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基石藥業-B：自願公告 - 基石藥業宣佈RET抑制劑普吉華（普拉替尼膠囊）由境外轉移至境内生產的藥品上市注冊申請已獲國家藥品監督管理局藥品審評中心受理

CSTONE PHARMA-B: VOLUNTARY ANNOUNCEMENT - CSTONE ANNOUNCES THE ACCEPTANCE OF RET INHIBITOR GAVRETO (PRALSETINIB) MANUFACTURING LOCALIZATION APPLICATION BY CENTER FOR DRUG EVALUATION OF CHINA NMPA

香港交易所 ·  Apr 8 20:00
Summary by Moomoo AI
基石藥業宣佈其RET抑制劑普吉華®（普拉替尼膠囊）的境內生產上市註冊申請已於2024年4月9日獲得國家藥品監督管理局藥品審評中心受理。此舉意味著該公司將有望在短期內實現普吉華®與另一款藥物泰吉華®（阿伐替尼片）的本地化生產，預計將大幅降低生產成本並增加供應靈活性，更好地滿足國內市場需求。楊建新博士，基石藥業首席執行官兼執行董事，表示這將增強公司在中國市場的競爭優勢。普吉華®是中國首款獲批的RET抑制劑，用於治療特定類型的非小細胞肺癌和甲狀腺癌，並已在國際醫學期刊發表研究結果，顯示其在多種RET融合陽性實體腫瘤中具有良好的療效和安全性。基石藥業與Blueprint Medicines公司就普吉華®和泰吉華®在大中華地區的獨家開發和商業化權利達成了合作協議。
基石藥業宣佈其RET抑制劑普吉華®（普拉替尼膠囊）的境內生產上市註冊申請已於2024年4月9日獲得國家藥品監督管理局藥品審評中心受理。此舉意味著該公司將有望在短期內實現普吉華®與另一款藥物泰吉華®（阿伐替尼片）的本地化生產，預計將大幅降低生產成本並增加供應靈活性，更好地滿足國內市場需求。楊建新博士，基石藥業首席執行官兼執行董事，表示這將增強公司在中國市場的競爭優勢。普吉華®是中國首款獲批的RET抑制劑，用於治療特定類型的非小細胞肺癌和甲狀腺癌，並已在國際醫學期刊發表研究結果，顯示其在多種RET融合陽性實體腫瘤中具有良好的療效和安全性。基石藥業與Blueprint Medicines公司就普吉華®和泰吉華®在大中華地區的獨家開發和商業化權利達成了合作協議。
Cornerstone Pharmaceuticals announced that its domestic production registration application for the RET inhibitor Phuket® (Platini Capsules) was accepted by the National Drug Administration's Drug Review Center on April 9, 2024. This means that the company expects to achieve localized production of Phuket® and another drug, Tajiva® (avattinic tablets) in the short term, which is expected to significantly reduce production costs and increase supply flexibility to better meet domestic market demands. Dr. Yang Jianxin, CEO and Executive Director of Keystone Pharmaceuticals, said this will strengthen the company's competitive advantage in the Chinese market. Phuket® is China's first approved RET inhibitor for the treatment of specific types of non-small cell lung and thyroid cancer and has been published in an international medical journal showing good efficacy and safety in multiple RET fusion-positive solid tumors. Keystone Pharmaceuticals has reached a cooperation agreement with Blueprint Medicines for exclusive development and commercialization rights in Phuket® and Taijihua® in Greater China.
Cornerstone Pharmaceuticals announced that its domestic production registration application for the RET inhibitor Phuket® (Platini Capsules) was accepted by the National Drug Administration's Drug Review Center on April 9, 2024. This means that the company expects to achieve localized production of Phuket® and another drug, Tajiva® (avattinic tablets) in the short term, which is expected to significantly reduce production costs and increase supply flexibility to better meet domestic market demands. Dr. Yang Jianxin, CEO and Executive Director of Keystone Pharmaceuticals, said this will strengthen the company's competitive advantage in the Chinese market. Phuket® is China's first approved RET inhibitor for the treatment of specific types of non-small cell lung and thyroid cancer and has been published in an international medical journal showing good efficacy and safety in multiple RET fusion-positive solid tumors. Keystone Pharmaceuticals has reached a cooperation agreement with Blueprint Medicines for exclusive development and commercialization rights in Phuket® and Taijihua® in Greater China.
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