SINOVAC Initiated a Phase III Clinical Trial on Bivalent Vaccine Against Hand Foot and Mouth Disease (HFMD)
Sinovac Biotech (NASDAQ: SVA) has launched enrollment for a Phase III clinical trial of its bivalent vaccine candidate against Hand Foot and Mouth Disease (HFMD). The vaccine targets both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16), marking the first Phase III trial for a multivalent HFMD vaccine globally.
The Phase III trial will evaluate efficacy, safety, and immunogenicity in children aged 6-71 months. Previous Phase I/II trials initiated in September 2023 showed favorable safety and immunogenicity results. The company has also developed a tetravalent enterovirus vaccine, recently approved for clinical trials, targeting EV71, CA16, CA10, and CA6.
HFMD primarily affects children under 5 years old, representing 90% of total cases.
Sinovac Biotech (NASDAQ: SVA) ha avviato l'arruolamento per un trial clinico di Fase III del suo candidato vaccinale bivalente contro la Malattia Mano-Piede-Bocca (HFMD). Il vaccino è mirato sia all'Enterovirus 71 (EV71) che al Coxsackievirus 16 (CA16), rappresentando il primo trial di Fase III per un vaccino multivalente contro la HFMD a livello globale.
Il trial di Fase III valuterà l'efficacia, la sicurezza e l'immunogenicità in bambini di età compresa tra 6 e 71 mesi. I precedenti trial di Fase I/II iniziati a settembre 2023 hanno mostrato risultati favorevoli in termini di sicurezza e immunogenicità. L'azienda ha inoltre sviluppato un vaccino contro gli enterovirus tetravalente, recentemente approvato per i trial clinici, che mira a EV71, CA16, CA10 e CA6.
La HFMD colpisce principalmente i bambini di età inferiore ai 5 anni, rappresentando il 90% dei casi totali.
Sinovac Biotech (NASDAQ: SVA) ha iniciado la inscripción para un ensayo clínico de fase III de su candidato a vacuna bivalente contra la Enfermedad Mano-Pie-Boca (HFMD). La vacuna tiene como objetivo tanto el Enterovirus 71 (EV71) como el Coxsackievirus 16 (CA16), marcando el primer ensayo de fase III para una vacuna multivalente contra la HFMD a nivel mundial.
El ensayo de fase III evaluará la eficacia, la seguridad y la inmunogenicidad en niños de 6 a 71 meses. Ensayos previos de fase I/II iniciados en septiembre de 2023 mostraron resultados favorables en seguridad e inmunogenicidad. La compañía también ha desarrollado una vacuna tetravalente contra enterovirus, recientemente aprobada para ensayos clínicos, que se dirige a EV71, CA16, CA10 y CA6.
La HFMD afecta principalmente a niños menores de 5 años, representando el 90% de los casos totales.
시노백 생물공학 (NASDAQ: SVA)은 손발입병(HFMD) 대한 이수선 백신 후보의 3상 임상 시험 등록을 시작했습니다. 이 백신은 엔테로바이러스 71(EV71)와 콕사키바이러스 16(CA16)을 대상으로 하며, 다가백신 HFMD의 처음 있는 3상 시험입니다.
3상 임상 시험은 6개월에서 71개월 사이의 어린이의 효능, 안전성 및 면역원성을 평가할 것입니다. 2023년 9월 시작된 이전 1상/2상 시험에서 안전성과 면역원성에 대한 긍정적인 결과가 나타났습니다. 이 회사는 EV71, CA16, CA10, CA6를 대상으로 하는 4가 엔테로바이러스 백신도 개발했으며, 최근 임상 시험 승인을 받았습니다.
HFMD는 주로 5세 미만의 어린이에 영향을 미치며, 전체 사례의 90%를 차지합니다.
Sinovac Biotech (NASDAQ: SVA) a lancé l’inscription pour un essai clinique de phase III de son candidat vaccin bivalent contre la maladie main-pied-bouche (HFMD). Le vaccin cible à la fois l'Entérovirus 71 (EV71) et le Coxsackievirus 16 (CA16), marquant le premier essai de phase III pour un vaccin multivalent contre la HFMD au niveau mondial.
L'essai de phase III évaluera l'efficacité, la sécurité et l'immunogénicité chez les enfants âgés de 6 à 71 mois. Les essais précédents de phase I/II, lancés en septembre 2023, ont montré des résultats favorables en matière de sécurité et d'immunogénicité. L'entreprise a également développé un vaccin tétavalent contre les entérovirus, récemment approuvé pour des essais cliniques, ciblant EV71, CA16, CA10 et CA6.
La HFMD touche principalement les enfants de moins de 5 ans, représentant 90 % des cas totaux.
Sinovac Biotech (NASDAQ: SVA) hat die Einschreibung für eine klinische Studie der Phase III für seinen bivalenten Impfstoffkandidaten gegen Hand-, Fuß- und Mundkrankheit (HFMD) gestartet. Der Impfstoff richtet sich sowohl gegen das Enterovirus 71 (EV71) als auch gegen das Coxsackievirus 16 (CA16) und markiert die erste Phase-III-Studie für einen multivalenten HFMD-Impfstoff weltweit.
Die Phase-III-Studie wird die Wirksamkeit, Sicherheit und Immunogenität bei Kindern im Alter von 6 bis 71 Monaten bewerten. Frühere Phase I/II-Studien, die im September 2023 gestartet wurden, zeigten positive Ergebnisse in Bezug auf Sicherheit und Immunogenität. Das Unternehmen hat außerdem einen tetravalenten Enterovirus-Impfstoff entwickelt, der kürzlich für klinische Studien genehmigt wurde und auf EV71, CA16, CA10 und CA6 abzielt.
HFMD betrifft hauptsächlich Kinder unter 5 Jahren und macht 90 % der Gesamtfälle aus.
- First-ever Phase III trial for multivalent HFMD vaccine globally
- Positive Phase I/II trial results showing favorable safety and immunogenicity
- Additional tetravalent vaccine approved for clinical trials targeting four virus types
- None.
Insights
The initiation of Phase III trials for SINOVAC's bivalent HFMD vaccine represents a significant milestone in pediatric infectious disease prevention. The vaccine's potential to target both EV71 and CA16 addresses a important gap in current HFMD prevention strategies. Initial Phase I/II results showing favorable safety and immunogenicity profiles are particularly encouraging. The market opportunity is substantial, considering HFMD affects primarily children under 5, who represent 90% of total cases.
The parallel development of a tetravalent vaccine candidate targeting four virus types (EV71, CA16, CA10 and CA6) further strengthens SINOVAC's competitive position in the HFMD vaccine market. This comprehensive approach to virus coverage could potentially establish a new standard in HFMD prevention, particularly in regions where the disease burden is high.
This development positions SINOVAC advantageously in the untapped multivalent HFMD vaccine market. Being first-to-market with a bivalent vaccine could provide significant commercial opportunities, especially in Asia-Pacific regions where HFMD is endemic. The advancement of both bivalent and tetravalent vaccines demonstrates SINOVAC's strategic approach to market segmentation and product differentiation.
The successful progression through clinical trials could significantly impact SINOVAC's market valuation, particularly given their current market cap of
The first phase III clinical trial on a multivalent HFMD vaccine in the world
The Phase III clinical trial is designed to be a multicenter, randomized, double-blind, controlled trial to evaluate the efficacy, safety and immunogenicity of this vaccine candidate in infants and young children aged 6 to 71 months.
SINOVAC has initiated a phase I/II clinical trial on its bivalent vaccine in
HFMD can be caused by several enteroviruses, which often exhibit low cross-immunogenicity, leading to insufficient protection. HFMD mainly affects children under 5 years old, accounting for at least
Dedicated to providing comprehensive protection for children, SINOVAC will collaborate with partners to advance clinical research on both bivalent and tetravalent enterovirus inactivated vaccines, with the goal of making these vaccines available in the market as soon as possible.
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a
SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under “Category 1 Preventative Biological Products” and commercialized in
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.
For more information, please visit the Company’s website at www.sinovac.com.
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Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-8279 9720
Email: ir@sinovac.com
Source: Sinovac Biotech Ltd.
FAQ
What are the target viruses for Sinovac's (SVA) new HFMD bivalent vaccine?
When did Sinovac (SVA) begin Phase I/II trials for the HFMD bivalent vaccine?
What age group is targeted in Sinovac's (SVA) Phase III HFMD vaccine trial?
How many virus types does Sinovac's (SVA) tetravalent HFMD vaccine target?
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