Xiamen University

China has approved its first domestically developed 9-valent human papillomavirus (HPV) vaccine on Thursday, creating new competitive pressure for Merck & Co.'s Gardasil/Gardasil 9 in a market where the US drugmaker has already paused shipments and withdrawn long-term sales projections.The newly approved vaccine, called Cecolin 9, was developed through a collaboration between Xiang An Biomedicine Laboratory, Xiamen University and Wantai BioPharm, and makes China only the second country after the US capable of independently producing high-valency HPV vaccines.The approval comes as Merck grapples with collapsing demand for Gardasil in China, where the company temporarily suspended shipments in February and rescinded its annual sales target of $11 billion for the jab by 2030. Still, CEO Robert Davis said at the time that China continued to represent "a significant long-term opportunity" for the franchise, attributing the shipping pause to excess inventory.Gardasil generated $8.6 billion globally in 2024, down 3% from the prior year, with first-quarter sales this year plummeting 41% to $1.3 billion. Merck has said the pause in Gardasil deliveries to China would last until at least mid-year.According to Chinese officials, Cecolin 9 has been tested in five clinical trials conducted across China since 2019, involving more than 11,000 healthy volunteers aged nine to 45, and demonstrated over 98% protection against persistent HPV infections and 100% protection against cervical infectionsThe vaccine covers the same high-risk HPV strains as Gardasil 9, including types 16 and 18, plus five other types (31, 33, 45, 52 and 58). For girls aged 9 to 17, two doses provided immune responses comparable to three doses in older women ages 18 through 26, Chinese officials said.The competitive threat extends to pricing as well, where Chinese HPV vaccines typically cost a tenth that of Gardasil at about CNY 300 ($42). "The perceptions of domestic products have been improving," said Justin Wang, partner at L.E.K. Consulting in Shanghai said in a recent Bloomberg report. "The huge price difference will result in a significant share going to domestic products."

THURSDAY, March 20, 2025 -- The burden of Alzheimer disease and other dementias (ADODs) rose globally from 1990 to 2021, according to a study published online in the April issue of the American Journal of Preventive Medicine . Manqiong Yuan, from Xiamen University in China, and colleagues described the global burden and temporal trends of ADODs from 1990 to 2021 using data from the Global Burden of Disease 2021 study. The researchers found significant disparities in the numbers, rates, and age-standardized rates of disability-adjusted life years across 204 countries/territories. For all age groups, women demonstrated higher disability-adjusted life-year numbers (rates). Worldwide, there was an increase in the age-standardized disability-adjusted life-year rate, which was high in high-middle and middle sociodemographic index regions but increased faster in low (average annual percentage change [AAPC], 0.227 percent) and low-middle (AAPC, 0.244 percent) sociodemographic index regions. Disability-adjusted life years of ADODs were skewed and higher in countries with higher sociodemographic development, with the inequality increasing over time except for education expenditure-related inequality. “Based on the results, it is necessary to further control risk factors of ADODs by promoting a healthy diet and regular exercise for preventing the development of ADODs in developed countries," lead author Ya Fang, M.D., Ph.D., also from Xiamen University, said in a statement. "However, enhancing basic healthcare, improving medical resource access and affordability, and raising ADOD awareness among the public in developing countries are also vital." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

WASHINGTON, Oct. 28, 2024 /PRNewswire/ -- MitrAssist Lifesciences, a leader in innovative cardiovascular medical devices, today unveiled the initial clinical results of its groundbreaking new product, SIKELIA™, during the 2024 Transcatheter Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C. The early findings demonstrate promising potential in improving outcomes for patients suffering from severe symptomatic aortic stenosis. SIKELIA transthoracic heart valve (THV) is designed for transcatheter aortic valve implantation (TAVI) procedure. It features a unique polymer leaflet design which allows enhanced durability and reduced thrombogenicity and calcification while lowering production costs. SIKELIA THV is also fully retrievable at 100% frame expansion allowing reposition in case of misplacement. The clinical trial results, involving 12 patients from 4 centers, with a maximum follow up of 27 months, revealed favorable safety and performance 1-year outcomes. A significant improvement in hemodynamic performance was demonstrated by reduced mean pressure gradient and increased effective orifice area. The functional status as assessed by NYHA class, 6-minute walk test and KCCQ score was improved significantly in all measures. In addition, at 1 year follow-up, normal leaflet mobility without hypoattenuated leaflet thickening (HALT) or calcification was confirmed in all patients. "The initial clinical results of SIKELIA™ mark a significant milestone in our mission to transform patient care," said Peggy Wang, CEO of MitrAssist. "We are excited about the potential SIKELIA has to improve outcomes for patients suffering from severe aortic stenosis. SIKELIA capabilities and these initial results provide a foundation for the next phases of clinical testing, and we look forward to continuing our work to bring this innovation to physicians and patients around the world." The presentation at the TCT Conference attracted the attention of top physicians, industry leaders and medical professionals eager to explore more about the product. Dr. Xiaochun Zhang from Zhongshan Hospital and the Shanghai Medical College of Fudan University presented the initial results of this first-in-human, prospective, single-arm, multicenter study, on behalf of the study investigators. In addition to Zhongshan Hospital, the participating centers included Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Xiamen Cardiovascular Hospital Xiamen University and Zibo Central Hospital. "The initial outcomes we are seeing from SIKELIA™ could represent a real breakthrough in the TAVR field," said Prof. Junbo Ge from Zhongshan Hospital, principal investigator of the clinical trial. "The potential for improving patients' outcomes is immense, and we are eager to continue gathering data and enhancing the application of this technology. These results are just the beginning, and they pave the way for more comprehensive studies in the near future." For further information, please visit MITRASSIST LIFESCIENCES LIMITED is a leading global company for innovative cardiovascular medical devices, focusing on providing advanced diagnostic and therapeutic solutions for cardiovascular patients. The company product line covers a wide range of applications in the cardiovascular field from structural heart disease to heart failure. MitrAssist is dedicated and committed to innovation and improving patient care. Logo: SOURCE MitrAssist Lifesciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED