Good news! Northland Biotech's Naked Plasmid NL003 BLA was accepted by NMPA

On July 16 2024, the valued client of Yaohai Bio-Pharma, Beijing Northland Biotechnology Co., Ltd. (Northland), announced that its independently developed Category 1 new therapeutic biological product, "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection (Code: NL003)," has received a "Notice of Acceptance" from the National Medical Products Administration (NMPA). This notification signifies the formal acceptance of the biologics license application (BLA) for NL003 and its progression into the new drug registration review process. Yaohai Bio-Pharma extends its heartfelt congratulations to Northland Biotech on this significant achievement.

NL003, an uncommercialized global Category 1 gene therapy, specifically targets critical limb ischemia. The absence of effective pharmacological options worldwide has rendered existing treatments inadequate, emphasizing a significant unmet medical need. NL003 employs an innovative mechanism to promote angiogenesis to treat distal ischemia, thereby mitigating severe clinical outcomes and enhancing patients' quality of life, while offering sustained therapeutic benefits.

Concurrently, its Phase III clinical trials address associated complications such as ulcers and rest pain. Accepting the biologics license application (BLA) for ulcers signifies the completion of research and development and represents a critical milestone toward commercialization. We anticipate the approval of NL003, with hopeful expectations of its potential to significantly improve the lives of patients suffering from critical limb ischemia.

Yaohai Bio-Pharma, a top CRDMO services provider for microbial expression, aided NL003's journey with process transfer, process optimization, sample preparation, and validation. Close collaboration fast-tracked registration. Yaohai Bio-Pharma leveraged its comprehensive quality regulatory system to promptly obtain the Class C Pharmaceutical Production License and actively assisted biologics license application (BLA) Biotech in applying for the Class B license, thereby facilitating the timely submission of the BLA for their product and ensuring the smooth progress of the market launch process.

About Northland

Northland was founded in 2004. It is an innovative biopharmaceutical enterprise specializing in the research and development, production, and sales of gene therapy drugs, recombinant protein drugs, and ophthalmic drugs. Guided by clinical needs and relying on its independent core technology platform, the company is primarily dedicated to the research and industrialization of new bioengineering drugs in the fields of cardiovascular diseases, metabolic diseases, rare diseases, and ophthalmic diseases.

About Yaohai Bio-Pharma

Yaohai Bio-Pharma, established in 2010, is a leading CRDMO service provider specializing in microbial expression systems and a national high-tech enterprise. Its business focuses on areas such as recombinant proteins/peptides, recombinant plasmids and novel vaccines, nanobodies, and nucleic acid drugs, aiming to build an open and integrated CRO/CDMO/MAH production and research service platform

We are also actively seeking institutional or individual global partners. We offer the most competitive compensation in the industry. If you have any questions, please feel free to contact us: [email protected]