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:1394251

Chemical Name: N-[2-(3,4-Dimethoxyphenyl)ethyl]-4,5-dihydrooxazole-2-amine hydrochloride; N-(4,5-Dihydrooxazol-2-yl)-N-[2-(3,4-dimethoxyphenyl)ethyl]amine hydrochloride
项目整合开发状态: Preclinical
项目研...
参考文献标题:Synthesis of imidazoline,oxazoline derivatives and antihypertensive activity
文献作者:Xu,J.Y.; et al.
参考来源:J Chin Pharm Univ 1998,29(5),336

新产品编号:1395833

Chemical Name: 6,7-Dimethoxy-2-methyl-1-[4-[2-(4-nitrophenoxy)ethoxy]benzyl}-1,2,3,4-tetrahydroisoquinoline hydrochloride
项目整合开发状态: Preclinical
项目研究机构: China Pharmaceutical University (Originato...
参考文献标题:Synthesis and biological activity of 1-(4-alkyloxy)benzyl-1,2,3,4-tetrahydroisoquinolines and related compounds
文献作者:He,L.W.; et al.
参考来源:Acta Pharm Sin 1998,33(10),741

Tryprostatin B, TPS-B

Chemical Name: (3S,8aS)-3-[2-(3-Methyl-2-butenyl)-1H-indol-3-ylmethyl]perhydropyrrolo[1,2-a]pyrazine-1,4-dione
项目整合开发状态: Biological Testing
项目研究机构:
合成路线:The compound was originally isolated ...
参考文献标题:Total synthesis of gypsetin,deoxybrevianamide E,brevianamide E,and tryprostatin B: Novel constructions of 2,3-disubstituted indoles
文献作者:Schkeryantz,J.M.; et al.
参考来源:J Am Chem Soc 1999,121(51),11964

SB-277011-A, SB-277011

Chemical Name: trans-N-[4-[2-(6-Cyano-1,2,3,4-tetrahydro-2-isoquinolinyl)ethyl]cyclohexyl]quinoline-4-carboxamide
项目整合开发状态: Preclinical
项目研究机构: GlaxoSmithKline (Originator)
合成路线:Esterificatio...
参考文献标题:Tetrahydroisoquinoline derivs.as modulators of dopamine D3 receptors
文献作者:Branch,C.L.; Stemp,G.; Johnson,C.N.(SmithKline Beecham plc)
参考来源:EP 0983244; WO 9850364

BM2419-1

Chemical Name: 1,3,6,8,10,11-Hexahydroxynaphthacene-5,12-dione
项目整合开发状态: Biological Testing
项目研究机构: Kaken (Originator)
合成路线:Title compound was generated during the extraction of saintopin (I)...
参考文献标题:Novel selective inhibitors for human topoisomerase I,BM2419-1 and -2 derived from saintopin
文献作者:Ishiyama,D.; Futamata,K.; Futamata,M.; Kasuya,O.; Kamo,S.; Yamashita,F.; Kanazawa,S.
参考来源:J Antibiot 1998,51(12),1069

BM2419-2

Chemical Name: 1,3,8,10,11-Pentahydroxy-6-methylnaphthacene-5,12-dione
项目整合开发状态: Biological Testing
项目研究机构: Kaken (Originator)
合成路线:Title compound was generated during the extraction of saint...
参考文献标题:Novel selective inhibitors for human topoisomerase I,BM2419-1 and -2 derived from saintopin
文献作者:Ishiyama,D.; Futamata,K.; Futamata,M.; Kasuya,O.; Kamo,S.; Yamashita,F.; Kanazawa,S.
参考来源:J Antibiot 1998,51(12),1069

新产品编号:1397415

Chemical Name: 7-[2-(2-Aminothiazolyl-4-yl)-2(Z)-(methoxyimino)acetamido]-3-(3-chloroisoxazol-5-ylvinyl)-3-cephem-4-carboxylic acid sodium salt
项目整合开发状态: Biological Testing
项目研究机构: Korea Inst. S...
参考文献标题:Studies on novel 3-isoxazolylvinylcephalosporins: I.Synthesis and biological activity of 7-[2-(2-aminothiazol-4-yl)-2-(alkoxy)iminoacetamido] derivatives
文献作者:Choi,K.I.; Cha,J.H.; Pae,A.N.; Cho,Y.S.; Chang,M.H.; Koh,H.Y.
参考来源:J Antibiot 1998,51(12),1117

新产品编号:1398997

Chemical Name: 4-[4-(2-Methoxyphenyl)piperazin-1-ylcarbonyl]-3-methyl-1-oxaspiro[4.5]dec-3-en-2-one
项目整合开发状态: Preclinical
项目研究机构: Universit?d'Auvergne-Clermont-Ferrand (Originator)
合成路线:The ...
参考文献标题:Synthesis of acetylenic spirobutenolide derivatives and evaluation of their growth inhibitory effect on cells in culture
文献作者:Bador,P.; et al.
参考来源:Arzneim-Forsch Drug Res 1990,40(II)(10),1135-1139

新产品编号:1400579

Chemical Name: 4-[4-(4-Fluorophenyl)piperazin-1-ylcarbonyl]-3-methyl-1-oxaspiro[4.5]dec-3-en-2-one
项目整合开发状态: Biological Testing
项目研究机构: Universit?d'Auvergne-Clermont-Ferrand (Originator)
合成路...
参考文献标题:Spirobutenolides substituted by arylpiperazinyl-carbonyl moieties.Synthesis and antinociceptive properties
文献作者:Bois,F.; et al.
参考来源:Arzneim-Forsch Drug Res 1998,48(12),1156

XU-065

Chemical Name: 3-[3-(4-Amidinobenzyloxy)isoxazol-5-ylcarboxamido]-2(R)-(butoxycarbonylamino)propionic acid methyl ester trifluoroacetate
项目整合开发状态: Preclinical
项目研究机构: Bristol-Myers Squibb (Origi...
参考文献标题:Cpds.containing basic and acidic termini useful as fibrinogen receptor antagonists
文献作者:Degrado,W.F.; Xue,C.-B.(DuPont Pharmaceuticals Co.)
参考来源:US 5563158; WO 9518111