Highlights (relevant audited data for the year ended 31 August 2024)- Revenue increased by 17% YoY to approximately RMB2,312 million;- Gross profit rose by 10% YoY to approximately RMB1,124 million;- Profit for the period attributable to owners of the Company rose by 16% YoY to      approximately RMB715 million;- Number of student enrolments increased by 11% YoY to approximately 95,600;- Payment of a final dividend of HK10.0 cents per share;- Dividend payout ratio of 30% for the year.HONG KONG, Nov 29, 2024 - (ACN Newswire via SeaPRwire.com) - Edvantage Group Holdings Limited (“Edvantage Group” or the “Group”, stock code: 0382.HK) has announced its audited FY2024 Annual Results for the year ended 31 August 2024 (the “Reporting Period”). During the Reporting Period, the Group actively responded to national policies, vigorously promoted industry-education integration, deepened the connotations of international education, continued to introduce unique new featured majors that match market and industry demands and fully embraced artificial intelligence (“AI”), succeeding in raising education quality and brand presence, thereby achieving steady growth in performance year after year.During the Reporting Period, the Group’s revenue totaled approximately RMB2,312 million, representing an increase of 17% as compared to the corresponding period of the preceding year. The increase was mainly attributable to the continuous enhancement of the Group’s education brand effectiveness, which drove a rise in the number of student enrolments and higher average tuition fees recorded by the Group’s domestic schools. Profit for the period attributable to owners of the Company rose by 16% YoY to approximately RMB715 million. The number of students enrolled in the Group’s schools continued to expand yearly, reaching approximately 95,600, with a year-on-year growth of approximately 11%. The Board of Directors of the Group has recommended the payment of a final dividend of HK10.0 cents per share for the year ended 31 August 2024, which, along with an interim dividend of HK9.6 cents per share, equates to a total annual dividend of HK19.6 cents per share and a dividend payout ratio of 30% for the year.From left to right: Mr. Yan Kwok Ting Sunny, Director of Investment, Corporate Finance & Investor Relations Department;Mr. Liu Yuk Tung, ChiefFinancial Officer; Ms. Liu Yi Man, Executive Director and Chief Executive Officer;Ms. Liu Wenqi, Chief Operating Officer;Fully embracing AI and continuously promoting the industry-education integrationOver the past year, the Group witnessed the groundbreaking development of the new generation of artificial intelligence technology. As a vocational education provider, the Group has developed in step with times, fully embracing AI in teaching, management and application. At present, all of its schools are actively promoting AI, fostering its popularity, with AI-embedded courses launched in seven colleges. Subsequent efforts will be made to promote those programmes to cover all faculties and students of all schools under the Group. Meanwhile, the Group actively responded to national policies, continuously deepened industry-education integration, and fully promoted the construction of industrial colleges, cooperating with multiple enterprises renowned in their respective industries to establish artificial intelligence and big data, digital trade, digitalised accounting and business services, research and tourism, jewelry, human resources and other industrial colleges. Those industrial colleges are all set up according to the Ministry of Education requirements for building modern industrial colleges that align with the country’s key industry development strategies, in order to nurture high-quality application-minded talent that emerging industries urgently need. In addition, the Group also entered into school-enterprise cooperation with numerous enterprises to build off-campus practice bases, further promoting the in-depth integration of education chains and industrial chains.Expanding exchange and cooperation of international education and deepening the connotations of international educationThe Group responded to the national advocacy for the opening up of education, “introduction of foreign schools”, and “international expansion of domestic schools”, continuously promoted the internationalisation of vocational education and expanded the partnership network with global renowned universities. By providing high-quality international programs and practice opportunities to students, the Group aims to cultivate innovative talents with global vision, to further raise the international influence of China’s vocational education. During the Reporting Period, the schools under the Group established in-depth cooperation with 51 foreign high schools in the United States of America, the United Kingdom, Canada, Japan and Australia, joining hands to create diverse high-quality international programmes. Furthermore, the Group comprehensively launched international study tours, organising 65 student and teacher study tours to France, Singapore, Hong Kong, China, Macau, China and other regions for short-term studies, with over 4,000 teachers and students participating during the Reporting Period. Looking forward, the Group will press on with deepening integration of its schools - domestic and international, strive to build a diversified international education cooperation network, actively promote Chinese vocational education to go global and build an internationally renowned Chinese vocational education brand.Consistently increasing investment in education to build a high-quality education brandThe Group has always adhered to the motto of "Establishing school of the century, Nurturing talents of the nation". Firmly believing that increasing investment in education is an important path towards high-quality education, the Group further expanded the new campus of Guangzhou Huashang College and Guangzhou Huashang Vocational College during the Reporting Period, which includes student dormitories, library, sports centre, teaching buildings and laboratories, providing solid support for future student enrollment and sustainable development of the Group. At the same time, it has kept increasing investment in building a high-quality teaching staff, which has expanded after the Guangzhou Huashang College and Guangzhou Huashang Vocational College established their Guangdong Province Doctoral Workstation respectively. The Group has launched a series of training workshops for teachers to continuously enhance their professionalism and practical teaching abilities, encouraging them to practice what they have learned and help improve school education and teaching quality. By introducing mentors from industries, it works together with enterprises in nurturing professional “dual-qualified” teachers and “dual-skilled” industry mentors, continuing to optimize the combined structure of full-time and part-time faculty teams. The in-depth and precise investment made by the Group in various areas crucial to strengthening school management has brought bountiful results. Guangzhou Huashang College placed third in scientific research competitiveness among private undergraduate colleges in China and has been designated as a key research base for humanities and social sciences among regular higher education institutions in Guangdong Province. Guangzhou Huashang Vocational College has been named a national exemplary vocational college, while the Urban Vocational College of Sichuan ranked second in China and first in Sichuan among Shanghai Ranking's 2024 Best Chinese Private Higher Vocational Colleges. These honors are a strong testament to the Group’s high-quality educational achievements.Looking ahead, the Group will continue to nurture innovative talent, focusing on such areas as industry and education integration, internationalization, and AI to keep up with industry and social development needs, increase investment in education, and keep building a high-quality education brand. It is committed to nurturing highly-skilled interdisciplinary corporate leaders for the country and industries around the world, while continuously making positive contributions to the sustainable development of vocational education.About Edvantage Group Holdings LimitedEdvantage Group Holdings Limited (“Edvantage Group” or the “Group”, stock code: 0382.HK) is the largest private business higher education and vocational education group in the Greater Bay Area, and an early mover in education sector in pursuing international expansion, listed in Hong Kong Main Board on 16 July 2019. The total number of full-time student enrolments of the Group was approximately 96,000 as of 31 August 2024. Operated 9 private education institutions, namely, Guangzhou Huashang College (Applied Undergraduate), Guangzhou Huashang Vocational College (Higher Vocational Education) and Guangdong Huashang Technical School (Secondary Vocational Education) located in Guangdong Province, the PRC; Urban Vocational College of Sichuan (Higher Vocational Education) and Urban Technician College of Sichuan (Secondary Vocational Education) in Sichuan Province, the PRC; GBA Business School (GBABS) in Hong Kong, the PRC; Global Business College of Australia (GBCA) and Edvantage Institute Australia (EIA) in Australia; as well as Edvantage Institute (Singapore) (EIS) in the downtown of Singapore.While focusing on school operations, the Group also actively fulfil corporate social responsibility, extensively contributing to social welfare programmes including charity, poverty alleviation, education and revitalisation, in order to take the initiative in repaying society through action. Since its listing, the Group has made outstanding contributions in the field of ESG and has won the “Best ESG Innovation Award” from Zhitong Finance and the “Outstanding Enterprise for ESG Innovative Practice” from Gelonghui in 2024. Copyright 2024 ACN Newswire via SeaPRwire.com.

HONG KONG, Nov 29, 2024 - (ACN Newswire via SeaPRwire.com) - The Hong Kong Institute of Directors ("HKIoD") announced the winners of its Award Series for Director Excellence (the "Awards") – comprising the long-established Directors of the Year Awards ("DYA") and the inaugural Climate Governance Awards ("CGA"), at its Annual Dinner yesterday at the Hong Kong Convention and Exhibition Centre.  The event began with an opening speech by Dr Christopher To, Chairman of the HKIoD. Dr The Hon Moses Cheng Mo Chi, Non-official Member of the Executive Council of HKSARG, Mr Xu Wei Gang, Director General, Department of Economic Affairs, Liaison Office of the Central People's Government in HKSAR, Ms Salina Yan, JP, Permanent Secretary for Financial Services and the Treasury (Financial Services), and Dr Kelvin Wong, Chairman, Securities and Futures Commission ("SFC") and Chairman, Accounting and Financial Reporting Council ("AFRC") were invited as guests of honour. The response to the Awards submissions was overwhelmingly positive. After a lively discussion among the judges, this year's 19 winners, including directors and boards, were selected - all embodying the theme "Leading with Agility in an Era of Innovation". The awardees have demonstrated not only agility, but also the vision, courage and wisdom to lead against the backdrop of a demanding economic environment and prevailing geopolitical tensions. Moreover, they highlight the importance of having directors who can guide their companies in identifying the risks and opportunities associated with climate change, which are vital for ensuring the sustainability of the world and humanity.The Awardees of HKIoD Award Series* for Director Excellence 2024 are listed below:*Two series of Awards:- "DYA", acronym for "Directors Of The Year Awards"- "CGA", acronym for "Climate Governance Awards"In alphabetical order of names within categoryListed Companies CategoriesExecutive DirectorsDYAMr Chan Wai MingTown Ray Holdings LimitedCGAMs Clara Chan Yuen-shanLee Kee Holdings LimitedDYAMr Fu FanChina Pacific Insurance (Group) Co., LtdCGA Mr Li Wai LeungHengan Internationals Group Company LimitedMr Peter Wong Wai-YeeThe Hong Kong and China Gas Company LimitedDYA & CGAMr Yan Jianguo JPChina Overseas Land & Investment LimitedNon-Executive DirectorsDYA Dr Chung Shui Ming TimpsonChina Railway Group LimitedDr Tseng Shieng-chang CarterTCL Electronics Holdings LimitedProf Wang YijiangTCL Electronics Holdings LimitedBoardsDYA & CGAChina Resources Beer (Holdings) Company LimitedCGAHong Kong and China Gas Company LimitedDYA & CGAPing An Insurance (Group)Company of China, LtdCGAUnited Company RUSAL, international public joint-stock companyNon-listed Companies CategoriesExecutive DirectorsDYAMs Michelle ChanAS Watson IndustriesCGA Ir Prof Daniel M.ChengDunwell Technology (Holdings) Limited) (Dunwell Group)Ir Dr Cheng Sai Yau, VincentArup Fellow and Director of Climate and Sustainability in East AsiaDYAMr Orr Ka-yeung KevinWinner Medical (Hong Kong) LtdStatutory/ Non-profit-distributing Organisations CategoriesBoardsDYAHong Kong Tourism Board*In addition: recognition of Excellence in Board DiversityThe Institute of Internal Auditors Hong Kong*In addition: recognition of Excellence in Board DiversityThe guests of honour, special guests and officials to join the group photos together with the awardees (2nd row).About "HKIoD Award Series for Director Excellence"The HKIoD Award Series for Director Excellence is a project organised by The Hong Kong Institute of Directors ("HKIoD") and consists of two series of Awards.The first series, Directors Of The Year Awards, was inaugurated in 2001 as the first ever such Awards organised in Asia. As directors are ultimately responsible for corporate governance and leading the company in prosperity and integrity, the objectives of the Awards are to recognise outstanding boards and directors and to promote good practices in corporate governance and director professionalism. The Awards have become an annual project of impact in the community organised by HKIoD together with over 100 Project Partners. To date, 255 Awardees have been recognised for their achievements in demonstrating exemplary high standards in corporate governance and director practice.Inaugurated in 2024, Climate Governance Awards constitute the second series of HKIoD Awards with the objectives to recognise and inspire exemplary achievements in climate governance and to advocate climate action by directors. There are 10 awardees who have been acknowledged in the inaugural edition of the awards. It is critical time now for directors to address the risks and opportunities of climate change in board agendas and their governance role.Candidates are open to public nomination, with data processed in well-defined and stringent procedures, followed by interviews with independent consultants in utmost due diligence and finally selected by independent judges with high standards and fair judgment.  Awards are presented by company categories, viz Listed Companies, Non-listed Companies and Statutory/Non-profit-distributing Organisations, and by capacities, viz Executive Directors, Non-Executive Directors and Boards.About The Hong Kong Institute of Directors ("HKIoD")The Hong Kong Institute of Directors ("HKIoD") is Hong Kong's premier body representing directors working together to advance corporate sustainability in creating long-term value for companies, their owners, stakeholders, humankind and Planet Earth through advocacy and standards-setting in corporate governance and director professionalism. Led by Founder Chairman Dr The Hon Moses Cheng, HKIoD was founded in 1997. Throughout the years, HKIoD is honoured to have the Chief Executive of HKSAR as the Institute's Patron. Membership of HKIoD comprises of directors from diverse industries and corporate types and includes Executive Directors, Non-Executive Directors and Independent Non-Executive Directors.  With multi-culturalism and international perspectives, HKIoD organises activities that cover director training, seminars and forums, collective director voice, guideline establishment, public education, Award Series for Director Excellence, assessment of Corporate Governance Scorecard for listed companies etc.As a member body of the Global Network of Director Institutes ("GNDI"), HKIoD is committed to global collaboration in promoting good corporate governance and director professionalism. HKIoD is the appointed Host of the Hong Kong Chapter of Climate Governance Initiative, a global network that collaborates with the World Economic Forum in actively promoting directors' address of the risks and opportunities of climate change.For details please visit:http://www.hkiod.com|http://www.gndi.org|https://climate-governance.org/Media Enquiries:Award Series for Director Excellence:Strategic Public Relations Group LimitedThe Hong Kong Institute of DirectorsBrenda Chan+852 2114 4396/ brenda.chan@sprg.com.hkOdessa So +852 2889 4988/ odessa.so@hkiod.com Copyright 2024 ACN Newswire via SeaPRwire.com.

LONDON, Dec 2, 2024 - (ACN Newswire via SeaPRwire.com) - Spritzer has once again demonstrated its dominance in the bottled water industry by being named "Brand of the Year" in the national beverage division’s Water Category at the prestigious 2024–2025 World Branding Awards. The recognition marks Spritzer’s 10th consecutive win at the global awards, a testament to the brand’s enduring excellence in quality, branding, and consumer trust which further solidifies its position as Malaysia’s leading mineral water brand.Spritzer’s Head of Public Relations, Winnie Chin, accepting the Brand of the Year award under the national beverage division’s Water Category during the recent World Branding Awards at the Tower of LondonThe accolade was awarded by the World Branding Forum (WBF), a global non-profit organization devoted to advancing branding standards worldwide, at the annual World Branding Awards event which recognizes exceptional global and national brands across various categories. Winners in each category were evaluated through a rigorous process involving brand valuation, market research, and online public voting, showcasing a holistic assessment of brand strength and consumer trust. Most importantly, as the award evaluation relies heavily on consumer voting (70%), Spritzer’s continued wins over the years demonstrates the brand’s ability to consistently resonate with audiences and exceed customer expectations.Accepting the award on behalf of Spritzer during the awards ceremony held at the iconic Tower of London was Winnie Chin, Spritzer’s Head of Public Relations, who acknowledged the profound significance of this milestone: “We are honoured to receive this award for the 10th year running. Our achievements would not be possible without the unwavering support of our consumers, whose steadfast loyalty has made the Spritzer brand a household name. We also extend our gratitude to our partners for their collaboration and support and especially to our dedicated team for their hard work and creativity that have made this journey possible. We are deeply humbled and motivated to continue elevating our brand to greater heights, to build on Spritzer’s brand strength and commitment to excellence in all aspects of our company.”The award is a milestone that recognises Spritzer as a benchmark for consistency and adaptability to maintain brand trust and address emerging consumer needs in the ever-evolving market landscape. The company’s consistency, adaptability, and innovation have not only propelled it to the forefront of Malaysia’s bottled water industry but have also established it as a benchmark for quality, sustainability and innovation on a global stage. Spritzer’s decade-long winning streak at the awards exemplifies the brand’s commitment to producing high-quality natural bottled water and its reputation as a consumer-preferred brand.Building on this monumental achievement, Spritzer reaffirms its commitment to quality assurance as it continues to deliver bottled water with natural benefits and premium standards. The brand emphasises its dedication to sustainability goals and innovation as it continues to focus on advancing efforts to become a circular brand by 2030, aligned with global environmental initiatives, while leveraging cutting-edge technologies to introduce consumer-focused solutions to meet emerging needs.For more details about Spritzer, please visit our website at https://www.spritzer.com.my/.About Spritzer:Established in 1989, Spritzer Group has been a pioneer in providing Malaysians with natural mineral water sourced from a 440-acre green rainforest. Committed to innovation, Spritzer Group leads the Malaysian bottled water industry through manufacturing, distribution, marketing, and sales of its diverse product line. From renowned natural mineral water to refreshing non-carbonated fruit-flavoured drinks, each product is carefully crafted to meet consumer needs.Comprising eight business subsidiaries, Spritzer Group specializes in the production and distribution of silica-rich natural mineral water, sparkling natural mineral water, distilled drinking water, carbonated fruit-flavoured drinks, and non-carbonated fruit-flavoured drinks.With over 30 years of experience, Spritzer Group is Malaysia's largest and only listed bottled water producer. For more information, please visit www.spritzer.com.my. Copyright 2024 ACN Newswire via SeaPRwire.com.

SHANGHAI, Dec 2, 2024 - (ACN Newswire via SeaPRwire.com) - 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(R) (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis.  VELSIPITY(R) 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(R) 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(R) 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(R) (etrasimod)VELSIPITY(R) 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(R) in ulcerative colitis.About Everest MedicinesEverest 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. Copyright 2024 ACN Newswire via SeaPRwire.com.

上海, 2024年12月2日 - (亚太商讯 via SeaPRwire.com) - 云顶新耀（HKEX 1952.HK）是一家专注于创新药研发、临床开发、制造和商业化的生物制药公司，今日宣布中国香港卫生署已正式受理伊曲莫德（VELSIPITY(R)）用于治疗中重度活动性溃疡性结肠炎成人患者的新药上市许可申请（NDA）。伊曲莫德是一款每日一次口服的一线先进疗法，不仅使用方便、疗效佳，而且具有良好的安全性特征。伊曲莫德已于去年10月和今年2月先后在美国和欧盟获得新药上市批准，同时，伊曲莫德也于今年4月获得中国澳门特别行政区药物监督管理局批准上市，并于今年10月通过"港澳药械通"政策在粤港澳大湾区落地。云顶新耀首席执行官罗永庆表示："我们非常高兴看到伊曲莫德的新药上市许可申请在中国香港获得正式受理。自身免疫性疾病是我们的重点关注领域和重要价值的潜在增长动力。到2030年，中国的溃疡性结肠炎患者人数预计将达到约100万人，超过2019年患者人数的一倍以上，存在迫切且巨大的未被满足的临床需求。伊曲莫德已在中国澳门获批，并通过"港澳药械通"政策率先在粤港澳大湾区落地。今年我们预计也将在中国大陆地区递交伊曲莫德的新药上市许可申请。期待伊曲莫德在更多地区获批，进一步扩大可及性，造福广大患者。"伊曲莫德亚太临床试验牵头研究者、世界胃肠病学会执行理事、亚太消化学会副主席、中国人民解放军空军军医大学附属西京医院吴开春教授表示："祝贺伊曲莫德取得的这一新进展，为中国香港的患者带来了希望。伊曲莫德具有良好的获益-风险特征，这种新一代S1P受体调节剂通过每日一次口服的治疗方案，可快速起效，并达到无激素缓解、黏膜愈合，可为中重度活动性溃疡性结肠炎成人患者提供先进的治疗选择。我们期待伊曲莫德在大中华区及其他亚洲国家早日获批，为患者带来福音。"伊曲莫德的申请是基于ELEVATE UC III期注册研究（ELEVATE UC 52和ELEVATE UC 12）的结果，该研究旨在评价既往对至少一种常规治疗、生物制剂或Janus激酶（JAK）抑制剂治疗失败或不耐受的中重度活动性溃疡性结肠炎患者，每日一次服用2mg 伊曲莫德的安全性和疗效。在ELEVATE UC 52和ELEVATE UC 12中，纳入了一半以上严重活动性溃疡性结肠炎患者（mMS≥7），并有近三分之一患者曾接受过生物制剂或JAK抑制剂治疗。伊曲莫德的UC研究也是迄今唯一纳入了孤立性直肠炎患者的UC研究。这两项随机、双盲、安慰剂对照研究均达到了所有主要和关键次要终点，安全性特征与既往研究一致。在ELEVATE UC 52研究中，第12周时，接受伊曲莫德治疗的患者临床缓解率为27.0%（安慰剂组7.0%, 差异20.0%，P<0.001）；第52周时，接受伊曲莫德治疗的患者临床缓解率为32.0%（安慰剂组7.0%，差异26.0%，P<0.001）。在ELEVATE UC 12研究中，接受伊曲莫德治疗的患者12周临床缓解率为26.0%（安慰剂组15.0%，差异11.0%，P<0.05）。在这两项研究中，伊曲莫德治疗组所有关键性次要终点均达到统计学意义的显著改善，包括第12周和52周的临床应答、内镜改善和组织学内镜下黏膜改善终点以及第52周的无激素缓解和持续临床缓解。伊曲莫德的安全性与之前的研究一致，最常见的不良反应是贫血和头痛。云顶新耀在亚洲地区（包括中国大陆、中国台湾和韩国）开展的伊曲莫德多中心、随机、双盲、安慰剂对照III期研究，是迄今为止完成的最大规模的亚洲中重度溃疡性结肠炎的III期注册临床研究，总计 340名中重度溃疡性结肠炎患者随机接受伊曲莫德或安慰剂治疗。此前公布的诱导期结果显示，伊曲莫德2mg治疗的患者的临床缓解率为25.0%，安慰剂治疗的患者为5.4%（差值20.4%，p<0.0001）。与安慰剂组相比，伊曲莫德治疗的患者所有关键次要终点均有显著的临床意义和统计学意义的改善。随后，今年7月份公布的维持期顶线结果证实，在经过40周的维持期治疗后，伊曲 莫德组与安慰剂组相比，主要终点和所有关键次要终点均具有显著的临床意义和统计学意义（p<0.0001）的改善，其他包括黏膜愈合、内镜恢复正常等的次要终点也均达到具有显著临床意义和统计学意义（p<0.0001）的改善。维持期治疗显示了伊曲莫德良好的安全性，安全性数据与已知特征一致，没有观察到新的安全性信号。维持期的研究结果将在近期的国际学术会议发布。关于伊曲莫德（VELSIPITY(R), etrasimod）伊曲莫德（VELSIPITY(R)，etrasimod）是一种每日一次口服的高选择性鞘氨醇-1-磷酸（S1P）受体调节剂，采用优化的药理学设计，与S1P受体1、4和5结合。伊曲莫德目前已在美国、欧盟、加拿大、澳大利亚、英国、瑞士、以色列以及中国澳门和新加坡获得新药上市批准。关于云顶新耀云顶新耀是一家专注于创新药和疫苗研发、临床开发、制造和商业化的生物制药公司，致力于满足亚洲市场尚未满足的医疗需求。云顶新耀的管理团队在中国及全球领先制药企业从事过高质量研发、临床开发、药政事务、化学制造与控制（CMC）、业务发展和商业化运营，拥有深厚的专长和丰富的经验。云顶新耀已打造多款疾病首创或者同类最佳的药物组合，公司的治疗领域包括肾科疾病、感染性和传染性疾病、自身免疫性疾病。有关更多信息，请访问公司网站：www.everestmedicines.com。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述，乃基于本公司或管理层在做出表述时对公司业务运营情况及财务状况的现有看法、相信、和现有预期，可能会使用"将"、"预期"、"预测"、"期望"、"打算"、"计划"、"相信"、"预估"、"确信"及其他类似词语进行表述。这些前瞻性表述并非对未来业绩的保证，会受到风险、不确定性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展等各种因素及假设的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司及各附属公司、各位董事、管理人员、顾问及代理未曾且概不承担更新该稿件所载前瞻性表述以反映在本新闻稿发布日后最新信息、未来项目或情形的任何义务，除非法律要求。 Copyright 2024 亚太商讯 via SeaPRwire.com.