Today (May 10), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Arbutus Biopharma and Qilu Pharmaceutical jointly submitted a clinical trial application for AB-729 injection, which was accepted. According to public information, AB-729 is an RNAi drug developed by Arbutus for the treatment or prevention of hepatitis B. In December 2021, Qilu Pharma and Arbutus entered into an exclusive license agreement and strategic cooperation for the development and commercialization of the drug candidate in Greater China (including mainland China, Hong Kong, Macau and Taiwan), with down payment and milestones for this cooperation Payments up to $285 million. Chronic hepatitis B is a potentially life-threatening infection of the liver caused by the chronic hepatitis B virus (HBV), which can lead to cirrhosis and liver cancer. The reason why chronic hepatitis B is difficult to cure is that in addition to the replication of HBV in the body, a large number of proteins produced by the virus will inhibit the immune response of the human body, resulting in the inability of immune cells to control the replication of the virus. Therefore, to reactivate the function of immune cells, it is necessary to reduce the expression of viral proteins. RNA interference (RNAi) is a mechanism present in living cells that inhibits the expression of specific genes, thereby affecting the production of specific proteins. AB-729 is a hepatocyte-targeting RNAi drug that uses a novel covalently coupled N-acetylgalactosamine (GalNAc) delivery technology developed by Arbutus and can be administered subcutaneously. In preclinical models, AB-729 inhibits HBV viral replication, reduces all viral RNA transcript copies, and reduces all HBV antigens, including hepatitis B surface antigen (HBsAg), showing pan-genotypic activity across all HBV genotypes . The effect of AB-729 against hepatitis B ha

China's National Medical Products Administration (NMPA) has approved (tofacitinib citrate) for active ankylosing spondylitis (AS) in whom one or more TNF blockers are insufficiently effective or intolerable adult patients. After the approval, Shanghai Changzheng Hospital and Peking University First Hospital issued the first prescription for patients, benefiting patients with ankylosing spondylitis as soon as possible. According to the press release, Shangjie, as the first and only oral small-molecule targeted drug approved for the treatment of ankylosing spondylitis in China, will bring breakthroughs in the field of AS treatment. Tofacitinib is a JAK inhibitor previously approved in China for the treatment of moderate to severe rheumatoid arthritis. The approval of the new indication for ankylosing spondylitis is the second indication approved in China. According to the press release, tofacitinib is a novel mechanism of action compared to existing drugs in the treatment of ankylosing spondylitis. By blocking the JAK-STAT pathway in immune cells, it can directly or indirectly block the signal transduction of a variety of AS-related cytokines, so as to inhibit inflammation and alleviate the disease. Professor Xu Huji, the leading expert of the China Phase 3 clinical research project for the indication of tofacitinib in ankylosing spondylitis and director of the Department of Rheumatology and Immunology of Shanghai Changzheng Hospital, said that AS patients are mostly young and middle-aged men. It will cause irreversible structural damage. If it is not treated in time or improperly treated, it will affect the ability to work and bring a burden to the family and society. Shangjie's Phase 3 clinical study for AS is a randomized, double-blind, placebo-controlled study conducted in 75 centers in 14 countries, of which approximately 18% of patients are enrolled in China. It is expected that the approval of Shangjie's AS indication will brin

Today (April 11), the official website of the National Medical Products Administration (NMPA) of China announced that Pfizer`s oral JAK1 inhibitor abrocitinib (abrocitinib, the Chinese brand name is Cipike) has been approved in China. Marketed for adult patients with refractory, moderate-to-severe atopic dermatitis who do not respond well to other systemic treatments (such as hormones or biological agents) or who are not suitable for the above treatments. Abuxitinib is a once-daily oral JAK1 inhibitor, inhibition of JAK1 is thought to modulate multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukins IL-4, IL-13, IL- 31. IL-22 and thymic stromal lymphopoietin (TSLP). In September 2021, abroxitinib was approved for the first time in the UK for the treatment of adults and adolescents over 12 years of age with moderate to severe atopic dermatitis, followed by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The product expresses a positive opinion and recommends its approval for marketing. In the United States, the FDA has accepted the New Drug Application for abrutinib, and has granted the drug breakthrough therapy designation and priority review status for the treatment of patients over 12 years of age with moderate to severe atopic dermatitis. Previously, abraxitinib tablets have achieved positive results in multiple Phase 3 clinical trials in patients with moderate to severe atopic dermatitis, showing statistically significant improvements in skin symptom clearance, disease severity, and placebo. Compared with the drug, the itching symptoms of the patients were rapidly improved. For example, in a randomized, double-blind, placebo-controlled Phase 3 clinical study called JADE MONO-1, after 12 weeks of treatment, 43.8% and 23.7% of patients in the placebo group had or near complete disappearance (IGA score 0/1), compared with 7.9% in the placebo group. Fu