Exciting News! YaoHai Bio Congratulates Northland Biotech on Successful Drug Registration Testing of NL003
Yaohai-Bio
Microbial Expression System CRDMO Service Provider
Northland
Innovative Biopharmaceutical Manufacturer
September 26, 2024Yaohai-Bio's Key Strategic Partner —— Beijing Northland Biotechnology Co., Ltd.(hereinafter referred to as Northland) has independently developed a Class 1 new biological product for therapeutic use, the Sedominogene Injection – “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” (code name NL003), which has received the "Drug Registration Inspection Report" and the "Drug Registration Standard Review Opinion" issued by the National Institutes for Food and Drug Control.The report states: "This product was tested according to the declared quality standards, and the results met the requirements." This marks that both the NL003 bulk solution and formulation have passed the pre-registration inspection, meeting the quality standards, and the new drug registration review has taken another step forward.Yaohai-Bio extends warm congratulations on another new milestone achieved by its partner!
Drug registration inspection is a crucial part of the drug registration review process, and passing the drug registration inspection is a necessary condition for obtaining a drug registration certificate. The National Medical Products Administration, based on the application of drug registration applicants and in accordance with legal procedures, conducts strict testing and evaluation of various aspects related to drug quality to ensure the quality and safety of drugs.NL003 has successfully passed the registration inspection, indicating that it has established a production and quality control system in compliance with GMP standards, with stable production processes and controllable quality.
NL003 is the first plasmid-based gene therapy drug independently developed by Northland in China. It is a Class 1 innovative biologic drug used for treating severe lower limb ischemic diseases.The Phase III clinical study of NL003 is being conducted for two indications: ulcers and rest pain. The registration application for the ulcer indication was officially accepted in July 2024. The study for the rest pain indication was officially unblinded in August 2024, with primary results meeting expectations. The company is currently organizing statistical analysis and drafting the clinical trial summary report, with plans to submit a new drug registration application within the year. In accordance with regulatory review requirements, the company will fully cooperate with pharmaceutical regulatory authorities on tasks such as on-site inspections for registration. Meanwhile, it is actively preparing for commercialization to accelerate the market launch of NL003.
Yaohai-Bio sincerely congratulates our partner Northland on this significant progress. We also eagerly look forward to the early approval and market launch of NL003, which aims to fill the existing gap in this medical field and provide patients with related diseases more diverse and effective treatment options!
Beijing Northland Biotechnology Co., Ltd. was established in 2004. It is an innovative biopharmaceutical company specializing in the research, production, and sales of gene therapy drugs, recombinant protein drugs, and ophthalmic drugs. Guided by clinical needs, the company relies on its proprietary core technology platform to focus on the research and industrialization of bioengineering new drugs in areas such as cardiovascular diseases, metabolic diseases, rare diseases, and ophthalmic diseases.
The company boasts a rich and highly mature pipeline of drug development, with 11 novel bioengineering drugs currently under research corresponding to 13 indications, three of which have entered the clinical research stage. Apart from NL003, its recombinant human interleukin-11 for injection (code name NL002) has entered Phase III clinical trials, while its recombinant human thymosin beta 4 for injection (code name NL005) is undergoing Phase II clinical research; multiple ophthalmic drugs are being successively developed and launched. The company holds 22 authorized patents and has undertaken eight national-level "Major New Drug Creation" projects.
Yaohai-Bio, established in 2010, is a leading CRDMO service provider specializing in microbial expression systems and a national high-tech enterprise. The company focuses on fields such as "recombinant proteins/peptides, recombinant plasmids and novel recombinant vaccines, nanobodies, and nucleic acid drugs," and is committed to building an open and integrated CRO/CDMO/MAH industry-research service platform.
The company continuously improves and perfects its R&D, production, quality management, and control service systems, building a distinctive platform technology. With comprehensive service capabilities, extensive project experience, and leading scale advantages, it has successfully delivered more than 200 projects, spanning the entire lifecycle from early research, IND clinical trial applications, GMP production of clinical samples, to commercial production.
In the future, the company will continue to uphold the service philosophy of "Devoted Service, Co-create the Future" and take "Establishing Global Standards, Accelerating Drug Development, and Achieving a Healthy Life" as its mission, continuously empowering global new drug creation.