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Sinovac Information Pack Case study: Sinovac’s PiCoVacc COVID-19 vaccine

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Sinovac Information Pack Case study: Sinovac’s PiCoVacc COVID-19 vaccine

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  • June 21, 2024
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  • 2023/2024
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ACTUALSTUDY
Case study: Sinovac’s PiCoVacc COVID-19 vaccine Phase 3 Ongoing


R&D commencement: January 2
In-clinic: Humans dosed: 744 (expected Pha
Phase II Funding disclosed: N/A
Vaccine type: Inactivated vaccin

Asset overview

 PiCoVacc is a COVID-19 vaccine candidate based on a chemically inactivated formulation of the SARS-CoV-2 virus developed by Sinovac
 PiCoVacc uses a proven formulation that induces a SARS-CoV-2-specific neutralizing antibody response, conferring immunity
 Sinovac has partnered with Dynavax to use their CPG 1018 adjuvant, which boosts the immune response to inactivated vaccines (e.g., HEPLIS


Development timeline

 Sinovac announced the beginning of a combined Phase I/Phase II clinical trial on April 20, 2020
 Sinovac recently expanded its manufacturing capabilities by acquiring space and funding; over 70K square meters of land were acquired in add
to funding from the Bank of Beijing to prepare for scaled production


Reasons for optimism
 The antibodies generated by PiCoVacc appear to be effective against multiple known mutations of the virus, and have shown promise in trials o
macaques
 No evidence of antibody-dependent enhancement, an occasional side effect in which some antibodies generated by a vaccine can be beneficia
the virus

, Phase 3 Ong

Case study: Sinopharm/Wuhan Institute of Virology’s inactivated vaccine can
R&D commencement: Q1 202
In-clinic: Humans dosed: 96 (expected Pha
Phase II Funding disclosed: $141M
Vaccine type: Inactivated vaccin
Asset overview
 The COVID-19 vaccine candidate developed by Sinopharm/Wuhan Institute of Virology is based on an inactivated formulation of the SARS-CoV
virus
 Chinese state-owned pharmaceutical group Sinopharm has partnered with the Wuhan Institute of Virology to co-develop their first inactivated va
which induces a SARS-CoV-2-specific neutralizing antibody response

Development timeline
 First and second phases of the trial for the vaccine candidate were launched in April 2020, with trial participants from the first phase still under
observation
 Chairman of Sinopharm, Liu Jingzhen, stated that a fund of 1B yuan (~$141M) has been set up to support vaccine R&D efforts
 Sinopharm intends to conduct the third phase of the trial and expects that the safety and efficacy study will take one year to complete all three
phases

Reasons for optimism
 Phase I of trials for the vaccine candidate has demonstrated a strong safety profile so far
 Sinopharm’s inactivated vaccine is the third COVID-19 vaccine candidate to be approved in China; once successfully synthesized, inactivated
vaccines can be produced on a large scale while other types of vaccines developed using new technologies are limited due to a lack of product
capacity

, Phase 3 O

Case study: Sinopharm/Beijing Biological Products’ inactivated vaccine candidate

R&D commencement: April 202
In-clinic: Humans dosed: N/A
Phase II Funding disclosed: N/A
Vaccine type: Inactivated vaccin
Asset overview

 The COVID-19 vaccine candidate is based on an inactivated formulation of the SARS-CoV-2 virus (specifically using Vero cells)
 Chinese state-owned pharmaceutical group Sinopharm has partnered with Beijing Tiantan Biological Products to co-develop this inactivated vac
(in addition to the vaccine developed in partnership with Wuhan Institute)



Development timeline

 There is little information on the Sinopharm/Beijing Tiantan vaccine partnership; according to the Chinese Clinical Trial Registry, the study regist
was filed at the end of April
 However, Sinopharm has been actively working on other COVID-19 vaccines that can potentially be leveraged for this project



Reasons for optimism

 Sinopharm already has two potential vaccines in the pipeline through partnerships with other institutes in China

,

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