Hybio Pharmaceutical Co., Ltd.

Company Profile

1. Peptide Formulations To date, the company has obtained consistency evaluation approval or deemed approval for 18 products (including 13 peptide injections and 5 solid formulations). The company is actively advancing the R&D and international commercialization of peptide formulations such as Tirzepatide, Semaglutide, Liraglutide, Glatiramer Acetate, Lanreotide, and Cetrorelix, aiming to achieve a high market share. A clear short-, medium-, and long-term product development roadmap has been established: Short-term focus: Key products include Liraglutide Injection, Teriparatide Injection, Cetrorelix, Glatiramer Acetate, Semaglutide, Tirzepatide, as well as innovative drugs such as HY3000 Nasal Spray (indicated for the prevention of coronavirus infection, currently in Phase III clinical trials) and HY3003 GLP-1R/GIPR/GCGR triple agonist for weight loss and diabetes (discovered via silicon-based chip and AI screening, with lead compound selection and API process validation completed; development of long-acting weekly, ultra-long-acting monthly, and oral formulations has commenced). Medium-term planning: Covers promising products including Abaloparatide, Difelikefalin, Lanreotide, Icatibant, Linaclotide, and Plecanatide. Long-term layout: Focuses on cutting-edge areas such as small-molecule nucleic acid drugs (e.g., Inclisiran for hypercholesterolemia and Zilebesiran for hypertension), antimicrobial peptides, peptide–drug conjugates (PDCs), anti-tumor peptides, peptide vaccines, and PEGylated cyclic peptides such as Pegcetacoplan for the treatment of geographic atrophy. In terms of resource integration and innovative R&D, the company actively promotes internal–external synergy. In addition to developing triple-agonist innovative drugs for weight loss and diabetes, it has established a strategic collaboration with Sinopharm to develop cannabidiol (CBD)–based innovative drugs, while promoting the integration and commercialization of peptide and oligonucleotide technologies. The company also keeps a close watch on emerging targets such as ActRII, PCSK9, ANGPTL3, and AGT for novel drug opportunities. Manufacturing capacity is being expanded in parallel: a hundred-gram-scale siRNA API pilot platform is expected to be completed within the year, kilogram-scale capacity is targeted for 2026, and formulation development and regulatory submission will follow accordingly. 2. Active Pharmaceutical Ingredients (APIs) The company develops and manufactures peptide APIs, small-molecule APIs, and peptide intermediates. Its Wuhan subsidiary has obtained Drug Manufacturing Licenses for 33 peptide APIs, and several products — including Tirzepatide, Semaglutide, Liraglutide, Ganirelix Acetate, Carbetocin, Atosiban Acetate, Desmopressin Acetate, and Terlipressin Acetate — have entered production and are being supplied to international markets. The company has a robust API pipeline, with 20 U.S. DMFs, 4 EU DMFs, 6 EU CEPs, and 14 China DMFs filed. As the global API market recovers and patents for peptide drugs expire, the company’s API business is expected to experience steady growth. 3. Oligonucleotides With the continuous breakthroughs of oligonucleotide therapeutics in chronic disease treatment, the global market for nucleic acid APIs is expected to grow steadily year by year. The company has strategically deployed resources in this area and is accelerating R&D and production efforts. Currently, the company is developing Inclisiran API and conducting in-depth process optimization. Meanwhile, the Wuhan subsidiary is constructing a dedicated oligonucleotide API manufacturing facility to meet the growing market demand and further expand production capacity. Moving forward, the company plans to initiate and develop more nucleic acid API projects to prepare for market expansion and strengthen its market position. 4. CRDMO Services Building on its international regulatory qualifications (including U.S. FDA and EU EMA certifications), the company is advancing the globalization of generic drugs while expanding into new business areas. It provides one-stop CRDMO (Contract Research, Development and Manufacturing Organization) services for global clients — covering peptide APIs, peptide formulations, oligonucleotide drugs, and pharmaceutical intermediates — including R&D, manufacturing, clinical trial support, and commercialization services. Leveraging its two major bases in Wuhan and Shenzhen Pingshan, the company has established a fully integrated peptide drug development platform encompassing both APIs and finished formulations. With its strong capabilities in R&D, regulatory filing, and manufacturing built over years of expertise in peptide drugs, the company delivers comprehensive, end-to-end CRDMO services that support the entire process from lab-scale to pilot-scale to commercial production.