Recently, CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as “PCV13i”) has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population. CanSinoBio’s PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory. At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines. In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal ...
Recently, BIOKANGTAI’s wholly-owned subsidiary, Beijing Minhai Biotechnology, has signed a sales contract with its Indonesian partner, in which a detailed agreement was made on the quantity, unit price, total amount of the order, and shipment date of the world’s first dual-carrier 13-valent pneumococcal conjugate vaccine developed and produced by BIOKANGTAI to be exported to Indonesia. In October 2023, Minhai Biotech obtained the Marketing License for 13-valent Pneumococcal Polysaccharide Conjugate Vaccine issued by the Indonesian Food and Drug Administration, marking that the vaccine has the basic conditions for sale in the local market in Indonesia. The signing of this contract indicates that after years of market expansion, Kangtai’s 13-valent pneumococcal vaccine has formally opened for overseas sales, and as the relevant work continues to progress, this variety will bring new growth points for the company’s 2024 annual results. Dr. Lucia Rizka Andalusia, Acting Head of Indonesia’s Food and Drug Regulatory Agency ...
At the kick-off meeting held at the Center for Disease Control and Prevention in Pu’er City, Yunnan Province, regarding the REC610 China Phase I clinical trial project, the investigator introduced the background of the disease, information about the REC610 product, and gave a detailed introduction of the overall design of the clinical trial, the trial process, and the precautions and other aspects of the clinical trial. After the meeting, the research team sorted out the trial process to support the smooth development of the subsequent trial. REC610 carries a novel adjuvant, BFA01, developed by the Company, which promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies, and is intended to be used for the prevention of herpes zoster in adults aged 40 years and above. Previously, data from an interim analysis of the FIH clinical trial of REC610 in the Philippines using GlaxoSmithKline ...
HPV is a common group of viruses which can sometimes lead to cancer The NHS is urging both parents and young people between the ages of 12 and 13 years to take up having the human papillomavirus (HPV) vaccine to meet the NHS cervical cancer elimination goal. New figures from the UK Health Security Agency have shown that around one in six girls and one in five boys are not fully vaccinated by year 10. HPV is a very common group of over 100 viruses which affect the skin, sometimes causing genital warts or cancer. The HPV vaccine works to protect against a variety of cancers, including cervical, head and neck, anal and genital cancers. It is currently offered to all 12- to 13-year-olds within schools and community clinics and requires parental consent to receive the vaccine from NHS nurses. New statistics from the UK Health Security Agency has shown ...
Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as “BIOKANGTAI”), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as “the Company”), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as “20-valent Pneumococcal Conjugate Vaccine”) developed by BIOKANGTAI. (hereinafter referred to as “Minhai Biotechnology”), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology: I. Main contents of the acceptance notice Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the “People’s Republic of China Administrative License Law”, Article 32 of the provisions of ...
Approximately one in five children will be hospitalised to treat measles The NHS has announced the launch of its new catch up campaign to get millions of children booked in for their missed measles, mumps and rubella (MMR) vaccine. The new campaign aligns with the health services efforts to protect children from becoming seriously ill as cases of measles rise across the UK. MMR are highly infectious illnesses that can lead to blindness, deafness and swelling of the brain. Considered more infectious than COVID-19, NHS analysis has shown that one infected child in a classroom can infect up to nine other unvaccinated children. In total, more than 3.4 million children under the age of 16 are currently unprotected and are at risk of catching MMR. The new campaign will assure that all parents of children from the age of six to 11 years are contacted to book an appointment with ...
Emergent BioSolutions was awarded a 5-year, $235.8 million contract with the U.S. Department of Defense to supply the anthrax vaccine BioThrax to the various branches of the military. Under the terms of the deal, Emergent is guaranteed a purchase minimum of $20.1 million, with future orders estimated to be worth at least $20 million for each following year. Beyond the initial 5-year term, the contract has a 5-year option that could extend the deal to 2033. In all, the procurement pact could be worth up to $235.8 million, the company said in a Jan. 11 release. “Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” Paul Williams, senior vice president, products head at Emergent, said in the release. Founded in 1998, Emergent has been a long-time supplier of anthrax countermeasures to the U.S. ...
(“CanSinoBio” or the “Company”) has recently initiated a Phase I clinical trial of its recombinant polio vaccine in Australia and has completed the enrollment of the first subject. The Company has completed the clinical trial filing with the Therapeutic Goods Administration (TGA) under the Department of Health of Australia, and the vaccine has received ethical approval for the clinical trial from the Australian Human Research Ethics Committee prior to the filing of the clinical trial protocol. The Company’s virus-like particle (VLP)-based recombinant polio vaccine, which is based on the Company’s protein structure design and VLP assembly technology, is expected to contribute to the global control and eradication of polio. The recombinant polio vaccine is a non-infectious polio vaccine that does not rely on live viruses in the production process and is expected to have good safety and immunogenicity. Unlike the marketed attenuated and inactivated polio vaccines, the non-infectious VLP polio ...
GSK has a lot of experience with its shingles vaccine Shingrix in getting the older population to take their shots; now, with the approval of the world’s first RSV vaccine last year, the U.K. Big Pharma is looking for a slow burn approach for its latest respiratory shot. During GSK’s official J.P. Morgan Healthcare Conference 2024 presentation, CEO Emma Walmsley and Chief Commercial Officer Luke Miels spoke on how the company is looking to carve out a RSV market with its new vax Arexvy. “Creating a market is absolutely fundamental,” Walmsley said during the JPM presentation. “Three years ago, I don’t know how broadly the awareness was of the general public about RSV for older adults, even though it’s a scale disease that hospitalizes tens of thousands of Americans that were on, sadly 15,000 died. “So, we’re at very early stages of penetration of the market. I think competition and ...
Three years after it received its Emergency Use Listing (EUL) and with 950 million doses now delivered worldwide, nOPV2 has been prequalified by the WHO, following analysis of outcomes in vaccinated populations, confirming the strong safety profile and effectiveness of the vaccine. The nOPV2 vaccine helps to protect children from polio while lowering the risk of vaccine-derived outbreaks. Prequalification is a mark of quality assurance granted by the WHO and will make it easier for more countries to access and use nOPV2. Now it is granted, WHO member countries can obtain and use nOPV2 without the need to meet the strict readiness and monitoring requirements previously required under EUL. Prequalification will therefore ensure broad and long-term accessibility for international agencies to distribute nOPV2 in developing countries. Dr Andrew Macadam, Principal Scientist at the MHRA said: Until it has been completely eradicated, polio will continue to be a threat to children ...
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