TherVacB - A Multi-center Phase 1b/2a Trial to Assess Safety, Tolerability and Immunogenicity of a Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate

This study is an open-label, ascending dose phase 1b/2a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.

Start Date01 May 2025

Sponsor / Collaborator

Ludwig-Maximilians-Universität München

NCT04490499

/ CompletedPhase 3

A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®

The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.

Start Date02 Sep 2020

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03691610

/ CompletedPhase 3

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
* To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

Start Date04 Oct 2018

Sponsor / Collaborator

Sanofi Pasteur SA

100 Clinical Results associated with Hepatitis B vaccine recombinant(Sanofi)

100 Translational Medicine associated with Hepatitis B vaccine recombinant(Sanofi)

100 Patents (Medical) associated with Hepatitis B vaccine recombinant(Sanofi)

1,276

Literatures (Medical) associated with Hepatitis B vaccine recombinant(Sanofi)

01 May 2025·Vaccine

Implementation of school-based vaccination in French middle schools: Efficient or not?

Article

Author: Clément, Julie ; Roger, Hélène ; Verdon, Renaud ; Fournier, Anna ; Piednoir, Emmanuel ; Martin, Anne ; Michon, Jocelyn ; Baldolli, Aurelie

INTRODUCTIONDespite various vaccination campaigns coordinated by French authorities, vaccine coverage (VC) in France remains low, especially for human papillomavirus (HPV). The Agence Regionale de Santé established a mandate for vaccination centres in Normandy to develop a school-based vaccination program in public middle schools. The aim of this study was to analyse the efficiency of this program after four academic years (2019-2023).MATERIALS AND METHODSAuthorization from the parents was required to update each of the following recommended vaccinations for their children (aged 11-13-years-old): diphtheria-tetanus-poliomyelitis-pertussis; hepatitis B virus (HBV); measles, mumps and rubella; meningococcal C; and HPV vaccines. Adolescents for whom at least one vaccine has been accepted were seen by the doctor and were vaccinated if needed. Global VC was defined as being vaccinated for all French mandatory and recommended vaccines. The objective of this study was to compare the proportions of global VC pre and post implementation of the school vaccination program during the period study.RESULTSDuring the study period, 199 schools were visited. Among the 18,476 students, 33.6 % (n = 6217) of the students' parents accepted at least one vaccine, and 4464 students were vaccinated (81.9 %, 4464/5450). Global preintervention VC was 10.7 % (n = 585), which increased to 65.7 % (n = 3585) after the vaccine intervention (p < 0.0001). VC increased from 64.8 % in preintervention to 87.5 % in postintervention (p < 0.0001) for the meningococcal C vaccine, from 67.6 % to 85.6 % (p < 0.0001) for the HBV vaccine and from 14.6 % (n = 675/4614) to 79.9 % (n = 3685/4614) (p < 0.0001) for the HPV vaccine. In multivariate analysis, the post-COVID-19 period (2021-2022) was significantly associated with not being up to date for at least one vaccine (OR: 1.4 [1.2-1.9]).CONCLUSIONOur study determined that school vaccination program effectively improved VC for all recommended vaccines and should not be restricted to certain vaccines, such as HPV.

01 Mar 2025·Clinical Rheumatology

Hepatitis B vaccine and juvenile idiopathic arthritis: comparison of the seropositivity rates with healthy children at the time of diagnosis and booster dose response under treatment

Article

Author: Çakan, Mustafa ; Nepesov, Merve Işeri ; Yamanel, Rabia Gönül Sezer ; Gür, Güşta Uysal

INTRODUCTION/OBJECTIVESThe study aimed to determine whether in children with newly diagnosed juvenile idiopathic arthritis (JIA) hepatitis B surface antibody (anti-HBs) differs from healthy children and to see whether the revaccination is safe and effective under JIA treatment.METHODSPatients who were followed up with a diagnosis of JIA between January 2020 and February 2024 were included. The control group consisted of healthy children matched for age and gender. Patients with JIA who were seronegative and revaccinated against hepatitis B virus (HBV) at follow-up visits were evaluated in terms of antibody responses and side effects after vaccination.RESULTSThe study included 187 patients with JIA, 104 (55.6%) girls. In the JIA group, the mean anti-HBs levels were 120.8 ± 228.3 IU/L, and 64.7% of patients had anti-HBs levels ≥ 10 mIU/ml, while in the control group, the mean anti-HBs levels were 184.9 ± 304.4 IU/L, and 68.7% of children had protective antibody level against HBV. Sixty-six patients with JIA in whom anti-HBs level < 10 IU/L received an additional three doses of HBV vaccine. After booster vaccination, only one patient had anti-HBs level < 10 IU/L; in the other 65 JIA patients, the mean anti-HBs levels were 530.4 ± 320.8 IU/L. None of the patients observed serious side effects or JIA exacerbation after vaccination.CONCLUSIONSAlthough the mean anti-HBs levels in newly diagnosed JIA patients were lower than in healthy children, no difference was found in the seropositivity rates. Vaccination against HBV during JIA treatment is safe and effective and should be encouraged. Key Points • Hepatitis B virus infection remains a public health problem and publications are indicating that vaccine responses may be lower in autoimmune diseases such as juvenile idiopathic disease. • The mean antibody levels against the HBV vaccine in newly diagnosed JIA patients were lower than in healthy children. • The fact that patients diagnosed with JIA were revaccinated under treatment and no side effects were observed will support the vaccination of these patients.

04 Feb 2025·JAMA

A Randomized Clinical Trial

Article

Author: Zhang, Hua ; Dai, Erhei ; Pan, Calvin Q. ; Zou, Huaibin ; Zheng, Thomas Q. ; Chen, Xiuli ; Yang, Cuili ; Zhu, Lin ; Wu, Jinjuan ; Wang, Yuming ; Li, Suwen ; Mei, Shanshan ; Chen, Tianyan ; Liu, Yingxia ; Mo, Zhongfu

ImportanceStandard care for preventing mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in highly viremic mothers consists of maternal antiviral prophylaxis beginning at gestational week 28 combined with an HBV vaccine series and HBV immune globulin (HBIG) at birth. However, HBIG is unavailable in some resource-limited areas.ObjectiveTo determine whether initiating tenofovir disoproxil fumarate (TDF) at gestational week 16 combined with HBV vaccinations for infants is noninferior to the standard care of TDF at gestational week 28 combined with HBV vaccinations and HBIG for infants in preventing MTCT in mothers with HBV and high levels of viremia.Design, Setting, and ParticipantsAn unblinded, 2-group, randomized, noninferiority clinical trial was conducted in 7 tertiary care hospitals in China. A total of 280 pregnant individuals (who all identified as women) with HBV DNA levels greater than 200 000 IU/mL were enrolled between June 4, 2018, and February 8, 2021. The final follow-up occurred on March 1, 2022.InterventionsPregnant individuals were randomly assigned to receive either TDF starting at gestational week 16 with HBV vaccinations for the infant or TDF starting at gestational week 28 with HBV vaccinations and HBIG administered to the infant.Main Outcomes and MeasuresThe primary outcome was the MTCT rate, defined as detectable HBV DNA greater than 20 IU/mL or hepatitis B surface antigen positivity in infants at age 28 weeks. Noninferiority was established if the MTCT rate in the experimental group did not increase by more than an absolute difference of 3% compared with the standard care group, as measured by the upper limit of the 2-sided 90% CI.ResultsAmong 280 pregnant individuals who enrolled in the trial (mean age, 28 years; mean gestational age at enrollment, 16 weeks), 265 (95%) completed the study. Among all live-born infants, using the last observation carried forward, the MTCT rate was 0.76% (1/131) in the experimental group and 0% (0/142) in the standard care group. In the per-protocol analysis, the MTCT rate was 0% (0/124) in the experimental group and 0% (0/141) in the standard care group. The between-group difference was 0.76% (upper limit of the 2-sided 90% CI, 1.74%) in all live-born infants and 0% (upper limit of the 2-sided 90% CI, 1.43%) in the per-protocol analysis. Both comparisons met the criterion for noninferiority. Rates of congenital defects and malformations were 2.3% (3/131) in the experimental group and 6.3% (9/142) in the standard care group (difference, 4% [2-sided 95% CI, −8.8% to 0.7%]).Conclusions and RelevanceAmong pregnant women with HBV and high levels of viremia, TDF beginning at gestational week 16 combined with HBV vaccination for infants was noninferior to the standard care of TDF beginning at gestational week 28 combined with HBIG and HBV vaccination for infants. These results support beginning TDF at gestational week 16 combined with infant HBV vaccine to prevent MTCT of HBV in geographic areas where HBIG is not available.Trial RegistrationClinicalTrials.gov Identifier: NCT03476083

News (Medical) associated with Hepatitis B vaccine recombinant(Sanofi)

18 Apr 2024

·www.prnewswire.com

YS Biopharma Granted Phase I Clinical Trial License of Therapeutic Chronic Hepatitis B Virus Vaccine

GAITHERSBURG, Md., April 18, 2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (Nasdaq: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic hepatitis B virus ("HBV") infection, has been granted clinical trial approval by the Philippine Food and Drug Administration ("PFDA"). In light of the approval, the Company is preparing to initiate a Phase I clinical trial for YS-HBV-002 in the Philippines, which is expected to begin in June 2024. Chronic HBV infection is a major global health concern, with an estimated 254 million people suffering from the condition, with 1.2 million new infections each year, according to the World Health Organization (WHO). Those infected are at higher risk for cirrhosis, liver failure, and liver cancer, with between 15%-40% of chronic HBV patients afflicted with one or more of these conditions. In 2022, HBV infection resulted in an estimated 1.1 million deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). Chronic HBV infections occur in both developing and developed countries, constituting a significant unaddressed public health threat. At present, the efficacy of existing anti-viral treatment paradigms is limited, and no cure for chronic HBV has yet been developed. Despite the availability of preventive vaccines for hepatitis B infection, there remains an urgent need for effective therapies for individuals who are already infected and have progressed to chronic stages of infection. Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, "The approval of YS-HBV-002 by the Philippines FDA and Ethics Committee represents a significant milestone in our efforts to develop innovative therapies for chronic hepatitis B infection. At present, there is no effective vaccine treatment option for patients suffering from chronic HBV, leaving them at higher risk for other conditions affecting the liver and significantly hampering their quality of life. With our recent approval and upcoming clinical study, we hope to provide these patients with a safe and effective solution to combat this significant unaddressed public health threat. As always, we plan to conduct the clinical trial to the highest safety and ethical standards, and we are eager to take the next step towards delivering these much-needed treatment options to chronic HBV patients." The Phase I clinical trial for YS-HBV-002 will mark an important milestone in addressing this unmet medical need. This trial will employ a double-blind, randomized, placebo-controlled, dose-escalation approach, and aims to evaluate the safety, immunogenicity, and efficacy of YS-HBV-002 among adult patients diagnosed with chronic HBV infection. By targeting both humoral and cellular immune responses, YS-HBV-002 has the potential to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients. About YS-HBV-002 YS-HBV-002 is a new generation of therapeutic HBV vaccine based on the proprietary technology and clinical results of YS-HBV-001, the first generation of HBV vaccine in the pipeline of YS Biopharma. YS-HBV-002 is formulated with several key components, including recombinant core and surface hepatitis B antigens, and YS Biopharma's proprietary PIKA adjuvant. This carefully designed set of components has the potential to activate both innate and adaptive immune responses in patients, thereby generating a more robust and targeted response to the virus. The re-establishment of a desirable and comprehensive immune response is the first step towards the eradication of chronic HBV infection from the body. About YS Biopharma YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of YS Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, YS Biopharma's ability to source and retain talent, and the cash position of YS Biopharma. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma's management and are not predictions of actual performance. YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading "Risk Factors" in the Post-effective Amendment No. 2 to the Company's Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements. Investor Relations Contact Alyssa Li Director of Investor Relations Email: [email protected] Robin Yang Partner, ICR, LLC Tel: +1 (212) 537-4035 Email: [email protected] SOURCE YS Biopharma Co., Ltd.

Phase 1VaccineDrug ApprovalImmunotherapy

11 Nov 2023

·www.prnewswire.com

Global HBV Vaccine Market Set to Reach $2.47 Billion by 2023, Driven by Rising HBV Cases Among Infants

DUBLIN, Nov. 10, 2023 /PRNewswire/ -- The "Global Hepatitis B Virus (HBV) Vaccine Market (by End User, Composition, & Region): Insights and Forecast with Potential Impact of COVID-19 (2022-2027)" report has been added to ResearchAndMarkets.com's offering. The global hepatitis B virus (HBV) vaccine market is on a growth trajectory, expected to reach a market value of US$2.47 billion by 2023, with a robust Compound Annual Growth Rate (CAGR) of 5.33% during the projected period. Hepatitis B virus (HBV) is a liver-infecting virus transmitted through various means, including contact with infected blood or bodily fluids, sexual contact, sharing needles, or exposure in healthcare settings. Perinatal transmission from infected mothers to newborns is also a significant concern. HBV Vaccine: Key to Eradicating Hepatitis B The HBV vaccine stands as a crucial tool in the World Health Organization's (WHO) mission to eliminate HBV by 2030. Since the approval of the first HBV vaccine in 1981, significant advancements have occurred in the development of HBV vaccines. Vaccine recommendations have evolved over time, now advocating for universal HBV immunization for all individuals under the age of 60. Segmentation The global HBV vaccine market is segmented by end-user into Adult and Pediatric categories. The Adult HBV vaccine segment further divides into mono vaccine and combination vaccine subsegments. Combination vaccines are expected to experience the fastest growth during the forecast period, offering protection against multiple causal agents and reducing individual vaccine packaging costs. For instance, the Twinrix combination vaccine provides protection against both hepatitis B and hepatitis A. Geographic Insights Geographically, the global HBV vaccine market is divided into five regions: The US, China, European Union, Japan, and the Rest of the World (ROW). The United States leads the global market due to a high demand for the HBV vaccine, driven by ongoing HBV infection threats. Factors such as increasing HBV prevalence, government initiatives promoting vaccination, technological advancements in vaccine production, and rising healthcare expenditure are expected to sustain market growth. The European Union and the UK are poised for significant expansion, driven by improved healthcare infrastructure, active government efforts to combat HBV, and established hospital reimbursement systems. Ongoing technological advancements, increased accessibility, and rising disposable income will further boost HBV vaccination in the European region. Drivers: Rising HBV Cases Among Infants The growing incidence of HBV infection among infants is fueling the demand for HBV vaccines. Perinatal transmission of HBV poses a substantial public health challenge, leading to chronic HBV infection in infants. Chronic HBV infection can result in severe health complications, including liver cirrhosis and liver cancer. To prevent perinatal transmission, the WHO recommends testing all pregnant women for HBV infection and vaccinating infants of HBV-positive mothers soon after birth. The increasing prevalence of HBV among infants is driving greater demand for HBV vaccines as parents seek to protect their children from the virus. Challenge: Inequitable Access to Vaccines Inequitable access to vaccines remains a critical issue, particularly in impoverished areas where awareness and initiatives have faced barriers. Limited access to vaccines may be attributed to challenges such as insufficient storage facilities, lack of government support in remote regions, low literacy rates, limited health knowledge, and financial constraints. Furthermore, the unequal development and distribution of HBV vaccines and antibodies in underserved areas hinder market growth. Trend: AI Revolutionizes Vaccine and Drug Design Recent advancements in biochemistry, structural biology, immunology, microbiology, genomics, and data science have opened doors for innovation. Bioinformatics, harnessing computer techniques for biological sciences, has led to immunoinformatics, which leverages artificial intelligence and machine learning to predict complex immune system activities, such as B cell and T cell epitope prediction. The integration of AI in vaccine and drug design is poised to accelerate vaccine development, enhance efficacy, and drive the HBV vaccine market's growth. COVID-19 Impact The COVID-19 pandemic significantly impacted the HBV vaccine market by disrupting vaccine production and supply chains. Shortages of raw materials and transportation disruptions led to vaccine shortages in some regions. Additionally, pandemic-related funding shifts affected vaccination programs, including HBV initiatives. However, post-COVID prospects for the HBV vaccine market are promising. The COVAX Facility, led by WHO, has worked to ensure access to essential vaccines, including HBV vaccines. More than 2 billion doses of HBV vaccines have been secured and delivered globally through this initiative, supporting HBV vaccine production in the post-COVID era. Analysis of Key Players The global HBV vaccine market exhibits moderate concentration with growing acquisitions, collaborations, and product launches. Key players in the market include Merck & Co., Inc., GlaxoSmithKline, Sanofi, VBI Vaccines Inc., Shenzhen Kangtai Biological Products Co., Ltd., Dynavax Technologies Corporation, Meiji Group (KM Biologics), LG Chem Ltd., Cyrus Poonawalla Group (Serum Institute of India Pvt.), and Indian Immunologicals Limited. Top Impacting Factors Growth Drivers Increasing Geriatric Population Increasing Healthcare Expenditure Growing Instances of HBV Among Infants Increase in Liver Cancer and Cirrhosis Deaths due to HBV Challenges High Cost of Vaccine Development Inequitable Access to Vaccines Trends Use of AI in Vaccine and Drug Design Technological Advancements in Vaccine Administration Favorable Government Initiatives and Policies For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo - SOURCE Research and Markets

VaccineDrug Approval

22 Sep 2023

·synapse.patsnap.com

Analysis on the Clinical Research Progress of MAO-B inhibitors

Monoamine oxidase-B (MAO-B) is an enzyme found in the human body that plays a crucial role in the metabolism of neurotransmitters such as dopamine. It specifically breaks down excess dopamine, preventing its accumulation and maintaining a balance in the brain. By regulating dopamine levels, MAO-B helps to control various neurological functions, including mood, cognition, and movement. Dysfunction or inhibition of MAO-B has been linked to neurodegenerative disorders like Parkinson's disease, as well as psychiatric conditions such as depression and anxiety. Understanding the role of MAO-B is essential for developing therapeutic interventions that target this enzyme to treat these disorders effectively. MAO-B Competitive LandscapeAccording to the data provided by Patsnap Synapse-Global Drug Intelligence Database: the following figure shows that as of 20 Sep 2023, there are a total of 54 MAO-B drugs worldwide, from 57 organizations, covering 42 indications, and conducting 244 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, organizations, clinical trials, clinical results, and drug patents related to this target. The analysis of the current competitive landscape of target MAO-B reveals that Viatris Inc., Newron Pharmaceuticals SpA, Zambon Company SpA, Teva Pharmaceutical Industries Ltd., and FP Pharmaceutical Corporation are the companies growing fastest. Parkinson Disease is the most targeted indication, followed by Depressive Disorder, Major, and Alzheimer Disease. Small molecule drugs are progressing rapidly, indicating intense competition. The United States, Japan, and the European Union are leading in the development of drugs targeting MAO-B, with China also making progress. The future development of target MAO-B is promising, with ongoing research and development efforts by various companies and countries. First Generation of Monoamine Oxidase B (MAO-B) Inhibitors: Selegiline HydrochlorideSelegiline Hydrochloride is a small molecule drug that primarily targets MAO-B. It is used in the treatment of Parkinson's disease, a nervous system disorder characterized by tremors, stiffness, and difficulty with movement. The drug is also indicated for certain endocrinology and metabolic diseases. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The drug was first approved for use in the United States in June 1989, making it a well-established treatment option for Parkinson's disease. It is worth noting that Selegiline Hydrochloride has received orphan drug status, indicating that it is used to treat rare diseases or conditions. The originator organization of Selegiline Hydrochloride is Sanofi, a multinational pharmaceutical company. Sanofi has played a significant role in the development and commercialization of this drug. Selegiline Hydrochloride has reached the highest phase of development, with global approval. This means that it has successfully undergone clinical trials and met the necessary regulatory requirements for market authorization. The drug has also received approval in China, further expanding its availability to patients. As a small molecule drug targeting MAO-B, Selegiline Hydrochloride works by inhibiting the activity of this enzyme. By doing so, it helps to increase the levels of certain neurotransmitters in the brain, such as dopamine, which are essential for proper nerve cell communication. This mechanism of action is particularly beneficial for individuals with Parkinson's disease, as the condition is associated with a deficiency of dopamine. In summary, Selegiline Hydrochloride is a small molecule drug developed by Sanofi. It is primarily used for the treatment of Parkinson's disease and has received global and Chinese approval. The drug targets the enzyme MAO-B and has been granted orphan drug status. Its approval in 1989 in the United States signifies its long-standing presence in the market as an effective treatment option for Parkinson's disease. Second-generation MAO-B inhibitors: Rasagiline mesylateRasagiline mesylate is a small molecule drug that primarily targets MAO-B. It is used in the treatment of nervous system diseases and endocrinology and metabolic diseases. Specifically, it is indicated for the management of Parkinson's disease, particularly primary Parkinson's disease. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The drug was developed by Teva Pharmaceutical Industries Ltd. in collaboration with the Technion-Israel Institute of Technology. It received its first approval in the United States in May 2006, making it available for use in patients. The approval process for Rasagiline mesylate involved priority review, indicating that it was considered a high-priority drug due to its potential therapeutic benefits. Rasagiline mesylate has successfully completed the highest phase of clinical trials, both globally and in China, leading to its approval in these regions. This suggests that the drug has demonstrated its safety and efficacy in treating Parkinson's disease, meeting the regulatory requirements set by the respective authorities. As a small molecule drug, Rasagiline mesylate is designed to interact with the MAO-B enzyme, which plays a role in the breakdown of certain neurotransmitters in the brain. By inhibiting MAO-B, the drug helps to increase the levels of these neurotransmitters, thereby improving the symptoms associated with Parkinson's disease. The approval of Rasagiline mesylate represents a significant milestone in the treatment of Parkinson's disease, providing patients with an additional therapeutic option. The drug's success in clinical trials and subsequent approval highlights its potential to address the unmet medical needs of individuals suffering from this debilitating neurological disorder. In summary, Rasagiline mesylate is a small molecule drug that targets MAO-B and is approved for the treatment of Parkinson's disease. Developed by Teva Pharmaceutical Industries Ltd. and the Technion-Israel Institute of Technology, it has successfully completed clinical trials and received regulatory approval in the United States and China. Its approval signifies its potential to improve the lives of patients with Parkinson's disease, offering a new treatment option in the field of biomedicine.

100 Deals associated with Hepatitis B vaccine recombinant(Sanofi)

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KEGG	Wiki	ATC	Drug Bank
-	-	J07BC01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	Norway	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis B	Iceland	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis B	Liechtenstein	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis B	European Union	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis D	Iceland	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis D	Liechtenstein	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis D	Norway	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis D	European Union	Merck Sharp & Dohme BV	27 Apr 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningococcal Infections	Phase 3	Puerto Rico	Sanofi Pasteur SA	17 Sep 2018
Meningococcal Infections	Phase 3	United States	Sanofi Pasteur SA	17 Sep 2018
Meningitis	Discovery	United States	Sanofi Pasteur SA	16 Dec 2009
Hepatitis B	Discovery	Italy	Sanofi Pasteur SA	01 Oct 2008
Diphtheria	Discovery	Canada	Sanofi Pasteur SA	01 Jan 1999
Poliomyelitis	Discovery	Canada	Sanofi Pasteur SA	01 Jan 1999
Tetanus	Discovery	Canada	Sanofi Pasteur SA	01 Jan 1999
Whooping Cough	Discovery	Canada	Sanofi Pasteur SA	01 Jan 1999

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03673462 (MET41, CTgov)	Phase 3	Meningococcal Infections	2,797	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus+Measles, Mumps, and Rubella Virus Vaccine+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 1: MenACYW Conjugate Vaccine)	waufaggisf(qqnvhxksbv) = okrcvxeria fhbvmdeeqk (cphuqvxudw, lxrogcktor - yckuohrvmg) View more	-	05 Oct 2023
				W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 2: MENVEO®)	waufaggisf(qqnvhxksbv) = zgepmrxbhe fhbvmdeeqk (cphuqvxudw, hhpdkpyojm - klenjadllq) View more
NCT04490499 (V419-013, CTgov)	Phase 3	Hepatitis B	207	HBVAXPRO™	nfkioznxev(skcrmpcovo) = xxtfvzqowo tmlubbscch (jpjfbcfnbo, ghhggiyhkc - ozaxymelor) View more	-	05 Sep 2021
EASL2021	Not Applicable	Chronic liver disease	103	HBVaxpro40	(zijlhxujqv) = efmrabnguz hkkdocuypx (dlortzgqqv ) View more	Positive	23 Jun 2021
				HBVaxpro40 (Fendrix)	(zijlhxujqv) = rnuyhhkeds hkkdocuypx (dlortzgqqv ) View more
NCT01049035 (CTgov)	Phase 2	Meningitis \| Meningococcal Infections	580	Rotavirus Vaccine+Quadrivalent Meningococcal Polysaccharide (A, C, Y,+Diphtheria CRM197 Protein)+Rubella Virus Vaccine Live+Tetanus Toxoids+Hepatitis B Vaccine+Pneumococcal 7-valent Conjugate Vaccine (+Pneumococcal 13-valent Conjugate Vaccine (+Varicella Virus Vaccine Live (Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months)	ctvyfpgvgw(qtjcjmvbhr) = auqbmohdle pdimeukbab (fvogapcrus, ojugcydyan - znutrqugmx) View more	-	09 Jun 2020
				Rotavirus Vaccine+Quadrivalent Meningococcal Polysaccharide (A, C, Y,+Diphtheria CRM197 Protein)+Rubella Virus Vaccine Live+Tetanus Toxoids+Hepatitis B Vaccine+Pneumococcal 7-valent Conjugate Vaccine (+Pneumococcal 13-valent Conjugate Vaccine (+Varicella Virus Vaccine Live (Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months)	ctvyfpgvgw(qtjcjmvbhr) = xcoekqjjxz pdimeukbab (fvogapcrus, ezoddzfojs - mqchmjoqju) View more
IAS2009	Not Applicable	HIV Infections	26	Double-dose hepatitis-B vaccine	yjkhopypsr(dvmwnvwyfx): OR = 2.56 (95% CI, 0.84 - 7.83)	Positive	01 Jan 2009
				Single-dose vaccine

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Hepatitis B vaccine recombinant(Sanofi)

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