YolTech Therapeutics, a biotech company developing in vivo gene editing therapies to treat rare genetic diseases, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially approved the YOLT-201 investigational new drug (IND) application for a Phase I study, marking that the drug candidate has officially entered the registration clinical development stage.. The first patient has been dosed with YOLT-201 in Investigator initiated trial(IIT) by the end of 2023, achieving promising preliminary efficacy and safety results. ATTR is a debilitating genetic disease, caused by misfolded transthyretin protein (TTR) forming amyloid fibrils and depositing in various organs and tissues in the body such as myocardium in the heart and peripheral nerves in the limbs. Depending on the mutation involved, hATTR can occur in people in their teens and 20s, though other forms are typically diagnosed in people over 50 years of age. YOLT-201 is ...
Organiser: Informa Markets Time:17 – 19 April 2024 address:3-2-1 Aiakle Koto ku, Tokyo 135 0063 Japan Exhibition hall: Tokyo Big Sight International Exhibition Center Product range: Apis: vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western drugs Ingredients Excipients and dosage forms: excipients, flow AIDS, enteric materials, antioxidants, sweeteners, penetration enhancers, preservatives, disintegrators, coating materials, surfactants, sunshades, flavors, filter AIDS, stabilizers, lubricants, plasticizers, solvents, flavor straighteners, coloring agents, clarifying agents, PH regulators, etc Natural extract: plant extract, animal extract, traditional Chinese medicine raw material, functional food raw material, health care raw material, nutrition and health raw material, supplement, dietary fiber, beauty cosmetics raw material Biological product reagents: antibody, nucleic acid/protein synthesis, carrier and construction, cell biology detection, animal/plant protein/antigen/polypeptide, nucleic acid ...
Chronic kidney disease (CKD) is increasingly becoming a major health issue worldwide. For those diagnosed with CKD, the rate of disease progression can vary, with some individuals experiencing a rapid deterioration in kidney function. Healthcare providers need to spot patients who are newly diagnosed with CKD and are at a heightened risk of rapid disease progression. Early identification can allow for timely interventions that could slow down, or in some cases, prevent the progression of the disease. Now, researchers have made a breakthrough by discovering a simple method to identify individuals at high risk for rapid CKD progression, an advancement that could greatly enhance prevention and treatment strategies. In a comprehensive study, a team of researchers from Aarhus University (Aarhus, Denmark) examined the precise risk of rapid CKD progression utilizing data from Danish health registers. This study provides valuable insights for medical professionals on identifying patients who are more likely ...
Noncommunicable diseases (NCDs), such as cardiovascular disease, cancer, chronic respiratory disease and diabetes, are responsible for 75% of deaths worldwide. People affected by humanitarian emergencies are at increased risk of NCDs. It is estimated that strokes and heart attacks are up to 3 times more likely following a disaster. However, care and treatment for NCDs are often not included as a standard part of humanitarian emergency preparedness and response, which focus on the most immediate needs. To support integration of essential services for NCDs into emergency preparedness and humanitarian response, the World Health Organization (WHO), the Kingdom of Denmark, the Hashemite Kingdom of Jordan, the Republic of Kenya, and UNHCR, the UN Refugee Agency, are jointly convening a global high-level technical meeting on NCDs in humanitarian settings on 27-29 February in Copenhagen, Denmark. Humanitarian emergencies in recent years are becoming more complex and interconnected. Hunger and shortages of essential goods ...
NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ — TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLRP3 inflammasome inhibitor. The NLRP3 inflammasome is a pivotal component of the human innate immune system. Aberrant activation of NLRP3 is strongly linked with a variety of inflammatory disorders, including obesity, neurodegenerative diseases, NASH, inflammatory bowel disease (IBD), dermatitis, and atherosclerosis. “Immuno-inflammation is one of TransThera’s key therapeutic areas of interest. Over the past three years, we have achieved breakthroughs with the NLRP3 inhibitor program.” said Jennifer Sheng, Vice President of Biology at TransThera. “Our clinical candidate compound TT-02332 is a highly potent NLRP3 inhibitor that has shown promising efficacy in a number of disease-relevant in vivo animal models. The compound exhibits desirable pharmacokinetic/ pharmacodynamic (PK/PD) properties, suitable for once-daily dosing. TT-02332 demonstrates an ...
Don Tracy, Associate Editor Early-stage trial results indicate that NLRP3 inflammasome inhibitors were able to achieve nearly the same weight loss as Wegovy while also reducing inflammatory biomarkers linked to heart disease. Results from an early-stage study found that a novel therapy for Parkinson disease produced nearly the same weight loss effect as the blockbuster GLP-1 receptor agonist Wegovy (semaglutide), while also lowering inflammatory biomarkers associated with heart disease. In a study published by The Journal of Pharmacology and Experimental Therapeutics, researchers for NodThera, a clinical-stage biotech developing brain-penetrant NLRP3 inhibitors to treat chronic inflammatory diseases, aimed to discover the efficacy of the investigational NLRP3 inflammasome inhibitors NT-0249 and NT-0796 in reversing obesity-related complications. They focused on systemic inflammation and astrogliosis in the hypothalamus. To find a sufficient answer, the study relied on diet-induced obesity (DIO) mouse models treated with NT-0249 and NT-0796 to assess their impact on obesity reversal. ...
On February 21, the National Medical Product Administration approved the marketing application pf the innovative traditional Chinese medicine Category 1.1 drug Jiuwei Cough Oral Liquid applied by Zhuohe Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Zhuohe Pharmaceutical”). According to the NMPA official website, a randomized, double-blind, placebo and active drug parallel controlled multi-center clinical trial has been conducted. The results show that in terms of the main efficacy indicators: cough disappearance rate and cough disappearance time the test group is better than the placebo group and non-inferior to the positive drug group. This medicine is used for relieving lungs and cough, acute tracheobronchitis and cough that belongs to wind-heat syndrome according to traditional Chinese medicine. The launch of this drug provides more treatment option for patients with acute tracheobronchitis cough. Anti-rheumatic, anti-tumor… According to Zhuohe Pharmaceutical’s public information, the company has professional R&D and innovation capabilities in multiple disciplines ...
ROCKVILLE, M.D. and SUZHOU, China, February 21,2024 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that it has entered into a clinical trial collaboration and supply agreement with ImmVirX Pty Limited (“ImmVirX”) to evaluate the combination therapy of ImmVirX’s investigational oncolytic virus IVX037 with Innovent’s TYVYT® (sintilimab injection), the Chinese market-leading anti-PD-1 inhibitor. ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) of intratumoral IVX037 in Australia. Initial results from Part 1a of the trial indicate that multiple injections of IVX037 have been well tolerated and show early signs of inducing potentially beneficial inflammatory cytokines/chemokines, such as CXCL10, with antitumor activity observed in the injected lesions of some subjects. Part 1b of the trial, set to begin in mid-2024, evaluates the anticancer activity ...
ROCKVILLIE, MD. and SUZHOU, China, February 20, 2024— Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA). RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye ...
The US Food and Drug Administration (FDA) has granted orphan drug designation to Ionis Pharmaceuticals’ olezarsen, an investigational ligand conjugated antisense medicine for familial chylomicronemia syndrome (FCS). This rare genetic disease is characterised by extremely high triglyceride levels and can lead to recurrent acute pancreatitis (AP). Olezarsen is an RNA-targeted therapy aimed at reducing the production of apolipoprotein C-III (ApoC-III), a protein that regulates triglyceride metabolism. It is currently undergoing evaluation for individuals at risk of diseases caused by elevated triglyceride levels, including FCS. In January 2023, the US regulator awarded fast track designation to olezarsen for FCS. Ionis is also investigating its potential to treat severe hypertriglyceridemia (sHTG) in Phase III clinical trials. FCS patients experience triglyceride levels that are significantly higher than normal, leading to life-threatening conditions such as AP and potential damage to vital organs. No currently FDA-approved therapies exist for FCS, and standard treatments for lowering ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.