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基石藥業-B：自願公告 - 基石藥業宣佈舒格利單抗第五項適應症在中國獲批，用於胃癌一線治療

CSTONE PHARMA-B: VOLUNTARY ANNOUNCEMENT - CSTONE ANNOUNCES THE FIFTH INDICATION APPROVED FOR SUGEMALIMAB IN CHINA AS FIRST-LINE TREATMENT OF GASTRIC CANCER

香港交易所 ·  Mar 15 00:00
Summary by Moomoo AI
基石藥業宣布，其開發的舒格利單抗新適應症在中國獲得國家藥品監督管理局（NMPA）批准，用於治療表達PD-L1（綜合陽性評分≥5）的不可手術切除的局部晚期或轉移性胃及胃食管結合部腺癌的一線治療。這是舒格利單抗在中國獲批的第五項適應症，也是基石藥業獲得的第13項新藥上市申請的批准。GEMSTONE-303研究顯示，舒格利單抗聯合化療能顯著延長患者的無進展生存期（PFS）和總生存期（OS），並且這些差異具有統計學顯著性與臨床意義。基石藥業首席執行官楊建新博士表示，這進一步證實了舒格利單抗的臨床價值和潛力，並期待與美國FDA及歐洲EMA等全球監管機構溝通，推動舒格利單抗在全球的註冊上市進程。此外，基石藥業已與輝瑞達成戰略合作，共同推動舒格利單抗在中國大陸地區的開發和商業化。
基石藥業宣布，其開發的舒格利單抗新適應症在中國獲得國家藥品監督管理局（NMPA）批准，用於治療表達PD-L1（綜合陽性評分≥5）的不可手術切除的局部晚期或轉移性胃及胃食管結合部腺癌的一線治療。這是舒格利單抗在中國獲批的第五項適應症，也是基石藥業獲得的第13項新藥上市申請的批准。GEMSTONE-303研究顯示，舒格利單抗聯合化療能顯著延長患者的無進展生存期（PFS）和總生存期（OS），並且這些差異具有統計學顯著性與臨床意義。基石藥業首席執行官楊建新博士表示，這進一步證實了舒格利單抗的臨床價值和潛力，並期待與美國FDA及歐洲EMA等全球監管機構溝通，推動舒格利單抗在全球的註冊上市進程。此外，基石藥業已與輝瑞達成戰略合作，共同推動舒格利單抗在中國大陸地區的開發和商業化。
KEYSTONE PHARMACEUTICALS ANNOUNCED THAT ITS DEVELOPED SUGARLONE ANTIDOTE HAS BEEN APPROVED IN CHINA BY THE NATIONAL DRUG ADMINISTRATION (NMPA) FOR THE TREATMENT OF LOCAL LATE-STAGE OR TRANSIENT GASTRIC AND GASTROESOPHAGEAL COMBINED CANCERS WITH NON-SURGICAL REMOVAL OF PD-L1 (COMPOSITE POSITIVE SCORE ≥5). This is the fifth prescription for Sugarlicone to be approved in China and the 13th approval of a new drug listing application received by Cornerstone Pharmaceuticals. THE GEMSTONE-303 STUDY SHOWED THAT SUGARINE ANTIMICROBIAL CHEMOTHERAPY SIGNIFICANTLY EXTENDED PATIENT PROGRESSION-FREE SURVIVAL (PFS) AND TOTAL SURVIVAL (OS), AND THESE DIFFERENCES WERE STATISTICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT. Dr. Yang Jianxin, CEO of Keystone Pharmaceuticals, said that this further demonstrates the clinical value and potential of Sugaricenanti, and looks forward to communicating with global regulatory bodies such as the US FDA and EMA in Europe to advance the registration process for Sugaricene worldwide. In addition, Keystone Pharmaceuticals has reached a strategic partnership with Pfizer to jointly promote the development and commercialization of Sugarlicone in mainland China.
KEYSTONE PHARMACEUTICALS ANNOUNCED THAT ITS DEVELOPED SUGARLONE ANTIDOTE HAS BEEN APPROVED IN CHINA BY THE NATIONAL DRUG ADMINISTRATION (NMPA) FOR THE TREATMENT OF LOCAL LATE-STAGE OR TRANSIENT GASTRIC AND GASTROESOPHAGEAL COMBINED CANCERS WITH NON-SURGICAL REMOVAL OF PD-L1 (COMPOSITE POSITIVE SCORE ≥5). This is the fifth prescription for Sugarlicone to be approved in China and the 13th approval of a new drug listing application received by Cornerstone Pharmaceuticals. THE GEMSTONE-303 STUDY SHOWED THAT SUGARINE ANTIMICROBIAL CHEMOTHERAPY SIGNIFICANTLY EXTENDED PATIENT PROGRESSION-FREE SURVIVAL (PFS) AND TOTAL SURVIVAL (OS), AND THESE DIFFERENCES WERE STATISTICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT. Dr. Yang Jianxin, CEO of Keystone Pharmaceuticals, said that this further demonstrates the clinical value and potential of Sugaricenanti, and looks forward to communicating with global regulatory bodies such as the US FDA and EMA in Europe to advance the registration process for Sugaricene worldwide. In addition, Keystone Pharmaceuticals has reached a strategic partnership with Pfizer to jointly promote the development and commercialization of Sugarlicone in mainland China.
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