“We are pleased to have initiated the submission of an NDA for sovleplenib in China as we look to bring this new remedy to patients with ITP,” said Dr. Weiguo Su, Chief Executive Officer, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. Our presentation includes information from the successful Phase III ESLIM-01 trial in China that demonstrated a durable reaction rate of sovleplenib for patients. There is a significant need for new treatments for ITP number one in adults, which may particularly affect patients’ quality of life. life.
About sovleplenib
Sovleplenib is a new selective Syk inhibitor for once-daily oral administration. Syk is a major component of B-cell receptor and FcR signaling and is an established target for the treatment of several subtypes of B-cell lymphomas and autoimmune diseases.
Results from the Phase I/II study conducted in China and published in The Lancet Hematology showed an immediate and sustained increase in platelet count in patients previously treated for ITP. Among patients who received the recommended Phase II dose of 300 mg once daily (“RP2D”), 40% of patients had a durable response, explained as a platelet count equal to or greater than 50×109/L at 4 out of six visits in weeks 14 to 24 of the study. All patients with RP2D had been previously treated with glucocorticoids and 80% had been previously treated with thrombopoietin or thrombopoietin receptor agonists. Among patients who won treatment at all doses up to week 24 of the study, drug-emergent adverse events (“TEAEs”) resulted in dose relief or discontinuation in 7% of patients, and no treatment discontinuation. No Grade 3 or higher TEAD occurred in more than one patient at week 24 of the study.
HUTCHMED currently holds all rights to sovleplenib worldwide. In addition to ITP, sovleplenib is being studied in autoimmune hemolytic anemia with warm antibodies (NCT05535933) and indolent non-Hodgkin lymphoma (NCT03779113).
About PTI
ITP is an autoimmune disease characterized by immune destruction of platelets and decreased platelet production. Patients with ITP are at increased risk for excessive bleeding and bruising. 1 ITP is also associated with fatigue (reported in up to 39% of adults with ITP). and impaired quality of life. 2,3,4,5,6. The number one ITP in adults is 3. 3/100,000 adults per year with a prevalence of 9. 5 per 100,000 adults. 7 Based on this prevalence rate, it is estimated that approximately 110,000 patients live with the number one ITP in China, in addition to 56,000 patients in the United States. Germany, France, Italy, Spain, the United Kingdom and Japan. It is estimated that up to 145,000 patients are living with chronic diseases. ITP in primary pharmaceutical markets, with the exception of China. 8
ITP in adults is a heterogeneous disease that can persist for years, even with the most productive care available, and remedies are rarely curative. Despite the availability of several remedies with other mechanisms of action, the chronicity of the disease remains a problem. Many patients increase drug resistance and are therefore prone to relapse. 9 Therefore, there remains a significant population of patients who have limited sensitivity to agents that have recently been acquired and who need new remedies.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative commercial-stage biopharmaceutical company. She is committed to the discovery, global progression, and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 employees in all its companies, in the midst of which there is a team of approximately 1,800 people in oncology/immunology. Since its inception, HUTCHMED has focused on bringing cancer drug applicants from in-house discoveries to patients around the world, with its first 3 oncology drugs now approved and advertised in China, the first of which is also advertised in the United States. For more information, please visit: www. hutch-med. com or contact us on LinkedIn.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s existing expectations regarding long-term events, adding its expectations regarding the submission of an NDA for sovleplenib for the treatment of ITP to the NMPA and the timing of this submission, the cure prospects of sovleplenib for the treatment of patients with ITP, and the further progression of sovleplenib in this and others indications. others. Forward-looking statements involve dangers and uncertainties. These dangers and uncertainties include, among other things, assumptions related to the timing and effects of clinical studies and the sufficiency of clinical knowledge to assist NDA approval of sovleplenib for the treatment of patients with ITP or other indications. . in China or other jurisdictions, its ability to obtain accelerated regulatory government approvals or not at all, the protection profile of sovleplenib, HUTCHMED’s ability to finance, implement and complete its clinical progression plans and commercialization opportunities for sovleplenib, the timing of those events and the effect of COVID-19 on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. For more information on those and other dangers, see HUTCHMED’s filings with the U. S. Securities and Exchange Commission, the Hong Kong Stock Exchange Limited and on AIM. HUTCHMED assumes no legal responsibility to update or revise the data contained in this press release, whether as a result of new data, long-term occasions or cases or otherwise.
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