[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the protective efficacy, safety, and immunogenicity of freeze-dried live attenuated varicella vaccine (VZV-7D) in people aged 1-12 years.

主要目的：评价接种1剂VZV-7D疫苗42天后预防实验室确诊水痘病例的保护效力。次要目的：1）评价接种1剂VZV-7D疫苗42天后预防实验室确诊典型水痘及重度水痘病例的保护效力；2）评价1-12周岁人群接种VZV-7D疫苗的安全性；3）评价1-12周岁人群接种1剂VZV-7D疫苗的免疫原性。探索性目的：1）观察并评价接种1剂VZV-7D疫苗后的水痘样疹发生情况；2）评价VZV-7D疫苗免疫学指标与保护效力的关系。

[Translation]

Primary Objective: To evaluate the protective efficacy of a single dose of VZV-7D vaccine against laboratory-confirmed varicella 42 days after vaccination. Secondary Objectives: 1) To evaluate the protective efficacy of a single dose of VZV-7D vaccine against laboratory-confirmed typical and severe varicella 42 days after vaccination; 2) To evaluate the safety of VZV-7D vaccine in individuals aged 1-12 years; and 3) To evaluate the immunogenicity of a single dose of VZV-7D vaccine in individuals aged 1-12 years. Exploratory Objectives: 1) To observe and evaluate the incidence of varicella-like rash after vaccination with a single dose of VZV-7D vaccine; and 2) To evaluate the relationship between immunological parameters and protective efficacy of the VZV-7D vaccine.

Start Date19 Jun 2025

Sponsor / Collaborator

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

CTR20250880

/ RecruitingPhase 1

评价注射用重组人PD-1抗体单纯疱疹病毒（rHSV-1-APD1）治疗晚期肝细胞癌的安全性、生物分布和初步疗效的单臂、剂量爬坡Ⅰ期临床研究

[Translation] A single-arm, dose-escalating phase I clinical study to evaluate the safety, biodistribution and preliminary efficacy of recombinant human PD-1 antibody herpes simplex virus for injection (rHSV-1-APD1) in the treatment of advanced hepatocellular carcinoma

主要目的：评价rHSV-1-APD1治疗晚期肝细胞癌患者的安全性和耐受性，确定最大耐受剂量（MTD）/推荐的II期临床剂量（RP2D）和剂量限制性毒性（DLT）。次要目的：评价rHSV-1-APD1治疗晚期肝细胞癌患者的生物分布特征。评价rHSV-1-APD1治疗晚期肝细胞癌患者的初步抗肿瘤疗效。探究rHSV-1-APD1治疗晚期肝细胞癌患者的药效学和免疫原性。

[Translation]

Primary objectives: To evaluate the safety and tolerability of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma, determine the maximum tolerated dose (MTD)/recommended phase II clinical dose (RP2D) and dose-limiting toxicity (DLT). Secondary objectives: To evaluate the biodistribution characteristics of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma. To evaluate the preliminary anti-tumor efficacy of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma. To explore the pharmacodynamics and immunogenicity of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma.

Start Date28 Apr 2025

Sponsor / Collaborator

Zhejiang Yangshengtang Biotechnology Co., Ltd.

[+2]

NCT06866574

/ Active, not recruitingPhase 3IIT

A Multicenter, Randomized, Double-Blind, Aluminum Adjuvant-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E. Coli) in Chinese Males Aged 18 to 45 Years

This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in Chinese males aged 18-45 years.

Start Date11 Apr 2025

Sponsor / Collaborator

Xiamen University

[+1]

100 Clinical Results associated with Yangshengtang Co., Ltd.

0 Patents (Medical) associated with Yangshengtang Co., Ltd.

Literatures (Medical) associated with Yangshengtang 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: Wu, Wenlong ; Zhang, Qiufen ; Xu, Aiqiang ; Feng, Yi ; Yan, Bingyu ; Zhang, Li ; Huang, Shoujie ; Lv, Jingjing ; Jiang, Zechun ; Pan, Huirong ; Liu, Jiaye ; Cao, Qingfan ; Liu, Haidong ; Xu, Fujie

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 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

An ultra-sensitive, multiplexed, and cost-effective POCT system for the detection of co-infecting respiratory viruses, including SARS-CoV-2, Flu A, Flu B, and RSV, within 30 min

Article

Author: Zhang, Jun ; Zhang, Dongxu ; Chen, Zhongfu ; Song, Liuwei ; Ye, Huiming ; Qiao, Shan ; He, Shuizhen ; Liu, Jumei ; Liu, Shengda ; Zhang, Shiyin ; Yan, Lizhen ; Xu, Qunshan ; Zuo, Weilun ; Li, Tingdong ; Yang, Lianwei ; Ge, Shengxiang ; Xia, Ningshao ; Lin, Hao ; Wang, Bin ; Zheng, Yuxiang

The co-circulation of respiratory viruses, including SARS-CoV-2, Influenza A (Flu A), Influenza B (Flu B), and respiratory syncytial virus (RSV), poses a significant public health threat. Timely recognition of these viruses allows healthcare professionals to implement effective infection control measures, allocate medical resources properly, and prevent complications from incorrect treatments. Multiplex nucleic acid testing Point-of-care test (mNAT-POCT) circumvents issues of traditional tests, such as high demands on laboratory environments, personnel, and equipment, and limited target analyses, allowing its use in point-of-care settings. However, challenges include primer-primer interactions during fast amplification, high automation requirements, configuring multiple fluorescence channels to avoid spectral overlap, and balancing rapid thermal cycling with sensitive fluorescence signal collection. To address these issues, we developed the multiplexed reverse transcription-quantitative PCR (RT-qPCR) POCT system iNAT SARS-CoV-2/Flu A/Flu B/RSV Assay. This assay enables quick, automatic, and accurate detection of multiple pathogens, improving diagnostic and treatment efficiency for syndromic infectious diseases. The limit of detection (LoD) is 45 copies/mL for SARS-CoV-2, 133 copies/mL for Flu A, 57 copies/mL for Flu B, and 212.5 copies/mL for RSV, with a turnaround time (TAT) of 30 min. Clinical sample analysis showed a 99.36 % agreement with National Medical Products Administration (NMPA) approved reference tests. In conclusion, the iNAT SARS-CoV-2/Flu A/Flu B/RSV Assay performs excellently in detecting and differentiating SARS-CoV-2, Flu A, Flu B, and RSV in respiratory infections, which is crucial for accurate diagnoses.

01 Aug 2025·VACCINE

Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study

Article

Author: Yu, Xiaoshan ; Chen, Shasha ; Zhang, Dengxiang ; Xie, Fangqin ; Zhong, Sumei ; Wang, Xiujuan ; Huang, Qinbiao ; Zhang, Qiufen ; Zhang, Dongjuan ; Li, Junrong ; Wang, Rui

INTRODUCTION:

The first recombinant hepatitis E vaccine (Escherichia Coli), Hecolin® (Xiamen Innovax, China), was approved for people aged ≥16 years. Innovax has developed a thiomersal-free formulation process change according to the requirement of 2020 Chinese Pharmacopoeia. This study aimed to evaluate the safety and immunogenicity of the thiomersal-free hepatitis E vaccine compared with the licensed hepatitis E vaccine in people aged ≥16 years.

CLINICAL TRIAL REGISTRATION:

NCT06564116.

METHODS:

This was a single-center, randomized, double-blind, active-controlled study conducted in China. Eligible participants were randomly assigned in a 1:1 ratio to the thiomersal-free hepatitis E vaccine group (HEV-TF group) or the hepatitis E vaccine group (HEV group) stratified by sex and age. Each participant received three doses of the vaccine intramuscularly at 0, 1 and 6 months. Safety was evaluated based on adverse events (AEs) occurred within 30 days following each dose, serious adverse events (SAEs) and pregnancy events occurred during the study period. Immunogenicity was evaluated through quantification of anti-HEV IgG in serum samples collected at 0 and 7 months.

RESULTS:

A total of 612 eligible participants were enrolled and received at least 1 dose of vaccine. 558 participants were included in the per protocol set for immunogenicity. All participants seroconverted in both groups by month 7. The seroconversion rate difference was 0.00 % (95 % confidence interval [CI] -1.38 to 1.34). The geometric mean concentrations (GMCs) in HEV-TF group and HEV group were 16.57 U/mL and 18.47 U/mL, respectively. The GMC ratio was 0.90 (95 % CI 0.79 to 1.01). The overall AEs rates were similar between the groups (16.88 % vs. 12.50 %). Most of AEs were grade 1 or 2. No vaccine-related SAE occurred during the study period.

CONCLUSIONS:

The thiomersal-free hepatitis E vaccine demonstrated non-inferior immunogenicity compared with the licensed hepatitis E vaccine Hecolin® and showed an acceptable safety profile.

News (Medical) associated with Yangshengtang Co., Ltd.

10 Jul 2025

·www.fiercepharma.com

Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount

Merck has reportedly been offering three-dose courses of its HPV vaccine Gardasil 9 at the price of two doses in some areas of China. China’s first domestically made nine-valent HPV vaccine, a direct competitor to Merck’s Gardasil 9, is being priced at 499 yuan ($70) per dose, the state-owned Xinhua News Agency reports.The shot’s developer, Wantai BioPharm’s Xiamen Innovax Biotech, has set the sticker at an approximately 60% discount compared with the roughly 1,300 yuan-per-dose price for Gardasil 9 in China.A lower price from a local competitor, while expected, marks another blow to Merck’s under-pressure Gardasil franchise. Thanks to its performance in China, Gardasil had been a top growth driver for the New Jersey pharma giant up until the second quarter of 2024. At that time, declining China sales slowed Gardasil’s year-over-year quarterly growth to merely 1%, compared with 14% during the three months before. As Gardasil represents Merck’s second-largest product behind cancer blockbuster Keytruda, news of the slowdown triggered a rare 9% share price drop for the company.The situation has not improved since then. In the first quarter of 2025, Gardasil sales declined 41% to $1.3 billion, as its sales in China plummeted by about $1.1 billion. Excluding China, the shot’s sales grew 14%.Merck has a multifold explanation for Gardasil’s dramatic downturn in China. Besides a chilling effect from the Chinese government’s anti-corruption drive targeting the entire healthcare field, Merck CEO Rob Davis has cited a slowdown in “discretionary consumer spending” as one reason for a cooling across China’s vaccine space.Because HPV vaccines are not included in China’s national immunization program, people must pay out of pocket to get vaccinated. Then entered Wantai and its vaccine. In June, the company’s nine-valent HPV shot Cecolin 9 became China’s first domestically produced jab to win an approval. The approval is for girls and women ages 9 to 45 years old. The shot is given in two doses for those 9 to 17 years of age and as a three-dose regimen for adults.By comparison, Gardasil 9 covers the same age range, but its two-dose course is for those aged 9 to 14 years. Thanks to an expansion in April, Gardasil 9 boasts a unique authorization in men ages 16 to 26 years old.In a head-to-head study conducted in women ages 18 to 26 years in China, Cecolin 9 showed noninferior immune responses and similar adverse reaction rates compared with Gardasil 9, with some slight differences in each HPV type.Merck apparently has been trying to offset its price disadvantage. Media reports suggest that the company, through its local partner Chongqing Zhifei Biological Products, has been offering three-dose courses of Gardasil 9 at the price of two doses in some areas. The U.S. drugmaker has also ramped up its marketing push for Gardasil in the country. Despite the headwinds, the Chinese HPV market still has great potential. Only 27% of Chinese women who were eligible had received at least one dose of an HPV vaccine, Wantai noted in an investor communication Tuesday, citing Chinese CDC data. Compared with the roughly 67% penetration rate in Western countries, HPV vaccines still have much room to grow in China, the Chinese company said.Wantai said it’s currently working to get Cecolin 9 onto the World Health Organization prequalification list to pave the way for its introduction outside China. The company is also testing the nine-valent shot in men in a phase 3 study and is developing a 21-valent version, as well.

Drug ApprovalVaccinePhase 3

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

100 Deals associated with Yangshengtang Co., Ltd.

100 Translational Medicine associated with Yangshengtang Co., Ltd.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 17 Sep 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

IND Approval

Phase 1

Phase 2

Phase 3

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Human papillomavirus 16/18 vaccine recombinant bivalent(Xiamen Innovax)	Uterine Cervical Cancer More	Approved
Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)	Uterine Cervical Cancer More	Approved
Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)	Hepatitis E More	Approved
DelNS1-2019-nCoV-RBD-OPT1(Beijing Wantai Biological) ( SARS-CoV-2 S protein )	COVID-19 More	Approved
Sudapyridine ( ATP synthase )	Tuberculosis, Multidrug-Resistant More	Phase 3

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis