Delving into the Latest Updates on Guangxi Lugang Biomedical Technology Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Guangxi Lugang Biomedical Technology Co., Ltd. in Guangxi is an innovative pharmaceutical research and development firm jointly funded and established by Fangchenggang Culture & Tourism Group and SIGLAN Group. The inception of the company took place in September 2020. Capitalizing on SIGLAN Group's comprehensive and robust platform for drug discovery and development, Egret Harbor Bio focuses primarily on the development of anti-cancer therapies, supplemented by treatments for central nervous system ailments and infectious diseases. The company has successfully established a diverse research and development pipeline spanning antibody drugs, small molecule pharmaceuticals, and advanced drug formulations.

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Neoplasms

Biological products

Disease domain score

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Technology Platform

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Targets

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Disease Domain	Count

Neoplasms	1

Top 5 Drug Type	Count

Biological products	1

主要目的：评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的安全性和耐受性；确定AHT-102注射液的最大耐受剂量（MTD）和/或II期临床研究推荐剂量（RP2D）。次要目的：评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的药代动力学（PK）特征；评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的免疫原性；采用实体瘤疗效评价标准1.1版（RECISTV1.1）评估AHT-102注射液在CLDN18.2阳性晚期实体瘤受试者的初步抗肿瘤活性。探索性目的：采用免疫治疗实体瘤疗效评价标准（iRECIST）评估AHT-102注射液在CLDN18.2阳性晚期实体瘤受试者的初步抗肿瘤活性（仅RECISTV1.1评价为PD后采用iRECIST评价）；评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的药效学（PD）特征；在剂量扩展阶段，评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者血液分子标志物水平的变化。

[Translation]

Primary objectives: To evaluate the safety and tolerability of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors; To determine the maximum tolerated dose (MTD) and/or recommended dose (RP2D) of AHT-102 injection for Phase II clinical studies. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors; To evaluate the immunogenicity of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors; To evaluate the preliminary anti-tumor activity of AHT-102 injection in subjects with CLDN18.2-positive advanced solid tumors using the Solid Tumor Efficacy Evaluation Criteria Version 1.1 (RECIST V1.1). Exploratory purpose: Use the immunotherapy efficacy evaluation criteria for solid tumors (iRECIST) to evaluate the preliminary anti-tumor activity of AHT-102 injection in subjects with CLDN18.2-positive advanced solid tumors (iRECIST evaluation is used only after RECISTV1.1 is evaluated as PD); Evaluate the pharmacodynamic (PD) characteristics of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors; In the dose expansion phase, evaluate the changes in the levels of blood molecular markers in subjects with CLDN18.2-positive advanced solid tumors treated with AHT-102 injection.

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Sponsor / Collaborator

Guangxi Lugang Biomedical Technology Co., Ltd.

100 Clinical Results associated with Guangxi Lugang Biomedical Technology Co., Ltd.

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0 Patents (Medical) associated with Guangxi Lugang Biomedical Technology Co., Ltd.

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100 Deals associated with Guangxi Lugang Biomedical Technology Co., Ltd.

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100 Translational Medicine associated with Guangxi Lugang Biomedical Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 03 Aug 2025

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

IND Approval

1

Phase 1 Clinical

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