Delving into the Latest Updates on Shenzhen Main Luck Pharmaceuticals, Inc. with Synapse

Overview

Tags

Neoplasms

Hemic and Lymphatic Diseases

Immune System Diseases

Small molecule drug

Monoclonal antibody

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	4
Immune System Diseases	3
Hemic and Lymphatic Diseases	3
Endocrinology and Metabolic Disease	2
Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3
Monoclonal antibody	1

Top 5 Target	Count

HER2(Receptor tyrosine-protein kinase erbB-2)	1
DNA x Top II	1
RXRs(Retinoid X receptor)	1
Top II(Topoisomerase II)	1

主要研究目的本研究考察餐后条件下，单次口服深圳万乐药业有限公司研制的米拉贝隆缓释片（受试制剂，规格：25mg/片）与Avara Pharmaceutical Technologies,Inc.生产的米拉贝隆缓释片（参比制剂，规格：25mg/片，商品名：Betmiga®/貝坦利®）的药动学特征，评价两制剂间的生物等效性。次要研究目的评价单次口服25mg的米拉贝隆缓释片受试制剂和参比制剂（商品名：Betmiga®/貝坦利®）在健康受试者中的安全性。

[Translation]

Main research purpose This study examines the single oral administration of mirabegron sustained-release tablets (test preparation, specification: 25 mg/tablet) developed by Shenzhen Wanle Pharmaceutical Co., Ltd. and mirabeg produced by Avara Pharmaceutical Technologies, Inc. under postprandial conditions. The pharmacokinetic characteristics of Longon sustained-release tablets (reference preparation, specification: 25mg/tablet, trade name: Betmiga®/Betanil®) were evaluated to evaluate the bioequivalence between the two preparations. Secondary research purpose To evaluate the safety of the test preparation and reference preparation (trade name: Betmiga®/Betanil®) of a single oral administration of 25 mg mirabegron extended-release tablets in healthy subjects.

Start Date02 Mar 2021

Sponsor / Collaborator

Shenzhen Main Luck Pharmaceuticals, Inc.

CTR20200775 / CompletedNot Applicable

米拉贝隆缓释片人体生物等效性试验

[Translation] Bioequivalence study of mirabegron sustained-release tablets in humans

主要研究目的：本研究考察空腹和餐后条件下，单次口服深圳万乐药业有限公司研制的米拉贝隆缓释片与Avara Pharmaceutical Technologies，Inc.生产的米拉贝隆缓释片的药学特征，评价两制剂间的生物等效性。次要研究目的：评价单次口服25mg的米拉贝隆缓释片受试制剂和参比制剂（商品名：Betmiga®/貝坦利®）在健康受试者中的安全性。

[Translation]

Main research purpose: This study examines the efficacy of a single oral administration of mirabegron extended-release tablets developed by Shenzhen Wanle Pharmaceutical Co., Ltd. and mirabegron extended-release tablets produced by Avara Pharmaceutical Technologies, Inc. under fasting and postprandial conditions. Pharmaceutical characterization and evaluation of bioequivalence between two preparations. Secondary study purpose: To evaluate the safety of the test preparation and reference preparation (trade name: Betmiga®/Betanil®) of 25 mg mirabegron extended-release tablets administered as a single oral dose in healthy subjects.

Start Date26 Apr 2020

Sponsor / Collaborator

Shenzhen Main Luck Pharmaceuticals, Inc.

CTR20180720 / SuspendedPhase 1

评价WLB -302与美罗华在非霍奇金淋巴瘤患者中药代动力学、免疫原性、安全性的随机、双盲的临床研究

[Translation] A randomized, double-blind clinical study to evaluate the pharmacokinetics, immunogenicity, and safety of WLB-302 and rituximab in patients with non-Hodgkin's lymphoma

主要：评价单次给药后重组人鼠嵌合抗CD20单克隆抗体注射液（WLB-302）与美罗华®主要药代动力学参数 AUC (0 - t) 的相似性；次要： 1.给药后WLB-302与美罗华 ®AUC0-∞及 Cmax 的相似性； 2.给药后WLB-302与美罗华 ®在非霍奇金淋巴瘤患者中CD19、CD20阳性B细胞计数变化； 3.给药后WLB-302与美罗华 ®在非霍奇金淋巴瘤患者中不良事件发生率的差异,ADA、实验室、生命体征、心电监测、心电图、体格检查的变化。

[Translation]

Primary: To evaluate the similarity of the main pharmacokinetic parameter AUC (0 - t) between recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection (WLB-302) and Rituxima® after a single dose; Secondary: 1. The similarity of AUC0-∞ and Cmax between WLB-302 and Rituxima® after administration; 2. The changes in CD19 and CD20 positive B cell counts between WLB-302 and Rituxima® in patients with non-Hodgkin's lymphoma after administration; 3. The differences in the incidence of adverse events between WLB-302 and Rituxima® in patients with non-Hodgkin's lymphoma after administration, and the changes in ADA, laboratory, vital signs, ECG monitoring, electrocardiogram, and physical examination.

Start Date15 Jan 2019

Sponsor / Collaborator

Shenzhen Main Luck Pharmaceuticals, Inc.

100 Clinical Results associated with Shenzhen Main Luck Pharmaceuticals, Inc.

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0 Patents (Medical) associated with Shenzhen Main Luck Pharmaceuticals, Inc.

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2

Literatures (Medical) associated with Shenzhen Main Luck Pharmaceuticals, Inc.

Zhongguo Shengwu Zhipinxue Zazhi

Optimization of culture medium for production of monoclonal antibody against human epidermal growth factor receptor 2 by using design of experiment

Author: Yu, Yu-gen ; Li, Ruo-zhu ; Xiang, Gang ; Zhang, Hui-juan ; Wu, Ze-xuan

Objective To optimize the culture medium for production of monoclonal antibody (McAb) against human epidermal growth factor receptor 2 (HER2) by using design of experiments (DOE) so as to increase the expression level of McAb.Methods The effects of various basal media and feeding media on cell d. and expression of McAb against HER2 in engineering cell were investigated by DOE with Minitab software.Results After optimization by DOE, the viable cell d. of recombinant cell strain reached 296 × 10⁵ cells/mL at most.However, the expression level of antibody titer reached 2.07 g/L at most, which increased by 72% compared with that before optimization (1.20 g/L).The quality of antibody was similar to that of antibody developed previously as control.Conclusion An optimized combination of basal media and feeding media was obtained, by which the cell d. and antibody expression level increased.The optimized combination was suitable for production of McAb against HER2, indicating DOE as an effective method for rapidly increasing the expression level of antibody within a short time period.

Zhongguo Shengwu Gongcheng Zazhi

Promotion in protein a chromatography of WLB303 monoclonal antibody by using dual flowrate to load sample

Author: Yu, Yu-gen ; Luo, Hao-hui ; Deng, Yi-xi ; Meng, Guo-ji ; Li, Le

With the advances in cell culture expression levels and production capacity in the last two decades, it is crucial to improve the binding capacity of protein A resin and decrease processing time.Then the dual flowrate loading strategy is proposed.A cubic equation of GE MabSelect dynamic binding capacity (DBC) was created by measuring several DBC values of the retention time with WLB303 mAb.A unique DBC table of GE MabSelect was generated subsequently to design dual flow rate loading strategy.The fastest dual flowrate loading mode was firstly confirmed by using purified WLB303 mAb to practice on a 2.7 mL column.And it was demonstrated to show obvious promotion in process efficiency by using clarified harvest to practice on a 7 mL column.

100 Deals associated with Shenzhen Main Luck Pharmaceuticals, Inc.

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100 Translational Medicine associated with Shenzhen Main Luck Pharmaceuticals, Inc.

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Pipeline

Pipeline Snapshot as of 05 Nov 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 1 Clinical

1

Phase 3 Clinical

Approved

2

4

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pirarubicin Hydrochloride ( DNA x Top II )	Breast Cancer More	Approved
Daunorubicin Hydrochloride ( Top II )	Infectious Diseases More	Approved
Bexarotene ( RXRs )	Cutaneous T-Cell Lymphoma More	Phase 3
Recombinant anti-HER2 humanized monoclonal antibody(Shenzhen Main Luck Pharmaceuticals, Inc.) ( HER2 )	Breast Cancer More	Phase 1
Rituximab biosimilar(Shenzhen Main Luck Pharmaceuticals, Inc.) ( CD20 )	Non-Hodgkin Lymphoma More	Suspended