An Innovative Platform for Developing New Biologics

General Regeneratives possesses a new generation of biologics screening platform, “Prometheus Technology”, to highly efficiently discover functional genes critical for disease self-healing, and develop innovative biologics by using genetic engineering, protein, and antibody engineering to produce novel recombinant proteins and antibodies.

5 Therapeutic Areas
  • Immuno-Oncology
  • Autoimmune Diseases

    /AID

  • NASH
  • Cardiovascular Diseases

  • Cartilage Diseases
Pipeline

General Regeneratives has established a robust protein & antibody R&D pipeline developed successfully by “Prometheus Technology” with global patents for various indications in 5 therapeutic areas including immuno-oncology, AID/Autoimmune diseases, NASH, cardiovascular diseases, and cartilage diseases.

News
  • GR009 Targeting a Novel Immune Suppressor for Cancer Immunotherapy
    2019-09-17

    Prof. Wei Han, Founder and CEO of General Regeneratives (Shanghai) Ltd., was invited to give a speech on "GR009-Targeting a Novel Immune Suppressor for Cancer Immunotherapy",...


    Presented by Wei (William) Han, Founder & CEO, General Regeneratives at ATBP 2019

    The 3rd Antibody-based Therapeutics & BioProduction Forum (ATBP2019) was successfully held on September 4th-6th at Intercontinental Shanghai Pudong Hotel, and approximately 500 executiveand senior professionals in the research, process/product development and manufacturing of therapeutic antibody and biologics attended. The antibody-based therapeutics have entered the new era of drug discovery and development, and research has expended to neurodegenerative diseases, and antibody-drug conjugates. Over 70 antibody-based therapeutics have been approved, and the market will reach approximately USD 138.6 billion by 2024. In the meanwhile, Bio-industry in China has also grown rapidly, and the bioprocessing technology and manufacturing capability have been matured gradually. Following the earlier development of biosimilars, biotech companies in China are moving quickly towards developing the innovative biologics. ATBP 2019 was set up to facilitate the communication and partnerships to accelerate the biologics R&D, analysis, and product development technology.


    Prof. Wei Han, Founder and CEO of General Regeneratives (Shanghai) Ltd., was invited to give a speech on "Targeting a Novel Immune Suppressor for Cancer Immunotherapy", sharing research and development of innovative immunotherapy, GR009 with discovery of new target, CXCL4. He introduced what R&D team has discovered over years of research: 5-fluorouracil (5-FU) chemotherapy induced overexpression of CXCL4, which inhibited immune response by activating CXCL4's receptor, CXCR3, therefore promoted the growth of CRC cells and resulted in tumor relapse and metastasis. 5-FU chemotherapy also damaged intestinal mucosa and bone marrow, which were the main causes of chemotherapy-induced diarrhea and neutropenia. In-depth study found that CXCL4 activated p38-p53-caspase 3 pathway through CXCR3 to induce apoptosis of intestinal epithelial crypt cells, and CD8+ T cells to inhibit function of tumor-infiltrating CD8+ T cells. By this pathway, CXCL4 down-regulated PD1 expression on Treg expression, enhanced function of Tregs, and reduced CD8+/Treg ratio.

    Based on the study of new mechanism and new target for CXCL4, it was confirmed in animal study that CXCL4 mAb, GR009 reduced weight loss, diarrhea, and mortality caused by 5-FU, as well as weight loss, and mortality induced by cyclophosphamide (CTX). GR009 inhibited 5-FU induced apoptosis in the intestinal crypt required CXCR3 and p53. Through increasing antitumor CTL cytotoxic function after chemotherapy, GR009 could enhance apoptosis of cancer cells and inhibit CRC relapse and proliferation.


    Summary of our research findings is CXCL4 working as a new immune suppressor to inhibit antitumor immune response, including inhibition of CD8+ T cell activation; acceleration of Treg activation, upregulation of PD1 in CD8+ T to accelerate apoptosis of CD8+ T cells; down-regulation of PD1 in Treg to protect Tregs, and to reduce apoptosis.

    In the future, more research will be planned to enable CXCL4 mAb, GR009 to provide new treatment in new MOA, target, and new structure by elevating immunosurveillance to prevent recurrence, and decreasing chemotoxicities to improve patient's quality of life. 



    About General Regeneratives

    General Regeneratives (Shanghai) Limited was established in 2007 by Professor Wei Han, a doctoral supervisor from School of Pharmacy, Shanghai Jiao Tong University. General Regeneratives possesses a new generation of biologics screening platform, "Prometheus Technology", to efficiently discover functional genes critical for disease self-healing, and develop innovative biologics by using genetic engineering, protein, and antibody engineering to produce novel recombinant proteins and antibodies. The technology has been successfully applied to uncover the mechanisms governing disease self-healing on various organs including bone marrow, liver, pancreas, cartilage, heart, gut epithelial, and thymus.
    Over 10 years research, General Regeneratives has established a robust protein and antibody R&D pipeline developed successfully by "Prometheus Technology" for various indications. Up to now, 12 new investigational new drugs in 5 therapeutic areas including immuno-oncology, AID/autoimmune diseases, NASH, cardiovascular diseases, and cartilage diseases are developed.
    General Regeneratives will continue to pursue innovative technology in drug discovery and development to provide new products for unmet medical needs and improve the quality of life for patients worldwide.


  • GR007, First-in-Class Multi-organ Protector Against Chemotoxicities
    2019-05-19

    GR007, First-in-Class Multi-organ Protector Against ChemotoxicitiesPresented by Prof. Wei Han at 2019 Shanghai Biomedical Investment and Financing Summit and Results Promotion Conference Shanghai Biomedical Science and Technology Industry Promotion Center


    Presented by Prof. Wei Han at 2019 Shanghai Biomedical Investment and Financing Summit and Results Promotion Conference


    Shanghai Biomedical Science and Technology Industry Promotion Center, Shanghai Kechuang Center Equity Investment Fund Management Co., Ltd., Shanghai Pudong New Area Science and technology Innovation Promotion Center co-sponsored the "2019 Shanghai Biomedical Investment and Financing Summit and Results Promotion Conference" was successfully held in Shanghai International Convention Center on May 16, 2019.

     

    Over 11 years of development and promotion, this conference has become a major and professional event in China to gather scientific research institutions, biotech companies and capital companies in biomedical field to exchange information, release outstanding research results, and to promote the collaboration between capital and biomedical industry. It’s the excellent integrated service platform to gather the innovation resources from technology and finance in Shanghai.  



    Shanghai Jiao Tong University Prof. Wei Han, Founder of General Regeneratives (Shanghai) Ltd., was invited to present “GR007, First-in-Class Multi-organ Protector Against Chemotoxicities”to share GR007's development with participants. Prof. Han expressed his research was inspired by the Prometheus in Greek mythology for liver repair and regeneration. He postulated the “Regeneromics” hypothesis to guide his research to uncover the mystery of disease self-healing character. The aim is to find tissue regeneration steady state expression gene, elucidate its role in the process of disease, and use its action mechanism to develop new product techniques for disease prevention, diagnosis and treatment.





    He founded the proprietary “Prometheus Technology” to effectively discover functional genes critical for disease self-healing, and to accelerate the development first-in-class biologics. Compared with traditional drug discovery, this innovative technology platform can shorten drug discovery to 2 years with low investment cost of 3-6 million dollars. The technology has been successfully applied to uncover the mechanisms governing disease self-healing on various organs including bone marrow, pancreas, liver, cartilage, heart, gut epithelial, and thymus.



    Over 10 years research, General Regeneratives has established a robust protein & antibody R&D pipeline which is 12 investigational new drugs from GR007 to GR019 developed successfully by “Prometheus Technology” for various indications in 5 therapeutic areas including immuno-oncology, AID/autoimmune diseases, NASH, cardiovascular diseases, and cartilage diseases. He took the first innovative drug, GR007, a multi-organ protector against chemotoxicities as an example to share with participants how he developed it from discovery to preclinical and clinical stages with relevant research data. GR007 has demonstrated its good safety profile and preliminary efficacy in phase 1 clinical trial, and phase 2 clinical trial is ongoing. GR007 is concurrently developed on potential indications of gouty arthritis, combination with chemotherapy to enhance efficacy against colorectal cancer, and with immune checkpoint inhibitors for cancer treatment.


    General Regeneratives anticipates 5 new drug candidates entering clinical trials and the 1st biological license application within 3 years.





  • Prof. Wei Han Was Appointed to Be a Member in Expert Committee
    2019-05-18

    The "21st Shanghai International Forum on Biotechnology and Pharmaceutical Industry(BIO-FORUM 2019)", which is hosted by Modern Biotechnology & Pharmaceutical Industry Office of Shanghai Municipality, opened on May 16, 2019 at the Shanghai …

    The "21st Shanghai International Forum on Biotechnology and Pharmaceutical Industry(BIO-FORUM 2019)", which is hosted by Modern Biotechnology & Pharmaceutical Industry Office of Shanghai Municipality, opened on May 16, 2019 at the Shanghai International Convention Center to promote the research, development and industrialization of biotechnology and medicine in China with updated trends of biomedical technology and development.


    Bio-forum 2019 focused on the theme of “Innovation Driven High-quality Development of Biomedical Industry to gather approximately 600 overseas and domestic experts in biomedical industry to explore and discuss new technology, development, and regulations on artificial intelligence and drug innovation; antibody drug innovation and industrialization; in vitro diagnostic and precision medicine, clinical biobank and human generic resource management; biomedical big data and artificial intelligence; biomedical engineering technology and innovation.



    At the opening ceremony, the establishment and appointment of the expert committee were initiated, and it was mainly responsible for the consultation of the development direction planning of the platform, the suggestions of attracting the talent team, the technical development trend, and the evaluation of the expert team from the platform. Mr. Zhu Qigao, deputy director of Shanghai Science and Technology Commission and Mr. Jiu Wenjin, Deputy Inspector of the Shanghai Development and Reform Commission, issued certificates to members of the expert committee in Shanghai Biomedical Industry Technology Functional Platform.




    Shanghai Jiao Tong University Prof. Wei Han, Founder of General Regeneratives was honored and appointed to be an member in expert committee, and received the expert certificate at the opening ceremony of Bio-forum 2019 to assist Shanghai as the center of global innovation and life science.



  • Case Sharing of Preclinical and Clinical Development in First-in-Class Biologics
    2019-04-24

    The sixth China International BioCon 2019 was successfully held on April 18-20 at Royal Crown Hotel, Dishui Lake, Shanghai. The conference consisted of the CEO Summit Forum, the fifth International Symposium on Biopharmaceutical Innovation and Research, t

    The sixth China International BioCon 2019 was successfully held on April 18-20 at Royal Crown Hotel, Dishui Lake, Shanghai. The conference consisted of the CEO Summit Forum, the fifth International Symposium on Biopharmaceutical Innovation and Research, the Biopharmaceutical Clinical Development Forum and the Process Development and Amplification Forum.

    BioCon 2019 focused on the theme of ”Exploring the way to Biopharma Industrialization and Commercialization”, to gather overseas domestic experts in industry, explore the latest global regulatory and policy of biopharmas, protein engineering design and structural optimization, clinical development and trial design strategies, CMC and process verification difficulties, manufacturing efficiency improvement and market layout, application and prospect of cutting-edge biotechnologies to speed commercialization. Besides, Biocan also provided an excellent platform to let more than 700 participants and 50 exhibitors discuss potential collaboration to accelerate industrial cooperation and development.    

    Prof. Wei Han, Founder, Chairman & CEO of General Regeneratives (Shanghai) Ltd., was invited to present “Case Sharing of Preclinical and Clinical Development inFirst-in-Class Biologics with Multiple Indications” to share his R&D experience on GR007, a first-in-class innovative multi-organ protector against chemotoxicities.

     

     

    In his speech, professor Han expressed he was inspired by the myth of Prometheus from ancient Greece. According to the liver self-repair and regeneration, he postulated the “Regeneromics” hypothesis to guide his research to uncover the mystery of disease self-healing characters. He defined the Regeneromics as a field of biotechnology deciphering the functional genome of initiation, progress, and recovery of self-healing diseases. Drugs are developed thereafter to prevent the onset, stop the progress, and/or accelerate the recovery of the diseases.

     

    He founded the proprietary “Prometheus Technology” to effectively discover functional genes critical for disease self-healing, and to accelerate the development of first-in-class biologics. The technology has been successfully applied to uncover the molecular mechanisms of the diseased organs, including bone marrow, pancreas, liver, cartilage, heart, gut epithelial, and thymus.

    Over 10 years research, General Regeneratives has established a robust protein & antibody R&D pipeline which is 12 investigational new drugs from GR007 to GR019. They were developed successfully by “Prometheus Technology” for various indications in 5 therapeutic areas including immuno-oncology, AID/autoimmune diseases, NASH, cardiovascular diseases, and cartilage diseases. He took the first innovative drug, GR007, a multi-organ protector against chemotoxicities as an example to share with participants how he developed it from discovery to preclinical and clinical stages with relevant research data. GR007 has demonstrated its good safety profile and preliminary efficacy in phase 1 clinical trial, and phase 2 clinical trial is ongoing. GR007 is concurrently developed on potential indications of gouty arthritis, combination with chemotherapy to enhance efficacy against colorectal cancer, and with immune checkpoint inhibitors for cancer treatment.

    During Q&A section, the participant asked whether the company considered to increase dose of chemotherapy to enhance efficacy. Prof. Han expressed that phase II clinical trial, led by Prof. Ji Li in PI, Professor Li Jin (李进), in Shanghai Oriental hospital has designed to increase chemotherapy dose in the FOLFIRI regimen to evaluate whether GR007 can enhance efficacy to help more patients with colorectal cancer.  

    Group photo of the moderator and speakers. 

  • General Regeneratives Receives IND Approval for Its First Product GR007
    2018-10-16

    Shanghai, China, Apr 10, 2019 – General Regeneratives (Shanghai) Limited has recently received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for its first innovative product, GR007, a human interleukin

    Shanghai, China, Apr 10, 2019 – General Regeneratives (Shanghai) Limited has recently received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for its first innovative product, GR007, a human interleukin-1 receptor antagonist (rhIL-1Ra) injection to expend treatment on patients with gout in China.

    GR007 is an innovative biological product developed by General Regeneratives by binding with L-1 receptor 1(IL-1RI) to block IL-1 signal pathway to relieve inflammation reaction from gouty arthritis. GR007 has received clinical approval in 2016 from NMPA (formerly CFDA) for multi-organ protector against chemotoxicities. GR007 has its clinical result from phase I clinical trial presented at CSCO 2018, and phase II trial is ongoing. GR007 is planned to start phase I clinical trial on gout treatment soon.

    About GR007

    GR007, a first-in-class innovative human interleukin-1 receptor antagonist (rhIL-1Ra) that General Regeneratives holds global intellectual property rights, has entered Phase II clinical trial with potential indications of multi-organ protector against chemotoxicities and combination therapy in the second-line colorectal cancer (CRC) patients. GR007 is concurrently developed on potential indications of gouty arthritis, combination with chemotherapy to enhance efficacy against colorectal cancer, and with immune checkpoint inhibitors for cancer treatment.

    About General Regeneratives

    General Regeneratives (Shanghai) Limited was established in 2007 by Professor Wei Han, a doctoral supervisor from School of Pharmacy, Shanghai Jiao Tong University. General Regeneratives possesses a new generation of biologics screening platform, “Prometheus Technology”, to efficiently discover functional genes critical for disease self-healing, and develop innovative biologics by using genetic engineering, protein, and antibody engineering to produce novel recombinant proteins and antibodies. The technology has been successfully applied to uncover the mechanisms governing disease self-healing on various organs including bone marrow, liver, pancreas, cartilage, heart, gut epithelial, and thymus.

    Over 10 years research, General Regeneratives has established a robust protein & antibody R&D pipeline developed successfully by “Prometheus Technology” for various indications. Up to now, 12 new investigational new drugs in 5 therapeutic areas including immuno-oncology, AID/autoimmune diseases, NASH, cardiovascular diseases, and cartilage diseases are developed.

    General Regeneratives will continue to pursue innovative technology in drug discovery and development to provide new products for unmet medical needs and improve the quality of life for patients worldwide.

    For more information, please contact:
          E-mail: info@grbiologics.com
          Tel: +86 21 6163 7612

  • General Regeneratives Receives IND Approval
    2018-09-27

    In July 2016, a new landmark recombinant protein investigational drug - GR007 was approved by the CFDA, which was developed by General Regenerative (Shanghai) Co., Ltd independently. As the first-in-class drug for clinical trials, preclinical studies indi

    In July 2016, a new landmark recombinant protein investigational drug - GR007 was approved by the CFDA, which was developed by General Regenerative (Shanghai) Co., Ltd independently. As the first-in-class drug for clinical trials, preclinical studies indicate that it can be used to prevent and treat multiple organ toxicity and side effects of chemotherapy, and improve the success rate of chemotherapy and the quality of life on patients.

    GR007 approved that " innovative drug development based on Regeneromes " has achieved temporary success, and greatly promoted the research of other new drug candidates with global patents, including chondrocyte growth factor, T lymphocyte protection antibody, hematopoietic stem cell protection antibody. These new drugs are designed to promote cartilage regeneration treating cartilage diseases, improve anti-tumor immunity, and prevent tumor recurrence.

  • 10 Year Anniversary
    2017-10-31

    It is 10 years now since General Regenerative (Shanghai) Co., Ltd. was established. We grow up since a newborn baby, and the company has made great progress in the past ten years. Ten years is just a moment in history, but it is so magnificent for us. We

    It has been 10 years since General Regenerative (Shanghai) Co., Ltd. was established. We grow up since a newborn baby, and the company has made great progress in the past ten years. Ten years is just a moment in history, but it is so magnificent for us. We have been working hard on development of innovative drugs for the past ten years.

    Flowers, flags and balloons are everywhere in the office on October 25th. Investors, founders, employees and guests gathered to celebrate the 10th anniversary of the company. The founder and the investor expressed their expectations for future. We all cheered for the company’s achievements, enjoy the wonderful moment.

Join Us

Our R&D team has extensive experience in the early development, clinical development, translational medicine, and commercialization of a range of biological drugs in leading international pharmaceutical and biotech companies.

Release Time: