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-212

Chemical Name: 1-[2-(Diphenylmethoxy)ethyl]piperidine-4-acetic acid
项目整合开发状态: Phase I
项目研究机构: Meram (Originator)
合成路线:The title compound was obtained by two related procedures.Reaction of 4-p...
参考文献标题:Benzhydryloxyethylpiperidine derivs.,process for their preparation and pharmaceutical compsns.,in which they are present
文献作者:Buzas,A.; Merour,J.-Y.; Ollivier,R.(Laboratoires Meram SA)
参考来源:EP 0259227; US 4983614

A-53385(anhydrous; free acid), Abbott-53385(anhydrous; free acid), A-56234

Chemical Name: 8-Chloro-3-(2-fluorophenyl)-5,6-dihydrofuro[3,2-f]]-1,2-benzisoxazole-6-carboxylic acid potassium salt monohydrate
项目整合开发状态: Phase I
项目研究机构: Abbott (Originator)
合成路线:Catalytic ...
参考文献标题:ABBOTT-53385
文献作者:Mannhold,R.
参考来源:Drugs Fut 1985,10(5),363

Calphostin C, UCN-1028C

Chemical Name: 12-[2(R)-(Benzoyloxy)propyl]-4,9-dihydroxy-1-[2(R)-(4-hydroxyphenoxycarbonyloxy)propyl]-2,6,7,11-tetramethoxy-3,10-dihydroperylene-3,10-dione
项目整合开发状态: Preclinical
项目研究机构: Kyowa H...
参考文献标题:Carbene complexes in the synthesis of complex natural products: Total synthesis of the calphostins
文献作者:Merlic,C.A.; et al.
参考来源:J Am Chem Soc 2000,122(13),3224

T-506

Chemical Name: 2'-Deoxy-5-fluoro-3'-oleoyluridine 5'-[2-(trimethylammonio)ethyl]phosphate hydrate
项目整合开发状态: Phase II
项目研究机构: Toyama (Originator)
合成路线:The reaction of 2'-deoxy-5-fluoro-3'-O-ol...
参考文献标题:Novel 5-fluro-2'-desoxyuridine derivs.and their salts,process for theirpreparation and antitumor compsns.containing them
文献作者:Hori,T.; Myokan,I.; Miyabara,S.(Toyama Chemical Co.,Ltd.)
参考来源:CH 670091; DE 3535766; FR 2571374; GB 2166740; JP 1986091196; JP 1986171498; US 4684631; US 4740503

Calphostin A, UCN-1028A

Chemical Name: 1,12-Bis-[2(R)-(Benzoyloxy)propyl]-4,9-dihydroxy-2,6,7,11-tetramethoxy-3,10dihydroperylene-3,10-dione
项目整合开发状态: Biological Testing
项目研究机构: Kyowa Hakko (Originator)
合成路线:The bro...
参考文献标题:Carbene complexes in the synthesis of complex natural products: Total synthesis of the calphostins
文献作者:Merlic,C.A.; et al.
参考来源:J Am Chem Soc 2000,122(13),3224

Genaconazole, SM-9164(RR-isomer), Sch-42426(SS-isomer), Sch-42427(RR-isomer), Sch-39304, SM-8668

Chemical Name: (?-(2R*,3R*)-2-(2,4-Difluorophenyl)-3-(methylsulfonyl)-1-(1,2,4-triazol-1-yl)-2-butanol
项目整合开发状态: Phase III
项目研究机构: Sumitomo Pharmaceuticals (Originator), Schering-Plough (License...
参考文献标题:Synthesis of SCH 42427 labelled with 14C in two different positions
文献作者:Koharski,D.; Saluja,S.; Hesk,D.; Bowlen,C.; Duelfer,T.; McNamara,P.
参考来源:J Label Compd Radiopharm 1992,31(6),445

YM-461

Chemical Name: 1-(3-Phenylpropyl)-4-[2-(3-pyridyl)thiazolidin-4(R)-ylcarbonyl]piperazine fumarate
项目整合开发状态: Preclinical
项目研究机构: Yamanouchi (Originator)
合成路线:Adamantylbenzoic acid (I) was conv...
参考文献标题:Aromatic esters and thioesters,process for their preparation and their use in human or animal therapeutics and in cosmetics
文献作者:Shroot,B.; Eustache,J.; Bernardon,J.-M.(CIRD Galderma)
参考来源:AU 8928608; EP 0325540

新产品编号:1001915

Chemical Name: 6-Chloro-1-methyl-4-oxo-7-(1-piperazinyl)-4H-[1,3]thiazeto[3,2-a]-1,8-naphthyridine-3-carboxylic acid hydrochloride
项目整合开发状态: Biological Testing
项目研究机构: Nippon Shinyaku (Originato...
参考文献标题:Aromatic esters and thioesters,process for their preparation and their use in human or animal therapeutics and in cosmetics
文献作者:Shroot,B.; Eustache,J.; Bernardon,J.-M.(CIRD Galderma)
参考来源:AU 8928608; EP 0325540

新产品编号:1003497

Chemical Name: cis-(1,3-Diaminocyclohexane)(sulfato-O,O')platinum(II)
项目整合开发状态: Biological Testing
项目研究机构: Ajinomoto (Originator)
合成路线:By condensation of trans-(-)-1,2-diaminocyclohexane (I) ...
参考文献标题:Antitumor activity of platinum complexes of 1,2-diaminocyclohexane isomers
文献作者:Speer,R.J.; et al.
参考来源:J Clin Hematol Oncol 1978,8(2),44-50

Caracasanamide

Chemical Name: 3-(3,4-Dimethoxyphenyl)-N-[4-[3-(3-methyl-2-butenyl)guanidino]butyl]propenamide
项目整合开发状态: Biological Testing
项目研究机构: Consiglio Nazionale delle Ricerche (Originator)
合成路线:The re...
参考文献标题:Guanidine derivs.having hypotensive activity,compsn.containing them,and process for obtaining them
文献作者:Delle Monache,G.; Delle Monache,F.; Botta,B.; Bonnevaux Castillo,S.; Espinal,R.; De Luca,C.; Carmignani,M.(Consiglio Nazionale delle Ricerche)
参考来源:EP 0330629; JP 1990003661; US 5059624