不良事件/反应报告

https://www.walvax.com/public_information/?type=5&id=1

不良事件/反应报告

Company Introduction

Shanghai Zerun Biotech Co., Ltd. (Zerun Biotech) was founded in 2003 and is located in Zhangjiang Hi-Tech Park, Pudong New Area, Shanghai. Focusing on the research, development and industrialization of new recombinant human vaccines, Zerun Biotech is undertaking several national new drug development projects and has been recognized as National Hi-Tech Enterprise. At the end of 2012, Zerun Biotech became a holding subsidiary of Yunnan Walvax Biotechnology Co., Ltd., a listed vaccine company on Shenzhen Growth Enterprise Market. Adhering to the belief of Life is priceless and technology is limitless” and the purpose of “Help everyone live a healthy life”, the company is dedicated to becoming the pride domestically and the pioneer globally in the vaccine industry. The company keeps innovating and has established a complete quality management system, been continuously optimizing R&D and manufacture processes, and improving product quality to ensure the safety and efficacy of various vaccine products. Meanwhile, relying on Walvax’s leading industrialization and market sales and other comprehensive advantages, Zerun Biotech has grown into an innovation-driven biopharmaceutical company based on a high- tech platform with an entire system from research and developing to industrialization. Till date, the company has received a number of national major creation of new drugs funds and Shanghai scientific research fund for the national 11th, 12th and 13th Five-Year Plan. At the same time, Zerun Biotech attaches great importance to intellectual property protection for its core technologies of the projects under development. Up to now, 20 domestic invention patents (including pending patents) and 22 international invention patents have been authorized.

丰富跨国药企背景的研发创新团队

丰富跨国药企背景的研发创新团队1

Mission and Vision

  • Our Principle

    For everyone’s health
    Everyone longs for health, regardless of age, wealth, or class;
    Everyone is created equal, regardless of age, wealth, or class;
    Serves everyone’s health with the best vaccine technology and the best vaccine products.

  • Our Mission

    Spreading health, creating beauty.
    Use better vaccines to make people’s lives better, more professional services to make customers and partners better, outstanding management to make employees grow better, and more active engagement to make communities, industries and society better.

  • Our Vision

    Become the pride of vaccine industry in China, the leader of vaccine industry in the world.

Management Team

  • Jiankang (Jack) Zhang

     CEO

     

            As a seasoned professional executive, Mr. Zhang has been working in biomedical companies and global public health institution for more than three decades. His career has covered across from state-owned enterprise, foreign enterprise, international health institution and private company. His previous positions included the Deputy Managing Director of Shanghai Institute of Biological Products, a subsidiary of China National Biotech Group, General Manager of Haemonetics China Subsidiary, Chief Representative of PATH China office, and Chief Operation Officer of Ustar (Hangzhou) Biotechnology Co., Ltd.

            Mr. Zhang owned an MBA from China Europe International Business School (CEIBS) in Shanghai, China, a master of Medical Library and Information Sciences (MLIS) from Dominican University, Illinois, USA, a Bachelor of Arts from Fudan University, Shanghai China, and a diploma in public health issued by Shanghai Municipal Health Bureau.

  • Chenliang Zhou  Ph.D

    Executive Vice President

     

            Dr. Zhou has been promoted as Executive Vice President since May 2022. He is fully accountable for the company's Basic Research Department, Technology Development Department, and R&D project management. In addition, he assists the CEO with overall operations of the company.

           Joined Shanghai Zerun in 2015,Dr. Zhou has consecutively served as R&D engineer, supervisor and manager of Basic Research Department, director of upstream R&D department, and executive vice president. He has rich experience in new vaccine R&D development and project management as well as strong team management capabilities.    

          Dr. Zhou holds a bachelor's degree in animal science from Jilin University and a doctorate in pathogen biology from Shanghai Medical College, Fudan University, and has a title of senior engineer. So far, he has published 10 academic papers, obtained 5 authorized invention patents, and 14 pending patents. In 2019, he was awarded the title of Shanghai Youth Science and Technology Rising Star.

     

  • Zhiying Cui

     Vice President

     

            Zhiying Cui has served as Vice President since April 1, 2021, and is accountable for quality management and operational assurance of the company.

            She joined Zerun in 2006, and her role has ranged from Production QC and QA engineer, QA manager, director of Quality Management and Regulatory Affairs, and to vice president. Ms. Zhiying Cui has over 20 years of experience in vaccine R&D and production quality management in the biopharmaceutical industry. She is familiar with laws and regulations concerning the new version of GMP, ICH and WHO vaccine Pre-qualification. She has accumulated extensive experience in vaccine quality management and regulatory compliance. Prior to joining Zerun, Ms. Cui worked at Beijing Institute of Biological Products Co., Ltd, and Shanghai Huatai Biotechnology Co., Ltd., Fosun Pharma.

            Ms. Cui holds a master degree in International Pharmaceutical Engineering Management(IPEM)from Peking University and senior professional title.

  • Jiao An, Ph. D, 

    Vice President 

     

            Dr. An has been promoted to the Vice President since May 2022, and is fully accountable for the development, optimization and characterization of upstream, downstream and formulation processes, and also the establishment of pilot process and pilot production.

            Dr. An has rich experience in novel vaccine design and process development, and good team management skills. She joined Shanghai Zerun in 2018, and has served as senior researcher, and manager of the Technology Development Department, director of the Process R&D Departments, and vice president. Prior to joining Zerun, she served in WuXi AppTec (Shanghai) Co., Ltd., working on protein crystallization, structure determination and functional analysis. 

            Dr. An holds a bachelor's degree and a doctorate in biology from Jilin University. She has published seven papers, obtained two authorized invention patent and two pending patents.

  • Lingyun Zhou, Ph. D

    Vice President 

     

            Dr. Zhou Lingyun has served as the vice president since November 2022, and is fully accountable for quality research and control, analytical method development, optimization and validation of all the products under development.

            Since joining Shanghai Zerun in 2011, Dr. Zhou Lingyun has successively served as the engineer, deputy manager, manager, director of the Quality Research Department and vice president. She is experienced in virus vaccine R&D and quality research and has a good ability of team management. 

            Dr. Zhou Lingyun holds a bachelor's degree in bioengineering and a doctorate in biochemistry from East China University of Science and Technology. From 2010 to 2011, she conducted post-doctoral research in the College of Biomedical Engineering, University of Arkansas. So far, she has undertaken quality researches of many municipal and national projects ("the 12th Five-Year Plan", "the 13th Five-Year Plan" major new drug development.

History

  • February
    Obtained USD8.15 million grant from CEPI for COVID-19 vaccine development

    March
    Obtained Drug Manufacturing License for HPV2 vaccine (WALRINVAX) from NMPA

    August
    Obtained IND approval for the recombinant protein novel coronavirus variant vaccine from NMPA

     

     

  • June
    Obtained IND approval for COVID-19 vaccine from NMPA

    July
    Obtained USD13.1 million grant from CEPI for COVID-19 vaccine development

    September
    The wholly-owned subsidiary Beijing Zerun Innovative Biotech was established

    November
    Obtained USD3.84 million grant from CEPI for COVID-19 vaccine development

  •  May
    Completed Phase III clinical summary report of the bivalent HPV vaccine
    Shanghai Zerun's covid-19 vaccine research and development project received US$1 million in funding

    June
    Completed the registration application for the production and marketing of the bivalent HPV vaccine and obtained the acceptance number

    December
    9-valent HPV vaccine obtains Phase I clinical trial report

     

     

  • March
    9-valent HPV vaccine starts phase I clinical trail in Sichuan

    June
    The bivalent HPV vaccine industrialization project received 34 million special funding from the National Development and Reform Commission

    Recombinant enterovirus the 71 virus-like particle vaccine (Pichia pastoris) obtained a lnvestigational new drug application issued by the  National Food and Drug Administration

    October
    Signed a 9-valent HPV vaccine funding agreement with the Bill Gates Foundation (2.5 million  US dollars); the bivalent HPV vaccine funding project signed with the Bill Gates Foundation was successfully completed

     

  • January
    Yuxi Zerun obtained a drug production license issued by Yunnan Food and Drug Administration 

     

  • December
    The 9-valent HPV vaccine obtained the lnvestigational new drug application approval of the  National Food and Drug Administration

     

  • January
    Established a wholly-owned subsidiary Yuxi Zerun Biotechnology Co., Ltd. in Yuxi, Yunnan, to promote the industrialization of a bivalent HPV vaccine

    July
    Therapeutic cervical cancer vaccine obtains the lnvestigational new drug application from the National Food and Drug Administration

  • November
    The bivalent HPV vaccine enters Phase III clinical trials

  • April
    Zerun Biotech hepatitis A vaccine passed the national GMP certification (2010 version)
     
    October
    The bivalent HPV vaccine enters Phase II clinical trials

  • February
    The bivalent HPV vaccine enters Phase I clinical trials

    December
    Signed a cooperation framework agreement with Walvax Biological,and formally became Zerun Biological Holding Company

  • June
    The bivalent HPV vaccine obtained the lnvestigational new drug application approval of the  National Food and Drug Administration

  • Obtained the first batch of certificates

    Inactivated hepatitis A vaccine (Vero cells)-Veroxin officially launched

    Zerun Biotech signed a hepatitis A vaccine export agreement with an Indian biomedical company, and initiated product registration and sales in more than 20 countries including India

  • Therapeutic HPV vaccine was funded by the National "Eleventh Five-Year Plan for Major New Drug Development and Innovation Projects". This is the first time that the biological sector has received a national funding project.

    Passed SFDA registration on-site verification

    Obtained SFDA "Drug Registration Approval" (including adult and child specifications)

    June
    Passed certification and obtained drug GMP certificate

  • May
    Established a joint venture company---Shanghai Zerun Anke Biopharmaceutical Co., Ltd.

  • February
    Obtained "Pharmaceutical Production License", production and quality control facilities were put into trial operation

  • January
    Hepatitis A vaccine completed clinical trials and started to apply for Biologics License Application

  • February
    Complete the project design and start the construction of clean manufacturing site

  • Inactivated hepatitis A vaccine became a national "863" project

  • May
    Founded in Shanghai