Peptide Drug Development

API Process Development

Complex Formulation Challenges & Solutions

Highly Challenging Quality Research

Extensive Reg & Clin Experience

Large-Scale Production Platform

Mastered advanced international solid-phase peptide synthesis, plus core technologies (high-efficiency solid-phase cyclisation, sequence-specific small peptide separation). Independently developed/produced diverse peptide APIs and drugs from domestic raw materials, with large-scale production capacity.

Key Peptide Synthesis Technologies

Protective amino acid resin multi-substitution method
High-efficiency solid-phase coupling & modification technologies
Fragment synthesis technology
Multiple cyclic peptide synthesis technology
Multiple cyclic peptide synthesis technology
Small peptide separation sequencing technology
Large-scale solid-phase peptide synthesis preparation technology

Peptide drugs: High molecular weight, strong hydrophilicity, prone to GI enzyme degradation, poor intestinal absorption – oral bioavailability typically <1%. IV administration requires frequent injections due to short in vivo half-life (minutes), reducing compliance and increasing infection risk.

Solutions: Oral formulations (improve compliance) and controlled-release technologies (extend blood concentration duration, reduce dosing frequency) enhance therapeutic stability and usability.

Multi-dosage formulation technology platform, including:

Drug impurity research: 2D HPLC + HRMS for structural characterization of process/degradation impurities in peptides/oligonucleotides; establishes rational impurity control strategies.
Advanced drug structure research: Orthogonal methods (CD, SEC-MALS, AUC) characterize secondary/tertiary structures and aggregation states of peptides/oligonucleotides, meeting FDA/NMPA review requirements.
Packaging material compatibility: Custom protocols for diverse dosage forms and packaging (borosilicate glass, rubber stoppers, plastic containers), providing comprehensive reports compliant with global pharmacopoeia/regulations.

Hybio: Comprehensive quality research platform (meets reporting standards) with experienced peptide/small molecule quality teams and robust systems, including:

Comprehensive QC for peptide/small molecule APIs & formulations
Stability research system for peptides/small molecules
Impurity research system for peptides/small molecules
Structural confirmation system for peptides/small molecules

Specialized Research Techniques

Peptide drug racemic impurity analysis (qual/quant)
Peptide drug degradation impurity analysis (qual/quant)
Peptide drug adduct/defective peptide analysis (qual/quant)
Peptide drug racemic amino acid study
Drug structural confirmation (primary, secondary, tertiary, higher-order)

Seamless Shift: From Fast Clinical Development to Commercialization

Optimized trial design, accelerated recruitment & integrated data shorten new drug time-to-market. E.g., Hybio's anti-COVID-19 peptide rapidly advanced to Phase III via close regulatory communication; Semaglutide Injection (Class 2) weight management indication became China's first Phase III entry, showcasing clinical translation efficiency.

Synchronized Regulatory Filing & Compliance

Expert in NMPA/FDA review logic/requirements; skilled in resolving approval issues via technical-policy integration. Dedicated IND/ANDA teams offer end-to-end R&D, full project management & filing. Hybio's Class 1 HY3000 nasal spray: IND approved in 9 months from initiation.

Hybio's 100-acre Wuhan API base has 6 production units, with over 1,500 kg/year peptide API capacity. By 2024 end, 5-kg lixisenatide, >10-kg semaglutide/tirzepatide per batch were validated. B01 synthesis & B05 purification workshops are being renovated; post-renovation, annual API capacity will hit 5,000–10,000 kg.

Peptide API Production System

Imported full-auto synthesizers
Large-scale automated purification platforms.
Seamless lab-to-large-scale transition (e.g., Hybio's ton-level peptide tech) ensures controllable commercialization costs & quality.