Core Viewpoint - The company, Sihuan Pharmaceutical Holdings Group Ltd. (01244), has announced that the National Medical Products Administration (NMPA) has officially accepted its new drug application (NDA) for Envida (generic name: Envafolimab injection, original research code: KN035) in combination with Gemcitabine and Oxaliplatin (GEMOX) for first-line treatment of unresectable or metastatic biliary tract cancer (BTC) [1] Group 1 - The acceptance of the NDA is based on the results of a Phase III clinical trial (KN035-CN-005) [1] - The clinical trial was designed as a randomized, parallel-controlled, multi-center Phase III study targeting Chinese patients with advanced first-line biliary tract cancer [1] - The trial aims to evaluate the efficacy and safety of Envida (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]

智通财经APP讯，思路迪医药股份(01244)发布公告，国家药品监督管理局(NMPA)已正式受理公司商业 化产品恩维达® (通用名：恩沃利单抗注射液，原研代号：KN035)联合吉西他滨和奥沙利铂(GEMOX)方 案，用于一线治疗不可切除或转移性胆道癌 (BTC)的新药上市申请(NDA)。此次受理基于III期临床试验 (KN035-CN-005)的临床研究结果，这是一项针对中国晚期一线胆道癌患者设计的随机、平行对照、多 中心III期临床试验，旨在评估恩维达®(KN035)联合GEMOX方案对比单纯GEMOX方案的疗效与安全 性。 ...

Core Viewpoint - The company, Sihuan Pharmaceutical Holdings Group Ltd. (01244), has announced that the National Medical Products Administration (NMPA) has officially accepted the new drug application (NDA) for its commercial product Envita® (generic name: Envolimab injection, original research code: KN035) in combination with Gemcitabine and Oxaliplatin (GEMOX) for first-line treatment of unresectable or metastatic biliary tract cancer (BTC) [1] Group 1 - The acceptance of the NDA is based on the results of a Phase III clinical trial (KN035-CN-005) [1] - The clinical trial was designed as a randomized, parallel-controlled, multi-center Phase III study targeting Chinese patients with advanced first-line biliary tract cancer [1] - The trial aims to evaluate the efficacy and safety of Envita® (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has officially accepted the new drug application (NDA) for the commercial product Envita® (generic name: Envolimab injection) from the company, which is intended for first-line treatment of unresectable or metastatic biliary tract cancer (BTC) in combination with the GEMOX regimen [1]. Group 1 - The acceptance of the NDA is based on the results of a Phase III clinical trial (KN035-CN-005) [1]. - The clinical trial is a randomized, parallel-controlled, multi-center study designed for advanced first-line biliary tract cancer patients in China [1]. - The trial aims to evaluate the efficacy and safety of Envita® (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone [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。 本公告乃由思路迪医药股份有限公司（「本公司」，連同其附屬公司統稱為「本集 團」）自願作出。 本公司董事會（「董事會」）欣然宣佈，國家藥品監督管理局(NMPA)已正式受理 本公司商業化產品恩維達® （通用名：恩沃利單抗注射液，原研代號：KN035）聯 合吉西他濱和奧沙利鉑(GEMOX)方案，用於一線治療不可切除或轉移性膽道癌 (BTC)的新藥上市申請(NDA)。 此次受理基於III期臨床試驗(KN035-CN-005)的臨床研究結果，這是一項針對中國 晚期一線膽道癌患者設計的隨機、平行對照、多中心III期臨床試驗，旨在評估恩 維達®(KN035)聯合GEMOX方案對比單純GEMOX方案的療效與安全性。 關於恩維達® （通用名：恩沃利單抗注射液，原研代號：KN035） 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） 自願公告 恩維達®一線 ...

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。 ...