公司名稱: 思路迪医药股份有限公司 呈交日期: 2026年1月6日 I. 法定/註冊股本變動 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 本月底法定/註冊股本總額： HKD 500,000 FF301 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01244 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | HKD | | 0.001 | HKD | | 500,000 | | 增加 / 減少 (-) | | | | | | | HKD | | 0 | | 本月底結存 | | | 500,000,000 | HKD | | 0.001 | ...

（文章来源：每日经济新闻） 每经AI快讯，思路迪医药股份(01244.HK)涨近7%，截至发稿涨6.77%，报4.73港元，成交额91.12万港 元。 ...

Core Viewpoint - Sihuan Pharmaceutical Holdings Group Ltd. (01244) shares rose nearly 7%, reaching HKD 4.73 with a trading volume of HKD 911,200, following the announcement of its product Envidat receiving orphan drug designation for gastric cancer and gastroesophageal junction cancer indications [1] Group 1: Product Development - Envidat (generic name: Envafolimab injection, original research code: KN035) has officially received orphan drug status for its third indication, following approvals for cholangiocarcinoma and soft tissue sarcoma [1] - The approval is based on the results of a Phase II clinical study demonstrating significant antitumor efficacy, with an objective response rate of 60% and a disease control rate of 100% when combined with the FOLFOX regimen [1] Group 2: Safety and Tolerability - The clinical study indicated that Envidat has good safety and tolerability, with no adverse events leading to treatment discontinuation or death reported [1]

Core Viewpoint - Sidley Pharmaceuticals (01244) announced that its commercial product Envita (generic name: Envafolimab injection, original research code: KN035) has officially received orphan drug designation for the indications of gastric cancer and gastroesophageal junction cancer, marking the third orphan drug indication approval following cholangiocarcinoma and soft tissue sarcoma [1] Group 1 - The approval is based on the results of the Phase II clinical study of Envita in patients with advanced gastric/gastroesophageal junction adenocarcinoma, which demonstrated clear antitumor efficacy [1] - The objective response rate of the combination with the FOLFOX regimen reached 60%, and the disease control rate was as high as 100% [1] - The safety and tolerability of the treatment were good, with no adverse events leading to treatment discontinuation or death reported [1]

格隆汇12月22日丨思路迪医药股份(01244.HK)宣布，旗下商业化产品恩维达®(通用名：恩沃利单抗注射 液，原研代号：KN035)针对胃癌和胃食管结合部癌适应症正式获得孤儿药资格认定，这是恩维达®继 胆管癌和软组织肉瘤适应症后成功获批的第三个孤儿药适应症。 此次获批基于公司开展的恩维达®晚期胃╱食管胃结合部腺癌的II期临床研究展现出明确的抗肿瘤疗 效，其联合FOLFOX方案的客观缓解率达60%，疾病控制率高达100%，且安全性与耐受性良好，无导 致治疗终止或死亡的不良事件发生。 ...

此次获批基于本公司开展的恩维达®晚期胃/食管胃结合部腺癌的II期临床研究展现出明确的抗肿瘤疗 效，其联合FOLFOX方案的客观缓解率达60%，疾病控制率高达100%，且安全性与耐受性良好，无导 致治疗终止或死亡的不良事件发生。 智通财经APP讯，思路迪医药股份(01244)发布公告，旗下商业化产品恩维达® (通用名：恩沃利单抗注 射液，原研代号：KN035)针对胃癌和胃食管结合部癌适应症正式获得孤儿药资格认定，这是恩维达® 继胆管癌和软组织肉瘤适应症后成功获批的第叁个孤儿药适应症。 ...

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分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 3D Medicines Inc. 思路迪医药股份有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1244） 關於恩維達® （通用名：恩沃利單抗注射液，原研代號：KN035） 恩維達® （通用名：恩沃利單抗注射液，原研代號：KN035）是重組人源化抗程序 性死亡配體1（「PD-L1」）單域抗體Fc融合蛋白。恩維達®由康寧傑瑞生物製藥（「康 寧傑瑞」，一間於2018年3月28日根據開曼群島法律註冊成立並於香港聯合交易所 有限公司（「聯交所」）上市（股份代號：9966）的獲豁免有限公司及其附屬公司（均 為獨立第三方））自主研發，2016年起與本公司合作開發。於2020年3月30日， 江蘇康寧傑瑞生物製藥有限公司（「江蘇康寧傑瑞」，為康寧傑瑞的全資附屬公 司）、本公司及江蘇先聲藥業有限公司（「江蘇先聲」，為先聲藥業集團有限公司的 附屬公司，其股份於聯交所上市（股份代號：2096））訂立一份合作協議（「 ...

Group 1: Industry Developments - China's medical isotope self-sufficiency has made significant progress, with the establishment of a complete eco-friendly autonomous industrial chain for iodine-131 production, including precursor preparation, reactor irradiation, and nuclear drug development [1] - The global nuclear medicine market is projected to reach nearly $39 billion by 2032, indicating strong growth potential in the sector [1] - The number of approved radiotherapy devices in China has exceeded 90, with over 70% being domestically produced, marking a shift from reliance on imports [2] Group 2: Company Updates - China National Nuclear Corporation's subsidiary, Atomic High-Tech Co., has signed a commercial cooperation agreement with Novartis for the radioligand therapy drug, which is the first approved targeted PSMA therapy for advanced prostate cancer in China [3] - Yuan Da Pharmaceutical has 15 innovative nuclear drugs in the R&D registration phase, with a significant revenue increase in its nuclear medicine segment, achieving approximately HKD 420 million in revenue, a year-on-year growth of nearly 106% [3] - Sillod Medical has completed the first patient dosing in a study for its radiolabeled drug, 177Lu-PSMA-3D1015, aimed at treating metastatic castration-resistant prostate cancer, positioning it as a potential best-in-class product [4]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 思路迪医药股份有限公司 呈交日期: 2025年12月4日 I. 法定/註冊股本變動 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01244 | 說明 | | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 258,177,000 | | 0 | | 258,177,000 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 258,177,000 | | 0 | | 258,177,000 | 第 2 頁 共 10 ...

公司名稱: 思路迪医药股份有限公司 呈交日期: 2025年11月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01244 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | HKD | | 0.001 | HKD | | 500,000 | | 增加 / 減少 (-) | | | | | | | HKD | | 0 | | 本月底結存 | | | 500,000,000 | HKD | | 0.001 | HKD | | 500,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 本月底法定/註冊股本總額： ...