美通社

2024-12-02 07:40

Everest Medicines Announces Acceptance of VELSIPITY® New Drug Application in Hong Kong

SHANGHAI, Dec. 2, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that Department of Health of the Government of the Hong Kong Special Administrative Region, China, has accepted Everest's New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis.  VELSIPITY® is an effective and convenient, once-daily, oral treatment for patients with moderately-to-severely active UC that has already been approved in the U.S. and E.U., and other countries, by Everest's licensing partner, Pfizer. In Everest territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the NDA for VELSIPITY® in April of this year and was implemented in the Guangdong-Hong Kong-Macau Greater Bay Area this October through the "Hong Kong and Macau Medicine and Equipment Connect" policy.

"Autoimmune disease is a core focus and a significant growth driver for our company. The number of UC patients in China is projected to double from 2019 to 2030 to approximately one million, highlighting the urgent need for novel treatments." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Previously, VELSIPITY® has already been approved in Macau, China, and was implemented in the Greater Bay Area through the connect policy. The company also plans to submit the NDA for approval by China's National Medical Products Administration (NMPA) this year, with the aim of benefiting more Chinese patients as soon as possible."

"This is an important advancement for etrasimod, bringing hope to patients in Hong Kong, China. This new-generation S1P receptor modulator is an oral, once-daily treatment that can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief, " said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's Asia clinical trial. "We hope China and other Asian countries can obtain approvals as soon as possible to benefit more patients."

The acceptance of the NDA was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients with moderately to severely active UC who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.

Everest conducted a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainland China, China Taiwan and South Korea. This is the largest Phase 3 trial of moderately-to-severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The previously announced results of the induction period indicate that the clinical remission rate for patients treated with etrasimod 2mg was 25.0%, compared to 5.4% for those treated with placebo (difference 20.4%, p<0.0001). Compared to the placebo group, patients treated with etrasimod demonstrated significant clinical and statistically significant improvements in all key secondary endpoints. Subsequently, the topline results from maintenance period released in July of this year confirmed that after 40 weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed. The results of the maintenance period will be released at an international academic conference.

About VELSIPITY® (etrasimod)

VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau, China for VELSIPITY® in ulcerative colitis.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

source: Everest Medicines

【你點睇?】美國總統特朗普批評烏克蘭總統澤連斯基是「一位未經選舉的獨裁者」,俄烏戰爭早應停止。你是否認同特朗普的說法?► 立即投票

人氣文章
最近7天
1
港股 | 蕭猷華:內地AI發展迅速,阿里巴巴股價看俏
2
高息定存 | 一周高息合集,銀行高息搶存,富邦1個月4.88厘,華僑1年期3.6厘
3
PapaHome淘寶家具實體店22日開幕,選址尖沙咀中港城,料創100個就業機會
4
高息定存 | 華僑銀行推新春港元定存優惠,88天或188天享3.68厘
5
英偉達 | DeepSeek衝擊AI晶片行業結構 英偉達暴跌仍未急抄底
6
高息定存 | 一周高息合集,蛇年定存金蛇起舞,1個月定存高達8厘
7
啟德體育園明天足球賽測試,4.4萬公僕參與涉逾400萬車馬費
8
電騙 | 黃俊碩:多管齊下,防治內地留學生受騙
9
環球央行 | 歐洲央行宣布再次減息0.25厘,符合市場預期
10
一本萬利 | 2025年的五個「勿」(有片)
11
易經看世界 | 乙巳蛇年趨吉五招:言行注意甚麼?應遠離甚麼人?(有片)
12
專訪 | 關稅戰 | 香港物流協會副會長梁庭彰:美物流商停收包裹對跨境電商打擊重大
13
高息定存 | 一周高息合集,減息預期降溫,銀行3個月最高5.68厘,6個月3.55厘
14
港股 | 午市前瞻 | iPhone SE難救中國市場 專家提醒比電已超買
15
【FOCUS】螺絲殼裏做道場,DeepSeek致勝啟示
16
大S | 台灣藝人徐熙媛因流感併發肺炎逝世,享年48歲
17
DeepSeek推出即上蘋果中國區榜首,能力直追OpenAI
18
【FOCUS】悟空、哪吒、DeepSeek,如何啟示香港
19
日入而息 | 習近平據報下周見科企領袖,證監會審視8券商孖展風控,大酒店轉蝕9億
20
收市短打 | 楊韻銳:港股升勢有成交配合 惟留意關鍵阻力位!
21
新世界 | 摩通:新世界若債務違約或打開行業「潘朵拉盒子」
22
港股 | 午市前瞻 | AI應用概念炒作有錢途 下階段部署邊隻好?
23
【FOCUS】侵侵呼籲全球「降息」,日銀祭18年最激進加息
24
彭博亞洲20大富裕家族,香港5大家族上榜,新地郭氏排名最高,無李嘉誠李兆基?
25
港股 | 蕭猷華:春節假後,恒指逐步上望21000點
26
高息定存 | 信銀國際12個月港元定存高達3.5厘
27
神州經脈 | 特朗普或與華討論關稅,人民幣大漲,滬指連升兩周
28
David Webb:因病情惡化,將有序結束個人財經網站
29
民營企業座談會 | 習近平在京出席民營企業座談會
30
AI | 蔡崇信確認阿里與蘋果合作,撰文談DeepSeek崛起帶來兩大啟示
專業版
HV2
精裝版
SV2
串流版
IQ 登入
強化版
TQ
強化版
MQ

etnet榮膺「第九屆傳媒轉型大獎」四大獎項

【限時優惠$68/月】申請etnet強化版MQ手機串流報價服務 捕捉板塊輪動,提高獲利勝算

etnet榮獲HKEX Awards 2023 「最佳證券數據供應商」大獎

2025-26年度財政預算案

大國博弈

貨幣攻略

說說心理話

Watch Trends 2024

北上食買玩

Art Month 2024

理財秘笈

流感高峰期

山今養生智慧

輕鬆護老