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更新于：2025-09-09
WuXi AppTec Co., Ltd.
更新于：2025-09-09
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肿瘤
消化系统疾病
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CTR20233997
[18F]BF3-BPA注射液在中国健康成年受试者中的药代动力学、生物分布和安全性的I期临床研究
CTR20232429
评价TISA-818-Inj治疗急性呼吸窘迫综合征患者的安全性和初步有效性的随机、双盲、安慰剂对照的II期临床试验
CTR20231955
评价THDBH130片在肾功能正常和轻-中度肾功能不全的成年男性受试者中单次给药的安全性、耐受性、药代 /药效动力学特征和碘海醇测定肾小球滤过率的I期临床研究
100 项与 无锡药明康德新药开发股份有限公司 相关的临床结果
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2025-08-01SYNTHESIS-STUTTGART
Development of an Efficient Synthesis toward a 4,4-Difluoropiperidine Intermediate Bearing a Pyridine N-Oxide Motif at the Carbon Stereocenter
作者: Ma, Zhou ; Sun, Liang ; Li, Ling ; Radtke, M. Alex ; Mancheno, Danny E. ; Gurung, Sing R. ; Chen, Heng ; Yang, Wuxing ; Xie, Shiping ; Zhang, Zhi
Abstract:
The synthesis of a 4,4-difluoropiperidine intermediate, a key component of an MRGPRX2 antagonist, is challenging due to the presence of a gem-difluoro moiety adjacent to a stereocenter which also bears a reactive pyridine N-oxide motif. The initial discovery chemistry route required chiral supercritical fluid chromatography (SFC) at the end of the synthesis to provide enantiopure product. XtalFluor-E was used for deoxyfluorination on a ketone adjacent to a p-pyridylmethyl position, resulting in very low yields due to the elimination of HF. After several unsuccessful attempts for a de novo asymmetric synthesis, we focused our attention on the process development for a more practical synthesis than the existing route. A much higher yielding deoxyfluorination was enabled by SF4 and HF. Furthermore, the chiral SFC was replaced by an efficient classical resolution at a much earlier stage of the synthesis, taking advantage of the basicity of the pyridine moiety before oxidation to the pyridine N-oxide. Although not all stages have been scaled up in the plant scale, the new synthesis is much more practical and has improved the overall yield from 12% to 23% for this challenging molecule.
2025-08-01JOURNAL OF ORGANIC CHEMISTRY
Development of a Scalable Synthesis of a HPK1 Inhibitor Featuring a Direct α-Arylation of Boc-Protected N,N-Dimethylamine by Palladium-Mediated Negishi Cross-Coupling
Article
作者: Braganza, John ; Mu, Qiming ; Liu, Tongnan ; Gallego, Rebecca ; Zhou, Ru ; Meng, Fanxiu ; Morse, Peter ; Zhao, Xin ; Del Bel, Matthew ; Berritt, Simon ; Matthews, Jean ; Tucker, Joseph ; Dechert Schmitt, Anne-Marie ; Lafontaine, Jennifer ; Monfette, Sebastien ; Sun, Bin ; Brown, Adam ; He, Mingying ; Nair, Sajiv ; Zhang, Lei ; Sach, Neal ; Wu, Chaobo ; Liao, Pingyong ; Zhou, Dahui ; Knauber, Thomas
The development of an improved synthesis of the potent HPK1 inhibitor, compound 1, is described. Two primary strategies were explored during this process: metallaphotoredox decarboxylative coupling and Negishi cross-coupling, both focusing on the direct installation of Boc-protected amine in a single step. Through the optimized Pd-catalyzed Negishi cross-coupling, a robust procedure was established for preparing the compound 9 from 3 in a single step on a 20 g scale. This optimization successfully reduced the overall synthesis steps required to produce 1 from 11 to 6, achieving a 28% overall yield.
2025-06-30EUROPEAN JOURNAL OF ENDOCRINOLOGY
Phase 1 study and population PK/PD modeling of long-acting growth hormone, GB08, to guide pediatric dosing
Article
作者: Qin, Suofu ; Peng, Hengxin ; Lin, Yanqing ; Xu, Jiajun ; He, Wen ; Shang, Wei ; Zhu, Jiang
Abstract:
Objective:
Growth hormone deficiency (GHD) requires long-term treatment, but daily injections and adverse effects of current therapies often pose adherence challenges in children. GB08, a novel Fc-GH, leverages the extended half-life of Fc-fusion proteins to reduce injection frequency with potential for improved safety. This study evaluates the safety, immunogenicity, pharmacokinetics, and pharmacodynamics profiles of GB08 in healthy adults. The findings, along with population PK/PD modeling, will guide dosing strategies for a Phase 2 trial in pediatric GHD patients.
Design:
The study consisted of 2 parts: a randomized, double-blind, placebo-controlled single ascending dose trial and a randomized, open-label, parallel-group positive control trial.
Methods:
Subjects received a single dose of GB08 (0.16-2.4 mg/kg), 0.2 mg/kg of Jintrolong, or 7 daily doses of Norditropin (0.035 mg/kg/day). Evaluations included adverse events (AEs), immunogenicity, pharmacokinetics, and pharmacodynamics.
Results:
GB08 demonstrated a favorable safety profile with low immunogenicity, no serious AEs reported, and all AEs were mild to moderate. Pharmacokinetics and pharmacodynamics revealed dose-dependent increases, with GB08's half-life ranging from 81.7 to 110.0 h, supporting its potential for once-weekly injection. PK/PD modeling identified an optimal adult dose of 0.7 mg/kg. Further allometric scaling of adult PK data to develop a pediatric PK model suggested optimal pediatric dose of 0.8 mg/kg, balancing efficacy and safety profiles.
Conclusion:
GB08 provides notable advantages over traditional therapies, like short-acting GH, by enhancing treatment adherence and offering a potentially safer alternative. The findings from this study will guide dosing strategies for Phase 2 trial in children with GHD.
100 项与 无锡药明康德新药开发股份有限公司 相关的药物交易
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100 项与 无锡药明康德新药开发股份有限公司 相关的转化医学
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管线布局
2025年09月10日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
药物发现
27
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临床申请批准
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3
临床1期
临床2期
1
2
临床3期
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12
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