Yangshengtang Co., Ltd.

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.

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.

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