Zhitong Finance App learned that Genting Xinyao (01952) is a biopharmaceutical company focusing on R&D, clinical development, manufacturing and commercialization of innovative drugs and vaccines. Today, it was announced that the Macau Special Administrative Region Drug Administration has officially approved the marketing license application for VELSIPITY (VELSIPITY, etrasimod) for the treatment of adult patients with moderate to severe active ulcerative colitis. Macau, China became the first region where Eqamod was approved within the Genting Xinyao Asia Authorized Zone. Itramod is a first-line advanced treatment that is taken orally once a day. It is not only easy to use and has good curative efficacy, but also has good safety characteristics. Itramod was approved for marketing as a new drug in the US and EU in October of last year and February of this year, and became the first and only new-generation oral treatment for ulcerative colitis approved in the EU for patients aged 16 and above.
Luo Yongqing, CEO of Genting Xinyao, said, “We are very happy to see that Itramod's new drug marketing application has been approved in Macau, China. Autoimmune diseases are a potential growth driver for our focus areas and important values. By 2030, the number of patients with ulcerative colitis in China is expected to reach about 1 million, more than double the number of patients in 2019. There is an urgent and huge unmet clinical need. We will rely on favorable policies such as the Guangdong-Hong Kong-Macao Greater Bay Area's “Hong Kong and Macau Drug Connect” to speed up the accessibility of this major autoimmune drug to patients in mainland China. The company plans to submit a new drug marketing application for itramod in mainland China this year, benefiting more Chinese patients.”
Professor Wu Kaichun of the Xijing Hospital Affiliated to the Fourth Military Medical University of the Chinese People's Liberation Army said, leading researcher of the Asia-Pacific Clinical Trial of Itramod, executive director of the World Gastroenterology Society, and Professor Wu Kaichun of the Xijing Hospital affiliated to the Fourth Military Medical University of the Chinese People's Liberation Army, said, “The approval of Iqamod in Macau is a very important milestone, benefiting patients in Asia, especially in Greater China. The drug has good benefit-risk characteristics. This new-generation S1P modulator can be rapidly effective through an oral, once-daily treatment plan, and can achieve hormone-free relief and mucosal healing, and can provide advanced treatment options for adult patients with moderate to severe active ulcerative colitis. Up to now, Asia-Pacific clinical trial data have shown positive top-line results during the 12-week induction period. We look forward to the early approval of itramod in Greater China and other Asian countries, bringing good news to patients.”
Itramod's approval was based on the results of the ELEVATE UC phase III registration study (ELEVATE UC 52 and ELEVATE UC 12) to evaluate the safety and efficacy of taking 2 mg of itramod once daily in patients with moderate to severe active ulcerative colitis who have failed or were intolerant to at least one conventional treatment, biological agent, or Janus kinase (JAK) inhibitor. In ELEVATE UC 52 and ELEVATE UC 12, nearly one-third of patients were treated with biologics or JAK inhibitors, respectively. Itramod's UC study is also the only UC study to date to include patients with isolated proctitis. Both randomized, double-blind, placebo-controlled studies reached all major and critical secondary endpoints, and safety characteristics were consistent with previous studies.
In the ELEVATE UC 52 study, patients treated with itramod had a clinical remission rate of 27.0% at week 12, while the clinical response rate in the placebo control group was 7.0% (difference 20.0%, P<0.001); at week 52, patients treated with itramod had a clinical remission rate of 32.0%, while in the placebo control group, the clinical remission rate was 7.0% (difference of 26.0%, P<0.001). In the ELEVATE UC 12 study, patients treated with itramod had a clinical remission rate of 26.0%, while the placebo control group had a clinical remission rate of 15.0% (difference of 11.0%, P<0.05). In both studies, all key secondary endpoints in the itramod treatment group showed significant clinically and statistically significant improvements, including endoscopic, symptomatic, and histologic endpoints at week 12 and 52 weeks, and hormone-free remission and sustained clinical remission at week 52. Itramod's safety is consistent with previous studies. The most common adverse effects are headache and dizziness (incidence greater than 5%).
Genting Xinyao is conducting a multicenter, randomized, double-blind, placebo-controlled phase III study of itramod in the Asian region (including China and South Korea). The study included patients with moderate to severe active ulcerative colitis who had failed or were intolerant to at least one conventional treatment, biologic agent, or Janus kinase (JAK) inhibitor. After 12 weeks of induction therapy, the itramod group achieved clinically significant and statistically significant improvements at the primary endpoint, all key secondary endpoints, and other secondary endpoints (including mucosal healing, symptom relief, and endoscopic improvement). Overall, itramod 2 mg was well tolerated. The safety characteristics were consistent with previous studies with itramod, and no new safety signals were observed. Patients who responded to itramod treatment during the induction period were once again randomly assigned to take itramod 2 mg or placebo once a day and continued to receive maintenance treatment for 40 weeks. The Asian maintenance period data is expected to be released in the second half of 2024.