Home > Reistone Biopharma Ready to Initiate the Global Synchronous Clinical Study on Novel JAK1 Inhibitor
Reistone Biopharma Ready to Initiate the Global Synchronous Clinical Study on Novel JAK1 Inhibitor
Shanghai, October 22, 2018 / PR Newswire / -- On October 18, Reistone Biopharma Company Limited (“Reistone”) officially announced that, FDA approved its application for the phase II clinical trial of its SHR0302, a novel and small molecule JAK1 inhibitor. Dr. Min Wang Irwin, CEO of the company said that, “Reistone is committed to bringing the innovative drugs developed in China to the world. Approval of this clinical trial is an important starting point and a milestone for Reistone.”
SHR0302 was licensed by the investor of Reistone, Jiangsu Hengrui Pharmaceutical Co., Ltd. (“Hengrui”), and Reistone owns the global rights and interests except for rheumatoid arthritis and topical dermatology. FDA approved this application to conduct the clinical study of ulcerative colitis. The clinical study application of China has been completed at the end of August, while that in Europe is underway.
Ulcerative colitis is an autoimmune disease, and its inflammatory lesions are confined to large intestine mucosa and submucosa, mainly ulcer erosion. The lesions may affect the whole colon. Ulcerative colitis often reoccurs, and its various initial clinical manifestations include bloody diarrhea as the most common one, and abdominal pain, hematochezia, weight loss and emesis, which seriously affect the quality of life of patients. The causes of ulcerative colitis have not been identified, and are generally considered to be related with environment, heredity, infection and immune factors, etc. There are at least two million patients in the world, and the global sales of ulcerative colitis drugs in 2016 was nearly USD 5.0 billion.
At present, biologics include anti-TNF and IL-12/23 in addition to basic therapeutic drugs such as aminosalicylic acid, glucocorticoid and immunomodulator, but there are still unmet clinical needs, including high recurrence rate. Whereas the small molecule drug is convenient for administration, suitable for long-term treatment of 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. The highly selective JAK1 inhibitor can effectively inhibit the inflammation, and is relatively safe. Perhaps it will become a benchmark for a new generation of JAK inhibitors.
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, focusing on the development of innovative drugs that are urgently needed clinically, 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 a 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.
Dr. Min Irwin, co-founder and CEO of the company has more than 20 years of rich experience in research and management of multinational pharmaceutical companies. She engaged in drug R & D in North America in her early years, and led many global phase 2-3 clinical trials. Then she successively served as the head and vice president of drug R & D of Bayer, GlaxoSmithKline and Takeda in China and Asia Pacific. She established many complete teams for clinical development of drugs, including clinical development, medical affairs and regulatory affairs, drug safety and medical information, project management, etc. Under her leadership, about 20 new drugs and new indications were quickly approved for marketing in China and Canada. She worked as an investment partner in Qiming Venture Capital before starting her business. In addition, the entrepreneurial management team of the company consists of the members from top international companies, with rich experience in global clinical development, and can carry out clinical development and transformation of potential innovative drugs, maximize their clinical value and benefit the patients.
Reistone was invested by Hengrui. Hengrui is a domestically leading medical and health enterprise engaged in the pharmaceutical innovation, and the research, development, manufacturing and promotion of high quality drugs. Sun Piaoyang, chairman of Hengrui said that, “we are very glad to invest in Reistone. We believe that, with the efforts of Dr. Min Irwin and her management team, Chinese innovator drugs of Hengrui will be successfully introduced to European and American countries, and Reistone can exert its outstanding global clinical development capabilities and partner with more companies to successfully bring more innovative therapeutic drugs to global patients including those in China..”
Dr. Min Irwin said that, several autoimmune drugs of Reistone will enter into the clinical trial stage. In areas where autoimmune and other clinical needs are not met, Reistone is also looking forward to cooperating with the other innovative drug partners in China and other countries while maintaining a close cooperation with Hengrui.