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榮昌生物：自願公告 - 美國食品藥品監督管理局泰它西普用於治療原發性乾燥綜合徵快速通道認定

REMEGEN: VOLUNTARY ANNOUNCEMENT - FDA GRANTS TELITACICEPT FAST TRACK DESIGNATION FOR TREATMENT OF pSS

香港交易所 ·  Apr 2 07:01
Summary by Moomoo AI
榮昌生物製藥（煙台）股份有限公司宣布，其藥物泰它西普（商品名：泰愛®）獲得美國食品藥品監督管理局（FDA）的快速通道資格認定，用於治療原發性乾燥綜合徵（pSS）。此認定有助於加快藥物的開發和審查過程，以滿足嚴重或危及生命疾病的未被滿足的醫療需求。泰它西普於2023年年底獲得FDA批准進行III期新藥臨床研究。此外，泰它西普已於2023年11月在中國獲得完全上市批准，用於治療系統性紅斑狼瘡（SLE），並正在進行多種自身免疫性疾病的II期或III期臨床試驗。公司提醒股東及潛在投資者，在買賣公司股份時需審慎行事，因為無法確保泰它西普最終能成功上市銷售。
榮昌生物製藥（煙台）股份有限公司宣布，其藥物泰它西普（商品名：泰愛®）獲得美國食品藥品監督管理局（FDA）的快速通道資格認定，用於治療原發性乾燥綜合徵（pSS）。此認定有助於加快藥物的開發和審查過程，以滿足嚴重或危及生命疾病的未被滿足的醫療需求。泰它西普於2023年年底獲得FDA批准進行III期新藥臨床研究。此外，泰它西普已於2023年11月在中國獲得完全上市批准，用於治療系統性紅斑狼瘡（SLE），並正在進行多種自身免疫性疾病的II期或III期臨床試驗。公司提醒股東及潛在投資者，在買賣公司股份時需審慎行事，因為無法確保泰它西普最終能成功上市銷售。
Wing Cheong Biopharmaceuticals (Yantai) Co., Ltd. announced that its drug Taixip (trade name: Tai E®) has received rapid channel approval from the U.S. Food and Drug Administration (FDA) for the treatment of primary dry syndrome (PSs). This recognition helps speed up the development and review process of drugs to meet the unmet medical needs of serious or life-threatening diseases. TATSIP RECEIVED FDA APPROVAL FOR A PHASE III CLINICAL TRIAL OF THE NEW DRUG AT THE END OF 2023. In addition, Tetsupip was fully listed in China in November 2023 for the treatment of systemic lupus erythematosus (SLE) and is undergoing Phase II or Phase III clinical trials for several autoimmune diseases. THE COMPANY REMINDS SHAREHOLDERS AND POTENTIAL INVESTORS TO EXERCISE CAUTION WHEN BUYING AND SELLING THE COMPANY'S SHARES, AS IT CANNOT ENSURE THAT IT CAN ULTIMATELY BE SOLD SUCCESSFULLY.
Wing Cheong Biopharmaceuticals (Yantai) Co., Ltd. announced that its drug Taixip (trade name: Tai E®) has received rapid channel approval from the U.S. Food and Drug Administration (FDA) for the treatment of primary dry syndrome (PSs). This recognition helps speed up the development and review process of drugs to meet the unmet medical needs of serious or life-threatening diseases. TATSIP RECEIVED FDA APPROVAL FOR A PHASE III CLINICAL TRIAL OF THE NEW DRUG AT THE END OF 2023. In addition, Tetsupip was fully listed in China in November 2023 for the treatment of systemic lupus erythematosus (SLE) and is undergoing Phase II or Phase III clinical trials for several autoimmune diseases. THE COMPANY REMINDS SHAREHOLDERS AND POTENTIAL INVESTORS TO EXERCISE CAUTION WHEN BUYING AND SELLING THE COMPANY'S SHARES, AS IT CANNOT ENSURE THAT IT CAN ULTIMATELY BE SOLD SUCCESSFULLY.
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