Yilik® (Belumosudil Mesylate Tablets) Receives China Approval for Second-Line Treatment of Chronic Graft-versus-Host Disease

Yilaike^®Fill the Gap in Second-Line Treatment for Chronic Graft-Versus-Host Disease in China, Helping Chinese Patients with Chronic Graft-Versus-Host Disease Benefit Sooner

ShanghaiDecember 15, 2023/PR Newswire/ -- December 15, China -- Sanofi announced the world's first and only targeted drug approved for the treatment of chronic graft-versus-host disease (cGVHD), Belumosudil Mesylate Tablets (REZUROCK).^®) English trade name: Easycare^®Officially approved, this further accelerates Sanofi's promotion of the commercial launch of this innovative drug in China, enhancing patient access to medication and helping patients benefit as soon as possible.

Yilaike^®It is the world's first and only approved targeted ROCK2 inhibitor for the treatment of cGVHD, indicated for patients aged 12 years and older with cGVHD who have had an inadequate response to corticosteroids or other systemic therapies. Clinical trial data show that the overall response rate (ORR) can reach 75%, the 6-month failure-free survival rate (FFS) can reach 75%, and the 2-year overall survival rate can reach 89%. Based on its excellent efficacy and favorable safety profile, it has been recommended by the 2023 Chinese Society of Clinical Oncology (CSCO) guidelines.

Glucocorticoids, with or without calcineurin inhibitors (CNI), are the standard first-line treatment for cGVHD. Previously, there were no approved second-line treatment options in China. Elok^®After being approved for the second-line treatment of cGVHD, it has become the only approved drug for second-line treatment of cGVHD, filling the gap in this treatment area and providing Chinese cGVHD patients with a new treatment opportunity. As an innovative targeted drug, Ilyack...^®Can significantly reduce the dosage of hormones, or even discontinue their use.

Yi Lai Ke^®HasAnti-inflammatoryAndAnti-fibrosisThe dual mechanism of action, inHelp patients restore immune balanceAt the same time, it can inhibit ROCK2 in fibroblasts, effectively preventing G-actin from polymerizing into F-actin and blocking myocardin-related transcription factor (MRTF) from altering the expression of pro-fibrotic genes, thereby suppressing myofibroblast differentiation.Prevent the progression of fibrosis。

As we all know, fibrosis has a significant impact on organ function and the entire body, especially pulmonary fibrosis, which is considered a "stubborn" and difficult-to-reverse condition. Yilaik.^®The mechanism of action has been confirmed toReversalFibrosis Caused by cGVHD, greatly changing the treatment effect of fibrosis and improving the quality of life of patients. Not only that, Yilaik^®The "selective" targeting feature can also minimize the impact on other immune checkpoints, reducing adverse reactions.

Sanofi Greater China President Eric Shi said: "Transplant rejection or chronic graft-versus-host disease has a significant impact on patients' quality of life. We are pleased that the Chinese brand name of Berubicin Mesylate Tablets is Yilaik.^®Officially approved, this means that we can further accelerate the accessibility of this world's first drug in China, helping Chinese patients gain access to high-quality drug treatments as soon as possible and improving their quality of life. Sanofi always puts patients at the center, focusing on "first-in-class" and "best-in-class" innovative treatment solutions, accelerating the introduction, launch, and accessibility of innovative products, and continuously meeting the health needs of the Chinese people.