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About us

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About us

Hybio Pharmaceutical Co., Ltd., a national high-tech enterprise, specialized in R&D, production and marketing of peptide drugs, with a focus on peptide drugs and Oligonucleotide Drug. Listed on the Shenzhen Stock Exchange in 2011 (stock code: 300199), it is among China's earliest listed peptide drug companies.
Boasting national-level platforms like the National and Local Joint Engineering Laboratory for Peptide Drugs, it has undertaken multiple national projects and won honors including the Second Prize of National Technological Invention Award, China Patent Excellence Award, and entitled as National Intellectual Property Demonstration Enterprise.
GMP certified by China NMPA, US FDA, EU EMA, Brazil ANVISA, Australia TGA, Indonesian BPOM, South Korea MFDS, etc., it has built a vertical integrated industrial chain covering API、finished dosage and marketing, securing supply chain from raw materials to drugs. Adhering to the vision of continuous innovation to lead the peptide industry, Hybio takes protecting life and health as its eternal mission.
29

Approval certificate for finished peptide preparations

9

New drug certificate

32

Clinical approval

Strategic layout

Supported by three strategies of "talent, innovation and globalization", the company builds a competitive "innovative + generic drugs" pipeline through "in-house R&D + internal-external resource integration". The company explores diversified peptide applications, and drives sustained, stable, rapid, healthy and efficient growth through product-led diversified operations.
Strategic layout
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Innovation and Mutually Beneficial Collaboration

As a leading pharmaceutical enterprise in the peptide industry, the company leverages its core strengths to build partnerships with world-class, resource-complementary entities globally—including advanced tech firms, research institutions, and pharmaceutical companies. Hybio collaborates with leaders like Huawei Cloud and iCarbonX to enhance drug discovery and process development capabilities. Meanwhile, Hybio works closely with research institutions such as the Institute of Microbiology (CAS), Shenzhen Institutes of Advanced Technology (CAS), Institute of Process Engineering (CAS), Shenzhen Bay Laboratory, and Shenzhen National Clinical Research Center for Infectious Diseases to advance R&D initiatives; and teams up with domestic and international pharmaceutical companies (e.g., Hikma, Ferring Pharmaceuticals, China National Pharmaceutical Group, and 3SBio Mandi) for product commercialization.
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OUR HISTORY

  • dna
    dna

    szhyyygf-file15Joint development with Carbon Cloud Intelligent Peptide Pharmaceutical on GLP-1R/GIPR/GCGR triple agonist peptide innovative drugs

    szhyyygf-file15Comprehensive collaboration with HUAWEI CLOUD, focusing on "AI smart medicine"

    szhyyygf-file15Strategic partnership with Sinopharm to explore new pathways for innovative drug R&D

    szhyyygf-file15Strategic cooperation with Jardine Jiaye to co-build a new ecosystem for sleep health management

    2025
    2024

    szhyyygf-file15Liraglutide Injection: FDA-approved, with around 2 million pens shipped to U.S.

    szhyyygf-file15Cooperation agreement with 3SBio Mandi for semaglutide injection (for weight loss)

    szhyyygf-file15Global commercial orders secured for GLP-1 formulations and APIs

  • dna
    dna

    szhyyygf-file15Hybio passes US FDA cGMP on-site inspection with "zero 483"

    szhyyygf-file15Global comprehensive collaboration with Ferring Pharma on reproductive peptide injections

    2023
    2021

    szhyyygf-file15GLP-1 drug licensing agreement signed for U.S. market export

    szhyyygf-file15Collaboration with Academician Gao Fu (CAS) on developing HY3000, a peptide nasal spray for COVID-19 prevention

  • dna
    dna

    szhyyygf-file15Atosiban: Approved in Germany, Spain (for treating women's preterm birth)

    szhyyygf-file15Eptifibatide: FDA-approved (anticoagulant)

    2020
    2019

    szhyyygf-file15Industrial Hemp Production Center, Dali, Yunnan, China

  • dna
    dna

    szhyyygf-file15Passed EU EMA inspection, Korean MFDS inspection

    2018
    2017

    szhyyygf-file15FDF production line passed the inspection of ANVISA in Brazil

  • dna
    dna

    szhyyygf-file15API production line approved by US FDA and EU authorities

    2015
    2014

    szhyyygf-file15Purchased Gansu Chengji Biopharmaceutical Co., Ltd. for $216 million

  • dna
    dna

    szhyyygf-file15New formulation facility granted CFDA GMP approval

    2013
    2011

    szhyyygf-file15Listed on the Shenzhen Stock Exchange Enterprise Market

  • dna
    dna

    szhyyygf-file15Launched China's first generic terlipressin

    2009
    2007

    szhyyygf-file15Global business expansion

  • dna
    dna

    szhyyygf-file15•Eptifibatide: Hybio's first new drug application

    szhyyygf-file15Launched China's first generic desmopressin

    2006
    2005

    szhyyygf-file15APIs (oxytocin solution, triptorelin acetate) obtained drug GMP certification

  • dna
    dna

    szhyyygf-file15•Thymopentin launched

    szhyyygf-file15Somatostatin launched

    2004
    2003

    szhyyygf-file15Achieve large-scale production under GMP standards

  • dna
    dna

    szhyyygf-file15Established China's first peptide R&D center

    2000
    1998

    szhyyygf-file15Hybio established

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corporate culture

API base

Hybio Pharmaceutical (Hubei) Wuhan subsidiary is a national high-tech enterprise specializing in the research, production and marketing of peptide characteristic APIs, a specialized and special new small and medium-sized enterprise in Hubei Province, a green factory in Hubei Province, and a health enterprise in Hubei Province. The company is located in the Airport Demonstration Industrial Park in Huangpi District, Wuhan City, designed and built in accordance with international cGMP standards, introducing international leading production technology and advanced equipment, and a world-class biomedical production base. With advanced automatic peptide synthesis system, automatic purification system and advanced facilities and equipment, with a complete GMP management system and professional and technical personnel, the peptide API production base has passed the official GMP certification of China/the United States/Australia and other countries.

  • International standard certification

    sss (1) Meets cGMP, EU-GMP, FDA-GMP requirements

  • Large-scale capacity expansion

    sss (2) It is expanding its API production line and is committed to building a world-class peptide API and biomedical production base

  • Intelligent production system

    sss (3) Equipped with fully automated synthesis/purification systems and state-of-the-art facilities

Industrial hemp base

Relying on the relevant industrial policies of Yunnan Province and Dali Prefecture, Hybio Pharmaceutical (Yunnan) Dali Subsidiary focuses on the development of four major business segments, with industrial hemp products and medical institution preparations as the main development business, and pharmaceutical culture media, nicotine and natural plant extracts as auxiliary business segments. The company has the advantages of GMP management standards of pharmaceutical enterprises, and can quickly cut into the research and development and production of traditional Chinese medicine preparations, industrial hemp drugs, and natural plant extracts for health products, forming a comparative advantage in the industrial chain - in the purification and processing of industrial hemp CBD, traditional Chinese medicine preparations, and natural plant extracts, it has process design technical capabilities, and can fully support drug research and development, production, patent application, registration, efficacy evaluation and other technical links, and quickly realize the industrialization ability of products. It can purify CBD crystals + CBD full-spectrum oil at the same time, as well as the compatibility of traditional Chinese medicine preparations and natural plant extracts as raw materials and other processes, which is conducive to the development of diversified products.

  • Dual-core drive

    sss (1) Industrial hemp products, preparations for medical institutions

  • Characteristic process technology

    sss (2) CBD purification (crystals + full-spectrum oil), traditional Chinese medicine preparations and plant extract processing

  • GMP empowerment

    sss (3) Pharmaceutical standards ensure compliant and efficient production

High value-added pharmaceutical intermediates

Hybio Pharmaceutical (Gansu) Chengji Subsidiary is a large-scale high-tech modern comprehensive enterprise integrating R&D, production and sales of drugs and medical devices. It is one of the few dual-certificate enterprises in China with "Drug Production License" and "Medical Device Production License". The company covers an area of 117 acres and has a registered capital of 229 million yuan. The company has 170 drug registration approvals, including lyophilized powder injections, small-volume injections, tablets, capsules, granules, syrups, powders, oral liquids, APIs, large-capacity injections, etc. The company has 15 medical device registration certificates and 105 patented technologies.

  • Floor area

    sss (1) 117 acres

  • Drug registration approval

    sss (2) 170

  • Patented technology

    sss (3) 105 items

Preparation base

As a preparation production base, Hybio Pharmaceutical (Shenzhen) Pingshan Branch covers an area of 25,000 square meters and is listed as a "major construction project for industrial revitalization" by the National Development and Reform Commission. It is built with full reference to European and American cGMP standards, and has production lines representing the international advanced level, including 3 vial production lines, 1 cartridge production line and 1 pre-potting production line. Since it started production in 2013, it has successfully obtained GMP certificates from the following regulatory agencies: China NMPA, US FDA, EU EMA, Brazil ANVISA, Pakistan MOH, Indonesia BPOM, etc.

  • Floor area

    sss (1) 25,000 square meters

  • International advanced production line

    sss (2) vial production line, cartridge production line, pre-filling production line, etc

  • International GMP certification

    sss (3) China NMPA, US FDA, EU EMA, Brazil ANVISA, Pakistan MOH, Indonesia BPOM, etc

maps
  • szhyyygf-file18
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    API base
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    Industrial hemp base
  • szhyyygf-file20
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    High value-added pharmaceutical intermediates
  • szhyyygf-file19
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    Preparation base