Home > JAK1 Inhibitor of Reistone Biopharma Having Been Clinically Approved by US FDA and China NMPA
JAK1 Inhibitor of Reistone Biopharma Having Been Clinically Approved by US FDA and China NMPA
Shanghai, December 19, 2018 / PR Newswire / -- Recently, Reistone Biopharma Company Limited (“Reistone”) announced that, FDA approved its application for the Crohn’s disease phase II clinical trial of its SHR0302, a novel and small molecule JAK1 inhibitor. And, NMPA also approved its clinical trial application. The clinical study application in Europe is underway. Dr. Min Irwin, CEO of the company said that, “this is the second clinical trial license obtained in the United States since our establishment. Meanwhile, benefited from great reform of drug administrative approval system by NMPA in recent three years, we can simultaneously obtain NMPA's approval for this clinical trial. These two approvals enable Reistone to take another solid step in the global simultaneous development of innovative drugs.”
Crohn’s disease is an autoimmune inflammatory bowel disease, which can cause chronic gastrointestinal inflammation, with its course of disease manifested by inflammation recurrence and remission. Crohn’s disease may affect the whole digestive tract, and the distal ileum and proximal colon are most frequently affected. Small intestine resection is usually needed for patients with severe obstructive inflammation. However, repeated operations will shorten the intestinal tract, thus affecting nutrient absorption. There are at least 1million patients in the world, with very high unmet clinical needs. In 2016, the global Crohn’s disease therapeutics market size was close to USD 10.0 billion.
Wu Yihan, Chief Medical Officer of the company said that, “as there is no cure for the disease, the therapeutic principle of Crohn’s disease is to block the disease progression, induce and maintain the disease remission, and to avoid surgery and disease complications. The anti-TNFα antibody, a novel immunosuppressant developed ten years ago, has a great influence on the treatment of Crohn's disease. However, it has been found that the long-term use of these biologics in the treatment may cause lack of response caused by immunogenicity in some patients. Therefore, it may be necessary to increase the dosage and / or reduce the dosing interval for the patients. In addition, most patients cannot afford these expensive biologics. The small molecule drug is convenient for administration, suitable for long-term treatment of the patients.” The existing JAK inhibitors of the first generation are “Pan-JAK inhibitors”. Although inhibitors JAK1 and JAK3 are helpful to improve the anti-inflammatory efficacy, inhibitor JAK2 may also interfere with the signal transduction of erythropoietin and colony stimulating factor, thus causing anemia, neutropenia, lymphopenia and other safety problems As a highly selective JAK1 inhibitor, SHR 0302 can effectively inhibit the inflammation, and is relatively safe. Perhaps it will become a benchmark for a new generation of JAK inhibitors.
Multiple autoimmune drugs of Reistone will enter into the clinical trial stage in future. In areas where autoimmune and other clinical needs are not met, Reistone is looking forward to cooperating with the other innovative drug partners in China and other countries.
About Reistone Biopharma
Founded in January 2018 and headquartered in Shanghai, China, with branches in Beijing and Boston of the United States, Reistone Biopharma Company Limited (“Reistone”) is an innovative R & D-driven, global biopharmaceutical company, based on the development of innovative drugs that are urgently needed in clinic, in order to meet the demands of patients. At present, Reistone is committed to the global development of innovative drugs for autoimmune diseases. In this regard, it brings the Chinese innovations to the United States and Europe through cooperation with the company investor and domestically leading pharmaceutical company Hengrui; on the other hand, it also actively introduces the internationally leading innovative drugs by leveraging the rich experience of the company management team in the R & D of innovative drugs in China, to meet the clinical needs of Chinese patients.