Hitston Ltd. (abbreviated as "Hitston") is a world leading small nucleic acid drug CDMO service platform jointly established by HitGen Inc. (stock code: 688222.SH) and Easton Biopharmaceuticals (stock code: 688513.SH), specializing in providing pharmaceutical companies and research institutions with full value chain solutions from preclinical to commercial production.
Hitston Ltd.
World Leading Small Nucleic Acid Drug CDMO Service Supplier
Based on a 2000㎡ oligonucleotide GMP facility, 1000㎡ quality control laboratory, and HitGen's professional R&D laboratories, Hitston has achieved gram-to-kilogram-scale API production for IND applications, clinical Phase I-III, and early commercialization stages, with a total investment of nearly $15 Million, covering global demand.
Team Introduction
The company consists of over 100 professional researchers and technicians. The core team members all hold Doctor degrees and have over 10 years of experience in oligonucleotide design, synthesis, process development, and scale-up production. The leaders have domestic and oversea deep research and work experience, deeply involved in the entire nucleic acid drug industry chain.
Quality System
Global Compliance Certifications: NMPA/FDA/ISO9001 Full Coverage
Hitston facility has passed China NMPA GMP certification, U.S. FDA cGMP inspections, and ISO9001 system certification, and has undergone multiple audits by EU and Japanese clients. Its compliance is globally recognized. It has 30+ domestic registered varieties (A/I status) and international qualifications covering 3 EU CEPs, 3 JP DMFs, and 5 US DMFs/VMFs, providing one-stop China-US dual-reporting support.
9001 Certificate
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