About Us
Reinovax Biologics
About Reinovax

A fast-growing clinical stage biotech company focused on R&D and manufacturing of novel vaccines.

 

  • 2017
    Founded in
  • 2220m2
    R&D Center
  • 24Valent
    Pneumococcal Polysaccharide Conjugate Vaccine

Shanghai Reinovax Biologics Co., Ltd., (Reinovax), founded in Shanghai in 2017, focuses on research and development of innovative vaccines and recombinant protein-based biologics.

With the establishment of an R & D center in Zhangjiang Science City, Reinovax has built up an integrated research platform in molecular design and cloning, culturing and fermentation, purification and characterization, molecular coupling, immune assay, registration and IND filing, which provides strong support for the discovery of innovative biological products.

Reinovax, through its subsidiary Shanghai Microdom Biotech, constructed a 5000 m2 GMP pilot plant in Lingang, Shanghai. This facility supports scale-up process development, production of active ingredients, drug substances, adjuvants, drug products, filling, packaging, and analytical testing. It plays a key role in preparing clinical samples for Phase I-III trials and ensuring product quality and manufacturing process reproducibility.

Changchun Reinovax Biologics, a subsidiary of Shanghai Reinovax, established a 78,700 m2 EU-GMP compliant plant in Changchun, Jilin. The site can produce over 100 million doses of drug substances and 40 million drug products, featuring complete manufacturing lines for active ingredients, drug substances, products, adjuvants, filling, packaging, plus warehouses, animal facilities, and waste treatment.

PCV24 vaccine developed by Reinovax, featuring innovative design and manufacturing, has shown high immunogenicity and safety. Currently the phase II clinical trial for adults are nearly completed, and phase I trial for infantsis expected to be finished in the first half of next year.

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An Integrated System
An Integrated System

Shanghai Reinovax has set up wholly own subsidiaries Shanghai Mirodom and Changchun Reinovax  

R&D
R&D

Shanghai Reinovax Biologics Co., Ltd., (Reinovax) is a clinical stage biotech company focusing on discovery and development of innovative vaccines and recombinant protein-based biologics.

Shanghai Reinovax Biologics Co., Ltd.

 

Shanghai Reinovax Biologics Co., Ltd., (Reinovax) is a clinical stage biotech company focusing on discovery and development of innovative vaccines and recombinant protein-based biologics. The company has established a well sophisticated research platform as well as the capability for pilot scale process development and GMP manufacturing via its wholly own subsidiaries. The world’s first 24-valent pneumococcal polysaccharide conjugate vaccine with dual carrier protein by Reinovax has nearly completed the phase II trial for adults and is expected to start the phase III trial in 2025.   

Pilot Production
Pilot Production

Shanghai Microdom Biotech Co., Ltd. was established in Lingang Shanghai in March 2021, and is a wholly owned subsidiary of Shanghai Reinovax Biologics Co., Ltd. The company has the capacity for pilot-scale process development and manufacturing of clinical samples for Phase I-III trials.

Shanghai Microdom Biotech Co., Ltd.

 

Shanghai Microdom Biotech Co., Ltd. was established in Lingang Shanghai in March 2021, and is a wholly owned subsidiary of Shanghai Reinovax Biologics Co., Ltd. The company has the capacity for pilot-scale process development and manufacturing of clinical samples for Phase I-III trials.

Shanghai Microdom Biologics Co., Ltd. has a construction area of 5,025 square meters. The GMP-like workshop is equipped with various independent production lines for recombinant proteins, polysaccharides, adjuvants, conjugates, filling and packaging as well as analytical instruments.

GMP Manufacturing
GMP Manufacturing

Changchun Reinovax Biologics Co., Ltd. is a wholly owned subsidiary of Shanghai Reinovax Biologics Co., Ltd., with a focus on the commercial scale GMP manufacturing of polyvalent vaccines compliant with domestic, EU or WHO international standards.

Changchun Reinovax Biologics Co., Ltd.

 

Changchun Reinovax Biologics Co., Ltd. is a wholly owned subsidiary of Shanghai Reinovax Biologics Co., Ltd., with a focus on the commercial scale GMP manufacturing of polyvalent vaccines compliant with domestic, EU or WHO international standards. The company is located in the Biopharma Industry Park of Changchun High-tech Zone, Changchun, Jilin Province, with a construction area of approximately 77,600 square meters.

The manufacturing site has completed the construction and installation of equipment and instruments for all manufacturing suites, analytical laboratory, animal facility, warehouse, waste management, and office building. The validation process is currently ongoing.

History
History
2024
  • JULY.

    Completed the GMP Workshop Construction and Instrument Installation in Changchun

  • APR.

     Phase II trial in adults was started

  • APR.

    Phase I trial in infants and young children was started

2023
  • NOV.

    Phase I trial in adults was started

  • OCT.

    IND approval by NMPA for PCV24 clinical trial in infants

  • JAN.

    IND approval by NMPA for PCV24 clinical trial in adults

2021
  • MAR.

    Established a wholly-owned subsidiary,

    Shanghai Microdom Biotech Co., Ltd.

2020
  • MAY.

    Established a wholly-owned subsidiary, Changchun Reinovax Biologics Co., Ltd.

2019
  • APR.

    Initiated the pilot-scale process production for PCV24

2017
  • SEP. 

    Reinovax was established with an R&D center in Zhangjiang, Shanghai.

An Integrated System
An Integrated System
Corporate Culture
Company Culture
  • COMPANY VISION

    Striving for Better Health

  • COMPANY MISSION

    Developing Better Vaccines for People Worldwide

  • CORE VALUE

    Innovation, Quality, Dedication, Team-work

Exhibition
Exhibition
  • Shanghai Reinovax
  • Shanghai Microdom
  • Changchun Reinovax
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