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康希諾生物:自願公告 - 嬰幼兒用DTcP的新藥上市申請獲得受理

CANSINOBIO: VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF NEW DRUG APPLICATION FOR DTCP INFANT

HKEX ·  Dec 16 17:57

Summary by Futu AI

康希諾生物股份公司(康希諾生物)宣布其百白破疫苗(DTcP)已進入III期臨床試驗階段,標誌著該疫苗研發取得重大進展。DTcP疫苗是一種用於預防白喉、破傷風和百日咳的三合一疫苗,對兒童健康至關重要。此次進入III期臨床試驗,表明該疫苗已完成前期安全性和有效性評估,即將進入大規模人體試驗階段。根據公告,DTcP疫苗的III期臨床試驗計劃於2024年12月16日開始。試驗將涉及1至24個月大的嬰幼兒,共分為3個劑次,每次間隔6個月。這一試驗設計旨在全面評估疫苗在目標人群中的安全性、有效性和免疫原性。康希諾生物的首席執行官Xuefeng YU和首席財務官Shou Bai CHAO均對此項目表示高度重視,期待通過此次臨床試驗為公司的疫苗產品線增添新的重要成員。
康希諾生物股份公司(康希諾生物)宣布其百白破疫苗(DTcP)已進入III期臨床試驗階段,標誌著該疫苗研發取得重大進展。DTcP疫苗是一種用於預防白喉、破傷風和百日咳的三合一疫苗,對兒童健康至關重要。此次進入III期臨床試驗,表明該疫苗已完成前期安全性和有效性評估,即將進入大規模人體試驗階段。根據公告,DTcP疫苗的III期臨床試驗計劃於2024年12月16日開始。試驗將涉及1至24個月大的嬰幼兒,共分為3個劑次,每次間隔6個月。這一試驗設計旨在全面評估疫苗在目標人群中的安全性、有效性和免疫原性。康希諾生物的首席執行官Xuefeng YU和首席財務官Shou Bai CHAO均對此項目表示高度重視,期待通過此次臨床試驗為公司的疫苗產品線增添新的重要成員。
CANSINOBIO announced that its Diphtheria-Tetanus-Pertussis vaccine (DTcP) has entered the phase III clinical trial stage, marking significant progress in the vaccine development. The DTcP vaccine is a combination vaccine used to prevent diphtheria, tetanus, and pertussis, which is crucial for children's health. Entering phase III clinical trials indicates that the vaccine has completed preliminary safety and efficacy assessments and is about to enter large-scale human trials.According to the announcement, the phase III clinical trial for the DTcP vaccine is planned to start on December 16, 2024. The trial will involve infants aged 1 to 24 months and will be divided into 3 doses, with each dose spaced 6 months apart. This trial design aims to comprehensively assess the safety, efficacy, and immunogenicity of the vaccine in the target population. The CEO of CANSINOBIO, Xuefeng YU, and the CFO, Shou Bai CHAO, have both expressed high importance on this project and look forward to adding a new important member to the company’s vaccine product line through this clinical trial.
CANSINOBIO announced that its Diphtheria-Tetanus-Pertussis vaccine (DTcP) has entered the phase III clinical trial stage, marking significant progress in the vaccine development. The DTcP vaccine is a combination vaccine used to prevent diphtheria, tetanus, and pertussis, which is crucial for children's health. Entering phase III clinical trials indicates that the vaccine has completed preliminary safety and efficacy assessments and is about to enter large-scale human trials.According to the announcement, the phase III clinical trial for the DTcP vaccine is planned to start on December 16, 2024. The trial will involve infants aged 1 to 24 months and will be divided into 3 doses, with each dose spaced 6 months apart. This trial design aims to comprehensively assess the safety, efficacy, and immunogenicity of the vaccine in the target population. The CEO of CANSINOBIO, Xuefeng YU, and the CFO, Shou Bai CHAO, have both expressed high importance on this project and look forward to adding a new important member to the company’s vaccine product line through this clinical trial.

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