Transcenta Holding Limited 創勝集團醫藥有限公司 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，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 有關就解決截至2024年12月31日止年度的 年度報告內無法表示意見所採取措施及行動的最新進展 創勝集團醫藥有限公司（「本公司」，連同其附屬公司統稱為「本集團」）董事會 （「董事會」）謹此向股東及潛在投資者提供有關就解決其截至2024年12月31日止年 度的年度報告（「年報」）內所載的無法表示意見（「無法表示意見」）所採取措施及 行動的執行進度的最新進展。本公告所用但並無另行界定的詞彙應與年報中所賦 予該等詞彙的涵義相同。 自於2025年4月22日刊發年報、於2025年7月11日刊發最新進展公告、於2025年8 月27日刊發中期業績公告及於2025年10月22日刊發後續更新公告以來，本集團就 最初於年報內所載的九項關鍵措施持續取得切實進展，該等措施旨在增強其財務 狀況、提升流動性並解決無法表示意見。有關執行進度、狀況及預期成果的 ...

Core Insights - The company announced promising clinical results for osemitamab in combination with nivolumab and CAPOX as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma, presented at the ESMO Asia Congress 2025 [1][2] Group 1: Clinical Trial Results - The updated efficacy analysis from the TranStar102 trial showed a median progression-free survival (mPFS) of 16.6 months and an objective response rate (ORR) of 68% among 26 patients with CLDN18.2 expression ≥40% and PD-L1 CPS known [1] - The median duration of response (mDoR) was reported at 18 months, indicating significant clinical benefits from the treatment [1] - Higher CLDN18.2 expression patients demonstrated better PFS regardless of PD-L1 expression levels, suggesting consistent potential therapeutic benefits [1] Group 2: Safety and Clinical Benefit - The safety profile of osemitamab was consistent with previously reported data from the ASCO 2025 conference, indicating good safety and tolerability [2] - The principal investigator highlighted the consistent clinical benefits across different PD-L1 subgroups, suggesting the treatment could provide significant improvements for advanced gastric or gastroesophageal junction adenocarcinoma patients [2] - The global clinical development executive vice president of the company expressed optimism about the strong clinical benefit signals and the potential of osemitamab to offer substantial benefits to patients in need of more effective treatment options [2]

Core Insights - The study results presented at the ESMO Asia Congress 2025 indicate that the combination therapy of osemitamab with nivolumab and CAPOX shows promising clinical benefits for patients with advanced gastric or gastroesophageal junction adenocarcinoma [1][2] Group 1: Clinical Efficacy - The updated efficacy analysis from the TranStar102 trial shows a median progression-free survival (mPFS) of 16.6 months and an objective response rate (ORR) of 68% among 26 patients with CLDN18.2 expression ≥40% and known PD-L1 CPS [1] - The median duration of response (mDoR) is reported to be 18 months, indicating sustained efficacy of the treatment [1] - Higher CLDN18.2 expression correlates with better PFS outcomes regardless of PD-L1 expression levels, suggesting consistent therapeutic benefits across different patient subgroups [1] Group 2: Safety and Tolerability - The safety profile of the combination therapy remains consistent with previously reported data, indicating good tolerability and safety [1][2] - The treatment is expected to provide significant clinical benefits to patients who urgently need more effective treatment options for advanced gastric or gastroesophageal junction adenocarcinoma [2]

新分析结果进一步印证了osemitamab三联疗法所展现的令人鼓舞的临床获益。经过25.8个月的中位随访 观察，在26例CLDN18.2表达≥40%、≥2 + 且PD-L1 CPS 已知的患者中，中位无进展生存期(mPFS)达到 16.6个月，客观缓解率(ORR)为68%，中位缓解持续时间(mDoR)为18个月。值得关注的是，在PD-L1 CPS<1和≥1两个亚组中，CLDN18.2较高表达患者的PFS均优于较低表达患者，这表明 osemitamab的潜 在治疗获益不受PD-L1表达水平影响，具有一致性。 "探索性疗效分析持续表明，osemitamab联合标准治疗方案具有良好的临床获益，" 北京大学肿瘤医院消 化肿瘤内科及I期临床试验病区主任，本次研究的主要研究者沈琳教授表示，"不同PD-L1亚组患者的获 益一致性尤为值得关注，这表明该治疗方案有望为广大晚期胃或胃食管结合部腺癌患者带来具有临床意 义的获益改善。" 智通财经APP讯，创胜集团-B(06628)发布公告，公司董事会欣然宣布，osemitamab联合纳武利尤单抗与 CAPOX作为胃或胃食管结合部腺癌(TranStar102)一线治疗的I/II期临床 ...