|
Tuesday, November 26, 2024 |
|
'依拉环素临床应用综合评价项目'终期报告发布 |
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,今日宣布由国家卫生健康委抗菌药物临床应用与耐药评价专家委员会发起并主办的“依拉环素临床应用综合评价项目”总结会在北京举行,并发布了项目终期报告。 more info >> |
|
Tuesday, November 19, 2024 |
|
Everest Medicines Announces NEFECON(R)'s Full Approval in South Korea |
Today, Everest Medicines announced that NEFECON(R) has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea, indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion =1.0 g/day (or urine protein-to-creatinine ratio =0.8 g/g). This approval further expands NEFECON(R)'s footprint in Asia and provides Asian patients with a groundbreaking etiological treatment option for IgAN. more info >> |
|
雲頂新耀宣佈耐賦康(R)在韓國獲批 商業化進程再創里程碑 |
雲頂新耀(HKEX 1952.HK)宣佈,韓國食品藥品安全部(MFDS)已正式完全批准耐耐賦康(R)(布地奈德腸溶膠囊)的新藥上市許可申請,用於治療罹患原發性免疫球蛋白A腎病變(IgAN)的成人患者(尿蛋白≥1.0g/日或尿蛋白與肌酐比 (UPCR) ≥0.8g/g)。這一批准標誌著耐賦康(R)進一步擴大了其在亞洲的市場覆蓋範圍,並為亞洲IgAN患者提供了創新的對因治療方案。 more info >> |
|
云顶新耀宣布耐赋康(R)在韩国获批 商业化进程再创里程碑 |
云顶新耀(HKEX 1952.HK)宣布,韩国食品药品安全部(MFDS)已正式完全批准耐耐赋康(R)(布地奈德肠溶胶囊)的新药上市许可申请,用于治疗罹患原发性免疫球蛋白A肾病变(IgAN)的成人患者(尿蛋白≥1.0g/日或尿蛋白与肌酐比 (UPCR) ≥0.8g/g)。这一批准标志着耐赋康(R)进一步扩大了其在亚洲的市场覆盖范围,并为亚洲IgAN患者提供了创新的对因治疗方案。 more info >> |
|
Monday, November 11, 2024 |
|
雲頂新耀宣佈耐賦康(R)Ⅲ期試驗開放標籤第二療程擴展研究積極結果 |
是一家專注于創新藥研發、臨床開發、製造和商業化的生物製藥公司,今日宣佈耐賦康(R)(布地奈德腸溶膠囊,NEFECON(R))的全球III期臨床試驗NefIgArd研究開放標籤擴展(OLE)研究的結果近日在2024美國腎臟病學會(American Society of Nephrology, ASN)上公佈。 more info >> |
|
云顶新耀宣布耐赋康(R)Ⅲ期试验开放标签第二疗程扩展研究积极结果 |
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,今日宣布耐赋康(R)(布地奈德肠溶胶囊,NEFECON(R))的全球III期临床试验NefIgArd研究开放标签扩展(OLE)研究的结果近日在2024美国肾脏病学会(American Society of Nephrology, ASN)上公布。 more info >> |
|
Friday, October 25, 2024 |
|
Everest Medicines Announces the Launch of VELSIPITY(R) in the Guangdong-Hong Kong-Macau Greater Bay Area |
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, through the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY(R) has officially been approved for patients with moderately to severely active ulcerative colitis (UC) by the Guangdong Provincial Medical Products Administration and can first be used in the Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University, two of the medical institutions designated by the "Hong Kong and Macau Medicine and Equipment Connect" policy in the Greater Bay Area. more info >> |
|
云顶新耀宣布伊曲莫德(VELSIPITY)获批进入粤港澳大湾区 为溃疡性结肠炎患者带来新选择 |
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,得益于“港澳药械通”政策,伊曲莫德(VELSIPITY®)正式获得“粤港澳大湾区内地临床急需进口港澳药品批件”批准,可以在佛山复星禅诚医院、中山大学附属第一医院两家大湾区药械通政策指定的医疗机构先行使用,后续该产品将在其他药械通资质医院陆续引入。 more info >> |
|
雲頂新耀宣佈伊曲莫德(VELSIPITY(R))獲批進入粵港澳大灣區 為潰瘍性結腸炎患者帶來新選擇 |
雲頂新耀(HKEX 1952.HK)是一家專注于創新藥研發、臨床開發、製造和商業化的生物製藥公司,今日宣佈,得益於「港澳藥械通」政策,伊曲莫德(VELSIPITY(R))正式獲得「粵港澳大灣區內地臨床急需進口港澳藥品批件」批准,可以在佛山複星禪誠醫院、中山大學附屬第一醫院兩家大灣區藥械通政策指定的醫療機構先行使用,後續該產品將在其他藥械通資質醫院陸續引入。 more info >> |
|
Tuesday, October 22, 2024 |
|
Everest Medicines Announces Positive Results of Complete Chinese Subpopulation Data from the NEFECON Global Phase 3 NefIgArd Clinical Trial |
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 the "Kidney 360" magazine has published the complete two-year subpopulation data from Chinese patients in the Phase 3 NefIgArd clinical trial of NEFECON under the title "Efficacy and Safety of Nefecon in Patients With Immunoglobulin A Nephropathy From Mainland China: 2-Year NefIgArd Trial Results". more info >> |
|
|
|