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The results of the Phase II clinical trial for “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” were presented at the 28th International Union of Angiology World Congress.

发布时间：2018-10-31

Recently, the 28th International Union of Angiology World Congress (IUA) and the 10th China Capital Vascular Symposium (CCVS) were held at the Beijing International Conference Center. Professor Guo Lianrui from the Department of Vascular Surgery at Xuanwu Hospital, Capital Medical University, presented, on behalf of the entire research team, the results of the Phase II clinical study on “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” for the treatment of severe lower-limb arterial ischemic disease in China. The presentation at the conference was titled “Safety and Efficacy of Gene Naked Plasmid Therapy Expressing Two Subtypes of Hepatocyte Growth Factor in Patients with Severe Lower-Limb Arterial Ischemia for Pain and Ulcer Management.” Phase II of “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection”

15

2018-10

The Phase I multiple-dose clinical trial of “Recombinant Human Thymosin β4 for Injection” has officially commenced.

发布时间：2018-10-15

On October 12, 2018, the kickoff meeting for the Phase I multiple-dose clinical trial of “Recombinant Human Thymosin β4 for Injection” was officially held at the Conference Center of Beijing Century Tan Hospital, Affiliated to Capital Medical University. The protocol for this multiple-dose trial was developed based on the results from the Phase I single-dose study, with the aim of further evaluating the safety and tolerability of multiple doses, exploring the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT), and simultaneously assessing the pharmacokinetic (PK) characteristics and anti-drug antibody (ADA) indicators associated with multiple dosing. The meeting was chaired by Wang from the Phase I Clinical Trial Research Laboratory of Beijing Century Tan Hospital, Affiliated to Capital Medical University.

07

2018-08

NORTHLAND achieves, for the first time globally, large-scale production of a naked plasmid gene therapy drug at 500L.

发布时间：2018-08-07

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. A naked plasmid refers to plasmid DNA that is not associated with proteins, lipids, or other molecules that provide protection. Due to its ability to replicate autonomously and express the genetic information it carries, it is used in industries such as biopharmaceuticals, agriculture, and food, and is particularly widely applied in the biopharmaceutical sector. Naked plasmid-based

17

2018-07

Recombinant human interleukin-11 has completed Phase IIIa clinical trials and achieved the expected results.

发布时间：2018-07-17

The “Δ1-9, Alanine 10, Asparagine 134, Recombinant Human Interleukin-11” developed by Beijing Northland Biotechnology Co., Ltd. (hereinafter referred to as the drug) is a novel modified variant of natural human interleukin-11. It has undergone multiple innovative modifications in terms of molecular structure and production processes, and possesses independent intellectual property rights in China (invention patent: ZL01110081.8). Compared with similar products both domestically and internationally, its dosage is only one-third to one-fifth of that of comparable products, and it boasts distinct advantages such as clear efficacy and few adverse reactions. It holds promise to become a new-generation interleukin for the treatment of thrombocytopenia.

27

2018-06

The Phase II clinical trial results for the innovative gene therapy drug, recombinant human hepatocyte growth factor naked plasmid injection, in the treatment of lower limb ischemic disease have met expectations.

发布时间：2018-06-27

The recombinant human hepatocyte growth factor naked plasmid injection is a gene therapy drug independently developed by Beijing Northland Biotechnology Co., Ltd. It can be used for the treatment of indications such as peripheral arterial ischemic disease, coronary heart disease, and diabetic peripheral neuropathy. Currently, the Phase II clinical study for the indication of severe lower limb ischemia (CLI) has been completed in China, with positive trial data. The Phase III clinical trial is about to commence, and this drug is expected to become the first naked plasmid gene therapy drug in China to enter the pivotal Phase III clinical research stage. The Phase II clinical trial conducted by NORTHLAND employed a multicenter, randomized, double-blind, placebo-controlled parallel-group design.

18

2018-05

The discussion meeting on the Phase III clinical trial protocol for “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” was successfully held.

发布时间：2018-05-18

To develop a scientifically sound and rational clinical trial protocol, our company organized a discussion meeting on the Phase III clinical trial protocol for “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” on May 17, 2018. The meeting invited experts, including Director Liu Changwei from the Department of Vascular Surgery at Peking Union Medical College Hospital, to engage in thorough discussions on issues such as inclusion and exclusion criteria, efficacy endpoints, and principles for selecting injection sites for this trial. Chairman Xu Songshan, Vice President Han Chengquan, and all members of the Clinical Research Department attended the meeting. This meeting marked another expert consultation following the communication session held with the Center for Drug Evaluation in April 2018. The focus of this meeting was...

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