← Back to SVA filing summaryThis is the extracted source text from the SEC filing. Formatting may differ from the original document.
A. History and Development of the Company
The ultimate parent company is Sinovac Biotech Ltd. The principal executive offices of Sinovac Antigua are located at No. 39 Shangdi Xi Road, Haidian District, Beijing 100085, People's Republic of China. The telephone number at this address is +86-10-8279-9800. The registered office of Sinovac Antigua is c/o APN Corporate and Management Services Limited, Unit #4 Bryson's Complex, Friars Hill Road, St. John's, Antigua and Barbuda. The authorized agent for service of process in the United States is Cogency Global Inc., 122 East 42nd Street, 18th Floor, New York, New York 10168.
Sinovac Antigua was incorporated on March 1, 1999 in Antigua and Barbuda as an international business corporation with limited liability under the International Business Corporations Act of Antigua and Barbuda. Prior to adopting its current name on October 21, 2003, Sinovac Antigua was known as Net-Force System Inc. and was primarily engaged in the online gaming business.
Major Subsidiaries and Corporate Restructuring
Sinovac Antigua is a holding company. We conduct our business principally through our operating subsidiaries: Sinovac Beijing (incorporated in April 2001), in which we hold a 73.09% majority interest; Sinovac LS (incorporated in May 2009), in which we hold a 59.24% majority interest; Sinovac Dalian (incorporated in January 2010), in which we hold a 68.00% majority interest; and our wholly owned subsidiaries Sinovac Biomed (incorporated in April 2015), Sinovac Hong Kong (incorporated in October 2008), and Sinovac Singapore (incorporated in August 2020).
•Sinovac Beijing: In September 2003, Sinovac Antigua issued 10 million of its shares to Lily Wang as consideration for the acquisition of a 51% equity interest in Sinovac Beijing. Under PRC law, the transfer was recorded as a cash transaction, and regulatory approval was received in August 2004. We acquired an additional 20.6% equity interest in September 2004 for approximately $3.3 million in cash and a further 1.53% interest in October 2011 by contributing RMB18.6 million in unpaid dividends. We currently hold a 73.09% equity interest in Sinovac Beijing, with Shandong Sinobioway Biomedicine holding the remaining 26.91%.
•Sinovac Dalian: In November 2009, Sinovac Hong Kong entered into a joint venture with Dalian Jin Gang Group. Following its initial acquisition of a 30% interest for RMB60.0 million and an additional 25% interest for RMB50.0 million in 2010, Sinovac Hong Kong increased its equity ownership to the current 68.00% through a series of debt-to-equity swaps completed between 2016 and 2020.
•Sinovac LS: In May 2020, Prime Success and Vivo Capital invested $15 million in Sinovac LS to fund the further development of CoronaVac. In December 2020, Sino Biopharmaceutical Limited invested approximately $500 million for a 15.00% equity interest. As a result of these investments, our equity interest in Sinovac LS was diluted to 59.24%.
•Sinovac Chengdu: In 2024, through Sinovac LS, we acquired a biopharmaceutical company focused on innovative vaccines based in Chengdu and renamed it Sinovac (Chengdu) Biotech Co., Ltd. ("Sinovac Chengdu").
Global Expansion and Strategic Partnerships
To support our globalization strategy, we established Sinovac Hong Kong in 2008 and Sinovac Singapore in 2020 to focus on international registration, distribution, and export. Our recent strategic initiatives include the following:
•Keyvac (Turkey): In 2021, Sinovac LS formed a joint venture, Keyvac Biyolojik Ürünler Sanayi ve Ticaret Anonim Şirketi ("Keyvac"), with a local partner in Turkey to manufacture and commercialize vaccines. Sinovac LS holds a 55.00% equity interest in the venture.
•SKY Biologics: In 2023, Sinovac Hong Kong invested $101.4 million (RMB720 million) for a 45.00% equity interest in SKY Biologics Co., Ltd ("SKY Biologics"). In November 2023, SKY Biologics acquired a 94.03% equity interest in Synermore Biologics (Suzhou) Co., Ltd., which focuses on the development of monoclonal antibody drugs.
•BogotáBio (Colombia): In 2023, we were selected as the exclusive strategic partner to establish the first local human vaccine production facility in Bogotá, Colombia.
•Other Global Operations: As of the end of 2025, we had established subsidiaries in Bangladesh, Chile, Colombia, Indonesia, Mexico, the Philippines, and Thailand.
37
Capital Markets and Corporate Governance
•Offerings: We closed a private placement in 2008 for gross proceeds of $9.8 million and completed a public offering in February 2010 for net proceeds of approximately $61.8 million.
•Tender Offers: Between August 2023 and March 2024, a third party commenced unsolicited partial tender offers for our common stock at a price of $0.03 per share. Our board of directors unanimously recommended that shareholders reject each of these offers. Following the expiration of the tender offers, the third party acquired approximately 1.42 million shares, representing approximately 2.0% of our then-outstanding shares.
•Rights Agreement: In March 2016, we adopted the Rights Agreement. On January 16, 2025, the Privy Council ruled the Rights Agreement invalid. As a result, the Exchange Shares were cancelled and the Shareholder 2019 Rights Exchange Trust was dissolved.
For additional information regarding our principal capital expenditures, see "— D. Property, Plants and Equipment" and "Item 5. Operating and Financial Review and Prospects —B. Liquidity and Capital Resources — Capital Expenditures."
The SEC maintains an Internet site that contains our reports, proxy and information statements, and other information that we have filed electronically with the SEC at http://www.sec.gov.
Investor inquiries should be directed to us at the address and telephone number of our principal executive offices set forth above. Our website is http://www.sinovac.com. The information contained on our website does not form part of this annual report.
B. Business Overview
We are a fully integrated China-based biopharmaceutical company focused on the research, development, manufacturing and commercialization of vaccines for the prevention of human infectious diseases, including certain diseases with significant unmet medical needs. We have developed a comprehensive vaccine portfolio covering hepatitis A, hepatitis B, hand, foot and mouth disease ("HFMD") caused by enterovirus 71 ("EV71"), seasonal and pandemic influenza, COVID-19, pneumococcal disease, poliomyelitis, mumps, varicella, rabies and tetanus..
Key Regulatory and Product Milestones
•2002: Launched Healive (Hepatitis A Vaccine, Inactivated), the first of its kind developed by a China-based manufacturer. Healive subsequently passed WHO prequalification in 2017.
•2005: Obtained approvals for Bilive (Hepatitis A and B Combined Vaccine) and Anflu (Influenza Vaccine (Split Virion), Inactivated).
•2008-2009: Obtained production licenses for Panflu (Pandemic Influenza Vaccine (inactivated, adjuvanted)) and Panflu.1 (Influenza A (H1N1) Vaccine (Split Virion), Inactivated).
•2011-2016: Obtained production licenses for a mumps vaccine in 2011 and Inlive (Enterovirus Type 71 Vaccine, Inactivated) in 2015, with commercial launches following shortly thereafter.
•2019-2022: Obtained approvals and WHO prequalification for the live attenuated varicella vaccine and sIPV (Poliomyelitis Vaccine, Inactivated, Sabin Strains).
•2020-2021: Obtained approvals for TetrAnflu (Influenza Vaccine (Split Virion), Inactivated (Quadrivalent)), PnuPreve (23-Valent Pneumococcal Polysaccharide Vaccine), and conditional authorization for CoronaVac (COVID-19 Vaccine, Inactivated), which received WHO Emergency Use Listing in June 2021.
•2025: Obtained approval for the adsorbed tetanus vaccine for market launch.
38
Our Product Portfolio
Product Name [abbr.] Brand Name Indication
Hepatitis A Vaccine (Human Diploid Cell), Inactivated [HepA-I] Healive Hepatitis A
Hepatitis A and B Combined Vaccine [HepA&B] Bilive Hepatitis A and Hepatitis B
Influenza Vaccine (Split Virion), Inactivated [IIV3] Anflu Influenza
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent [IIV4] TetrAnflu Influenza
Pandemic Influenza Vaccine (Inactivated, adjuvanted) [PIV-I-Adj] Panflu Pandemic Influenza
Pandemic Influenza Vaccine (Split virion, adjuvanted) [PIV-SV-Adj] sPanflu Pandemic Influenza
H1N1 Influenza A Vaccine (Split Virion), Inactivated [pH1N1] Panflu.1 Influenza caused by H1N1pdm09
Enterovirus Type 71 Vaccine (Vero Cell), Inactivated [EV71] Inlive HFMD caused by EV71
23-Valent Pneumococcal Polysaccharide Vaccine [PPSV23] PnuPreve Pneumococcal disease
Poliomyelitis Vaccine (Vero Cell), Inactivated, Sabin Strains [sIPV] EraPolio Polio
Mumps Vaccine, Live [MuV] Mumps
Varicella Vaccine, Live [VAR] VARINOVA/PROVARIX Varicella
COVID-19 Vaccine (Vero Cell), Inactivated [COV-I] CoronaVac COVID-19
Tetanus Vaccine, Adsorbed [TT] Tetanus
Hepatitis Vaccines
Healive: Approved in 2002 and included in China's national immunization program in 2007. With WHO prequalification obtained in 2017, it is now registered in over 30 countries and international organizations, and authorized for use in more than 40 countries and regions. Our production line has an annual capacity of approximately 20 million doses.
Bilive: Approved in 2005, it is the only combined hepatitis A and B vaccine developed and marketed in China and is designed for the private-pay market. It received re-registration approval in July 2025.
Influenza Vaccines
Anflu and TetrAnflu (Seasonal Influenza): Anflu, a split virion influenza vaccine, was approved in 2005 and marketed beginning in 2006. It is sold in Asia, Africa, and the Americas, with approvals in 10 countries as of the end of 2025. TetrAnflu, our quadrivalent influenza vaccine, was approved in June 2020 and had been approved in nine countries or regions as of the end of 2025. In light of WHO recommendations, we expect to cease production and supply of TetrAnflu beginning in 2026. Our influenza vaccine production line, which has been used to manufacture Anflu, TetrAnflu, Panflu, and Panflu.1 interchangeably, has an annual production capacity equivalent to approximately 80 million doses of Anflu.
Panflu/sPanflu and Panflu.1 (Pandemic Influenza): Panflu is the first and only approved pandemic influenza vaccine available in China against the H5N1 influenza virus. sPanflu, a split virion pandemic influenza vaccine, was granted a production license in November 2011. Panflu and sPanflu did not undergo Phase III clinical trials, as the relevant authorities did not require them for regulatory approval. Panflu.1, approved in September 2009, was the first approved vaccine in the world against the H1N1 pandemic virus. These vaccines are not expected to generate revenues in the foreseeable future.
COVID-19 Vaccine (CoronaVac)
Granted conditional approval by the NMPA and WHO Emergency Use Listing in 2021, CoronaVac was authorized for individuals aged three and older and was utilized in over 70 countries during the pandemic. Due to shifts in global epidemic prevention policies and a declining market for inactivated COVID-19 vaccines, we ceased supplying CoronaVac in 2023.
Pediatric and Other Vaccines
Inlive (EV71): Inlive is a vaccine for the prevention of HFMD caused by EV71. Commercialized in 2016, it has expanded its age group coverage and obtained GMP certificates from five countries as of the end of 2025.
Varicella Vaccine: Approved in 2019 and WHO-prequalified in 2022, our varicella vaccine was the first Chinese varicella vaccine to receive WHO prequalification. It is commercially available in 20 countries and regions.
Sabin Inactivated Polio Vaccine (sIPV): Approved in 2021 and WHO-prequalified in 2022 for its single-dose presentation and in 2024 for its five-dose presentation. It is available for procurement by UN agencies in support of global polio eradication efforts.
23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23): Approved in December 2020 for the prevention of Streptococcus pneumoniae infections in adults and children over two years old.
39
Mumps Vaccine: Launched in 2012, our mumps vaccine was supplied until changes in China's vaccination protocols, which increasingly favored MMR combination vaccines, led us to cease supply after 2024.
Adsorbed Tetanus Vaccine (TT): Approved by the NMPA in August 2025. Indicated for use in trauma-prone individuals and in pregnant women for the prevention of maternal and neonatal tetanus.
Research and Development
Overview and Infrastructure
We are a leading vaccine research and development company in China, with a strategic focus on infectious and chronic diseases that present significant unmet medical needs. Our research infrastructure encompasses approximately 29,600 square meters of laboratory and manufacturing facilities, located primarily in the Daxing District of Beijing. We employ a research and development team of approximately 600 professionals and operate national-level post-doctoral and academic workstations. Our technological capabilities span multiple platforms, including inactivation, attenuation, recombinant protein, viral vector, and mRNA technologies. Our commitment for innovation amounted to $20.4 million, $25.5 million, $32.3 million as of December 31, 2025, 2024, and 2023. We also receive financial support from the PRC government for pre-clinical and clinical research conducted under government-sponsored programs.
Strategic Collaborations
Our strategy reflects a deliberate balance between in-house development and collaboration with leading domestic and international partners. Key partnerships include joint laboratories established with the Institute of Biophysics and the Institute of Process Engineering of the Chinese Academy of Sciences. We also serve as the lead institution for the Chinese branch of the BRICS Vaccine Research and Development Center. In the majority of our strategic R&D collaborations, we retain commercial rights to resulting products, positioning our partnerships to translate directly into long-term value creation.
Product Pipeline
Our pipeline comprises a diverse portfolio of vaccine and antibody candidates at various clinical and pre-clinical stages of development. The following table summarizes our key clinical-stage pipeline candidates as of the date of this annual report:
Additionally, we are developing a Pentavalent DTaP-IPV/Hib Combination Vaccine, currently in preclinical stages, alongside various other vaccines and antibodies targeting over 20 life-threatening diseases.
40
Sales and Marketing
Our sales strategy aims to expand our market share in the Chinese domestic market while strengthening our global presence and broadening international product distribution channels.
Chinese Mainland Domestic Market
In China, we focus on reinforcing our competitive edge in the private-pay market while pursuing expanded inclusion in government-funded programs. In 2018, we transitioned to a collaborative sales model that integrates our internal marketing team with third-party promotional agents, enhancing both compliance and market coverage. As of December 31, 2025, our marketing team—supported by over 50 third-party agents and approximately 1,000 promotional representatives—covered 2,821 district-level CDCs across 31 provinces and municipalities.
We support our products by providing medical education to healthcare professionals, managing provincial bidding processes, and developing innovative after-sales services, including commercial insurance compensation mechanisms for adverse vaccination events. Domestic sales accounted for 67.7% of our total revenues in 2025.
International Market
We pursue international commercialization by registering and distributing products in target overseas markets. By the end of 2025, we had exported our vaccines to nearly 80 countries. Our international expansion is underpinned by WHO Prequalification (PQ) for our hepatitis A vaccine (2017), varicella vaccine (2022), and polio vaccine (2022 and 2024).
•Hepatitis A Vaccine: Supplied to more than 40 countries and regions, with cumulative deliveries exceeding 130 million doses.
•Varicella Vaccine: Experiencing robust growth in overseas markets, driven by expanding demand in Latin America and other middle-income countries, particularly Argentina and Indonesia, as well as long-term supply agreements with Brazil.
•sIPV: Leveraging our WHO PQ status, we supply sIPV to low- and lower-middle-income countries through UN agencies, including UNICEF and PAHO, in support of the Global Polio Eradication Initiative.
•Influenza Vaccine: Delivered to 14 countries. In 2025, we secured an exclusive award under the Chilean government's national tender, covering approximately 8.3 million individuals (80% of the target population).
Seasonality
Our business is highly seasonal, primarily driven by the sales cycles of our influenza vaccines. The majority of our annual revenues from seasonal influenza vaccines are recognized between August and October, coinciding with pre-flu-season vaccination campaigns in the Northern Hemisphere. As a result, our operating results are subject to significant quarterly fluctuations. In addition, any residual winter-season sales activity in the first quarter is typically offset by a slowdown during the Chinese New Year holiday period, when CDC and hospital operations are substantially curtailed.
Suppliers
We obtain raw materials from both local and overseas suppliers. We generally maintain at least two qualified suppliers for each key raw material. The hepatitis B antigens used in the production of Bilive, however, are sourced exclusively from a single supplier, Beijing Biological. For a discussion of risks associated with this single-source dependency, see "Item 3. Key Information—D. Risk Factors—Risks Related to Our Company—If any of our third-party suppliers or manufacturers cannot adequately meet our needs, our business could be harmed." Raw materials are generally in adequate supply, and the prices we pay for them have remained stable. In the event of rising raw material costs, we seek to maintain our gross margins through ongoing improvements to our production processes and manufacturing techniques.
Manufacturing, Quality Management and Safety
Manufacturing Facilities and Capacities
We operate five manufacturing bases located in the Haidian, Changping, and Daxing districts of Beijing, as well as in Dalian (Liaoning province) and Chengdu (Sichuan province). Since December 2019, the NMPA has transitioned from issuing GMP certificates to conducting routine GMP inspections. As of the date of this annual report, all of our operational manufacturing facilities are in compliance with applicable NMPA GMP standards. The following table summarizes our commercial manufacturing capabilities:
41
Location Key Products / Facilities Designed Annual Capacity Quality & Certification Status
Haidian, Beijing Hepatitis (Healive/Bilive) Influenza (Anflu/Panflu) PPSV23 20 million doses * 15 million doses NMPA GMP compliant; WHO Prequalification (PQ) for Healive.
Changping, Beijing EV71 (Inlive) sIPV 20 million doses 40 million doses NMPA GMP compliant; WHO PQ for sIPV. Also includes filling/packaging.
Daxing, Beijing Influenza (Anflu) Adsorbed Tetanus Vaccine Large-scale production sites * 50 million doses N/A NMPA GMP compliant. Previously utilized for COVID-19 vaccines.
Dalian, Liaoning Live-attenuated vaccines (Varicella) 18 million doses NMPA GMP compliant; WHO PQ (Passed second audit in June 2025).
Chengdu, Sichuan Rabies vaccines 10 million doses NDA pending. GMP inspection expected by July 2026.
*In 2023, our influenza vaccine bulk production line at the Daxing site passed GMP inspection and was put into use, which increased our aggregate annual influenza vaccine production capacity (Haidian and Daxing combined) to 80 million doses.
Quality Management System
We have established a comprehensive quality management system covering the entire product lifecycle—from R&D, raw material procurement, and manufacturing to quality control testing, storage, and distribution. This system is designed and maintained in accordance with applicable regulatory requirements, including China's current GMP regulations and WHO prequalification standards. Our quality management system is built upon the following key elements, among others:
•Quality Risk & Supplier Management: We apply a risk-based approach to identify, assess, and mitigate potential quality risks, including those associated with raw material variability, process deviations, and environmental monitoring. We implement a rigorous supplier qualification and auditing program for all critical raw materials and component suppliers, including ongoing monitoring of performance and compliance.
•Process Validation & QC Testing: We perform process validation for all commercial manufacturing processes and maintain a change control system to evaluate, approve, and document any changes to facilities, equipment, materials, or procedures that may affect product quality. Our quality control laboratories are fully capable of conducting comprehensive testing of raw materials, in-process samples, and finished products, including potency, purity, sterility, and other attributes required by applicable pharmacopoeia standards.
Pharmacovigilance and Safety
We maintain a comprehensive pharmacovigilance system encompassing a dedicated organizational structure, detailed documentation, and standardized operating procedures ("SOP") to ensure safety monitoring throughout the product lifecycle. In strict compliance with regulatory requirements, we promptly report serious Adverse Events Following Immunization ("AEFI") to the relevant authorities. We systematically collect and analyze safety data from post-marketing surveillance, Phase IV clinical trials, dedicated safety studies, and published medical literature, and submit Periodic Safety Update Reports ("PSUR") on a regular basis. Additionally, we actively cooperate with regulatory authorities in AEFI investigations and provide all requisite supporting data.
Environmental Compliance
We proactively manage our environmental obligations and maintain strict compliance with all applicable environmental laws and regulations in the PRC. All our manufacturing facilities operate under approved environmental impact assessment reports. We obtained approval for our Changping facility construction plan from the Beijing Municipal Environmental Protection Bureau in 2011 and subsequently passed the government's environmental evaluation for the addition of the sIPV facility in 2016. Furthermore, the environmental impact assessment reports for the PPSV23 production facility at the Shangdi site and the CoronaVac production facility were approved in 2014 and 2020, respectively. In accordance with the PRC Environmental Impact Assessment Law, we will file new environmental impact assessment reports for approval should any material changes occur in the scale, nature, location, or production technologies of our manufacturing processes.
Strategic Collaborations
To bolster our R&D and commercialization capabilities, we maintain key strategic collaborations with international institutions and domestic academies. Historical funding and royalty expenditures under these agreements are detailed below:
•National Institutes of Health ("NIH"): We hold licenses for Rotavirus Strains and Monoclonal Antibodies (2009, amended 2022) and a Biological Materials License (2022). Financial terms include an initial $170,000 royalty, a $7,500 minimum annual royalty, 1.5% to 4.0% sales royalties, and up to $330,000 in clinical/commercial milestones.
42
Historical Expenditures: We made royalty payments of $15,000, $nil, and $80,000 for the years ended December 31, 2025, 2024, and 2023, respectively.
•INTRAVACC: A 50-year non-exclusive license agreement (signed 2014) to develop and commercialize sIPV. Terms include up to $2.4 million (€1.5 million) in entrance and milestone fees, plus a single-digit percentage worldwide sales royalty.
Historical Expenditures: We paid royalty fees of $1,033,922 (€899,169), $597,776 (€542,634), and $134,245 (€124,117) for the years ended December 31, 2025, 2024, and 2023, respectively. As of December 31, 2025, the Company had an outstanding liability of a royalty fee in amount of $748,001 (€650,464).
•Chinese Academy of Sciences ("CAS") - Institute of Biophysics: A five-year agreement (signed 2022, amended 2025) establishing a joint laboratory for neutralizing antibodies and RSV vaccines, with a total contract amount of $8.4 million.
Historical Expenditures: We made collaboration funding payments and project selection costs of $1.7 million, $1.7 million, and $1.8 million for the years ended December 31, 2025, 2024, and 2023, respectively.
•CAS - Institute of Process Engineering: A five-year agreement (signed 2022) focusing on recombinant protein adjuvants and mRNA delivery systems, with a total contract amount of $2.8 million.
Historical Expenditures: We made collaboration funding payments of $0.6 million, $0.6 million, and $0.6 million for the years ended December 31, 2025, 2024, and 2023, respectively.
•ATCC: In July 2025, we entered into a non-exclusive biological material license agreement with the American Type Culture Collection ("ATCC") to use certain ATCC Materials, including ATCC® VR-795™ Human herpesvirus 3, to develop, manufacture and commercialize a human varicella vaccine as the licensed product within the specified field of use under the agreement. The term of the license under the agreement is 30 years, unless earlier terminated in accordance with its terms. We agree to pay ATCC an initiation fee of $1.8 million within 30 days after the effective date, as well as an annual accrued royalty of 0.5% of the net sales of licensed products sold by us.
Historical Expenditures: We paid initiation fee of $1.8 million and accrued annual royalty fee of $0.7 million for the year ended December 31, 2025.
Competition
The global pharmaceutical, biopharmaceutical, and biotechnology industries are intensely competitive and characterized by rapid technological advancement and evolving competitive dynamics. As of the date of this annual report, there are approximately 50 registered vaccine manufacturers in China, of whom we estimate approximately 20 are our direct competitors. Our competitors include large integrated multinational corporations, domestic state-owned enterprises, and emerging private biopharmaceutical companies. Many of these competitors possess substantially greater financial, research and development, manufacturing, and marketing resources, as well as more extensive experience in navigating complex regulatory environments, executing large-scale clinical trials, and commercializing products globally.
Furthermore, as most vaccines in the Chinese Mainland private market are primarily paid for out-of-pocket by consumers, consumers tend to be both health-conscious and price-sensitive. We seek to position our products to address this demand by offering what we believe is a compelling value proposition: higher quality and safety profiles relative to lower-cost domestic alternatives, combined with greater affordability relative to comparable products offered by multinational competitors. Our ability to sustain this positioning also depends on our capacity to adapt promptly to China's continuously evolving regulatory and Pharmacopoeia standards, which may periodically reshape market dynamics and raise or lower entry barriers for both domestic and international participants.
Our direct competitors in the PRC and global markets by product category include:
•Hepatitis A: AIM Vaccine, IMBCAMS, Pukang Biological, CNBG (Domestic); GSK, Merck (International).
•Influenza: Hualan Vaccine, CNBG (Domestic); Abbott Laboratories, Sanofi (International).
•EV71 & sIPV: IMBCAMS, CNBG.
•Varicella: BCHT Biotechnology, CNBG, Kangtai Biological.
•PPSV23: CNBG, Walvax Biotechnology, Kangtai Biological.
•Tetanus: Chengdu Olymvax Biopharmaceuticals.
Global Footprint and Market Opportunities
To address evolving global health dynamics and demographic shifts, we have pivoted to a globally integrated model of "Local R&D + Local Production + Long-term Supply," moving beyond a traditional supplier role to become an infrastructure partner for sovereign health systems.
43
•Türkiye (Keyvac JV): Established in 2021 with a $100 million investment, Keyvac operates a facility with an annual capacity of 30 million doses. Following GMP certification in October 2023, it supports local licensing and production, cementing our position within the Turkish National Immunization Program.
•Latin America (Brazil & Chile): In Brazil, we signed 10-year Productive Development Policy (PDP) agreements with the Ministry of Health and local partners to supply approximately 60 million doses of varicella and rabies vaccines. In Chile, we secured an exclusive tender with Cenabast to provide seasonal influenza vaccines for the 2025 national campaign.
Intellectual Property
We rely on a combination of patents, trademarks, and trade secrets to protect our proprietary technology. As of the date of this annual report, we hold 158 issued patents related to our vaccines and antibodies in China. We maintain 111 trademark registrations across our operational regions, including core brands such as "SINOVAC," "Healive," "Anflu," "Inlive," and "CoronaVac." We have registered our domain names, including www.sinovac.com.cn and www.sinovac.com, with the China Internet Network Information Center. Additionally, we require all employees and partners to execute strict confidentiality and invention-assignment agreements to protect unpatented know-how and clinical data.
Insurance
We maintain property insurance coverage with an annual aggregate insured amount of approximately RMB6,424 million ($894 million) in 2025 to cover our property and facilities against claims arising from fire, earthquake, flood, and a wide range of other natural disasters. We carry worldwide (excluding the United States, Canada, and Europe) product liability insurance covering our vaccines such as HepA-I, IIV3, IIV4, EV71, VAR, and sIPV vaccines for the year 2025. We also carry product liability insurance covering all of our products distributed in the Chinese mainland. We maintain liability insurance to cover claims that may arise from incidents relating to certain clinical trials of our vaccine products. Our insurance coverage may not be sufficient to cover any claim for product liability or damage to our fixed assets. We do not maintain any business interruption insurance. See "Item 3. Key Information — D. Risk Factors — Risks Related to Our Company — We could be subject to costly and time-consuming product liability actions and, because our insurance coverage is limited, our exposure to such claims could cause significant financial burden."
Regulatory Framework in the PRC
Our operations are extensively regulated by the NMPA under the Pharmaceutical Administration Law, the Vaccine Administration Law, and other relevant regulations.
Drug Registration and Approval
•Clinical Trials: Following the completion of pre-clinical studies, an Investigational New Drug ("IND") application must be submitted to the NMPA. If no objection is raised within 60 days, Phase I through Phase III clinical trials may proceed, subject to compliance with Good Clinical Practice guidelines.
•Marketing Authorization: Upon completing clinical trials, we submit a New Drug Application ("NDA"). The NMPA evaluates the drug's safety, efficacy, and quality through technical dossier reviews and on-site GMP inspections. Approved authorizations are valid for five years.
•Batch Approval: Vaccines cannot be distributed commercially without batch release approval. The National Institutes for Food and Drug Control ("NIFDC") tests samples and reviews production records for every commercial lot before market distribution.
Vaccine Administration Law
The PRC Vaccine Administration Law enforces stringent lifecycle supervision:
•Market Classification: Vaccines are classified into immunization program vaccines and non-immunization program vaccines. Immunization program vaccines are government-funded vaccines administered under national or local immunization programs, while non-immunization program vaccines are generally voluntary vaccines paid for by vaccine recipients or their guardians.
•Compliance & Post-Market Management: Market authorization holders must establish robust quality traceability systems, submit annual reports on vaccine risk-benefit profiles, maintain sales records for at least five years post-expiration, and publicly disclose adverse reaction data and recall information.
•Compulsory Liability Insurance: Vaccine authorization holders are legally mandated to procure compulsory vaccine liability insurance. Failure to comply can result in fines of up to RMB2 million.
•Severe Penalties: Producing or selling substandard or counterfeit vaccines may result in severe penalties, including fines of up to 50 times the market value, confiscation of illegal gains and related equipment, and lifetime industry bans for responsible executives.
44
C. Organizational Structure
See "Item 3. Key Information – Corporate Structure."
D. Property, Plants and Equipment
Our operational footprint encompasses multiple facilities primarily dedicated to manufacturing, research and development, and corporate administration. A summary of our principal properties is set forth below.
Beijing Facilities
•Haidian District (Shangdi Site): We own and operate facilities in the Peking University Biological Industry Park totaling 122,203 square feet (11,353 square meters). This includes our corporate headquarters (24,434 square feet / 2,270 square meters) and the production plant for Healive and Bilive (97,769 square feet / 9,083 square meters). Additionally, we lease additional space in the same park from SinoBioway for the manufacturing of Anflu and PPSV23.
•Changping District (Manufacturing Site): We acquired the land use rights for this site, which covers 312,379 square feet (29,021 square meters) and features five buildings with a total construction area of 1,025,627 square feet (95,284 square meters). This site houses our commercial production facilities for EV71, sIPV, our central filling and packaging operations, and the recently completed Vaccine Quality Research Center.
•Changping District (SINOVAC Life City): We completed the construction of a new industrialization base in 2025 and named it SINOVAC Life City. Comprising seven main buildings with a total area of approximately 1,300,667 square feet (120,836 square meters) and representing a total investment exceeding RMB1 billion, this base serves as an integrated technology, service, and manufacturing platform for advanced biomedical research.
•Daxing District (Manufacturing Site): We operate extensive facilities primarily dedicated to vaccine production (including influenza, TT, and CoronaVac), with a total construction area of 3,417,140 square feet (317,463 square meters).
Regional Facilities
•Dalian (Manufacturing): Located at DD Port, our Dalian subsidiary operates nine buildings with a total construction area of 590,852 square feet (54,892 square meters). The facilities focus on the research, development, and manufacturing of live-attenuated vaccines, including varicella and mumps vaccines.
•Hangzhou (Manufacturing Development): In 2022, we acquired a 269,604-square-foot (25,047-square-meter) plot of land and commenced construction of a facility with a planned construction area of 766,939 square feet (71,251 square meters). The main structure has been completed, with overall project completion targeted for 2026.
•Chengdu (R&D and Manufacturing): Through our 2024 acquisition of Sinovac Chengdu, we entered into a 10-year lease agreement with Chengdu Bio-city Construction Co., Ltd. for approximately 154,440 square feet (14,348 square meters), utilized for R&D and vaccine production.