Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, citric acid giredestrant, for treating KRAS G12C mutated non-small cell lung cancer (NSCLC) patients [1] Group 1 - The clinical study is an open-label Phase II trial assessing the safety, tolerability, and efficacy of ABSK043 combined with citric acid giredestrant in patients with locally advanced or metastatic NSCLC carrying KRAS G12C mutations [1] - The collaboration agreement between Heyu Biopharmaceutical and Ailis was established in March 2025 for the combined treatment of ABSK043 and citric acid giredestrant [1] - Previous disclosures indicated another collaboration exploring the combination of ABSK043 with Ailis's developed Vemurafenib for treating advanced NSCLC, with the first patient dosing expected to be completed by December 2024 [1] Group 2 - Updated Phase I study results show that ABSK043 as a monotherapy has demonstrated good safety and impressive anti-tumor activity, particularly in patients with high PD-L1 expression and those with EGFR or KRAS mutations [1]

Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, citric acid gorasetinib, for treating KRAS G12C mutated non-small cell lung cancer (NSCLC) patients [1] Group 1 - The IND application was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China [1] - The study is an open-label Phase II clinical trial assessing the safety, tolerability, and efficacy of ABSK043 in combination with citric acid gorasetinib for patients with locally advanced or metastatic NSCLC carrying KRAS G12C mutations [1] - A previous collaboration between Heyu and Elysium was disclosed to explore the combination of ABSK043 with Elysium's developed drug, furmetinib, for treating advanced NSCLC, with the first patient dosing expected to be completed by December 2024 [1] Group 2 - Updated Phase I study results show that ABSK043 as a monotherapy has good safety and impressive anti-tumor activity, with higher response rates observed in patients with high PD-L1 expression and those with EGFR or KRAS mutations [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Abbisko Cayman Limited 和譽開曼有限責任公司 （於開曼群島註冊成立的有限公司） （股份代號：2256） 自願性公告 和譽醫藥的口服PD-L1抑制劑ABSK043與艾力斯的 KRAS G12C抑制劑枸櫞酸戈來雷塞片聯合用藥治療NSCLC的 IND申請獲CDE批准 徐耀昌博士 主席 上海，2025年8月20日 於本公告日期，本公司董事會包括執行董事徐耀昌博士、喻紅平博士及嵇靖博 士；以及獨立非執行董事孫飄揚博士、孫洪斌先生及徐海音女士。 1 和譽醫藥的口服PD-L1抑制劑ABSK043與艾力斯的KRAS G12C抑制劑枸櫞 酸戈來雷塞片聯合用藥治療NSCLC的IND申請獲CDE批准 於2025年8月20日，上海和譽生物醫藥科技有限公司（「和譽醫藥」）宣佈，其在研 的口服PD-L1抑制劑ABSK043與上海艾力斯醫藥科技股份有限公司（「艾力斯」）的 KRAS G12C抑制劑枸櫞酸戈來雷塞 ...