Xiushi Biopharma is an international leading high-tech enterprise focusing on large-scale biosynthesis of polypeptide drugs. We provide all-round products and services from drug research, clinical development to access to market for global biotechnology and pharmaceutical enterprises.
We have professional and experienced engineers and scientists, providing new polypeptide drug biosynthesis solutions, which help partners stay ahead of the polypeptide drug discovery, clinical development and market production.
We have more than 5000 square meters of R&D center and 20000 square meters of intelligent manufacturing base, which can meet the needs of different customers and products, while meeting the GMP conditions for drug production.
XIUSHI Biopharma is a CDMO specializing in the manufacturing of synthetic peptides and oligonucleotides for early-phase, late-phase development, and commercial production. XIUSHI Biopharma excels in large-scale, late-phase, and commercial production, boasting the production capability in kgs quantities.
We specialize in contract development and manufacturing organization ("CDMO") services, which include peptide chemistry, manufacturing, and controls ("CMC") development; as well as contract manufacturing organization ("CMO") services, encompassing peptide new chemical entities (NCEs) and generic drug commercial manufacturing.
XIUSHI Biopharma provides a comprehensive peptide-centric CDMO platform with vertically integrated capabilities in peptide drug development and manufacturing, adhering strictly to Good Manufacturing Practice (GMP) standards mandated by major regulatory authorities globally.
GMP Compliance XIUSHI Biopharma's GMP program strictly adheres to FDA/EU GMP guidelines.
Code of Federal Regulations Part 210/211 (21 CFR 210/211) and ICH Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7)
Relying on this technology, the institute has established a research and development platform for recombinant peptide (protein) innovative drugs, with recombinant drug research room, engineering cell design laboratory, drug green process laboratory, drug manufacturing engineering process laboratory, recombinant drug quality laboratory and recombinant drug preparation laboratory, and is equipped with a full set of advanced instruments and equipment, which can complete a full set of pharmaceutical research from drug screening to engineering bacteria construction, high-density fermentation, large-scale renaturation, product purification and refining to quality analysis.
Xiushi Biomedicine (Nantong) Co., Ltd. relies on the team of Professor Wan Minxi of the State Key Laboratory of Bioreactor Engineering of East China University of Science and Technology, and the core technical team is composed of returnees, professors and industry experts from well-known universities. At present, the company has 51 full-time employees, of which 27% are graduate students and intermediate engineers or above.
Xiushi Biopharmaceutical (Nantong) Co., Ltd. has also established close industry-university-research cooperation with a number of well-known pharmaceutical research institutions and well-known universities at home and abroad, including Johns Hopkins University, Tsinghua University, Chinese Academy of Sciences, China Pharmaceutical University, East China University of Science and Technology, Southwest University, etc. The institute undertakes a number of national key R&D programs and R&D projects of pharmaceutical companies, including peptide characterization and analysis, cell activity detection, animal pharmacodynamics, toxicology, pharmacokinetics and other new drug research and development content.
In addition, Xiushi Biopharmaceutical (Nantong) Co., Ltd. has established a complete technology transformation cooperation system for upstream and downstream enterprises, covering large pharmaceutical companies including Beite Pharmaceutical, Borui Biotechnology, Rundu Pharmaceutical, Hanxin Biotechnology, etc.
Development History
In 2020
Xiushi Biopharma (Nantong) Co., Ltd. established.
In 2021
Selected into Zilang Talents" project of Chongchuan District, Nantong,
Realizing the world's first biosynthetic complex cyclic peptide drug technology platform
In 2022
Selected into the first "New Research and Development Institution" in Nantong,
Reached commercial cooperation with ultra long-term diabetes treatment innovative drug project
In 2023
Completed angel round financing, won the "Valuable Field Award" Top 100 Future Medical Company of Arterinet 2023, selected into "Jianghai talents" project in Nantong, won the new industrialization outstanding enterprise - future industry cultivation, selected into "innovative and entrepreneurial talent" project of Jiangsu Province,
In 2024
Completed nearly 100 million RMB Pre-A round of financing
Company Culture
Xiushi Biotech is redefining the peptide industry through technological innovation, creating a more efficient, environmentally friendly, and safe vision.
Enterprise Honor
2020
Awarded Nantong City science and technology innovative enterprises.
2021
Awarded "Zilang Talents" in Nantong Chongchuan District.
Awarded "New R&D Institution" in Jiangsu Province.
2022
Jointly build "Joint Laboratory of Synthetic Biology Technology and Drugs" with State Key Laboratory of Bioreactor, East China University of Science and Technology.
Jointly build "Synthetic Biology Cosmetic Raw Material Efficacy Joint Laboratory" with Jiangnan University.
2023
Selected into “Jianghai talents of Nantong City”
Awarded “High-tech enterprise certificate of Jiangsu province”
Selected into “Double-innovative talents of Jiangsu province”
Awarded “New industrialized outstanding enterprise with future cultivation of Nantong City”
