This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.

开始日期2024-10-10

申办/合作机构

科兴（大连）疫苗技术有限公司

NCT06484686 / Not yet recruiting临床4期

An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine at 6 and 10 Years After Booster Dose Immunization With Live Attenuated Varicella Vaccine

This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.

开始日期2024-09-01

申办/合作机构

科兴（大连）疫苗技术有限公司

NCT06314724 / Enrolling by invitation临床3期

Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines: A Randomized, Double-blind, Active-controlled Phase Ⅲ Clinical Trial

This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac").

开始日期2024-03-01

申办/合作机构

科兴（大连）疫苗技术有限公司

100 项与水痘减毒活 (科兴控股生物) 相关的临床结果

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100 项与水痘减毒活 (科兴控股生物) 相关的转化医学

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100 项与水痘减毒活 (科兴控股生物) 相关的专利（医药）

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项与水痘减毒活 (科兴控股生物) 相关的新闻（医药）

2024-09-18

·Business Wire

New Long-Term Zeposia (ozanimod) Data Demonstrate Durable Efficacy and Consistent Safety in Relapsing Forms of Multiple Sclerosis

PRINCETON, N.J.--( BUSINESS WIRE )-- Bristol Myers Squibb (NYSE: BMY) today announced new data from the Phase 3 DAYBREAK trial demonstrating that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with Zeposia (ozanimod) for relapsing forms of multiple sclerosis. These findings showed that patients receiving continuous Zeposia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) loss through Month 60 (annualized least squares mean [LSM] % change from parent trial baseline: RADIANCE, −0.27; SUNBEAM, −0.35). Additionally, findings from a separate DAYBREAK OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events (TEAEs), with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia . These data and 12 additional abstracts will be presented at the 40 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark taking place September 18-20, 2024. “If not treated early upon diagnosis, multiple sclerosis can lead to significant, irreversible brain volume loss and cognitive decline,” said Jeffrey Cohen, MD, Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio and a paid consultant for Bristol Myers Squibb. “These new analyses reinforce the well-established safety and efficacy profile of Zeposia as an effective oral therapy, especially for newly diagnosed patients living with relapsing forms of multiple sclerosis.” Reductions in brain volume loss with Zeposia treatment The DAYBREAK OLE trial included 2,257 patients from the SUNBEAM and RADIANCE Phase 3 trials and evaluated rates of brain volume loss (Poster #P1623). Switching from interferon beta-1a (IFN-β) to Zeposia treatment consistently reduced rates of WBV loss (annualized LSM% change from RADIANCE baseline to Month 24 and DAYBREAK baseline to Month 24: −0.48 and −0.19, respectively, with a similar pattern observed in SUNBEAM). Additionally, similar reductions were observed for change in thalamic volume loss. High annualized LSM% reductions in cortical grey matter volume (CGMV) were observed with IFN-β (annualized change at Month 12 relative to SUNBEAM baseline: −1.02; annualized change at Month 24 relative to RADIANCE baseline: −0.59), but this trend reversed 12 months after switching to Zeposia in DAYBREAK (annualized LSM% increase relative to DAYBREAK baseline: patients from SUNBEAM, 0.10; patients from RADIANCE, 0.20), with low annualized LSM% CGMV loss observed thereafter. Established Zeposia safety profile confirmed with more than eight years of DAYBREAK data The final DAYBREAK OLE safety analysis (Poster #P1609) included 762 patients who were treated with continuous Zeposia with a median exposure of 83.9 months. Incident rates per 1,000 person-years decreased over time from the Phase 3 trials to Month 60 or more of the DAYBREAK OLE trial. Decreases were observed for overall TEAEs (896.1 versus 101.7), infections (300.5 versus 142.6), opportunistic infections (12.0 versus 4.9), cardiac (22.8 versus 9.5), hepatic (77.0 versus 15.7) and pulmonary disorders (11.3 versus 4.7), respectively. “The data presented at ECTRIMS further reinforce the long-term safety and efficacy of Zeposia and add to the robust body of evidence demonstrating its potential impact on decreasing disease progression over time,” said Alyssa Johnsen, MD, PhD , senior vice president and head of clinical development, Immunology, Cardiovascular and Neuroscience, Bristol Myers Squibb. “Building on our expertise with Zeposia , we are expanding our pipeline as we continue to look for new ways to advance the field of neuroscience. New modalities and disease targets fuel our goal of delivering medicines that elevate standards of care across neurological diseases, including multiple sclerosis.” Bristol Myers Squibb thanks the patients and investigators who participated in the Zeposia clinical trials. About DAYBREAK DAYBREAK was a Phase 3, multi-center, long-term open-label extension study to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with relapsing forms of multiple sclerosis (RMS). Eligible patients from the RADIANCE, SUNBEAM and RPC01-1001 trials diagnosed with RMS were enrolled to receive treatment until the end of the DAYBREAK. Patients in the trial received Zeposia 0.92 mg (equivalent to 1 mg). About SUNBEAM SUNBEAM was a pivotal, Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral Zeposia (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg, respectively) against weekly intramuscular Avonex ® for at least a 12-month treatment period. The study included 1,346 people living with RMS across 152 sites in 20 countries. The primary endpoint of the trial was annualized relapse rates during the treatment period. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months, number of gadolinium-enhanced brain MRI lesions at Month 12 and percent change from baseline in whole brain volume at Month 12. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator. About RADIANCE RADIANCE Part B was a pivotal, Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of oral Zeposia 0.92 mg (equivalent to 1 mg) against weekly intramuscular Avonex ® (interferon beta-1a) over a 24-month treatment period. The study included 1,320 people living with RMS across 150 sites in 21 countries. The primary endpoint of the trial was annualized relapse rates over 24 months. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months. About Multiple Sclerosis Multiple sclerosis (MS) is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate—a process that's currently irreversible. MS affects 700,000 people in Europe and approximately 2.9 million people worldwide. Relapsing forms of MS (RMS), including clinically isolated syndrome, relapsing remitting disease and active secondary progressive disease, is characterized by clearly defined attacks of worsening neurologic function. These attacks—often called relapses, flare-ups or exacerbations—are followed by partial or complete recovery periods. During these recovery periods, also called remissions, symptoms improve partially or completely with no apparent progression of disease. However, smoldering neuroinflammation can be present from the earliest stages of MS, which is underlying and continuous disease activity occurring simultaneously in different areas of the brain that contributes to disability accumulation. Since MS relapses are unpredictable, patients can feel frustrated, stressed or scared when they occur. RMS is the most common disease course at the time of diagnosis. Approximately 85% of patients are initially diagnosed with RMS, compared with 10%-15% diagnosed with progressive forms of the disease. Bristol Myers Squibb: Delivering Breakthrough Science for Meaningful Interventions in Neuroscience Neurological conditions represent some of the greatest challenges of our time because of their impact on society, including patients, caregivers, families and healthcare systems. At Bristol Myers Squibb, we are committed to advancing our robust pipeline of potential medicines for neurological disorders with the goal of modifying disease and improving quality of life. Leveraging genetics, biomarkers and predictive sciences, we target key pathways involved in the initiation and progression of neurological diseases to develop therapies with the potential to optimize patient outcomes. About Zeposia (ozanimod) Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in multiple sclerosis (MS) is unknown but may involve the reduction of lymphocyte migration into the central nervous system. Zeposia is approved in numerous countries around the world for the treatment of adults with relapsing forms of MS and adults with moderately to severely active ulcerative colitis. U.S. FDA APPROVED INDICATIONS ZEPOSIA ® (ozanimod) is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Moderately to severely active ulcerative colitis (UC) in adults. IMPORTANT SAFETY INFORMATION Contraindications: Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker Patients with severe untreated sleep apnea Patients taking a monoamine oxidase (MAO) inhibitor Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA. Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA. Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated. In the MS and UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS and UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects. Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has been reported in patients treated with S1P receptor modulators, including ZEPOSIA, and other MS and UC therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued. Immune reconstitution inflammatory syndrome (IRIS) has been reported in MS patients treated with S1P receptor modulators who developed PML and subsequently discontinued treatment. IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken. Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: with significant QT prolongation with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA. Women who become pregnant while taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry by calling 1-877-301-9314 or visiting www.zeposiapregnancyregistry.com . Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA. Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated. Macular Edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued. Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued. Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended. Severe Increase in Multiple Sclerosis (MS) Disability After Stopping ZEPOSIA: In MS, severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation. After stopping ZEPOSIA in the setting of PML, monitor for development of immune reconstitution inflammatory syndrome (PML-IRIS). Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA. Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension. In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, and headache. Use in Specific Populations: Hepatic Impairment: Dosage adjustment in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) is required, and use of ZEPOSIA in patients with severe hepatic impairment (Child-Pugh class C) is not recommended. For additional safety information, please see the full Prescribing Information and Medication Guide . About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of this study, that Zeposia (ozanimod) for the indication described in this release may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of Zeposia for such indication may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

临床结果临床3期上市批准疫苗

2024-09-03

·SINOVAC科兴

SINOVAC科兴甲肝和水痘疫苗在秘鲁获批

近日，SINOVAC科兴甲型肝炎灭活疫苗孩尔来福®（儿童剂型和成人剂型）及水痘减毒活疫苗陆续获得秘鲁药品、器械与药物理事会（General Directorate of Medicines, Supplies and Drugs ，DIGEMID）注册批准，均为秘鲁首款获批的中国甲肝疫苗及水痘减毒活疫苗。迄今为止，SINOVAC科兴的多款疫苗已在拉美11个国家获得注册批准。世界卫生组织（WHO）关于甲肝疫苗的立场文件（2022年版）中建议各国依据本国甲肝疫情、流行程度的转变、成本效益等考量，在国家免疫规划中为≥12月龄人群接种甲肝疫苗[1]。目前全球数十个国家和地区已将甲肝疫苗纳入到免疫规划中。秘鲁属于甲型肝炎（HAV）中等流行国家，在2023年以前并未将甲肝疫苗纳入国家免疫规划项目。一项于2014年12月至2015年6月的研究报告显示，秘鲁15岁以上人群的HAV感染率超过93%[2]；另一项于2020年发布的研究结果显示，秘鲁15-69 岁人群的甲型肝炎感染率很高，呈高度流行[3]。秘鲁卫生部于2023年将甲肝疫苗纳入国家免疫规划，为全国15月龄的婴儿接种甲肝灭活疫苗。水痘是由水痘-带状疱疹病毒引起的高度传染性疾病。WHO保守估计，水痘在全球每年导致420万例包括脑炎、肺炎和细菌感染在内的严重并发症所致住院病例，以及4200人死亡[4]。秘鲁卫生部于2018年将水痘疫苗纳入国家免疫规划，包含12月龄儿童1针水痘疫苗的接种，水痘发病率从2018年35.87/10万下降至2023年4.94/10万[5]。截至目前，SINOVAC科兴甲肝疫苗孩尔来福®和水痘减毒活疫苗已累计出口至全球超40个国家、地区和国际组织，两款疫苗均为目前国内唯一通过WHO预认证的同类疫苗产品，在秘鲁获批后将进一步满足当地对高品质疫苗产品的需求，更好助力当地甲肝和水痘的疾病防控。关于SINOVAC科兴甲肝疫苗孩尔来福® SINOVAC科兴生产的孩尔来福®是中国第一支甲型肝炎灭活疫苗，于2002年在中国获得药品注册批件上市销售，2017年通过世界卫生组织预认证，也是目前国内唯一一款通过世界卫生组织预认证的甲肝疫苗。上市20余年，孩尔来福®已累计出口全球30余个国家，累计使用超1亿剂次，产品的安全性和免疫原性有着丰富的临床证据，上市后陆续开展的Ⅳ期临床研究40余项，累计发表中英文论文近百篇，内容涵盖抗体应答速度、与进口灭活疫苗/减毒活疫苗的免疫原性比较、互换接种效果、免疫持久性、加强免疫效果、应急/群体性接种、安全性。此外，SINOVAC科兴还与韩国和印度相关机构联合开展了孩尔来福®Ⅲ期临床试验，以期为更多儿童提供保护。从已发布的研究数据看：孩尔来福®免疫接种后一周后即可产生免疫应答，快速起效；接种两剂孩尔来福®15年后，血清保护率仍为97.9%，模型估计孩尔来福®提供的保护可长达30年；并且孩尔来福®安全性良好，不良反应发生率极低。关于SINOVAC科兴水痘疫苗 SINOVAC科兴水痘减毒活疫苗于2019年12月18日获得中国国家药品监督管理局批准上市。 SINOVAC科兴水痘减毒活疫苗系用水痘-带状疱疹病毒减毒株（国际通用Oka株）接种于由SINOVAC科兴自主研发的SV-1株人二倍体细胞，经培养后采用具有核心专利的纯物理技术收获病毒，加入稳定剂冻干制成，收获过程不采用消化细胞活性化学添加剂（如EDTA），生产全程零抗生素添加，无残留、更安全。该疫苗各检定标准均符合世界卫生组织（WHO）及《中国药典》标准。 SINOVAC科兴水痘减毒活疫苗是国内首个将保护效力写入产品说明书的水痘减毒活疫苗,其Ⅲ期临床研究结果显示：1-12岁儿童接种疫苗后抗体阳转率为97.1％；疫苗对水痘确诊病例的保护效力为87.1％，对突破性水痘病例的保护效力89.2％，对中度以上水痘病例的保护效力为100%，并具有良好的安全性。 2022年11月3日，SINOVAC科兴的水痘减毒活疫苗通过世界卫生组织（WHO）预认证（Prequalification, PQ），是国内首款也是目前国内唯一一款通过WHO预认证的水痘疫苗。参考文献 [1]WHO position paper on hepatitis A vaccines – October 2022 [2]Cabezas C, Trujillo O, Gonzales-Vivanco Á, et al. Seroepidemiology of hepatitis A, B, C, D and E virus infections in the general population of Peru: A cross-sectional study. PLoS One. 2021 Apr 8;16(4):e0250185. doi: 10.1371/journal.pone.0250185]. PLoS One. 2020;15(6):e0234273. [3]Cabezas C, Trujillo O, Gonzales-Vivanco Á, et al. Seroepidemiology of hepatitis A, B, C, D and E virus infections in the general population of Peru: A cross-sectional study [published correction appears in PLoS One. 2021 Apr 8;16(4):e0250185. doi: 10.1371/journal.pone.0250185]. PLoS One. 2020;15(6):e0234273. Published 2020 Jun 15. doi:10.1371/journal.pone.0234273 [4]Varicella and herpes zoster vaccines: WHO position paper, June 2014. Wkly Epidemiol Rec. 2014;89(25):265-287. [5]PERÚ Ministerio de Salud. Número de casos de varicela, Perú 2018 –2023.Retrieved September 2, 2024, from http://www.dge.gob.pe/portal/docs/vigilancia/sala/2023/SE52/varicela.pdf

疫苗临床研究

2024-04-29

·BioSpace

SINOVAC Reports Unaudited Second Half of 2023 Financial Results and Files 2023 Annual Report on Form 20-F

BEIJING--(BUSINESS WIRE)-- Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, has filed its 2023 annual report on Form 20-F with the U.S. Securities and Exchange Commission for the year ended December 31, 2023. The annual report can be accessed on the Company's investor relations website at . The Company also reported its unaudited financial results for the second half and audited financial for the full year ended December 31, 2023. Second Half and Full Year 2023 Financial Summary Sales for the six months ended December 31, 2023 were $307.9 million, compared to $280.5 million in the prior year period. Sales in 2023 were $448.3 million, compared to $1.5 billion in the prior year. The Company posted $119.9 million of net loss attributable to common shareholders, or a loss of $1.20 per basic and diluted share, in the six months ended December 31, 2023, compared to net loss attributable to common shareholders of $373.7 million, or a loss of $3.76 per basic and diluted share, in the prior year period. The Company posted $105.9 million of net loss attributable to common shareholders, or a loss of $1.06 per basic and diluted share in 2023, compared to net income attributable to common shareholders of $107.9 million, or $1.08 per basic and $1.00 per diluted share, in the prior year period. Mr. Weidong Yin, Chairman, President and CEO of SINOVAC, commented “In 2023, SINOVAC has gradually adjusted from the state of mass supply of COVID-19 vaccine against pandemic back to normal operational status. I am pleased to see that the top line of our regular products still maintained growth in the year of 2023. After experiencing three years of the COVID-19 pandemic, the world is still facing the threat of various infectious diseases in 2023. As a leading biopharmaceutical products provider in China, SINOVAC continues to invest additional resources in R&D and production of vaccines, and keeps exploring additional opportunities in a broader biopharmaceutical industry. It is great to see every progress of our pipeline products, such as the recent approval of 5-dose sIPV from National Medical Products Administration (NMPA) and the approval of clinical trial for reassortant hexavalent rotavirus vaccine. Meanwhile, we are maintaining a strong international presence by providing high quality vaccines and localized production outside of China.” Business Updates Hepatitis A Vaccine – Healive®, the first and only WHO prequalified inactivated hepatitis A vaccine from China, is currently supplied both domestically and internationally. Healive®’s performance in public tender market in China was further improved in 2023. Influenza Vaccine – A new and state-of-the-art influenza vaccine production line started operations in Beijing. The plant, which complies with Chinese Good Manufacturing Practice guidelines and utilizes green production processes, enables automated production at scale that expands SINOVAC’s capacity to meet the growing global demand for high-quality influenza vaccines. SINOVAC’s influenza vaccines expand international market accessibility in 2023 by obtaining more overseas market approvals, such as in Pakistan and Chile. A study conducted recently in the Philippines and Chile demonstrated that the immunogenicity induced by SINOVAC’s quadrivalent influenza vaccine was non-inferior and the geometric mean titers were even higher in individuals aged 3 years and older, when compared with the control vaccine which was widely used. Varicella Vaccine – SINOVAC’s live attenuated varicella vaccine, the first WHO prequalified Chinese varicella vaccine, was successfully supplied to Türkiye this year. The varicella vaccine was also registered in Lebanon and Kenya in 2023. Hand Foot and Mouth Disease Vaccine – SINOVAC’s Enterovirus 71 (EV71) vaccine, Inlive®, has already safeguarded millions of children in China. In 2023, SINOVAC has initiated phase I clinical trials of its bivalent enterovirus inactivated vaccine, which aims to protect against hand, foot and mouth disease (HFMD) caused by enterovirus 71 (EV71) and coxsackievirus 16 (CA16). Strategic Developments - We achieved several milestones in the strategic development in 2023. In Türkiye, our first joint venture with a local partner has successfully completed construction of a vaccine production plant, and a GMP certificate was obtained from the Turkish Medicines and Medical Devices Agency. In Latin America, we participated in a tender issued by the government of Bogota, Colombia, for localizing human vaccine production, and we were successfully selected as the exclusive strategic partner with BogotáBio, a local vehicle for the localization project, which aims to build the first local human vaccine production facility with municipal partner in Colombia’s capital of Bogota. SINOVAC's extensive expertise and experience in vaccine R&D and production, and its successful track record in establishing vaccine manufacturing facilities will play a pivotal role in the new venture. At the end of 2023, SINOVAC completed an investment in Synermore Biologics (Suzhou) Co., Ltd., a company which focuses on the development and production of monoclonal antibody drugs in the fields of infectious diseases, malignant tumors and autoimmune diseases. The investment marks a key step for SINOVAC entering into the novel antibody drugs field. Unaudited Financial Results for the Second Half of 2023 Sales for the second half of 2023 were $307.9 million, compared to $280.5 million in the prior year period. The increase was mainly due to increased sales of our influenza vaccines. Selling, general and administrative expenses in the second half of 2023 were $235.3 million, compared to $667.7 million in the prior year period. The decrease was mainly due to lower expenses incurred in the COVID-19 employee incentive plan which was established in 2022. R&D expenses in the second half of 2023 were $193.4 million, compared to $257.7 million in the prior year period. Net loss in the second half of 2023 was $228.3 million, compared to net loss of $702.3 million in the prior year period. Net loss attributable to common shareholders was $119.9 million, or a loss of $1.20 per basic and diluted share, in the second half of 2023, compared to a net loss attributable to common shareholders of $373.7 million, or a loss of $3.76 per basic and diluted share, in the prior year period. As the Company announced on February 22, 2019, the Company’s board of directors determined that certain shareholders became acquiring persons, as defined in the Company’s rights agreement (“Rights Agreement”), under which a trigger event occurred. As a result, the Company issued new common and preferred shares of SINOVAC. Without the effect of implementing the Rights Agreement and newly-issued common and preferred shares, basic and diluted loss per share for the second half of 2023 would be $1.63. Non-GAAP adjusted EBITDA was a loss of $111.6 million in the second half of 2023, compared to a loss of $998.7 million in the prior year period. Non-GAAP net loss was $183.0 million in the second half of 2023, compared to a net loss of $805.8 million in the prior year period. Non-GAAP diluted loss per share in the second half of 2023 was $0.93 compared to a loss of $4.38 per share in the prior year period. Non-GAAP diluted loss per share in the second half of 2023, excluding the implementation of the Rights Agreement and the newly-issued common and preferred shares, would be $1.29. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures are included at the end of this earnings announcement. The Company’s financial statements for the second half of 2023 are prepared and presented in accordance with U.S. GAAP. However, they have not been audited or reviewed by the Company’s independent registered accounting firm. Financial Results for the Twelve Months Ended December 31, 2023 Sales in 2023 were $448.3 million, a decrease from $1.5 billion in the prior year. The decrease was due to decreased sales of CoronaVac®. Selling, general and administrative expenses in 2023 were $466.3 million, compared to $823.5 million in the prior year. The decrease was mainly due to lower expenses incurred in the COVID-19 employee incentive plan which was established in 2022. R&D expenses in 2023 were $344.5 million, compared to $442.1 million in the prior year. The Company continued to invest in the advancement of pipeline vaccines in 2023. Net loss in 2023 was $258.4 million, compared to a net income of $88.1 million in the prior year. Net income decreased primarily due to decreased sales. Net loss attributable to common shareholders was $105.9 million, or a loss of $1.06 per basic and diluted share, compared to net income attributable to common shareholders of $107.9 million, or $1.08 per basic and $1.00 per diluted share, in the prior year. Excluding the implementation of the Rights Agreement, as described above, and the newly-issued common and preferred shares, basic and diluted loss per share for 2023 would be $1.39. Non-GAAP adjusted EBITDA was a loss of $458.3 million in 2023, compared to a loss of $309.5 million in the prior year. Non-GAAP net loss in 2023 was $303.9 million, compared to a net loss of $177.0 million in the prior year. Non-GAAP diluted loss per share in 2023 was $1.32, compared to a loss of $0.37 per share in the prior year. Non-GAAP diluted loss per share in 2023, excluding the implementation of the Rights Agreement and the newly-issued common and preferred shares, would be $1.84 per share. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures are included at the end of this earnings announcement. As of December 31, 2023, cash and cash equivalents and restricted cash totaled $1.3 billion, compared to $4.3 billion as of December 31, 2022. In 2023, net cash provided by operating activities was $104.0 million, net cash used in investing activities was $2.9 billion, and net cash used in financing activities was $76.1 million. As of December 31, 2023, the Company had $76.1 million in bank loans due within one year. The Company expects that its current cash position will be able to support its operations for at least the next 12 months. Legal Proceedings As previously disclosed by the Company, on March 13, 2018, 1Globe Capital LLC (“1Globe”) filed a complaint against the Company in the Antigua Court. The trial of the matter took place from December 3 to 5, 2018. On December 19, 2018, the Antigua judge handed down his judgment (the “Antigua Judgment”), finding the Company fully in favor, dismissing 1Globe’s claim and declaring the Rights Agreement was validly adopted as a matter of Antigua law. On January 29, 2019, 1Globe filed a Notice of Appeal against the Antigua Judgment. On March 4, 2019, 1Globe filed an application for urgent interim relief, seeking an injunction to prevent the Company from continuing to implement its Rights Agreement until the resolution of the appeal. This application was heard on April 4, 2019, at which the Court of Appeal issued an order restraining the Company from operating the Rights Agreement in any way that affects 1Globe’s rights or shareholding or otherwise distributing the exchange shares (the “Exchange Shares”) to the Company’s shareholders who did not trigger the Rights Plan until after the determination of the appeal (the “Exchange Shares”). 1Globe’s appeal against the Antigua Judgment was heard on September 18, 2019, and the appeal decision was announced by the Eastern Caribbean Supreme Court, Court of Appeal (the “Court of Appeal”) on December 9, 2021, upholding the Antigua Judgment in each point. 1Globe applied for leave to appeal to the Judicial Committee of the Privy Council (the “Privy Council”), and the hearing of the application was held on February 24, 2022, in which the Court of Appeal granted 1Globe leave to appeal to the Privy Council on certain grounds, although not including the challenge to the validity of the Rights Agreement. On April 19, 2022, 1Globe renewed its application directly to the Privy Council for leave to appeal on its ground of appeal concerning the validity of the Rights Agreement. The final substantive hearing before the Privy Council is listed for July 10 to 11, 2024. The judgment will be reserved and delivered in writing at a later date. The appeal outcome is therefore pending. As previously disclosed, on March 5, 2018, the Company filed a lawsuit in the Court of Chancery of the State of Delaware, seeking a determination on whether 1Globe, the Chiang Li Family, OrbiMed Advisors, LLC and certain other shareholders of the Company had triggered the Rights Agreement. On April 12, 2018, 1Globe filed an amended answer to the Company’s complaint, counterclaims and a third-party complaint against the Company and Mr. Weidong Yin, alleging, among other allegations, that the Rights Agreement is not valid. On March 6, 2019, the Delaware Chancery Court entered a status quo order, providing that the Company not distribute any of the Exchange Shares to the Company’s shareholders who did not trigger the Rights Plan until the final disposition of the pending Delaware litigation or further order of the Court. On April 8, 2019, the Delaware Chancery Court stated that the Delaware litigation was pending the final outcome of 1Globe’s appeal of the Antigua Judgment. Separately, Heng Ren Investments LP (“Heng Ren”) filed suits against SINOVAC and Weidong Yin on May 31, 2019 in Massachusetts state court for the alleged breach of fiduciary duties and wrongful equity dilution. SINOVAC moved the matter from the state court to the United States District Court for the District of Massachusetts. Heng Ren alleged that Mr. Yin breached fiduciary duties owed to minority shareholders, that SINOVAC aided and abetted breaches of fiduciary duties and that both SINOVAC and Mr. Yin engaged in wrongful equity dilution. Heng Ren requested damages, attorney fees, and prejudgment interest. In July 2021, SINOVAC moved to dismiss Heng Ren’s amended complaint in the federal court in Massachusetts. On March 4, 2022, the court granted the motion as to the breach of fiduciary duty claims and denied the motion as to the wrongful equity dilution claim and denied reconsideration of its decision on the motion. SINOVAC has answered the complaint. Pursuant to the current schedule, the close of fact discovery is April 26, 2024, the deadline for initial summary judgment motions is August 23, 2024, and, should the case not be resolved through settlement or at summary judgment, trial is set to begin on December 9, 2024. On September 6, 2023, MW Gestion, an institutional asset manager based in France, filed a class action complaint on behalf of all SINOVAC shareholders against SINOVAC; Weidong Yin; and other managers and directors of SINOVAC, including Nan Wang, Simon Anderson, Yuk Lam Lo, Kenneth Lee, Meng Mei, and Shan Fu (the “Individual Defendants” and collectively with SINOVAC the “SINOVAC Defendants”); and Wilmington Trust National Association. MW Gestion alleges breach of contract, breach of fiduciary duty, and wrongful dilution claims against the SINOVAC Defendants, as well as aiding and abetting breach of contract and breach of fiduciary duty against the Individual Defendants. MW Gestion’s claims stem from a private investment in public equity transaction on July 2, 2018, and SINOVAC’s implementation of its Rights Agreement on February 22, 2019. SINOVAC and certain other defendants filed a motion to dismiss all claims on November 20, 2023, and the motion was fully briefed as of February 27, 2024. Status of Exchange Shares and Trading in the Company’s Shares As a result of the pending legal proceedings described above, the Exchange Shares are expected to remain in a trust for the benefit of the Company’s shareholders who did not trigger the Rights Plan until, at least, the conclusion of the appeal against the Antigua Judgment and the final disposition of the Delaware litigation or further order of the Delaware Chancery Court. The Exchange Shares remain issued and outstanding. The Nasdaq Stock Market LLC implemented a halt on trading of the Company’s common shares at the time the Exchange Shares were issued to the trust. The Company is currently unable to estimate when trading will resume, or if Nasdaq will take any additional action in regard to trading of the Company’s common shares. About SINOVAC Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases. 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 China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO. 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 new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations. For more information, please visit the Company’s website at . Safe Harbor Statement This press release may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price as a result of the trigger of the rights plan. Non-GAAP Financial Measures To supplement its consolidated financial statements, which are prepared and presented in accordance with GAAP, SINOVAC uses the following non-GAAP financial measures: non-GAAP adjusted EBITDA, non-GAAP net income (loss) and non-GAAP diluted earnings (loss) per share. For more information on these non-GAAP financial measures, please refer to the table captioned “Reconciliations of non-GAAP Measures to the Nearest Comparable GAAP Measures” in this results announcement. SINOVAC believes that non-GAAP adjusted EBITDA, non-GAAP net income (loss) and non-GAAP diluted earnings (loss) per share help identify underlying trends in its business that could otherwise be distorted by the effect of certain income or expenses that SINOVAC includes in net income and diluted earnings (loss) per share. SINOVAC believes that non-GAAP adjusted EBITDA, non-GAAP net income (loss) and non-GAAP diluted earnings (loss) per share provide useful information about its core operating results, enhance the overall understanding of its past performance and future prospects and allow for greater visibility with respect to key metrics used by our management in its financial and operational decision-making. Non-GAAP adjusted EBITDA, non-GAAP net income (loss) and non-GAAP diluted earnings (loss) per share should not be considered in isolation or construed as an alternative to income from operations, net income (loss), diluted earnings (loss) per share, or any other measure of performance or as an indicator of SINOVAC’s operating performance. These non-GAAP financial measures presented here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to our data. Non-GAAP adjusted EBITDA represents net income (loss) and excludes interest and financing expenses, interest income, net other income (expenses) and income tax benefit (expenses), and certain non-cash expenses, consisting of share-based compensation expenses, amortization and depreciation that SINOVAC does not believe are reflective of the core operating performance during the periods presented. Non-GAAP net income (loss) represents net income (loss) before share-based compensation expenses and foreign exchange gain or loss. Non-GAAP diluted earnings (loss) per share represents non-GAAP net income (loss) attributable to common shareholders divided by the weighted average number of shares outstanding during the periods on a diluted basis, including accounting for the effect of the assumed conversion of options. SINOVAC BIOTECH LTD. Consolidated Balance Sheets As of December 31, 2023 and 2022 (Expressed in thousands of U.S. Dollars) December 31, 2023 December 31, 2022 Current assets Cash and cash equivalents $ 1,270,131 $ 4,278,124 Restricted cash 5,166 8,253 Short-term investments 9,953,042 7,034,569 Accounts receivable - net 440,019 537,118 Inventories 139,874 180,719 Prepaid expenses and deposits 11,621 15,242 Income tax receivable 10,703 72,371 Total current assets 11,830,556 12,126,396 Property, plant and equipment – net 979,617 993,781 Prepaid land lease payments 65,540 69,815 Intangible assets - net 8,520 9,699 Long-term prepaid expenses 24 23 Long-term investments 684,285 661,440 Prepayments for acquisition of equipment 6,772 120,912 Deferred tax assets 29,790 71,118 Right-of-use assets 45,525 58,586 Other Non-current Assets 7,345 2,798 Total assets 13,657,974 14,114,568 Current liabilities Short-term bank loans and current portion of long-term bank loans 76,089 293 Loan from a non-controlling shareholder - 4,358 Accounts payable and accrued liabilities 973,949 905,923 Income tax payable 41,258 - Deferred revenue 20,127 17,955 Deferred government grants 1,586 15,120 Dividend payable 29,089 141,993 Lease liability 5,806 5,993 Total current liabilities 1,147,904 1,091,635 Deferred revenue 200 - Deferred government grants 5,865 4,477 Long-term bank loans 177,817 11,513 Deferred tax liability 263,711 241,526 Lease liability 39,271 52,516 Other non-current liabilities 439 240 Total long-term liabilities 487,303 310,272 Total liabilities 1,635,207 1,401,907 Commitments and contingencies Equity Preferred stock 15 15 Common stock 100 100 Additional paid-in capital 541,258 540,582 Accumulated other comprehensive income (loss) (490,055) (383,276) Statutory surplus reserves 1,539,584 1,538,013 Accumulated earnings 7,118,516 7,225,987 Total shareholders' equity 8,709,418 8,921,421 Non-controlling interests 3,313,349 3,791,240 Total equity 12,022,767 12,712,661 Total liabilities and equity $ 13,657,974 $ 14,114,568 SINOVAC BIOTECH LTD. Consolidated Statements of Comprehensive Income (Loss) For the six and twelve months ended 2023 and 2022 (Expressed in thousands of U.S. Dollars, except for numbers of shares and per share data) Six months ended December 31, Year ended December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) Sales $ 307,865 $ 280,471 $ 448,269 $ 1,492,761 Cost of sales (6,893) 430,094 181,516 684,456 Gross profit 314,758 (149,623) 266,753 808,305 Selling, general and administrative expenses 235,276 667,663 466,324 823,543 Provision for doubtful accounts 2,252 3,461 2,638 4,268 Research and development expenses 193,383 257,714 344,515 442,108 Loss on disposal and impairment of property, plant and equipment 78,408 1,927 78,720 5,213 Government grants recognized in income (22,331) (746) (22,423) (760) Total operating expenses 486,988 930,019 869,774 1,274,372 Operating loss (172,230) (1,079,642) (603,021) (466,067) Interest and financing expenses (1,996) (641) (2,260) (1,264) Interest income 55,525 106,820 85,114 190,818 Other income (expense), net 29,277 72,293 367,133 301,751 Income (loss) before income taxes (89,424) (901,170) (153,034) 25,238 Income tax benefit (expense) (138,918) 198,855 (105,321) 62,893 Net income (loss) (228,342) (702,315) (258,355) 88,131 Less: loss attributable to non-controlling interests 111,506 331,669 158,437 25,735 Net income (loss) attributable to shareholders of Sinovac (116,836) (370,646) (99,918) 113,866 Preferred stock dividends (3,024) (3,024) (5,982) (5,982) Net income (loss) attributable to common shareholders of Sinovac (119,860) (373,670) (105,900) 107,884 Net income (loss) (228,342) (702,315) (258,355) 88,131 Other comprehensive income (loss), net of tax of nil Foreign currency translation adjustments 154,217 (279,794) (280,426) (859,045) Unrealized gain 72,817 - 65,900 - Comprehensive loss (1,308) (982,109) (472,881) (770,914) Less: comprehensive loss attributable to non-controlling interests 48,879 445,656 266,184 370,882 Comprehensive income (loss) attributable to shareholders of Sinovac 47,571 (536,453) (206,697) (400,032) Earnings/loss per share Basic net income (loss) per share (1.20) (3.76) (1.06) 1.08 Diluted net income (loss) per share (1.20) (3.76) (1.06) 1.00 Weighted average number of shares of common stock outstanding Basic 99,638,043 99,502,243 99,607,574 99,502,243 Diluted 99,638,043 99,502,243 99,607,574 114,172,782 SINOVAC BIOTECH LTD. Consolidated Statements of Cash Flows For the six and twelve months ended 2023 and 2022 (Expressed in thousands of U.S. Dollars) Six months ended December 31, Year ended December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) Operating activities Net income (loss) $ (228,342) $ (702,315) $ (258,355) $ 88,131 Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Deferred income taxes 108,448 (67,172) 76,324 (83,010) Share-based compensation - - - - Inventory provision 39,903 83,800 52,527 140,004 Provision for doubtful accounts 2,252 3,461 2,638 4,268 Loss on disposal and impairment of property, plant and equipment 78,408 1,927 78,720 5,213 Depreciation of property, plant and equipment 57,983 78,660 140,467 153,819 Amortization of prepaid land lease payments 1,090 1,374 2,228 1,749 Amortization of intangible assets 1,523 932 2,050 1,029 Government grants recognized in income (5,518) (746) (22,423) (760) Investment income (172,847) - (248,085) - Changes in: Accounts receivable (8,287) 429,615 82,147 289,600 Inventories 6,530 (6,869) (16,766) 30,382 Income tax (recoverable) payable 107,202 (191,672) 101,378 (1,275,296) Prepaid expenses and deposits 1,682 (111,395) 3,265 22,519 Deferred revenue 4,957 (13,364) 2,883 (58,485) Accounts payable and accrued liabilities 156,638 536,063 109,430 (86,860) Other non-current assets/liabilities (7,634) (5,531) (4,431) (3,048) Net cash provided by (used in) operating activities 143,988 36,768 103,997 (770,745) Financing activities Proceeds from bank loans 33,808 1 243,395 151 Repayments of bank loans (158) (48) (308) (2,981) Proceeds from issuance of common stock, net of share issuance costs - - 676 - Dividend paid (326,464) (260,702) (328,080) (263,171) Proceeds from subsidiary's financing - - - 11,291 Government grants received 3,831 9,776 12,499 14,797 Repayments of loan from a non-controlling shareholder (4,244) (1,474) (4,245) (1,486) Net cash used in financing activities (293,227) (252,447) (76,063) (241,399) Investing activities Purchase of investments (1,593,895) (5,717,991) (8,222,005) (11,658,465) Proceeds from redemption and sales of investments 1,561,769 3,619,956 5,575,287 6,327,521 Proceeds from disposal of equipment 2 5 39 608 Proceeds from dissolution of subsidiary - 114,352 - 114,352 Acquisition of property, plant and equipment (51,601) (114,402) (144,543) (393,800) Prepaid land lease payments - (26,025) - (35,683) Acquisition of intangible assets (1,145) (9,568) (1,145) (9,568) Purchase of equity investments (108,975) (42,155) (133,767) (105,435) Distributions by equity method investees 679 - 2,021 - Net cash used in investing activities (193,166) (2,175,828) (2,924,113) (5,760,470) Effect of exchange rate changes on cash and cash equivalents and restricted cash (29,058) (189,210) (114,901) (560,769) Decrease in cash and cash equivalents and restricted cash (371,463) (2,580,717) (3,011,080) (7,333,383) Cash and cash equivalents and restricted cash, beginning of period 1,646,760 6,867,094 4,286,377 11,619,760 Cash and cash equivalents and restricted cash, end of period 1,275,297 4,286,377 1,275,297 4,286,377 SINOVAC BIOTECH LTD. Reconciliations of Non-GAAP measures to the nearest comparable GAAP measures For the six and twelve months ended 2023 and 2022 (Expressed in thousands of U.S. Dollars, except for numbers of shares and per share data) Six months ended December 31, Year ended December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) (Unaudited) (Unaudited) Net income (loss) $ (228,342) $ (702,315) $ (258,355) $ 88,131 Adjustments: Depreciation and amortization 60,596 80,966 144,745 156,597 Interest and financing expenses, net of interest income (53,529) (106,179) (82,854) (189,554) Other expense (income), net (29,277) (72,293) (367,133) (301,751) Income tax (benefit) expense 138,918 (198,855) 105,321 (62,893) Non-GAAP adjusted EBITDA (111,634) (998,676) (458,276) (309,470) Net income (loss) (228,342) (702,315) (258,355) 88,131 Add: Foreign exchange (gain) loss 45,308 (103,472) (45,543) (265,091) Non-GAAP net loss (183,034) (805,787) (303,898) (176,960) Net income (loss) attributable to common shareholders of Sinovac (119,860) (373,670) (105,900) 107,884 Add: Non-dilutive preferred stock dividends - - - 5,982 Net income (loss) attributable to common shareholders of Sinovac for computing diluted earnings per share (119,860) (373,670) (105,900) 113,866 Add: Non-GAAP adjustments to net income (loss) 27,280 (61,239) (26,069) (156,332) Non-GAAP net loss attributable to common shareholders of Sinovac for computing non-GAAP diluted earnings per share (92,580) (434,909) (131,969) (42,466) Weighted average number of shares on a diluted basis 99,638,043 99,502,243 99,607,574 114,172,782 Diluted earnings (loss) per share (1.20) (3.76) (1.06) 1.00 Add: Non-GAAP adjustments to net income (loss) per share 0.27 (0.62) (0.26) (1.37) Non-GAAP diluted earnings (loss) per share (0.93) (4.38) (1.32) (0.37)

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