[Translation] A single-center, randomized, double-blind, controlled clinical trial to evaluate the immunogenicity and safety of the scaled-up recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 9-valent vaccine (Escherichia coli) in Chinese women aged 18-26 years

主要目的：评价重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗（大肠埃希菌，600L工艺）的免疫原性是否非劣效于重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗（大肠埃希菌，60L工艺）。次要目的：评价试验疫苗的安全性。

[Translation]

Primary objective: To evaluate whether the immunogenicity of the recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli, 600L process) is non-inferior to that of the recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli, 60L process). Secondary objective: To evaluate the safety of the experimental vaccine.

Start Date06 Apr 2024

Sponsor / Collaborator

Xiamen Innovax Biotech Co., Ltd.

[+2]

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]

NCT06243666

/ Not yet recruitingNot ApplicableIIT

Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years

The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

Start Date20 Feb 2024

Sponsor / Collaborator

Xiamen University

[+1]

100 Clinical Results associated with Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

0 Patents (Medical) associated with Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Literatures (Medical) associated with Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China

Article

Author: Xu, Aiqiang ; Lv, Jingjing ; Xu, Fujie ; Huang, Shoujie ; Yan, Bingyu ; Zhang, Qiufen ; Cao, Qingfan ; Pan, Huirong ; Wu, Wenlong ; Zhang, Li ; Jiang, Zechun ; Feng, Yi ; Liu, Haidong ; Liu, Jiaye

Acute hepatitis E infection could induce severe outcomes among chronic hepatitis B (CHB) patients. Between 2016 and 2017, an open-label study was conducted to evaluate the immunogenicity and safety of hepatitis E vaccine (HepE) in CHB patients, using healthy adults as parallel controls in China. Eligible participants who were aged ≥30 y were enrolled in the study. The CHB group included participants who had ever developed symptoms of hepatitis because of CHB but was currently at a clinically stable stage, which was defined as ALT ≤ 1.5 times of upper limit of the normal range (ULN) in this study. The control group included healthy adults who had hepatitis B surface antigen (HBsAg) negative. HepE was administered for 0, 1, 6 months for all participants. At 1 month after the third-dose vaccination (month 7), the seroconversion rates of anti-HEV IgG were >97% in both groups. The geometric mean concentration (GMC) of anti-HEV IgG in the CHB group was non-inferior to the healthy adult group (0.69 WU/mL, 95% CI 0.55-0.85). The proportion of the participants with adverse events ≥ grade 3 was similar in both groups (p = .99), and no vaccine-associated severe adverse events were identified. Changes in the liver function indicators were not of clinical significance. The HepE was highly immunogenic and well tolerated among clinically stable CHB patients and healthy adults.

01 Apr 2025·Tissue and Cell

Development of a rat airway organoids model for studying chronic obstructive pulmonary disease

Article

Author: Yang, Hongwei ; Yu, Kang ; Liu, Nanyi ; Xian, Yangling ; Yang, Chuanlai ; Wang, Wei ; Xia, Ningshao ; Zhao, Huan ; Tan, Haoyin ; Ren, Zirui ; Fang, Changjian ; Pan, Dequan ; Zhang, Yali ; Huang, Xiumin ; Cheng, Tong ; Lin, Yanzhen

Chronic obstructive pulmonary disease (COPD) poses global health challenges owing to limited treatment options and high rates of morbidity and mortality. Airway organoids have recently become a valuable resource for the investigation of respiratory diseases. However, limited access to clinical tissue samples hinders the use of airway organoids to study COPD. Therefore, alternative models that can mimic human airway pathology without relying on human tissues are needed. In this study, airway organoids were developed from tracheal epithelial cells obtained from 8-week-old Sprague-Dawley rats and exposed to lipopolysaccharide (LPS) to induce COPD-like characteristics. Exposure to LPS leads to structural changes in organoids, including an increase in goblet cells, a decrease in ciliated cells, increased mucin production, and elevated levels of pro-inflammatory cytokines. The COPD drugs erdosteine and R-HP210 effectively reduced mucin secretion, although none was able to restore the function of ciliated cells. Inflammatory markers responded differently, with ensifentrine and erdosteine significantly reducing cytokine levels. These results demonstrate that rat airway organoids replicate important aspects of human COPD pathology, thus providing an accessible, ethical, and clinically relevant alternative to human tissues and traditional animal models to enhance our understanding of COPD pathogenesis and evaluate potential treatments.

15 Nov 2024·The Journal of Infectious Diseases

A Phase 1, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin) Vaccine in Healthy US Adults

Article

Author: Ballou, Cassandra ; Sherman, Jacob D ; Kao, Carol M ; Rouphael, Nadine ; Nolan, Lauren E ; Yildirim, Inci ; Scherer, Erin M ; Anderson, Evan J ; Agbakoba, Vivien ; Tippett, Ashley ; Beresnev, Tatiana ; Peters, Etza ; Kamidani, Satoshi ; Rostad, Christina A ; Shih, J Wai Kuo ; Karmali, Vinit ; Kleinhenz, Jennifer ; Natrajan, Muktha

AbstractBackgroundEstablishing the safety and immunogenicity of a hepatitis E virus vaccine in multiple populations could facilitate broader access and prevent maternal and infant mortality.MethodsWe conducted a phase 1, randomized, double-blinded, placebo-controlled (4:1 vaccine to placebo) trial of 30 µg HEV-239 (Hecolin, Xiamen Innovax Biotech Company Limited, China) administered intramuscularly in healthy US adults aged 18–45 years. Participants were vaccinated on days 1, 29, and 180. Participants reported solicited local and systemic reactions for 7 days following vaccination and were followed through 12 months after enrollment for safety and immunogenicity (IgG, IgM).ResultsSolicited local and systemic reactions between treatment and placebo group were similar and overall mild. No participants experienced serious adverse events related to HEV-239. All participants receiving HEV-239 seroconverted at 1 month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked 1 month following the second dose (geometric mean concentration [GMC], 6.16; 95% confidence interval [CI], 4.40–8.63), was boosted with the third dose (GMC, 11.50; 95% CI, 7.90–16.75) and persisted through 6 months.ConclusionsHEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults.Clinical Trials RegistrationNCT03827395.

News (Medical) associated with Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

21 Nov 2024

·www.echemi.com

Wantai BioPharma's Nine-Valent HPV Vaccine Approved, a Breakthrough in Cancer Prevention for Men

On November 18, 2024, Wantai Bio-issued an official announcement announcing that the clinical trial of its nine-valent HPV vaccine for the indication of the male population has been approved by the State Drug Administration. In the global male population, approximately 70,000 new cancer cases are associated with HPV infection each year, including penile, anal, oropharyngeal, and other head and neck cancers. About 90% of these cancer cases can be attributed to high-risk viruses such as HPV6, 11, 16 and 18. Wantai's nine-valent HPV vaccine covers the protection range of these viruses and can prevent precancerous lesions caused by these HPV viruses. Given the saturation of the female market and the fierce competition among domestic HPV vaccines, the market performance, including the nine-valent HPV vaccine of Moxadon, has shown weakness. In the first half of 2024, Merck's global sales of HPV vaccines increased by only 7% year-over-year, including 1% growth in the second quarter. The performance of domestic HPV vaccine manufacturers such as Wantai Biological and Watson Biological is even more worrying. The HPV vaccine for men is not an unprecedented innovation. As early as 2021, Merck launched a Phase 3 clinical trial of its nine-valent HPV vaccine in men in China to evaluate the vaccine's protective efficacy, immunogenicity and safety in men. In September last year, Merck's application for the male indication of the nine-valent HPV vaccine was accepted in China. According to market news, the male indication of Mersha East nine-valent HPV vaccine is expected to be approved in the fourth quarter of this year, and some offline community service stations have begun to make appointment registration. Wantai is not the first company to conduct research on male indications. The company has initiated a Phase I clinical trial of the nine-valent HPV vaccine in a male population in September 2022, involving healthy Chinese men aged 9 to 45 years. Cologuard is further ahead, initiating a Phase 3 clinical trial for a male indication of its nine-valent HPV vaccine in late 2022. Connaught Defender revealed that it is expected that by the end of 2027, the clinical trial will complete the follow-up of all subjects and submit the marketing application.

Drug ApprovalVaccinePhase 3Phase 1Phase 2

16 Mar 2024

·www.prnewswire.com

Global HIV Point of Care (POC) Tests Pipeline Landscape Report 2023: Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies

DUBLIN, March 15, 2024 /PRNewswire/ -- The "HIV Point of Care (POC) Tests Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies" report has been added to ResearchAndMarkets.com's offering. The report provides comprehensive information about the HIV Point of care (POC) Tests pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. HIV Point of care (POC) Tests is defined as medical diagnostic testing performed outside the clinical laboratory in close proximity to where the patient is receiving care. POC is typically performed by non-laboratory personnel and the results are used for clinical decision making. POC has a range of complexity and procedures that vary from manual methodologies to automated analyzers. POC devices are often 'handheld' or may be small portable analyzers. Scope Extensive coverage of the HIV Point of care (POC) Tests under development The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities The report reviews the major players involved in the development of HIV Point of care (POC) Tests and list all their pipeline projects The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage The report provides key clinical trial data of ongoing trials specific to pipeline products Recent developments in the segment / industry Reasons to Buy Formulate significant competitor information, analysis, and insights to improve R&D strategies Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage Identify and understand important and diverse types of HIV Point of care (POC) Tests under development Develop market-entry and market expansion strategies Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline In-depth analysis of the product's current stage of development, territory and estimated launch date Key Topics Covered: 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 HIV Point of care (POC) Tests Overview 3 Products under Development 3.1 HIV Point of care (POC) Tests - Pipeline Products by Stage of Development 3.2 HIV Point of care (POC) Tests - Pipeline Products by Territory 3.3 HIV Point of care (POC) Tests - Pipeline Products by Regulatory Path 3.4 HIV Point of care (POC) Tests - Pipeline Products by Estimated Approval Date 3.5 HIV Point of care (POC) Tests - Ongoing Clinical Trials 4 HIV Point of care (POC) Tests - Pipeline Products under Development by Companies 4.1 HIV Point of care (POC) Tests Companies - Pipeline Products by Stage of Development 4.2 HIV Point of care (POC) Tests - Pipeline Products by Stage of Development 5 HIV Point of care (POC) Tests Companies and Product Overview 6 HIV Point of care (POC) Tests- Recent Developments 6.1 Oct 10, 2023: Trinity Biotech Welcomes the Decision of the High Court of Kenya to Strike Out the Applications to Prevent the Procurement of Trinscreen HIV by the Kenyan Ministry of Health 6.2 Sep 27, 2023: Update on MedMira's Regulatory Path in Canada and the USA 6.3 Jun 14, 2023: Atomo and Newfoundland Sign Agreement for HIV Testing in Europe 6.4 Mar 22, 2023: Trinity Biotech welcomes TrinScreen HIV's inclusion in the New Kenyan HIV Testing Algorithm 6.5 Feb 28, 2023: Significant purchase order for HIV self-tests for Europe 7 Appendix A selection of companies mentioned in this report includes Abbott Rapid Diagnostics GmbH Aldatu Biosciences Inc Altratech Ltd Atomo Diagnostics Ltd Baebies Inc BBB Technologies Inc Beijing Wantai Biological Pharmacy Enterprise Co Ltd Binx Health Inc Bio-AMD Inc Biocartis Group NV BioHelix Corp Bluejay Diagnostics Inc Calypte Biomedical Corporation Centre International de Reference Chantal Biya Cepheid Inc ChipCare Corp CrossLife Technologies Inc Cue Inc Daktari Diagnostics, Inc. Diagnostics For All Inc Diagnostics for the Real World (Europe) Ltd Endeavor Sciences Inc Epinex Diagnostics Inc ERBA Molecular Ltd Fluxergy LLC GAIA Medical Institute LLC genedrive plc Group K Diagnostics Guangzhou Wondfo Biotech Co Ltd HA TECH Pty Ltd HeatFlow Technologies Inc Identifysensors LLC Imperial College London Integrated Diagnostics Inc (Inactive) Intuitive Biosciences Inc Jan Biotech Inc Jinvator Bio Med GmbH Johns Hopkins University Lynntech Inc Maxim Biomedical Inc MedMira Inc Micronics Inc Molbio Diagnostics Pvt Ltd MyMD Pharmaceuticals Inc Nanobiosym Inc Newmark Diagnostics LLC Northwestern University Osel Inc Philmedi Co Ltd Prenetics Ltd QuantuMDx Group Ltd Quidel Corp Radisens Diagnostics Ltd Rheonix Inc Roche Diagnostics International Ltd Sedia Biosciences Corp Sensible Diagnostics Inc Senzo Inc TheoremDx Inc Trinity Biotech Plc University of Connecticut University of Minnesota UrSure Inc Ustar Biotechnologies (Hangzhou) Ltd. Virax Biolabs Group Ltd Wave 80 Biosciences Inc Yaathum Biotech Pvt Ltd 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

01 Mar 2024

·www.prnewswire.com

Cervical Cancer Global Clinical Trials Review 2024: Clinical Trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End Point Status

DUBLIN, March 1, 2024 /PRNewswire/ -- The "Cervical Cancer - Global Clinical Trials Review, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. The clinical trial report provides an overview of Cervical Cancer Clinical trials scenario. This report provides top line data relating to the clinical trials on Cervical Cancer and includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. The report also provides prominent drugs for in-progress trials (based on number of ongoing trials). Report Scope The report provides a snapshot of the global clinical trials landscape Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment The Report provides enrollment trends for the past five years Report provides latest news for the past three months Key Benefits Assists in formulating key business strategies with regards to investment Helps in identifying prominent locations for conducting clinical trials which saves time and cost Provides top level analysis of Global Clinical Trials Market which helps in identifying key business opportunities Supports understanding of trials count and enrollment trends by country in global therapeutics market Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials Facilitates clinical trial assessment of the indication on a global, regional and country level Key Topics Covered: Report Guidance Clinical Trials Report Coverage Clinical Trials by Region Clinical Trials and Average Enrollment by Country Top Five Countries Contributing to Clinical Trials in Asia-Pacific Top Five Countries Contributing to Clinical Trials in Europe Top Countries Contributing to Clinical Trials in North America Top Five Countries Contributing to Clinical Trials in Middle East and Africa Top Five Countries Contributing to Clinical Trials in Central and South America Clinical Trials by G7 Countries: Proportion of Cervical Cancer to Oncology Clinical Trials Clinical Trials by Phase in G7 Countries Clinical Trials in G7 Countries by Trial Status Clinical Trials by E7 Countries: Proportion of Cervical Cancer to Oncology Clinical Trials Clinical Trials by Phase in E7 Countries Clinical Trials in E7 Countries by Trial Status Clinical Trials by Phase In Progress Trials by Phase Clinical Trials by Trial Status Clinical Trials by End Point Status Subjects Recruited Over a Period of Time Clinical Trials by Sponsor Type Prominent Sponsors Top Companies Participating in Cervical Cancer Therapeutics Clinical Trials Prominent Drugs Clinical Trial Profile Snapshots Company Coverage: Merck & Co Inc GSK plc F. Hoffmann-La Roche Ltd AstraZeneca Plc Pfizer Inc Bristol-Myers Squibb Co Jiangsu Hengrui Medicine Co Ltd Xiamen Innovax Biotech Co Ltd Sanofi Yangshengtang Co Ltd For more information about this clinical trials 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

Clinical StudyASCO

100 Deals associated with Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

100 Translational Medicine associated with Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Jan 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 3 Clinical

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

DelNS1-2019-nCoV-RBD-OPT1(Beijing Wantai Biological) ( SARS-CoV-2 S protein )	COVID-19 More	Approved
Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)	Human Papillomavirus Infection More	Approved
Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)	Hepatitis E More	Approved
9-Valent HPV Vaccine(Xiamen Innovax)	Human Papillomavirus Infection More	NDA/BLA
Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)	Human Papillomavirus Infection More	Phase 3

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