Sinovac Biotech

Sinovac Announces Product License for 23-Valent Pneumococcal Polysaccharide Vaccine

Retrieved on: 
Wednesday, December 9, 2020

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population.

Key Points: 
  • Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population.
  • This is our first bacterial vaccine product approved so far, broadening the potential of the companys product portfolio.
  • Sinovac started research and development of the 23-valent pneumococcal polysaccharide vaccine in 2009, completed pre-clinical studies in 2011 and was approved to conduct human clinical trials in May 2014.
  • The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016.

Sino Biopharm Invests in Sinovac LS, A Leading COVID-19 Vaccine Company in China

Retrieved on: 
Sunday, December 6, 2020

The investment will help Sinovac enhance its R&D and production capabilities of CoronaVac, a COVID-19 vaccine, and other development and operational activities of Sinovac LS.

Key Points: 
  • The investment will help Sinovac enhance its R&D and production capabilities of CoronaVac, a COVID-19 vaccine, and other development and operational activities of Sinovac LS.
  • On 13 April 2020, clinical research of CoronaVac has been officially approved by China National Medical Products Administration.
  • The inactivated COVID-19 vaccine candidate, or CoronaVac, developed by Sinovac LS is being tested in phase III trials in several countries outside of China.
  • Sinovac LS will be the marketing authorization holder of CoronaVac in China with a vaccine production license issued by China National Medical Products Administration if the vaccine is successfully developed.

Sinovac Secures Approximately $500 Million in Funding for COVID-19 Vaccine Development

Retrieved on: 
Sunday, December 6, 2020

Sinovac Biotech Ltd. (Sinovac or the Company) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that Sinovac Life Sciences Co., Ltd. (Sinovac LS) (formerly known as Sinovac Research and Development Co., Ltd.), a subsidiary of Sinovac, has secured approximately US$500 million in funding for further development, capacity expansion and manufacturing of the CoronaVac, its COVID-19 vaccine candidate, as well as conduct other development and operational activities.

Key Points: 
  • Sinovac Biotech Ltd. (Sinovac or the Company) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that Sinovac Life Sciences Co., Ltd. (Sinovac LS) (formerly known as Sinovac Research and Development Co., Ltd.), a subsidiary of Sinovac, has secured approximately US$500 million in funding for further development, capacity expansion and manufacturing of the CoronaVac, its COVID-19 vaccine candidate, as well as conduct other development and operational activities.
  • The investor, Sino Biopharmaceutical Limited, a leading innovative research and development driven pharmaceutical conglomerate in China, through affiliates, has invested approximately US$500 million in exchange for approximately 15% of the total equity interest of Sinovac LS.
  • The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016.
  • Sinovac Life Sciences Co., Ltd., (or Sinovac LS), previously known as Sinovac Research & Development Co., Ltd., is a research-based company incorporated in 2009 that conducts human vaccine research, development, manufacturing, and sales.

COVID-19 Vaccine Education and Equity Project Launches To Further Inclusion and Dialogue Around Potential COVID-19 Vaccines

Retrieved on: 
Wednesday, December 2, 2020

To learn more about the project and for details on how organizations and industry partners can get involved, click here .

Key Points: 
  • To learn more about the project and for details on how organizations and industry partners can get involved, click here .
  • For a list of COVID-19 Vaccine Education and Equity Project members, to-date, click here .
  • Statement from the COVID-19 Vaccine Education and Equity Project:
    "Authorized and approved COVID-19 vaccines are our best hope to protect against the virus that has singlehandedly changed everything.
  • The COVID-19 Vaccine Education and Equity Project strives to communicate scientifically accurate information including what we know and what we still need to learn.

COVID-19 Vaccine & Therapeutics Clinical Trial Analysis Report 2020: Regulatory Framework for COVID-19 Therapeutics and Vaccines Marketing Approvals

Retrieved on: 
Monday, November 30, 2020

DUBLIN, Nov. 30, 2020 /PRNewswire/ -- The "COVID-19 Vaccine & Therapeutics Clinical Trial Analysis 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Nov. 30, 2020 /PRNewswire/ -- The "COVID-19 Vaccine & Therapeutics Clinical Trial Analysis 2020" report has been added to ResearchAndMarkets.com's offering.
  • Many research institutes, healthcare organizations and biopharmaceutical companies worldwide are conducting clinical trials for COVID-19 vaccines and therapeutics.
  • The COVID-19 vaccine and therapeutics clinical trial analysis report consists of drugs and vaccines which are under clinical trials for the treatment of COVID-19.
  • The COVID-19 vaccine and therapeutics clinical trial analysis covered in this report is segmented by product type into small molecules, biologics, blood & plasma derivatives, monoclonal antibodies, vaccines, others.

Beijing Fourth Intermediate People’s Court Issues Judgement Against Sinobioway Medicine and Mr. Aihua Pan

Retrieved on: 
Monday, September 28, 2020

Sinovac Biotech Ltd. (NASDAQ:SVA) (Sinovac or the Company), a leading provider of biopharmaceutical products in China, announced today that the Fourth Intermediate Peoples Court of Beijing (Beijing Fourth Court) issued a judgement holding Sinobioway Bio-medicine Co., Ltd. (Sinobioway Medicine) and Mr. Aihua Pan (collectively, the Defendants) liable for torts and breaches of shareholder fiduciary duty.

Key Points: 
  • Sinovac Biotech Ltd. (NASDAQ:SVA) (Sinovac or the Company), a leading provider of biopharmaceutical products in China, announced today that the Fourth Intermediate Peoples Court of Beijing (Beijing Fourth Court) issued a judgement holding Sinobioway Bio-medicine Co., Ltd. (Sinobioway Medicine) and Mr. Aihua Pan (collectively, the Defendants) liable for torts and breaches of shareholder fiduciary duty.
  • The Beijing Forth Court found that the Defendants disrupted Sinovac Beijings production by cutting power, which resulted in Sinovac Beijing being forced to destroy the affected products with a total value of RMB15.404 million.
  • The Courts judgement holds that the Defendants breached their shareholder fiduciary duties under the PRC Company Law and are liable for Sinovac Beijings losses caused by their disruptive actions.
  • The Beijing Fourth Courts decision may be appealed within 15 days from the receipt of the ruling by the defendants or within 30 days by the plaintiff, respectively .

Sinovac’s Coronavac™, SARS-CoV-2 Vaccine (Vero Cell), Inactivated, Announces Approval for Phase I/II Clinical Trial in Adolescents and Children

Retrieved on: 
Wednesday, September 23, 2020

In this clinical trial, low dosage (300SU/dose) and medium dosage (600SU/dose) with two-dose immunization scheduled at 28-day intervals will be adapted.

Key Points: 
  • In this clinical trial, low dosage (300SU/dose) and medium dosage (600SU/dose) with two-dose immunization scheduled at 28-day intervals will be adapted.
  • The vaccine candidate appeared to be well tolerated for different dosage and no serious vaccine-related adverse events were reported.
  • The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016.
  • The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine.

Sinovac Commences Phase III Clinical Trials for COVID-19 Vaccine Candidate in Turkey

Retrieved on: 
Tuesday, September 22, 2020

Sinovac Biotech Ltd. (NASDAQ: SVA) (Sinovac or the Company), a leading provider of biopharmaceutical products in China, announced today that it has recently commenced phase III clinical trials for its inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or CoronaVac, in Turkey.

Key Points: 
  • Sinovac Biotech Ltd. (NASDAQ: SVA) (Sinovac or the Company), a leading provider of biopharmaceutical products in China, announced today that it has recently commenced phase III clinical trials for its inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or CoronaVac, in Turkey.
  • The phase III clinical trial seeks to test efficacy and safety of CoronaVac in Turkey and aims to be a pivotal study to support the licensure of this product.
  • This case-driven, randomized, double-blinded and placebo-controlled phase III clinical trial uses an adaptive design, and all participants will be enrolled in a step-by-step basis.
  • In addition to Turkey, the Company has partnered with several companies outside of China for phase III efficacy studies.

Sinovac Reports Preliminary Phase I/II Results of COVID-19 Vaccine in Elderly Volunteers

Retrieved on: 
Wednesday, September 9, 2020

The phase I/II clinical trial on elderly volunteers were randomized, double-blinded and placebo controlled trials with two-dose immunization scheduled at 28 day intervals.

Key Points: 
  • The phase I/II clinical trial on elderly volunteers were randomized, double-blinded and placebo controlled trials with two-dose immunization scheduled at 28 day intervals.
  • Both the seroconversion rate and GMT level for elderly volunteers were comparable to the adult group aged 18 to 59 years old.
  • According to the results, the medium dose was selected to enter into phase III trial.
  • Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, I am very pleased that our vaccine candidate shows promising results, especially on elderly volunteers who are a highly vulnerable group impacted by the COVID-19 pandemic.

Sinovac Signs Agreement with Bio Farma Indonesia for COVID-19 Vaccine Cooperation

Retrieved on: 
Tuesday, August 25, 2020

Under the said agreements, Sinovac is committed to supply Bio Farma bulk vaccine to enable the latter to produce at least 40 million doses of CoronaVac in Indonesia before March 2021; after March 2021, Sinovac will continue to supply the required quantity of the bulk vaccine until the end of 2021.

Key Points: 
  • Under the said agreements, Sinovac is committed to supply Bio Farma bulk vaccine to enable the latter to produce at least 40 million doses of CoronaVac in Indonesia before March 2021; after March 2021, Sinovac will continue to supply the required quantity of the bulk vaccine until the end of 2021.
  • Sinovac recognizes Indonesia as one of the countries where Sinovac will provide the technology licensing in respect of the CoronaVac to enable local production.
  • Currently, Bio Farma is conducting the Phase III Clinical Trial for Sinovacs CoronaVac in Bandung, Indonesia.
  • The cooperation between Sinovac and Bio Farma will not only further the development, production and technology licensing of the COVID-19 vaccine, but also facilitate the cooperation of the two companies in the future in the biopharmaceutical field.