Beijing Northland Biotechnology Co., Ltd. recently completed the preparation of Phase III clinical trial samples for "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection," with a production scale of 500L. According to investigations, the preparation of naked plasmid gene therapy drugs at a 500L scale represents the largest production scale ever achieved worldwide to date.

　　Naked plasmids refer to plasmid DNA that is not associated with proteins, lipids, or other molecules that provide protection. Due to their ability to replicate autonomously and express the genetic information they carry, naked plasmids are widely used in biopharmaceuticals, agriculture, food processing, and other industries—particularly in the field of biopharmaceuticals. Naked-plasmid-based gene therapy drugs deliver exogenous genes into target cells via naked-plasmid vectors and enable the expression of corresponding proteins within the body, thereby achieving therapeutic effects. With the rapid development of gene therapy drugs, research and application of naked-plasmid-based gene therapies have attracted considerable attention from research institutions and pharmaceutical companies. As of November 2017, there were approximately 428 clinical protocols worldwide involving naked-plasmid-based gene therapies (including DNA vaccines), of which 320 were in Phase I clinical trials, 91 in Phase II clinical trials, and 17 in Phase III clinical trials.

　　As of now, no naked plasmid-based gene therapy products have been approved for marketing worldwide. The production of naked plasmids is largely confined to laboratory and pilot-scale settings. Only a few companies in countries such as the United States, Germany, and Japan are professionally capable of manufacturing naked plasmid-based gene therapies, and their production scales typically range from 100 to 200 liters. Scaling up the production of naked plasmids is an urgent issue that must be addressed to enable the industrialization and commercialization of naked plasmid-based gene therapies.

　　The “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection,” developed by NORTHLAND, is a naked plasmid gene therapy drug composed of the pCK vector and a hybrid hepatocyte growth factor gene. It has now completed Phase II clinical trials. The drug has achieved large-scale production at a 500L capacity, marking a significant breakthrough in the development of naked plasmid gene therapies and serving as a crucial prerequisite for the company’s initiation of Phase III clinical trials. After years of dedicated effort, NORTHLAND’s research team has overcome technical challenges in areas such as naked plasmid fermentation, pretreatment, and purification, continuously optimizing process parameters and conditions. They have independently established the “NL-DNA-Tech” technology for the production of naked plasmid gene therapy drugs, which boasts stable production processes and reliable product quality, meeting the requirements for large-scale manufacturing.

　　The clinical samples of “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” produced by NORTHLAND this time have a yield exceeding 60%, a purity exceeding 97%, and a supercoiled ratio exceeding 90%. All tested items meet the quality standards for this product.

　　Mr. Xu Songshan, Chairman of NORTHLAND, stated: “The successful preparation of the Phase III clinical trial samples for the recombinant human hepatocyte growth factor naked plasmid injection not only serves as a test of the company’s scientific research capabilities but also ensures the smooth implementation of the product’s Phase III clinical trials, making it of great and far-reaching significance. The company will continue to carry out related research, further expand production scale, and build a world-leading, automated, and intelligent large-scale production system for naked plasmid drugs.”

　　 Company Introduction

　　Beijing Northland Biotechnology Co., Ltd. is an R&D-oriented high-tech enterprise primarily engaged in the development of therapeutic biological products. Founded in June 2004, the company is a key high-tech enterprise under the National Torch Program and a G20 innovation-leading enterprise in Beijing's biopharmaceutical industry. Its registered capital is 105.0392 million yuan, and its stock code is 430047.

　　 Project Introduction

　　The gene therapy drug—recombinant hepatocyte growth factor naked plasmid injection—developed by Beijing Northland Biotechnology Co., Ltd., has now completed Phase II clinical trials in China and will initiate Phase III clinical trials within this year. This drug is indicated for peripheral artery disease (PAD), diabetic peripheral neuropathy (DPN), acute myocardial infarction (Coronary Artery Disease, CAD), and amyotrophic lateral sclerosis (ALS). Currently, the clinical trial being conducted in China focuses on severe lower-limb ischemia (Critical Limb Ischemia, CLI), and the drug is expected to be available for sale in 2021. Meanwhile, Northland is planning to conduct clinical trials for other indications in China as well.

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