HANGZHOU HUADI GROUP CO., LTD.

Huadi Group was founded in February 2011 with its origins dating back to 1995. It was invested and established by a group of professionals specializing in biomedical research and development, with extensive experience in production, operation and management. The group focuses on the R&D and commercialization of innovative peptide-based biopharmaceuticals from natural sources, small molecule synthetic peptide innovative drugs, pharmaceutical intermediates, medical devices, bio-nutrition and health products, as well as bio-cosmetic raw materials. It has accumulated rich expertise in the R&D of Class I innovative drugs, international drug registration and export, with technological capabilities at the leading level both domestically and internationally. Huadi Group has constructed a full set of GMP-compliant production facilities, including biochemical drug extraction lines, dedicated production lines for naturally extracted peptide APIs for export, small molecule peptide API synthesis lines, and capsule production lines. Its drug R&D efforts are led by a GMP management team with 30 years of experience in R&D and industrialization. At the invitation of the National Pharmacopoeia Commission, Huadi Group has participated on multiple occasions in the revision of quality standards for biochemical drugs and the drafting of the GMP Appendix for Biochemical Drugs. It has played a leading and exemplary role in resolving key technical challenges in the biochemical pharmaceutical industry, including research on biological activity, method establishment, and related basic substance research, establishing itself as a benchmark enterprise in the sector. Huadi Group and its subsidiaries have undertaken dozens of national innovation fund projects. Its technological achievements have been granted a number of national new drug certificates, with more than 30 national invention patents authorized. Its flagship products include HGPF Capsules (a nationally exclusive new drug), TF Capsules, and Cerebroprotein Hydrolysate, all of which have been awarded the National Key New Product Certificate. In terms of innovative R&D projects: The “Personalized Cancer Therapy – Neoantigen Peptide” project has been applied to Class I innovative drug development and received clinical trial approval in April 2023. The “Platform for Plant Transient Expression of Medicinal Proteins, Peptides and Vaccines” has achieved core technological breakthroughs, with dozens of domestic and international invention patents filed. This project is poised to lead the next wave of innovative development in the industry.