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About us

Who is Hybio

Hybio Pharmaceutical Co., Ltd.,
Hybio Pharmaceutical Co., Ltd., established in April 2003, is a national high-tech enterprise specializing in the research, production, and sales of peptide pharmaceuticals. The company was listed on the Shenzhen Stock Exchange in 2011 (stock code: 300199) and it is distinguished as the first peptide enterprise listed in China. With subsidiaries in Pingshan, Wuhan, Hong Kong, Gansu Chengji, and Dali, Han Yu Pharmaceuticals operates in the fields of pharmaceuticals and medical devices. Our main products include peptide raw materials, custom peptides, cosmetic peptides, peptide formulations, solid dosage forms, medical devices, and peptide skincare products.
We have achieved significant regulatory milestones, obtaining GMP inspection certifications from various international authorities including NMPA (CFDA) of China, the US FDA, the EU's AEMPS, Brazil's ANVISA, and South Korea's MFDS. Its accomplishments include:
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New drug certificates

23

Clinical approvals

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GMP certificates in China, covering 13 APIs, injectable and solid dosages

25

Approval certificates for peptide finished formulations

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Overview

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  • FIRST listed peptide manufacturer in China. R&D, manufacture and commercialization  of therapeutic peptide APIs, peptide-based drugs. 01
  • PIPELINE of diabetes mellitus, obstetrics and gynecology, cardiovascular, gastroenterology, immunology, neurology, and skincare. 02
  • US FDA/EU cGMP standard, outstanding regulatory and quality team. 03
  • STRONG network coverage of sales & marketing over China mainland. Over 10 years’ experience in global market development. 04
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Our Culture

At Hybio Pharmaceutical, we are deeply committed to protecting health and life, with a culture grounded in a people-oriented approach. We prioritize our customers, fostering a spirit of pragmatism, innovation, and mutually beneficial cooperation.
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Vision

Our journey encompasses three key development stages: domestic expansion, international breakthrough, and global advancement. These stages reflect our strategic ambition to be a pioneering force in the pharmaceutical industry, driven by relentless pursuit of innovation.
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Mission and Values

We aim to be a leading international enterprise, continually advancing in therapeutic peptide research and development. Our values underscore our mission to enhance life with affordable medical solutions, maintaining the highest standards of quality and integrity.

Our History

Major historical events

1998:

Establishment of Hybio Pharmaceutical, marking the beginning of our journey.

2000:

Launch of the first Peptide Research and Development Center in China, showcasing our dedication to innovation.

2003:

Transition to large-scale production under Good Manufacturing Practice (GMP) standards.

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2004:

Introduction of Thymopentin and Somatostatin, expanding our product range.

2005:

Achievement of GMP approval, enhancing our quality standards.

2006:

Launch of Desmopressin, the first generic of its kind in China, and Eptifibatide, Hybio's first New Drug Application (NDA).

2007:

The beginning of our globalization efforts.

2009:

Launch of Terlipressin, another first generic in China.

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2011:

Hybio Pharmaceutical goes public with an IPO on April 7, 2011, on the China Stock Exchange.

2013:

Received GMP approval from CFDA for our new Finished Dosage Form (FDF) facility.

2014:

Acquisition of GS Changee Bio-Pharma Ltd. for US$216M.

2015-2018:

Passing of multiple international inspections including U.S. FDA, EU, Brazilian ANVISA, and KFDA, evidencing our commitment to global quality standards.

2019:

Inauguration of the Industrial hemp Production Center in Dali, China.

2020:

Introduction of medical-use face masks.

2021:

Development of a new drug, a Covid-19 nasal spray peptide drug.

2022-2023:

Passing the EU re-inspection on FDF site and undergoing TGA, FDA, and ANVISA inspections.

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Our Advantage

In the evolving world of peptide pharmaceuticals, Hybio Pharmaceutical actively engages with a profound commitment to research and development (R&D) and an unwavering dedication to quality. 

Our journey is fueled by a passion for innovation, a pursuit that has led us to invest significantly in our R&D efforts, reflecting a substantial 29.41% of our revenue back into research in Q1-3 2023 alone. This investment is a testament to our resolve to lead and redefine the industry standards.

  • Research and Development

    At the heart of our R&D prowess is our team, a diverse group of over 203 researchers, who constitute 20.80% of our workforce. This talented pool of individuals is not just a number; it represents a melting pot of ideas, expertise, and ambition. Collaborating with leading domestic and international research institutions, we've expanded our horizons, bringing on board more than 20 distinguished technical consultants who share our vision for the future of healthcare.
    Our commitment to innovation is also mirrored in our robust portfolio of intellectual property, presenting 277 Chinese patents and 30 global patent authorizations. These figures are more than just milestones; they are a clear indication of our leadership and pioneering spirit in the peptide sector. Our technological advancements are further evidenced by our proprietary core technologies for large-scale peptide production, which not only enhance production efficiency but also elevate the quality of our products, ensuring they meet the rigorous demands of cost-efficiency.

  • Quality System

    Quality is not just a component of our operational framework; it is the backbone of our manufacturing ethos. Our production sites for Active Pharmaceutical Ingredients (API) and Finished Dosage Forms (FDF) have successfully passed stringent inspections in critical markets, including China, the US, Europe, and South Korea. This global compliance underscores our commitment to adhering to international quality standards, ensuring that our products are synonymous with excellence.
    Our "quality first" philosophy is the foundation upon which our comprehensive quality management system is built. This system is not just about compliance; it's about exceeding expectations, ensuring the safety, efficacy, and superiority of our medicines. With certifications from US cGMP, EU GMP, Korean GMP, and other international benchmarks, we are not just claiming to prioritize quality; we are proving it with every product that leaves our facilities.

  • Industrialization System

    Further elevating our competitive edge is our comprehensive peptide drug industrialization system. This system encompasses advanced methodologies and technologies that streamline the transition from research to commercial-scale production. By integrating innovative synthesis techniques and purification processes, we ensure the scalability of our peptides, maintaining the highest standards of quality from lab to market. This seamless industrialization process underpins our capacity to swiftly bring groundbreaking peptide therapies to patients, reinforcing our commitment to advancing healthcare.
    At Hybio, we don't just develop peptide pharmaceuticals; we are setting new benchmarks for what it means to be at the intersection of innovation and quality. Explore the impact that our dedication, passion, and excellence have on healthcare, shaping a future where advanced treatments and quality care go hand in hand.

Recognition

“In the realm of dreams lies the potential for extraordinary achievements. When we dare to dream and act with conviction, the impossible becomes possible.”

Shaogui ZengHybio Founder

State & Local Joint Engineering Laboratory of Peptide Drug and Guangdong Engineering R&D Center of Peptide Drug

The R&D Center of Hybio Pharmaceutical was established in 2003. After more than a decade of development, it has been successively designated as the Guangdong Provincial Engineering Technology Research and Development Center for Peptide Drugs by the Guangdong Provincial Department of Science and Technology, and as the National and Local Joint Engineering Laboratory for Peptide Drugs by the National Development and Reform Commission.

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Our Honors