On January 19, 2022, Huadong Pharmaceutical (000963.SZ) announced that on January 18, 2022, Zhejiang Daoer Biotechnology Co., Ltd. (hereinafter referred to as "Doyle Biotechnology"), a holding subsidiary of the Company, received the "Notice of Approval of Drug Clinical Trials" approved by the State Drug Administration (NMPA), and the Application for the Phase I Clinical Trial of DR30303 for Injection of Biological Products Class 1 New Drugs declared by Doyle Biologics was approved. To evaluate the safety and tolerability, pharmacokinetics and preliminary efficacy of the humanized Clauddin 18.2 monoclonal antibody-DR30303 in the treatment of advanced solid tumors.
On April 26, 2021, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the Company, acquired 75% of the equity of Doyle Biotech, and DR30303 for injection is one of Doyle Bio's key innovative drugs under research.
In November 2021, Doyle Bio submitted a clinical trial application for DR30303 for injection to NMPA. DR30303 is a humanized IgG1 (immunoglobulin G1) monoclonal antibody that targets Claudin 18.2 and has been engineered by Fc engineering, which can specifically bind to tumor cells expressing Claudin18.2, and induce tumor cell death through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), thereby achieving the purpose of treating tumors.
Claudins are a class of integrin membrane proteins found in the tight junctions of the epithelium and endothelium and are an important part of the tight junctions. The human Claudin 18 gene can produce the Claudin 18.2 protein subtype, and multiple studies have pointed out that the Claudin 18.2 protein is not expressed in other normal tissues other than differentiated gastric mucosal epithelial cells, but only abnormally expressed in various tumors such as gastric cancer, pancreatic cancer, gastroesophageal junction cancer and ovarian cancer. The tumor-specific expression characteristics of CLDN18.2 have made it an important research and development target in the field of oncology.
At present, there is no anti-Claudin 18.2 class drug on the market in the world, and this time obtaining the approval notice for the clinical trial of DR30303 drug for injection is the first approved clinical trial application of Doyle Bio, which will enrich the company's product reserves in the field of tumor treatment, increase the coverage of the company's drugs in the field of innovative drugs and oncology treatment, accelerate the company's integration into the global innovative pharmaceutical industry, and further enhance the company's comprehensive competitiveness.
This article originated from Grand Gateway
![The State Council approved the establishment of cross-border e-commerce comprehensive pilot zones in 27 cities and regions[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)