Great News! Xiushi Biopharma's Semaglutide with New Bioprocess Successfully Completes DMF Filing in the U.S.!

On April 16, 2025, the U.S. FDA released the latest Drug Master File (DMF) list. Xiushi Biopharma's Semaglutide product, produced with a breakthrough bioprocess, successfully made the list (DMF number: 041460). This milestone achievement not only demonstrates Xiushi Biopharma's innovative strength but also marks a solid and remarkable step we have taken on the global pharmaceutical stage!

The US FDA website updated the DMF list on April 16, 2025

Authorization Letter of the Registration Number of Semaglutide replied by the FDA

About Semaglutide

Semaglutide, as a highly anticipated and popular drug, plays an important role in the fields of diabetes treatment and weight management. Xiushi Biopharma is well aware that only through continuous innovation can it stand out in the fierce competition in the pharmaceutical market. The Semaglutide product that has successfully applied for the U.S. DMF this time is produced using a new bioprocess. Since the beginning of its R&D, this process has incorporated the wisdom and efforts of the company's top scientific research team. After numerous experiments and optimizations, it has overcome a series of technical challenges such as the stability of raw materials, production efficiency, and product purity, achieving a perfect leap from theory to practice. Compared with traditional processes, the Semaglutide product produced by our new bioprocess has a higher purity and more stable quality, truly driving the quality upgrade through innovation.

About the DMF Filing

The U.S. FDA, as an authoritative institution in the global pharmaceutical regulatory field, has an extremely strict DMF filing process, with nearly stringent requirements for aspects such as the drug production process, quality control system, safety, and effectiveness. The successful completion of the U.S. DMF filing and the inclusion of Xiushi Biopharma's Semaglutide product in the list mean that our production process, product quality, etc. have been recognized by international authorities and we have obtained the "pass" for the international market. This achievement is not only a high affirmation of Xiushi Biopharma's persistent innovation, R&D, and strict quality management over the years, but also lays a solid foundation for subsequent products to explore the international market and participate in global pharmaceutical competition.

About Xiushi Biopharma

Xiushi Biopharma is a national high-tech enterprise that takes the lead internationally and focuses on the large-scale biosynthesis of polypeptide drugs. Xiushi Biopharma provides products and comprehensive services covering from drug research, clinical development to the product launch stage for global biotechnology and pharmaceutical enterprises.

The team of Xiushi Biopharma is composed of senior industry engineers and scientists. Relying on rich practical experience in the fields of synthetic biology and biomanufacturing, it offers brand-new solutions for the biosynthesis of polypeptide drugs to industry partners. The solutions provided by Xiushi Biopharma can help partners maintain a leading position in the discovery, clinical development, and commercial production of polypeptide drugs.

Xiushi Biopharma has a research and development center covering an area of more than 5,000 square meters and an intelligent manufacturing base of 20,000 square meters, which can meet the development and production needs of different customers and various products. At the same time, it has the conditions for drug production that comply with GMP standards.