Delving into the Latest Updates on Shanghai SynTheAll Pharmaceutical Co., Ltd. with Synapse

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Respiratory Diseases

Small molecule drug

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Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	4

Top 5 Target	Count

H+/K+ ATPase(Potassium-transporting ATPase)	1
TNIK(TRAF2 and NCK-interacting protein kinase)	1
RBP4(Retinol-binding protein 4)	1

Primary objective: To evaluate the safety of TISA-818-Inj in patients with acute respiratory distress syndrome (ARDS). Secondary objectives To evaluate the preliminary efficacy of TISA-818-Inj in patients with ARDS; To evaluate the population pharmacokinetic (Pop PK) characteristics of TISA-818-Inj in patients with ARDS. To evaluate the PK characteristics of TISA-818 in bronchoalveolar lavage fluid.

Start Date15 Nov 2023

Sponsor / Collaborator

Usun BioStartup

[+1]

CTR20230776 / CompletedPhase 2

一项评价INS018_055口服给药用于治疗特发性肺纤维化（IPF）受试者的安全性、耐受性、药代动力学和有效性的随机、双盲、安慰剂对照、IIa期研究

[Translation] A randomized, double-blind, placebo-controlled, Phase IIa study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of oral INS018_055 in subjects with idiopathic pulmonary fibrosis (IPF)

主要目的：评价与安慰剂相比，成人IPF受试者口服INS018_055长达12周的安全性和耐受性。次要目的评价IPF受试者口服INS018_055后的药代动力学 (PK) 评价与安慰剂相比，成人IPF受试者口服INS018_055长达12周在FVC下降方面的有效性评价与安慰剂相比，口服INS018_055治疗长达12周在改善生活质量（QoL）和功能指标方面的有效性评价与安慰剂相比，INS018_055口服给药对IPF急性加重的影响探索性目的为： ● 探索口服INS018_055对血液中IPF疾病相关的生物标志物的影响 ● 用高通量蛋白组学探索INS018_055在IPF病人血液蛋白质组中的潜在作用机制

[Translation]

Primary objective: To evaluate the safety and tolerability of oral INS018_055 for up to 12 weeks in adult IPF subjects compared with placebo. Secondary objectives To evaluate the pharmacokinetics (PK) of INS018_055 after oral administration in IPF subjects To evaluate the effectiveness of oral INS018_055 for up to 12 weeks in adult IPF subjects compared with placebo in terms of FVC decline To evaluate the effectiveness of oral INS018_055 treatment for up to 12 weeks compared with placebo in improving quality of life (QoL) and functional indicators To evaluate the effect of oral administration of INS018_055 on acute exacerbations of IPF compared with placebo Exploratory objectives are: ● To explore the effect of oral INS018_055 on IPF disease-related biomarkers in the blood ● To explore the potential mechanism of action of INS018_055 in the blood proteome of IPF patients using high-throughput proteomics

Start Date15 May 2023

Sponsor / Collaborator

Insilicon Intelligent Technology (Shanghai) Co., Ltd.

[+1]

CTR20230597 / TerminatedPhase 1

一项评价 AB-218 治疗晚期 IDH1 突变型胆管癌和其他实体瘤成人患者的安全性、药代动力学和初步疗效的 I 期、多中心、开放、单臂研究

[Translation] A Phase I, multicenter, open-label, single-arm study evaluating the safety, pharmacokinetics, and preliminary efficacy of AB-218 in adult patients with advanced IDH1-mutant cholangiocarcinoma and other solid tumors

1、评价 AB-218 治疗具有 IDH1 突变的晚期胆管癌和其他实体瘤（不包括脑胶质瘤）患者的安全性和耐受性 2、在晚期 IDH1 突变实体瘤（不包括脑胶质瘤）患者中确定 AB-218 的RP2D

[Translation]

1. Evaluate the safety and tolerability of AB-218 in patients with advanced cholangiocarcinoma and other solid tumors (excluding gliomas) with IDH1 mutations 2. Determine the RP2D of AB-218 in patients with advanced IDH1 mutation solid tumors (excluding gliomas)

Start Date19 Apr 2023

Sponsor / Collaborator

AnHeart Therapeutics (Hangzhou) Co., Ltd.Startup

[+1]

100 Clinical Results associated with Shanghai SynTheAll Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Shanghai SynTheAll Pharmaceutical Co., Ltd.

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2

Literatures (Medical) associated with Shanghai SynTheAll Pharmaceutical Co., Ltd.

03 May 2020·Xenobiotica

The characteristics and mechanism of co-administration of lovastatin solid dispersion with kaempferol to increase oral bioavailability

Article

Author: Cheng, Xu ; Ji, Weiwen ; Di, Liuying ; Cheng, Gang ; Li, Jiaqi ; Zou, Meijuan ; Piao, Hongyu

Lovastatin shows low bioavailability (lower than 5%) after oral administration because of the poor aqueous solubility and widely metabolized by CYP3A4.Lovastatin solid dispersion was designed to enhance the dissolution. The in vitro intestinal absorption study indicated an increase in the apparent permeability of different intestinal segments compared with crude lovastatin. In the range of 12.5-50 μg/ml, the absorption of both lovastatin and lovastatin solid dispersion were found to be a passive process in rat's jejunum and ileum, but not endocytosis process. CYP3A4 inhibitor (ketoconazole) significantly increased the intestinal absorption of lovastatin and lovastatin solid dispersion. However, P-glycoprotein efflux inhibitor (verapamil) had little effect on them.The absolute bioavailability of lovastatin and lovastatin acid after oral administration of lovastatin solid dispersion were increased by about 2.01-fold and 1.40-fold than that of lovastatin suspension. The oral bioavailability of lovastatin and lovastatin acid after oral administration of lovastatin solid dispersion with 10 mg/kg kaempferol (CYP3A4 inhibitor) were increased about 3.79-fold and 2.51-fold than that of lovastatin suspension, and the absolute bioavailability of lovastatin was up to 33.0%.As a result, co-administration of lovastatin solid dispersion with kaempferol could be a promising delivery system to improve the oral bioavailability of lovastatin.

01 Apr 2018·Applied Microbiology and BiotechnologyQ3 · ENGINEERING & TECHNOLOGY

The molecular basis for lipase stereoselectivity

Q3 · ENGINEERING & TECHNOLOGY

Review

Author: Meng, Xiao ; Xu, Xiaoqing ; Chen, Hui ; Li, Shengying ; Liu, Wenbo

Lipases are among the most applied biocatalysts in organic synthesis to catalyze the kinetic resolution of a wide range of racemic substrates to yield optically pure compounds. Due to the rapidly increased demands for optically pure compounds, deep understanding of the molecular basis for lipase stereoselectivity and how to obtain lipases with excellent asymmetric selectivity have become one of primary research goals in this field. This review is focused on the molecular factors that have impacts on the stereoselectivity of lipases including the steric complementarity between the lipase topological structure and its substrate, the regional structural flexibility, the hydrogen bonds between the residues around the catalytic site and the tetrahedral intermediates, and the electrostatic interactions between surface residues. Moreover, the synergistic effects of these structural factors on the catalytic properties including stereoselectivity, activity, and stability are also discussed.

100 Deals associated with Shanghai SynTheAll Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Shanghai SynTheAll Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 2 Clinical

2

1

Phase 3 Clinical

NDA/BLA

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Linaprazan glurate ( H+/K+ ATPase )	Esophagitis, Peptic More	NDA/BLA
Tinlarebant ( RBP4 )	Stargardt Disease More	Phase 3
UP-818-CC	Respiratory Distress Syndrome, Acute More	Phase 2
INS018_055 ( TNIK )	Idiopathic Pulmonary Fibrosis More	Phase 2
Safusidenib ( IDH1 )	IDH1 Mutation Cholangiocarcinoma More	Discontinued