.; Gunnet,J.; Andrade-Gordon,P.; DeGaravilla,L.; Hlasta,D.J.
参考来源:223rd ACS Natl Meet (April 7 2002,Orlando) 2002,Abst MEDI 35

DB-51838

Chemical Name: 5-(4-Methylpiperazin-1-ylcarbonyl)-3-[5-nitro-1,3-dioxo-1H-benzo[de]isoquinolin-2(3H)-yl]-N-[2-[2-[5-nitro-1,3-dioxo-1H-benzo[de]isoquinolin-2(3H)-yl]ethylamino]ethyl]benzamide
项目整合开...
参考文献标题:Naphthalimidobenzamide derivs.
文献作者:Suzuki,K.; Yamada,Y.; Asao,T.; Noguchi,K.; Wakida,M.(Taiho Pharmaceutical Co.,Ltd.)
参考来源:EP 1020446; US 6300331; WO 0001672

Adamantyl-SNO, NMI-1165

Chemical Name: N,N-Dimethyl-2-[2-(nitrososulfanyl)adamant-2-yl]acetamide
项目整合开发状态: Preclinical
项目研究机构: NitroMed (Originator)
合成路线:Paclitaxel (I) is selectively protected at the side-chain hyd...
参考文献标题:Design and synthesis of nitrosylated paclitaxel (NO-paclitaxel) and adamantanyl nitric oxide donor as antirestenosis agents
文献作者:Lin,C.-E.; et al.
参考来源:223rd ACS Natl Meet (April 7 2002,Orlando) 2002,Abst MEDI 36

新产品编号:2297573

Chemical Name: 2-[N-[2-(Trifluoromethyl)benzyl]carbamoylmethylsulfonyl]acetic acid
项目整合开发状态: Biological Testing
项目研究机构: Bayer (Originator)
合成路线:The condensation of 2-(trifluoromethyl)benzylam...
参考文献标题:Fumaryl acetoacetate hydrolase inhibitors for the treatment of cancer
文献作者:Dumas,J.
参考来源:223rd ACS Natl Meet (April 7 2002,Orlando) 2002,Abst MEDI 218

新产品编号:2299155

Chemical Name: 5-(Guanin-9-ylmethyl)-4(S)-hydroxytetrahydrofuran-2(S)-phosphonic acidammonium salt
项目整合开发状态: Biological Testing
项目研究机构: Shire BioChem (Originator)
合成路线:The condensation betwee...
参考文献标题:Novel antineoplasic phosphonate nucleosides
文献作者:Chan,L.; Nghe,P.; Vaillancourt,L.; Bubenik,M.
参考来源:223rd ACS Natl Meet (April 7 2002,Orlando) 2002,Abst MEDI 207

D-82318

Chemical Name: 1-(9-Acridinyl)-1-[4-(3-methoxyphenyl)piperazin-1-yl]methanone
项目整合开发状态: Preclinical
项目研究机构: Zentaris (Originator)
合成路线:The title amide is prepared by coupling between 9-acridi...
参考文献标题:Novel heteroaryl derivs.and the use thereof as pharmaceuticals
文献作者:Emig,P.; G黱ther,E.; Beckers,T.; Baasner,S.; Bcher,G.; Aue,B.(Zentaris AG)
参考来源:EP 1301485; WO 0208194

CMPD1, AXC-06728

Chemical Name: 5-(3,5,5,8,8-Pentamethyl-5,6,7,8-tetrahydronaphthalen-2-ylmethyl)-N-(2,4,6-trimethoxyphenyl)furan-2-carboxamide
项目整合开发状态: Preclinical
项目研究机构: Pfizer (Originator)
合成路线:The react...
参考文献标题:Non-peptide GnRH agent,methods and intermediates for their preparation
文献作者:Hong,Y.; Anderson,M.B.; Li,H.; Tompkins,E.V.; Luthin,D.R.; Faust,J.; Vazir,H.N.; Paderes,G.D.; Pathak,V.P.; Christie,L.C.(Agouron Pharmaceuticals,Inc.)
参考来源:EP 1105120; WO 0020358

NOBEX-AA-007

Chemical Name: 2-Hydroxy-5-[4-[N-(4-hydroxysuccinyl)sulfamoyl]phenylazo]benzoic acid
项目整合开发状态: Preclinical
项目研究机构: Nobex (Originator)
合成路线:The condensation of 4-nitrobenzenesulfonamide (I) wi...
参考文献标题:5-ASA derivs.having anti-inflammatory and antibiotic activity and methods of treating diseases therewith
文献作者:Ekwuribe,N.N.; Malson,E.; Riggs-Sauthier,J.(Nobex Corp.)
参考来源:US 6458776; WO 0218330