Exciting News: Nuosiland's NL003 New Drug Application Officially Accepted by China's NMPA, Marking a Critical Step Toward Commercialization!
Northland
Innovative Biopharmaceutical Manufacturer
July 16, 2024Raysino Biotech's Key Strategic Partner: Beijing Northland Biotechnology Co., Ltd.(hereinafter referred to as Northland Bio) announced that the company's self-developed Class 1 new biologic drug for therapeutic use, Sedoming Base Injection – "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection (code name NL003)," has received the Notice of Acceptance issued by the National Medical Products Administration (NMPA). This marks the formal acceptance of the NL003 new drug registration application, which has now entered the new drug registration evaluation process.Rays Biotechnology expresses its warm congratulations on this milestone achievement by its partner!
Screenshot source: CDE official website
As a leading one-stop service provider of microbial expression systems in the industry,In the NL003 project, Yaohai Biotechnology mainly participated in several key technical support and production tasks, including process transfer and optimization of process scale-up, clinical sample preparation, and process validation.
At the same time, in order to accelerate the registration and listing process of this project, both parties maintained close coordination. RCBio, with its comprehensive and compliant quality management system, as well as good communication with drug regulatory authorities, promptly obtained the C-License of the "Drug Production License" and actively assisted Northland Biotechnology in applying for the B-License, helping its product submit the NDA on schedule and ensuring the smooth progress of the listing process.
About NL003 Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection
NL003 is a Class 1 therapeutic biological product that has not been marketed in or outside of China. It is an innovative gene therapy drug developed for the treatment of critical limb ischemia (CLI). Currently, there are no effective therapeutic drugs available worldwide, and clinical treatments mainly rely on surgical methods such as interventional procedures and vascular bypass grafting, which have shown unsatisfactory results, indicating significant unmet medical needs. Compared with existing treatment methods, the NL003 treatment strategy is innovative, capable of addressing distal ischemia caused by vascular occlusion through therapeutic angiogenesis, achieving the therapeutic goal, avoiding progression to life-threatening conditions or significantly impacting the patient's quality of life, and providing sustained clinical benefits.
The Phase III clinical trial of NL003 is divided into two trial protocols, ulcer and rest pain, conducted simultaneously. The acceptance notification for the New Drug Registration Application for the NL003 ulcer indication marks a significant milestone for this project, signifying that NL003 has completed all research and development content and taken a crucial step toward new drug market approval. We look forward to NL003 obtaining market approval soon, bringing new hope to a wide range of patients with ischemic diseases of the lower limbs.
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 targeting 13 indications. Among these, three have entered the clinical research stage. In addition to NL003, its recombinant human interleukin-11 for injection (code name NL002) has progressed to Phase III clinical trials, while its recombinant human thymosin β4 for injection (code name NL005) is undergoing Phase II clinical studies. Multiple ophthalmic drug products are being successively developed and launched. The company holds 22 authorized patents and has undertaken eight national-level "Major New Drug Creation" projects.
YaoHai Biotechnology, established in 2010, is a leading CRDMO service provider specializing in microbial expression systems and a national high-tech enterprise. Its businesses focus on fields such as "recombinant proteins/peptides, recombinant plasmids and novel recombinant vaccines, nanobodies, and nucleic acid drugs," with the aim of creating 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 life cycle 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 " Dedicated Service, Co-create the Future," with the mission of "Setting Global Standards, Accelerating New Drug Development, and Achieving a Healthy Life," continuously empowering global new drug creation.