Recently, Chengdu Kanghua Biological Products Company Limited (“Kanghua Biological” or the “Company”) signed an Exclusive License Agreement with HilleVax.INC (“HilleVax”). INC (“HilleVax”). Kanghua Biologicals licensed HilleVax to develop, manufacture and commercialize Recombinant Hexavalent Norovirus Vaccine and its derivatives in areas other than China (including Hong Kong, Macao and Taiwan). Kanghua Biologicals will receive an initial payment of US$15 million for this transaction and is expected to receive milestone payments of US$255.5 million upon the achievement of certain development and sales milestones, and Kanghua Biologicals is also entitled to a single-digit percentage sales commission on net sales in territories other than China (including Hong Kong, Macao and Taiwan). Using genetic engineering technology, Kanghua Biologicals has constructed a recombinant hexavalent norovirus vaccine based on Virus-Like Particles (VLPs), which encompasses the six major prevalent genotypes of norovirus, and theoretically protects against more than 90% of norovirus infections and acute gastroenteritis caused by norovirus, ...
On January 3, 2024, the quadrivalent influenza virus lysate vaccine independently developed by Wuhan Institute of Biological Products of China Biologicals (WIBP) was granted a certificate of drug registration by the Ministry of Health and Prevention (MOHAP) of the United Arab Emirates (UAE). This is another international registration certificate obtained after the Kenyan registration certificate in 2023, marking the steady progress of the internationalization strategy of Wuhan Bioproducts Research Institute and the gradual opening of a new channel for exporting vaccine products to the Middle East. Influenza is an acute respiratory infectious disease caused by influenza virus. According to WHO’s estimation, about 600 million people are infected with influenza virus globally every year, and as many as 250,000 to 500,000 cases of death. Influenza vaccination is the most cost-effective preventive measure. Influenza vaccine of Wuhan Institute of Biological Products is prepared by a patented process without antibiotics and preservatives. It ...
Vaccine immunization has dramatically reduced the morbidity and mortality of invasive bacterial infectious diseases such as bloodstream infections. Although a large number of studies have demonstrated that immune protection requires vaccine-induced antibody production, human beings still lack a clear understanding of the cellular and molecular mechanisms of how vaccines provide immune protection. The current international consensus is that vaccines provide immune protection by activating phagocytes in the spleen and blood circulation to remove pathogens that invade the bloodstream. Recently, Jingren Zhang’s group and Linqi Zhang’s group at Tsinghua University School of Medicine, together with Haifa Zheng’s group at Beijing Minhai Biotechnology Co., Ltd, published a paper in Science Translational Medicine titled “Liver macrophages and sinusoidal endothelial cells The research paper, entitled Liver macrophages and sinusoidal endothelial cells execute vaccine-elicited capture of invasive bacteria, reveals that the liver is the main organ that executes vaccine-elicited immunoprotection, and elucidates the molecular mechanism ...
The World Health Organization (WHO) has said it has added a new malaria vaccine to its list of prequalified vaccines, marking a “significant milestone” in the prevention of the mosquito-borne disease. R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, is now the second malaria vaccine to be prequalified by the organisation following its prequalification of the RTS,S/AS01 vaccine in July 2022. Malaria places a particularly high burden on the African Region, where nearly half a million children die from the disease every year. Despite high demand, WHO outlined that the available supply of RTS,S has been limited and expects the addition of R21 to result in sufficient vaccine supply for children living in areas where malaria is a significant public health risk. Dr Kate O’Brien, director of WHO’s department of immunisation, vaccines and biologicals, said the decision marked “a huge stride in global health”. “This ...
AIM Bio is gearing up for the imminent launch of its blockbuster products, the 13-valent Pneumococcal Conjugate Vaccine and the 23-valent Pneumococcal Polysaccharide Vaccine. The production lines are ready and preparations are underway for WHO-PQ certification. These super vaccine factories have been designed and constructed according to WHO-PQ standards, fully preparing for the global market, showcasing Emergent’s forward-looking layout and arrangements in the international market. In Emergent’s super vaccine factories, the vaccine production process is monitored in real-time, and batches of vaccine products undergo online review and release. The entire production process is traceable with data records, minimizing human intervention, ensuring the repeatability and consistency of vaccine production, reducing the risk of human error, and lowering the risks of contamination and cross-contamination. The digitization and intelligence have reached a globally leading level. Represented by the workshop for the 13-valent Pneumococcal Conjugate Vaccine in Ningbo, these super vaccine factories designed and ...
On December 28, the first domestically developed oral trivalent reassortant rotavirus attenuated live vaccine (Vero cells) produced by China National Pharmaceutical Group Corporation (Sinopharm) Lanzhou Institute of Biological Products received the approval and issuance certificate from the China Food and Drug Inspection Research Institute. The vaccine has been sent to various regions across the country and is about to commence vaccination. Rotavirus is a major cause of severe acute diarrhea in infants and young children, with almost every child under the age of 5 being infected at least once. If not intervened in a timely manner, it may lead to systemic damage affecting respiratory, circulatory, and central nervous systems, and in severe cases, dehydration, shock, and even death. Both the World Health Organization (WHO) position papers and the ‘Expert Consensus on Immunization Prevention of Rotavirus Gastroenteritis in Children’ released in China in 2020 clearly state that vaccination with rotavirus vaccines ...
Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
Pharmaceutical Executive Editorial Staff Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The BLA has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed ...
On December 20, the kick-off meeting of “National Key Laboratory for R&D of New Vaccines for New Emerging Infectious Diseases” and the first meeting of the first Academic Committee were held at Sinopharm China Biologicals. Deng Jindong, Vice General Manager of Sinopharm and Chairman of China Bio, and Yang Xiaoming, Chief Scientist and Chief Engineer of Sinopharm, Chief Scientist of China Bio, and Director of the National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases, formally launched the “National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases”. Academician Zhao Jia, Academician Chen Xiangmei, Academician Li Zaikun, and Academician Wang Junzhi of the Chinese Academy of Engineering attended the launching meeting. After the launching meeting, the National Key Laboratory of New Vaccine Development for Emerging Infectious Diseases held the first meeting of the first academic committee. The Academic Committee listened to and passed ...
Recently, China-Saudi Arabia Investment Conference was held in Beijing. As a representative of China’s innovative vaccine enterprises, CanSino Bio signed a vaccine cooperation framework agreement with SPIMACO, a Saudi Arabian pharmaceutical manufacturing company, at the Major Investment Collective Signing Ceremony, in which the two parties will cooperate in the commercialization of innovative vaccines, joint R&D and clinical research, as well as localized production. According to the agreement, the cooperation will focus on promoting the entry of CanSino Bio’s quadrivalent conjugate vaccine Manhexin® into Saudi Arabia and other markets in the Middle East and North Africa region. In Saudi Arabia, the quadrivalent conjugate vaccine has been included in the country’s childhood immunization program, and there is a strong demand for a quadrivalent conjugate vaccine with longer-lasting immunoprotection effect and higher safety in the local market. Post-marketing data shows that Mannhexin®, a quadrivalent conjugate vaccine from CanSino Bio, has a very impressive ...
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