India Pharma Outlook Team | Tuesday, 12 March 2024
Everest Medicines is a biopharmaceutical company specializing in developing, manufacturing, and commercializing new medicines and vaccines. Recently, the Medicines Administration of the Macau Special Administrative Region of China has approved Everest's New Drug Application (NDA) for Velsipity (etrasimod).
This is an effective daily oral treatment for elderly patients with moderate to severe ulcerative colitis. It is worth noting that Velsipity is approved by Everest's licensing partner, Pfizer, in the US.
Rogers Yongqing Luo, the CEO of Everest Medicines, expressed his gratitude for the approval of their NDAs, "We are delighted to announce that our Velsipity NDA submission has been approved in Macau, making us the first licensee to receive approval in Asia. We are pleased to contribute to the successful launch of Nefecon in Macao. Patients have access to new medicines, and we also aim to use Greater Bay Area policies to accelerate access to medicines in mainland China."
The company is awaiting week 52 data from the Asian Phase 3 clinical trial. It plans to submit an NDA for NMPA approval in mainland China this year to provide patients with faster benefits. "Etrasimod has achieved significant milestones in Asia and is expected to benefit patients in Greater China shortly.
This next-generation S1P modulator is a one-day oral treatment that enables patients to achieve corticosteroid-free remission, mucosal healing, and rapid resolution of symptoms," said Professor Wu Kaichun of the First Affiliated Hospital of AFMU. He is the principal investigator of the etrasimod Asian clinical trial. "We hope that China and other Asian countries can get approval as soon as possible so that more patients can be effective."
The number of UC patients in China is projected to increase from 2019 to 2030. The projected number is expected to reach 1,000 million, highlighting the need for new treatments to address this growing health concern.
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