Zhitong Finance App learned that Genting Xinyao (01952) is a biopharmaceutical company focusing on the R&D, clinical development, manufacturing and commercialization of innovative drugs. Today, it was announced that VELSIPITY (etrasimod) issued its first prescription at Jinghu Hospital in Macau, China on December 11. This is also the first prescription issued by Equmod after being approved in Genting Xinyao's authorized area in Genting Xinyao Asia, marking the official beginning of this major product in the field of autoimmune diseases to benefit Asian patients.

Itramod is an innovative advanced treatment. It was officially approved by the Macau Special Administrative Region Drug Administration in April 2024. It is taken orally once a day to treat patients with moderate to severe active ulcerative colitis (UC) aged 16 and above. Ulcerative colitis is a chronic, recurrent, and nonspecific inflammatory disease. As the condition progresses, the disability rate and the incidence of colorectal cancer will continue to rise.

Professor Wu Kaichun of the Xijing Hospital affiliated to the PLA Air Force Military Medical University said, “Itramod has good benefit-risk characteristics,” said Professor Wu Kaichun, executive director of the World Gastroenterology Society, and vice chairman of the Asia Pacific Society of Digestive Medicine. This new-generation S1P modulator works quickly through an oral, once-daily treatment plan, and achieves hormone-free relief and mucosal healing. The results of the induction period and maintenance period of the recently announced Asian multi-center phase III clinical study further confirmed the clinical advantages of this drug. We look forward to the early approval of itramod in other parts of Asia to benefit more patients.”

Luo Yongqing, CEO of Genting Xinyao, said that the launch of the first EqlMod prescription in Macau, China is another milestone in Genting Xinyao's commercialization process. By 2030, the number of patients with ulcerative colitis in China is expected to more than double from 2019 to about 1 million, and there is a huge unmet need for innovative treatments. Following approval in Macau in April of this year, Itramod, as Genting Xinyao's third commercialized new drug, will bring new treatment options to more patients with ulcerative colitis. This year, we will also submit a new drug marketing license application for itramod in mainland China to further promote the accessibility of itramod to benefit more patients.

In the results of the Asian multi-center phase III clinical study on the treatment of moderate to severe active ulcerative colitis with itramod announced in July this year, itramod achieved positive top-line results in induction and maintenance treatment, and was safe and easy to take orally once a day, further providing a solid scientific basis and support for the widespread application of the drug in clinical practice. In October, the study's complete induction period data was published at the 32nd European Digestive Disease Week (UEGW 2024). The study results showed that all major and key secondary efficacy goals of the itramod treatment group achieved statistically significant and clinically significant improvements: treatment differences in clinical remission rate, endoscopic improvement rate, and clinical response rate compared to the placebo group reached 20.4%, 28.6%, and 32.0%, respectively.

Itramod was approved for marketing as a new drug in the US and the European Union in October of last year and February of this year. As Genting Xinyao's major product in the field of autoimmune diseases, Itramod also received approval for new drug marketing in Macau and Singapore in China in the first half of this year. In addition, Genting Xinyao also recently submitted a new drug marketing license application for itramod in Hong Kong, China, which was officially accepted.

In October of this year, thanks to the “Hong Kong and Macau Pharmacopeia” policy, Equlmode was officially approved by the “Guangdong-Hong Kong-Macao Greater Bay Area Clinically Urgent Import of Hong Kong and Macau Drugs”. It can be used first in the four medical institutions designated by the Greater Bay Area Pharmacopeia Policy, the First Affiliated Hospital of Sun Yat-sen University, Shenzhen Hospital of Southern Medical University, and Guangzhou United Family Hospital.