▎WuXi AppTec Content Team Report

Today (July 13), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Beijing Northland Biotechnology Co., Ltd. (hereinafter referred to as:Northland Biotechnology) has submitted itsClass 1 Innovative DrugThe new drug application for Sedominje Injection has been accepted by the CDE.According to the information on Northland's official website,CedominogeneInjection (Code NL003) is aRecombinant Human Hepatocyte Growth Factor Naked Plasmid Injection, isNorthland BiotechnologyThe one with the fastest R&D progress in the gene therapy drug pipelineProduct, is being developed forLower Extremity Ischemic DiseaseTreatment。

Screenshot source:CDE Official Website

Public information shows that the phase 3 clinical trial of NL003 is divided intoRest Pain and UlcerTwo trial protocols, with the resting pain trial planning to enroll 300 cases and actually enrolling 302 cases;The ulcer trial planned to enroll 240 cases, with an actual enrollment of 242 cases.Previously,NL003TargetingUlcer Indication TrialCompleted unblinding and announced primary data in February 2024, with results meeting expectations.

Not long ago (June 2024), Northland announced that NL003 is used for the treatment ofSevere Lower Limb Ischemic Disease with Rest Pain IndicationThe last subject of the Phase 3 clinical trial has completed the study, and the trial has now entered the final stages of subsequent data cleaning, unblinding, and statistical analysis.

Northland BiotechThe press release pointed out, Rest PainAll subjects in the trial have completed their participation, marking the end of nearly five years of subject enrollment and follow-up work for NL003's two pivotal trials on rest pain and ulcers.

Public information shows that Northland was established in 2004 and is engaged in the research, production, and sales of gene therapy drugs, recombinant protein drugs, and ophthalmic drugs.The companyMainly devoted to the research and development and industrialization of bioengineering new drugs in the fields of cardiovascular diseases, metabolic diseases, rare diseases, and ophthalmic diseases.

CurrentlyNorthland has more than 10New drug pipeline in bioengineering, with 3 already in clinical research stage. BesidesNL003, ItsRecombinant Human InjectionInterleukin-11 (CodeNL002) is in Phase 3 clinical trials, andRecombinant Human Thymosin β4 for Injection (Code NL005) is in Phase 2 clinical stage.

Screenshot source:Northland Official Website

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved July 13，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] The Last Subject of the NL003 Phase III Clinical Trial for Rest Pain in Critical Limb Ischemia Completes Departure from https://www.northland-bio.com/news/564.html