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$770 Million! AriBio authorizes Marketing Rights for a Drug to Treat Alzheimer’s Disease in China

It’s reported according to businesswire, AriBio recently announced that it has signed a licensing agreement for the exclusive marketing rights of AR1001, an investigational drug for the treatment of early Alzheimer’s disease, in China at a price of up to US$770 million. Considering the market competition and sales strategy of Alzheimer’s disease drugs in China, the licensee requested that no disclosure be made until the agreed time. The agreement includes an upfront non-refundable payment of 120 billion won (approximately US$90 million), with a total transaction value of up to 5.59 billion yuan (approximately US$770 million), including milestone payments and additional royalties. Upfront payments will begin in mid-2024. AR1001 is a phosphodiesterase type 5 (PDE5) inhibitor in development and an investigational oral drug for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed that AR1001 can inhibit neuronal apoptosis and restore synaptic plasticity, thus having neuroprotective effects. AR1001 also demonstrated a ...
- Source: drugdu
- 143
- March 28, 2024
EU recommendations for 2024/2025 seasonal flu vaccine composition

EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. Every year, EMA issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization (WHO) which are informed by regular monitoring activities on the prevalence and characteristics of different influenza viruses worldwide. Based on this data EMA’s Emergency Task Force (ETF) has issued a statement recommending a transition from quadrivalent to trivalent vaccines that do not include the B/Yamagata component. Currently, most authorised influenza vaccines are quadrivalent, which means that they are formulated to protect against the four main strains of influenza responsible for seasonal flu, A(H1N1)pdm09 and A(H3N2), B/Victoria and B/Yamagata. However, the B/Yamagata strain of the influenza B virus has not been detected in circulation since March 2020. This is thought to be due ...
- Source: drugdu
- 128
- March 28, 2024
Another Chiatai Tianqing’s contrast agent, iopromide injection, was approved for marketing

Recently, Chiatai Tianqing received the Certificate of Drug Registration approved and issued by the State Drug Administration (NMPA), in which the company’s product Iopromide Injection in the field of medical imaging was approved to be listed and deemed to have passed the consistency evaluation as the second domestic one. Iopromide injection is a diagnostic drug, which can be used for intravascular and intracorporeal imaging, and is currently widely used in clinical applications and has great potential. Iopromide is a tri-iodinated non-ionic water-soluble X-ray contrast agent with high iodine content and good contrast effect, which is used for computed tomography (CT) enhancement, arteriography and venography, arterial/venous digital subtraction angiography (DSA), cardiovascular angiography, venous urography, endoscopic retrograde cholangiopancreatography (ERCP), arthrocentesis, and other body cavity examinations. Iopromide has the advantages of stable nature, easy to use, lower toxic side effects than ionic iodine contrast agent, good systemic tolerance, etc., and has become a ...
- Source: drugdu
- 142
- March 28, 2024
BIO-THERA’s Phase II Clinical Trial Application for BAT8006 (ADC- FRα) for Injection Approved by US FDA

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data. BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located ...
- Source: drugdu
- 131
- March 28, 2024
Inizio Engage and Applied Driving partner to support clinical workers with safety app

The Companion+ Mobile Safety App will be rolled out to a further 115 users within the UK and US Inizio Engage has announced that it has teamed up with Applied Driving to support its clinical team as well as other lone workers using the Companion+ Mobile Safety App, a safer driving and personal safety solution. The app has been rolled out to 65 mobile employees, with plans to expand to a further 115 users within the UK and US. Developed by Applied Driving, Companion+ is designed to improve driver behaviour while protecting users in a sphere of safety. Comprising safety messages, video or e-learning modules tailored to the user’s specific needs, the app automatically sends triggered training to users after assessing at-risk driving events. “Companion+ will offer our mobile clinical team discreet safety and security, anytime,” said Caroline McGlynn, head of clinical solutions, Inizio Engage. “The… app possesses advanced functionality ...
- Source: drugdu
- 97
- March 28, 2024
Researchers identify group of biological markers found in high levels in TB patients

According to the World Health Organization, TB is responsible for over one million annual deaths Researchers from the National Institute for Health and Care Research’s (NIHR) Southampton Biomedical Research Centre have identified a group of biological markers of tuberculosis (TB) found in high levels among infected patients. Published in the Journal of Clinical Investigation Insight for World TB Day (24 March 2024), findings from the study could advance a simple blood test to speed up the diagnosis of the infection. According to the World Health Organization, TB is the world’s deadliest infectious disease, caused by a bacterium known as Mycobacterium tuberculosis, which is responsible for more than one million deaths each year. Estimated to affect ten million people globally every year, the highly contagious and easily transmitted TB spreads through the air when infected people cough, sneeze or spit, often affecting the lungs. Supported by the NIHR and the UK ...
- Source: drugdu
- 138
- March 28, 2024
Hong Kong Adventist Healthcare and Fosun Health Sign Strategic Cooperation Agreement

Recently, Hong Kong Adventist Hospital (HKAH) and Fosun Health signed a strategic cooperation agreement, combining the resources and experience of both parties in the healthcare field to jointly promote the improvement of healthcare services in the Greater Bay Area. The signing ceremony was held at Hong Kong Adventist Hospital. Mr. Ling Wangbao, President and CEO of Hong Kong Adventist Hospital, and Mr. Hu Hang, CEO of Fosun Health and Director of Foshan Fosun Chancellor Hospital, attended the event and signed the strategic cooperation agreement under the witness of senior management of both parties. According to the agreement, the two sides will have in-depth cooperation in artificial intelligence, telemedicine and other fields in the future, and deepen the innovation of medical technology and the development of medical services. At the same time, the cooperation will promote the sharing of medical information between Guangdong, Hong Kong and Macao, and through the establishment ...
- Source: drugdu
- 89
- March 27, 2024
Hengrui’s Thiotepa for Injection for Pre-treatment of Hematopoietic Stem Cell Transplantation Approved for Marketing

Recently, Hengrui Pharmaceuticals has received the Certificate of Drug Registration issued by the State Drug Administration, which approves Thiotepa for Injection (Trademark: Ruihang®, two specifications of 15mg and 100mg) to be listed in Class 3 of the Chemical Drugs, with the indication of “This product is suitable for the pre-treatment of allo-HSCT for children with β-thalassemia major (<18 years of age)”. The indication of the product is “This product is suitable for allogeneic hematopoietic stem cell transplantation (allo-HSCT) pretreatment for children (<18 years old) with beta-thalassemia major”. Thiotepa for injection is the first generic product in China and has been approved for sale in the United States and Europe. Thiotepa is the first Thiotepa product approved for transplantation preconditioning in China. Beta-thalassemia (β-thalassemia for short) is a common hemolytic disease in clinic, and there are about 300,000 patients with severe and intermediate β-thalassemia in China at this stage.1 Currently, the ...
- Source: drugdu
- 92
- March 27, 2024
CanSinoBio’s Quadrivalent Conjugate Vaccine Launches Phase III Clinical Trial in Indonesia

Recently, CanSinoBio’s Quadrivalent Conjugate Vaccine (QCV) initiated a Phase III clinical trial in Indonesia and completed the enrollment of the first subject. The clinical trial aims to evaluate the safety and immunogenicity of the vaccine in people aged 18-55 years. Currently, rheumatic encephalitis remains a serious challenge in global public health, and vaccination is the most cost-effective and efficient way to prevent it.2022 In June, CanSinoBio’s self-developed Mannhexin®, Asia’s first tetravalent rheumatic encephalitis conjugate vaccine, was officially approved for marketing, which fills the gap of China’s lack of high-end rheumatic encephalitis vaccines in this field. This clinical trial will expand the applicability of the quadrivalent conjugate vaccine to adults. According to the statistics, the incidence of epidemic epidemic is found in all age groups, among which the incidence rate is higher in children under 5 years old. Usually, the incidence rate of epidemic encephalitis decreases with age, but the incidence ...
- Source: drugdu
- 117
- March 27, 2024
CSPC obtains clinical approval for semaglutide weight loss indication

On March 25, CSPC Pharmaceutical Group (1093.HK) announced that the semaglutide injection developed by the group has been approved by the National Medical Products Administration of the People’s Republic of China to conduct the clinical trial in China for weight management indication in overweight or obese adult patients on the basis of calorie diet reduction and increased physical activity. It is also the second indication for this product to be approved for clinical trials after blood sugar control in adults with type 2 diabetes. Semaglutide injection is currently the most significant product in the field of weight loss and is still growing rapidly with broad market prospects. The raw materials used in this product are completely prepared through chemical synthesis, using advanced synthesis, purification and characterization technologies. The raw materials prepared are of higher purity, avoiding host proteins and other immunogenic substances introduced during the biological fermentation process, and ensuring ...
- Source: drugdu
- 97
- March 27, 2024

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