Delving into the Latest Updates on Beijing Aosaikang Pharmaceutical Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Aosaikang Pharmaceutical Co., Ltd. is a professional pharmaceutical company based in Nanjing, China. With a focus on research, development, production, and sales of drugs, the company offers a range of services including medical research and experimental development, technical consultation, technical services, import and export of goods and technology, and enterprise management. Established on December 24, 1996, Aosaikang Pharmaceutical Co., Ltd. has been dedicated to advancing the pharmaceutical industry and improving public health.

Tags

Neoplasms

Other Diseases

Digestive System Disorders

Small molecule drug

Colony-stimulating factors

Biosimilar

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	13
Endocrinology and Metabolic Disease	4
Nervous System Diseases	2
Immune System Diseases	2
Infectious Diseases	2
Hemic and Lymphatic Diseases	2

Top 5 Drug Type	Count

Small molecule drug	16
Biosimilar	2
Monoclonal antibody	2
Colony-stimulating factors	2
Bispecific antibody	1

Top 5 Target	Count

Proton pump	3
CSF-3R(Colony stimulating factor 3 receptor)	2
c-Met(Hepatocyte growth factor receptor)	2
VEGF x VEGF-A	1
CLDN18.2(Claudin 18.2)	1

This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).

Start Date25 Jan 2024

Sponsor / Collaborator

AskGene Pharma, Inc.

[+1]

CTR20234093 / CompletedPhase 1

ASKC202片的食物影响研究

[Translation] Food Effect Study of ASKC202 Tablets

主要研究目的：评价食物对健康受试者服用ASKC202片后药代动力学的影响。次要研究目的：评价健康受试者单次口服ASKC202片后的安全性。

[Translation]

Primary study objective: To evaluate the effect of food on the pharmacokinetics of ASKC202 tablets in healthy subjects. Secondary study objective: To evaluate the safety of ASKC202 tablets after a single oral administration in healthy subjects.

Start Date18 Dec 2023

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

CTR20233097 / CompletedNot Applicable

马来酸阿伐曲泊帕片在中国健康受试者中的随机、开放、两制剂、两序列、四周期重复交叉餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-dose, two-sequence, four-period repeated crossover bioequivalence study of avatrombopag maleate tablets in Chinese healthy subjects under fed conditions

主要目的：以江苏奥赛康药业有限公司生产的马来酸阿伐曲泊帕片（规格：20 mg）为受试制剂，按生物等效性试验的有关规定，与AKaRx Inc.持证、Kawashima Plant, Eisai Co., Ltd.生产的马来酸阿伐曲泊帕片（规格：20 mg，商品名：苏可欣®，参比制剂）对比在健康人体内的相对生物利用度，考察两制剂的餐后状态下生物等效性。次要目的：观察马来酸阿伐曲泊帕片受试制剂和参比制剂（商品名：苏可欣®）在健康受试者中餐后状态下给药的安全性。

[Translation]

Primary objective: To compare the relative bioavailability of Avatrombopag Maleate Tablets (specification: 20 mg) produced by Jiangsu Aosaikang Pharmaceutical Co., Ltd. in healthy human bodies with Avatrombopag Maleate Tablets (specification: 20 mg, trade name: Sukoxin®, reference preparation) produced by Kawashima Plant, Eisai Co., Ltd. and licensed by AKaRx Inc., and to investigate the bioequivalence of the two preparations in the postprandial state. Secondary objective: To observe the safety of the Avatrombopag Maleate Tablets test preparation and the reference preparation (trade name: Sukoxin®) in the postprandial state in healthy subjects.

Start Date24 Oct 2023

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Beijing Aosaikang Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Beijing Aosaikang Pharmaceutical Co., Ltd.

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80

Literatures (Medical) associated with Beijing Aosaikang Pharmaceutical Co., Ltd.

05 Apr 2024·Cancer Research

Abstract CT118: Phase I dose escalation of ASKC202, a novel cMET tyrosine kinase inhibitor, in patients with advanced solid tumors

Author: Wu, Lin ; Zeng, Shan ; Han, Luwei ; Li, Xingya ; Miao, Liyun ; Chen, Jing ; Li, Wei ; Liu, Baogang ; Wei, Xuyu ; Song, Tingting ; Zhou, Caicun

AbstractBackground ASKC202 is an oral and highly selective small molecule inhibitor which inhibits mesenchymal-epithelial transition. We report preliminary safety and efficacy data from an ongoing Phase I, FIH, dose-escalation study of ASKC202 in patients (pts) with advanced solid tumors (NCT05306132).Methods A two-part study was initiated to evaluate MTD, safety and tolerability, pharmacokinetics and preliminary antitumor activity of ASKC202, including dose escalation study (Part A) and dose expansion study (Part B). Responses were assessed per RECIST 1.1 every 2 cycles (6 weeks). AEs were graded using CTCAE v5.0.In Part A, dose escalation followed the accelerated titration combined with the "3+3" design. Patients with heavily pre-treated solid tumors received ASKC202 orally at doses of 50, 150, 300, 450 and 600 mg/day once daily. The treatment continued until disease progression, unacceptable toxicity or treatment termination. If the subject in the 50mg dose group developed DLT, the dose group was switched to a "3+3" design.Results As of November 30, 2023, 16 patients who are refractory or don’t respond to standard therapy were available received ASKC202 (50mg: N=1; 150mg: N=3; 300mg: N=6; 450mg: N=3; 600mg: N=3). 15/16 pts had pathological confirmation of non-small-cell lung cancer (except for 1 case of PSC). 8/16 pts had brain metastasis. 10/16 pts had cMET dysregulation including MET amplification (N=9; gene copy number 1.3-8.3) and MET missense mutation (N=1; p.S186L) with no patient having Exon 14 skipping mutation.ASKC202 was well-tolerated in all patients. No dose-limiting toxicity was observed in all dose levels (50 to 600 mg). The common TRAEs occurring in more than 20% of patients included: anemia (5/16), blood glucose elevation (5/16), ALT elevation (4/16),AST elevation (4/16) and peripheral edema (4/16). Grade 3 TRAEs were only observed in one patient (300mg QD), including anemia and hypokalemia. Among 14pts who had at least one post-baseline anti-tumor assessment, 5 pts achieved a confirmed partial response. The confirmed ORR is 35.7%. The median best percentage change in target lesion size from baseline (depth of response) was 51.8% and 3pts had duration of tumor response ≥ 6 months. ORR and DCR for patients with cMET alteration (N=8) was 62.5% (5/8) and 75.0% (6/8) respectively. One subject (150mg QD) with MET missense mutation (p.S186L) had a 67% tumor reduction in intracranial lesion from baseline. Exposure of ASKC202 increased dose-proportionally at dose range 50mg to 300mg, but less than dose-proportionally increased at 300mg to 600mg.Conclusions ASKC202 monotherapy was well-tolerated with manageable safety profile and showed anti-tumor signal and the central nervous system efficacy.Citation Format: Tingting Song, Caicun Zhou, Wei Li, Xingya Li, Lin Wu, Shan Zeng, Liyun Miao, Baogang Liu, Xuyu Wei, Jing Chen, Luwei Han. Phase I dose escalation of ASKC202, a novel cMET tyrosine kinase inhibitor, in patients with advanced solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT118.

01 Oct 2023·Clinical pharmacology in drug development

Effect of Food on the Pharmacokinetics of Limertinib (ASK120067) and its Main Metabolite in Healthy Chinese Volunteers.

Article

Author: Jiang, Bo ; Chen, Wenjun ; Lou, Honggang ; Guo, Haifang ; Jiang, Qianqian ; Ruan, Zourong ; Yang, Dandan

Limertinib (ASK120067) is a newly developed third-generation epidermal growth factor receptor tyrosine kinase inhibitor. This phase I, open-label, 2-period crossover study was conducted to evaluate the effect of food on the pharmacokinetics (PK) of limertinib and its active metabolite CCB4580030 in Chinese healthy volunteers (HVs). HVs were randomly assigned (1:1) to receive a single dose of limertinib (160 mg) under the fasted state in period 1 and fed condition in period 2, or vice versa. Twenty-four HVs were enrolled, and 20 HVs completed both study periods. PK were assessed before dosing and ≤72 hours after dosing. PK parameters were analyzed by a noncompartmental method. Limertinib was absorbed faster in the fasted state compared with the fed state. The geometric mean ratios (fed/fast) of maximum concentration, area under the plasma concentration-time curve from time 0 to the last quantifiable concentration, and area under the plasma concentration-time curve from time 0 to infinity for ASK120067 were 145.5%, 145.4%, and 141.9%, respectively. Geometric mean ratios of the PK parameters of CCB4580030 were >125.00% and 90% confidence intervals were outside the preset bioequivalent range. Safety profiles were similar in both prandial states, and limertinib was well tolerated. Food reduced the rate and increased the extent of limertinib absorption following oral administration. Whether limertinib can be administered regardless of prandial state in patients warrants further investigation of efficacy and safety.

02 Sep 2023·Expert Opinion on Drug Metabolism & Toxicology

Phase 1 study to evaluate the effects of rifampin or itraconazole on the pharmacokinetics of limertinib (ASK120067), a novel mutant-selective inhibitor of the epidermal growth factor receptor in healthy Chinese subjects

Article

Author: Guo, Haifang ; Ma, Tingting ; Cao, Bei ; Geng, Yan ; Zhao, Yu ; Liu, Ming ; Huang, Lei ; Yang, Yuanxun ; Lin, Hui ; Li, Juan

BACKGROUNDLimertinib is a novel mutant-selective and irreversible inhibitor of the epidermal growth factor receptor under development. A phase 1 open, two-period, single-sequence, self-controlled, two-part study was initiated to characterize the effects of a strong CYP3A4 inducer (rifampin) or inhibitor (itraconazole) on the pharmacokinetics of limertinib.RESEARCH DESIGN AND METHODSTwenty-four healthy subjects in each part received a single dose of limertinib alone (160 mg, Part A; 80 mg, Part B) and with multiple doses of rifampin 600 mg once daily (Part A) or itraconazole 200 mg twice daily (Part B).RESULTSCoadministration of rifampin decreased exposure (area under the plasma concentration-time curve from time 0 to infinity, AUC_0-inf) of limertinib and its active metabolite CCB4580030 by 87.86% (geometric least-squares mean [GLSM] ratio, 12.14%; 90% confidence interval [CI], 9.89-14.92) and 66.82% (GLSM ratio, 33.18%; 90% CI, 27.72-39.72), respectively. Coadministration of itraconazole increased the AUC_0-inf of limertinib by 289.8% (GLSM ratio, 389.8%; 90% CI, 334.07-454.82), but decreased that of CCB4580030 by 35.96% (GLSM ratio, 64.04%; 90% CI, 50.78-80.77).CONCLUSIONSOur study demonstrates that the concomitant use of limertinib with strong CYP3A inducers or inhibitors is not recommended. A single dose of limertinib, administered with or without rifampin or itraconazole, is generally safe and well tolerated in healthy Chinese subjects.CLINICAL TRIAL REGISTRATIONwww.clinicaltrials.gov identifier is NCT05631678.

100 Deals associated with Beijing Aosaikang Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Beijing Aosaikang Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 06 Oct 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

Discovery

2

1

Preclinical

Phase 1 Clinical

10

1

Phase 2 Clinical

Phase 3 Clinical

4

1

NDA/BLA

Approved

3

13

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Dexlansoprazole ( Proton pump )	Upper gastrointestinal hemorrhage More	Approved
Dexrazoxane Hydrochloride ( Top II )	Cytoprotective Agent More	Approved
Omeprazole Sodium ( Proton pump )	Hyperchlorhydria More	Approved
Limertinib ( EGFR T790M )	EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer More	NDA/BLA
ASKC109	Iron deficiency More	Phase 3