A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.

This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N=150) of which all participants in this arm will be included in the immunogenicity subset.

Start Date01 Jun 2024

Sponsor / Collaborator

International Vaccine Institute

[+3]

NCT06306196 / Not yet recruitingPhase 2IIT

A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals

Start Date01 Apr 2024

Sponsor / Collaborator

International Vaccine Institute

[+2]

CTR20230348 / Active, not recruitingPhase 4

重组戊型肝炎疫苗（大肠埃希菌）去汞工艺变更后的免疫原性及安全性研究

[Translation] Study on the immunogenicity and safety of recombinant hepatitis E vaccine (Escherichia coli) after mercury removal process change

1）评价去汞工艺生产的重组戊型肝炎疫苗（大肠埃希菌）的免疫原性是否非劣效于工艺变更前生产的含汞重组戊型肝炎疫苗（大肠埃希菌）；2）评价研究疫苗的安全性。

[Translation]

1) To evaluate whether the immunogenicity of recombinant hepatitis E vaccine (Escherichia coli) produced by the mercury-removal process is non-inferior to the mercury-containing recombinant hepatitis E vaccine (Escherichia coli) produced before the process change; 2) To evaluate the safety of the study vaccine.

Start Date22 Mar 2023

Sponsor / Collaborator

Xiamen Innovax Biotech Co., Ltd.

[+2]

100 Clinical Results associated with Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

100 Translational Medicine associated with Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

100 Patents (Medical) associated with Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

Literatures (Medical) associated with Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

31 Dec 2023·Emerging microbes & infections

Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial

Article

Author: Xia, Ningshao ; Li, Yufei ; Zhang, Jun ; Huang, Yue ; Hu, Xiaowen ; Zhuang, Chunlan ; Wei, Lihui ; Wu, Ting ; Hong, Ying ; Pan, Huirong ; Su, Yingying ; Zhong, Guohua ; Chen, Qi ; Huang, Shoujie ; Peng, Siying ; Qiao, Youlin ; Bi, Zhaofeng ; Zhang, Qiufen ; Jia, Xinhua

Special attention has been paid to Hepatitis E (HE) prophylaxis for pregnant women due to poor prognosis of HE in this population. We conducted a post-hoc analysis based on the randomized, double-blind, HE vaccine (Hecolin)-controlled phase 3 clinical trial of human papillomavirus (HPV) vaccine (Cecolin) conducted in China. Eligible healthy women aged 18-45 years were randomly assigned to receive three doses of Cecolin or Hecolin and were followed up for 66 months. All the pregnancy-related events throughout the study period were closely followed up. The incidences of adverse events, pregnancy complications, and adverse pregnancy outcomes were analysed based on the vaccine group, maternal age, and interval between vaccination and pregnancy onset. During the study period, 1263 Hecolin receivers and 1260 Cecolin receivers reported 1684 and 1660 pregnancies, respectively. The participants in the two vaccine groups showed similar maternal and neonatal safety profiles, regardless of maternal age. Among the 140 women who were inadvertently vaccinated during pregnancy, the incidences of adverse reactions had no statistical difference between the two groups (31.8% vs 35.1%, p = 0.6782). The proximal exposure to HE vaccination was not associated with a significantly higher risk of abnormal foetal loss (OR 0.80, 95% CI 0.38-1.70) or neonatal abnormality (OR 2.46, 95% CI 0.74-8.18) than that to HPV vaccination, as did distal exposure. Significant difference was not noted between pregnancies with proximal and distal exposure to HE vaccination. Conclusively, HE vaccination during or shortly before pregnancy is not associated with increased risks for both the pregnant women and pregnancy outcomes.

06 Dec 2023·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Analysis of adult vaccination in Shandong Province from 2018 to 2022].

Article

Author: Xu, A Q ; Li, R P ; Sun, H F ; Zhang, Y J ; Yu, Y ; Zhang, W Y

Objective: To analyze the utilization of adult vaccination among people aged 18 and above in Shandong Province from 2018 to 2022. Methods: Data on vaccination units in 2022 and individual cases of vaccination information for people aged 18 and above were extracted from the Shandong Immunization Information System. A descriptive analysis was conducted on the distribution of adult vaccination units and adult vaccination varieties. The total vaccination amount and vaccination rate were calculated. Results: By the end of 2022, there were 3 948 vaccination units providing adult vaccination in Shandong Province, with 0.36 adult vaccination clinics per 10 000 people. Adult vaccination including RabV(rabies vaccine for human use), InfV(influenza vaccine), HPV(human papillomavirus), HepB(hepatitis B vaccine), PPV23(23-valent pneumococcal polysaccharide vaccine), MenACYW135(meningococcal polysaccharide vaccine group ACYW135), MMR(measles, mumps and rubella combined attenuated live vaccine), HEV(hepatitise E vaccine), RZV(recombinant zoster vaccine), TV(tetanus vaccine) and HF(haemorrhagic fever with renal syndrome vaccine) vaccines were administered, with a cumulative dose of 40.056 9 million and an average of 0.1 doses per person per year from 2018 to 2022. The top three vaccines were RabV, InfV and HPV, accounting for 31.48%, 22.57%, and 15.93% of the total vaccination amount, respectively. The annual vaccination dose for adults increased from 3.477 3 million in 2018 to 13.308 6 million in 2022, with an average annual growth rate of 56.55%. The cumulative 5-year doses of RabV and TV were 15.90 doses per 100 people and 0.21 doses per 100 people. The average annual vaccination rate of InfV was 2.28%. The cumulative full vaccination rates of HPV, HepB, PPV23 and RZV were 12.44%, 1.61%, 0.52% and 0.17%, respectively. The cumulative 5-year doses of RabV and TV were 29.19 doses per 100 people and 0.43 doses per 100 people in the age group of 20 to<30 years old. The vaccination rates of InfV and PPV23 were 9.08% and 1.27% in the age group of 70 to<80 years old. The vaccination rate of RZV was 0.11% in the age group of 50 to<60 years old. The HPV vaccination rate was 18.09% in the age group of 20 to<30 years old, and the HepB, MenACYW135, MMR and HEV vaccination rates were 6.21%, 9.55%, 2.65%, and 2.83% in the 18-19 age group, respectively. Conclusion: There are relatively few types of adult vaccination in Shandong Province, with narrow coverage and low vaccination rates.

20 May 2023·Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology

[Prophylactic vaccines for hepatitis type E].

Article

Author: Liu, C ; Zheng, Z Z ; Xia, N S

Over the past few years, hepatitis type E has been increasingly recognized as an underestimated global disease burden. Populations with severe infection-related injuries or deaths include pregnant women, patients with underlying liver disease, and the elderly. Vaccines are the most effective means to prevent hepatitis type E virus (HEV) infection. However, the development of inactivated or attenuated vaccines is not feasible due to the lack of an efficient HEV cell culture system, so researchers have conducted in-depth research on recombinant vaccines. The capsid protein (pORF2), which the virion's open reading frame 2 encodes, contains almost exclusively the HEV neutralization site. Several candidate vaccines based on pORF2 have demonstrated potential for primate protection, with two being well tolerated and highly effective in preventing hepatitis type E in adults. Hecolin® (HEV 239 vaccine), the world's first hepatitis type E vaccine, was approved for marketing in China in 2012.

News (Medical) associated with Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

16 Nov 2023

·www.globenewswire.com

Roche launches automated serology hepatitis E virus tests, including a test to detect acute HEV infections, recommended in the new WHO 2023 Essential Diagnostics List

It is estimated that one third of the global population could be at risk for infection with Hepatitis E virus.1The new tests allow clinicians to diagnose acute and chronic infections amongst patients presenting with or without signs of the illness as recommended by the European Association for the Study of the Liver (EASL).2The tests complete Roche’s panel used for the differential diagnosis of acute viral hepatitis caused by the hepatitis A, B, C and E viruses. Basel, 16 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus (HEV) infections in countries accepting the CE mark. By testing for HEV infection, clinicians can support their patients to identify the cause of their symptoms and determine appropriate treatment, monitor for progression to severe acute HEV and prevent severe disease progression with antiviral treatment.1,2,6 Recognising the value of diagnostics, the World Health Organization (WHO) has developed an “Essential Diagnostics List” which includes in-vitro diagnostics that should be available in all countries to increase timely and life-saving diagnoses. This year for the first time, tests for HEV are included to aid in the diagnosis and surveillance of HEV infection.5 “These tests highlight Roche’s commitment to contributing to the elimination of infectious diseases globally. Infection with HEV, a virus of significant global impact, results in 70,000 deaths and 3,000 stillbirths annually,”3,4 said Matt Sause, CEO of Roche Diagnostics. “The Anti-HEV IgM inclusion in the newly released WHO 2023 Essential Diagnostics List, demonstrates the important role this test plays in disease management for patients globally. HEV testing also contributes to managing infected patients in high-risk groups and avoiding the misdiagnosis of drug-induced liver injury.1,2,6 They will also help to provide a more accurate estimate of the global HEV disease burden and inform governments and public health stakeholders on how to respond to the disease globally.5 As HEV is under-reported, the addition of these tests will support governments in managing outbreaks. These fully automated assays will support lab personnel by enabling them to run them more efficiently compared to manual tests, as they require smaller sample volumes than manual tests, enabling results to be available within 18 minutes. About the Elecsys Anti-HEV IgM and Anti-HEV IgG immunoassaysElecsys Anti-HEV IgM is an immunoassay for the in vitro qualitative detection of IgM antibodies to HEV in human serum and plasma, and is used as an aid to detect an acute or recently acquired HEV infection. Elecsys Anti-HEV IgG is an immunoassay for the in vitro quantitative determination of IgG antibodies to HEV in human serum and plasma, and is used as an aid to detect a recent or past HEV infection. The performance of both assays was evaluated in a multi-center study, which tested a total of more than 8,900 samples from presumed acute and recovered HEV infection for the determination of relative sensitivity, and from hospitalized patients, blood donors and pregnant women for the determination of relative specificity. The overall relative sensitivity of the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG assay was determined as 98.7% (95% CI 97.3 – 99.5%) and 99.1% (95% CI 98.0 – 99.7%), respectively. The overall specificity was determined as 99.4% (95% CI 99.2 – 99.6%) and 99.8% (95% CI 99.6 – 99.9%), respectively. The new assays are available for use on the cobas® e 411 analyzer, cobas e 601/602 modules, and the cobas e 402 and cobas e 801 analytical modules. They expand Roche’s comprehensive viral hepatitis serology test portfolio, and complete the test panel used for the differential diagnosis of acute hepatitis caused by the hepatitis A, B, C and E viruses (alongside the Elecsys Anti-HAV IgM, Elecsys Anti-HBc IgM, Elecsys HBsAg II, Elecsys Anti-HCV II, and Elecsys HCV Duo assays). About the World Health Organisation’s (WHO) 2023 Essential Diagnostics List (EDL)The World Health Organisation’s (WHO) 2023 Essential Diagnostics List (EDL) is an evidence-based register of in vitro diagnostics that supports countries to make national diagnostic choices. Updated biennially, the EDL is intended to support national in vitro diagnostics policy development and to improve access to IVD testing and clinical laboratory services. As well as informing national EDLs, it provides advice on prioritization of IVDs at different levels of the healthcare system. Additionally, it informs United Nations agencies and non-government organizations that support the selection, procurement, supply or donation of In Vitro Diagnostics along with guidance to the private health technology and manufacturing sectors about the IVDs priorities required to address global health issues.5 About hepatitis E virus (HEV)HEV is a pathogen of growing global public health concern.7,8 HEV includes 8 genotypes, of which HEV-1 to 4 are the most frequently detected globally. HEV-1 and HEV-2 infect only humans, whereas HEV-3 and HEV-4 can infect both humans and animals such as pigs, wild boar, rabbits and deer.9-15 It is estimated that HEV-1 and HEV-2 account for approximately 20.1 million HEV infections, 3.4 million symptomatic cases, 70,000 deaths, and 3000 stillbirths annually.3 HEV-1 and HEV-2 are commonly found in developing countries with poor sanitation, where HEV is transmitted through the fecal-oral route.7,10, 16 HEV-3 accounts for most of the sporadic HEV infections in developed countries while HEV-4 is mainly found in Asia. Both HEV-3 and HEV-4 are transmitted zoonotically, most commonly through undercooked meat.7,17,18 In several countries, occasional transmission of HEV-3 and HEV-4 through blood transfusion has been reported.7, 19,20 HEV infection usually causes a mild or subclinical infection with a self-limiting illness that lasts from 2 to 6 weeks.21, 22 Symptomatic hepatitis E is similar to other acute hepatitis infections (fatigue, nausea, vomiting as well as jaundice and elevated liver enzymes).21 High-risk populations are immunocompromised patients (specifically transplant organ recipients),22,21,23,24 patients with underlying liver conditions, and elderly people and pregnant women.9,19,13,25-27 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Webb GW, Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv Infect Dis. 2019;6:1-18[2]EASL. Clinical Practice Guidelines on hepatitis E virus infection. J Hepatol 2018;68:1256-1271[3] World Health Organization (WHO). Hepatitis E vaccine: WHO position paper. Wkly Epidemiol Rec. 2015;18:185-200.[4] Rein DB, et al. The global burden of hepatitis E genotypes 1 and 2 in 2005. Hepatology. 2012;55:988-997.[5] World Health Organization. WHO releases new list of essential diagnostics; new recommendations for hepatitis E virus tests, personal use glucose meters [Internet; updated 2023 Oct 19; cited Nov 2 2023]. Available from https://www.who.int/news/item/19-10-2023-who-releases-new-list-of-essential-diagnostics--new-recommendations-for-hepatitis-e-virus-tests--personal-use-glucose-meters[6] Kar P, Karna RA. A Review of the Diagnosis and Management of Hepatitis E. Curr Treat Options Infect Dis 2020;12:310–320[7] Khuroo MS, et al. Hepatitis E: Discovery, global impact, control and cure. World J Gastroenterol. 2016;22:7030-7045.[8] Webb GW, Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv Infect Dis. 2019;6:2049936119837162.[9] Li P, et al. The global epidemiology of hepatitis E virus infection: A systematic review and meta-analysis. Liver Int. 2020;40(7):1516-1528.[10] Goel A, Aggarwal R. Hepatitis E: Epidemiology, Clinical Course, Prevention, and Treatment. Gastroenterol Clin North Am. 2020;49:315-330.[11] Raji YE, et al. Hepatitis E Virus: An emerging enigmatic and underestimated pathogen. Saudi J Biol Sci. 2022;29:499-512.[12] Kamar N, et al. Hepatitis E. Lancet. 2012;379:2477-2488.[13] Aggarwal R, Goel A. Natural History, Clinical Manifestations, and Pathogenesis of Hepatitis E Virus Genotype 1 and 2 Infections. Cold Spring Harb Perspect Med. 2019;9:a032136.[14] Smith DB, et al. Update: proposed reference sequences for subtypes of hepatitis E virus (species Orthohepevirus A). J Gen Virol. 2020;101:692-698.[15] Purdy MA, et al. ICTV Virus Taxonomy Profile: Hepeviridae. 2022. J Gen Virol 2022;103(9).[16] Ruggeri FM, et al. Zoonotic transmission of hepatitis E virus in industrialized countries. New Microbiol. 2013;36:331-44.[17] Izopet J, et al. Hepatitis E virus infections in Europe. J Clin Virol. 2019;120:20-26.[18] World Health Organisation. Factsheet Hepatitis E. Last updated June 2022 [Internet, updated 2023 July, cited 2023 July 24]. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-e.[19] Al-Sadeq DW, et al. Laboratory challenges in the diagnosis of hepatitis E virus. J Med Microbiol. 2018;67(4):466-480.[20] Pérez-Gracia MT, et al. Hepatitis E: an emerging disease. Infect Genet Evol. 2014;22:40-59.[21] Kamar N, et al. Hepatitis E virus infection. Nat Rev Dis Primers. 2017;3:17086.[22] Lhomme S, et al. Hepatitis E Pathogenesis. Viruses. 2016;8:212.[23] Larrue H, et al. Hepatitis E, what’s the real issue? Liver Int. 2020;40(Suppl 1):43-47.[24] Lhomme S, et al. Risk of zoonotic transmission of HEV from rabbits. J Clin Virol. 2013;58:357-362.[25] Zhao Q, et al. Antigenic determinants of hepatitis E virus and vaccine-induced immunogenicity and efficacy. J Gastroenterol. 2013;48:159-168.[26] Aggarwal R. Hepatitis E: clinical presentation in disease-endemic areas and diagnosis. Semin Liver Dis. 2013;33:30-40.[27] Velavan TP, et al. Hepatitis E: An update on One Health and clinical medicine. Liver Int 2021;41:1462-1473. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Nathalie AltermattPhone: +41 79 771 05 25 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Dr. Rebekka SchnellPhone: +41 79 205 27 03 Sileia UrechPhone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 16112013_MR_Launch of Elecsys Anti-HEV IgM & Anti-HEV IgG_en

Clinical ResultClinical StudyDiagnostic Reagents

100 Deals associated with Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

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Hepatitis E	CN	Xiamen Innovax Biotech Co., Ltd.	01 Dec 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03827395 (HEV-239, Pubmed)	Phase 1	IgG \| IgM	-	HEV-239 (Hecolin®) Vaccine 30 µg	ljbcwqrvpd(geejfpmiwf) = No participants experienced serious adverse events related to HEV-239 nxjsdzoban (qqcxizxygv )	Positive	27 Mar 2024
NCT03827395 (CTgov)	Phase 1	Hepatitis E	25	HEV 239 (HEV-239)	rgdlxyyvvj(kveccvqlpa) = pmqavwmxuu bjmkqrbzbj (gholatgxoe, hudmupfyey - sipxshlrtb) View more	-	24 Sep 2021
				Placebo (Placebo)	rgdlxyyvvj(kveccvqlpa) = nmlzgttegi bjmkqrbzbj (gholatgxoe, qcngurgpih - onufebsepf) View more
NCT02964910 (CTgov)	Phase 4	Hepatitis B, Chronic \| Hepatitis E	475	Recombinant Hepatitis E Vaccine (Escherichia Coli) (the Chronic Hepatitis B Patients)	lqyjktgegh(iyluhntwpg) = axnhmmzkyy qgkwurecer (shrexbtexx, zvcbvyiqzz - jkkkahvrsu) View more	-	25 Jul 2019
				Recombinant Hepatitis E Vaccine (Escherichia Coli) (the Healthy Volunteer)	lqyjktgegh(iyluhntwpg) = xxnnguocwn qgkwurecer (shrexbtexx, funhugiaab - emekzolcsp) View more
NCT01014845 (Pubmed \| Hum Vaccin Immunother)	Phase 3	-	112,604	hepatitis E vaccine (Hecolin)	csbgiartwr(xhzxkmzppc) = Most of the adverse events were mild and comparable between participants with and without baseline hepatitis B surface antigen (HBsAg). No vaccine-related serious adverse events were reported. Rates of serious adverse events in HBsAg (+) or HBsAg (-) participants were also comparable between both groups. qtzyuwrxip (lskzpeyfvf )	-	01 Nov 2013
				Placebo (hepatitis B vaccine)

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Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

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