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。 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。 ...

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（「 ...

中信证券发布研究报告称，靶向放射性核素疗法(Targeted Radionuclide Therapy，TRT)是目前靶向治疗 最具潜力的发展方向之一，掀起创新核药研发新浪潮。核药赛道投融资交易火热，海外大药企争先入 局。国内多重利好共振，本土企业TRT研发优势显著。 智通财经APP获悉，据中核集团官微消息，在中核集团同位素生产协同平台的高效统筹下，我国医用同 位素自主化攻关再传捷报。平台充分发挥集团内部协同创新优势，整合中国原子能所属核理化院、核动 力院、中核高通、中核二七二铀业，攻克富集¹³ºTeO₂靶材辐照制备碘-131全产业链技术，形成了从 碘-131前置核素制备、反应堆辐照到核药研发的完整环境友好型自主产业链。 在高丰度、高纯度碲-130同位素制备方面，核理化院攻克了同位素分离与氧化物合成、提纯等多项关键 技术难题，成功制备出丰度超99%、核级纯度标准的¹³ºTeO₂靶材。 核理化院联合中核二七二铀业批量制备碲同位素分离介质，稳定保障碲同位素分离原料供给。 此项成果填补了国内高纯富集碲同位素规模化制备的空白，为我国高端核医学材料自主可控提供了核心 支撑。 根据MEDraysintell的数据，全球核 ...

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： ...

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9月30日 狀態: 新提交 | 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 | 本月底法定/註冊股本總額： HKD 500,000 FF301 第 1 頁 共 10 頁 v 1.1.1 致：香港交易及結算所有限公司 公司名稱: 思路迪 ...

Financial Performance - The company reported a significant increase in revenue, achieving a total of HK$500 million for the interim period, representing a 25% year-over-year growth[1]. - For the six months ended June 30, 2025, the company's revenue increased by 1.3% to RMB 209.2 million from RMB 206.4 million for the same period in 2024[35]. - The total comprehensive loss for the period was RMB 92.6 million, a decrease from RMB 114.1 million in the same period of 2024[136]. - Adjusted total comprehensive loss for the period was RMB 72.151 million for the six months ended June 30, 2025, compared to RMB 97.659 million for the same period in 2024[51]. - The gross margin improved to 60%, up from 55% in the previous year, due to cost optimization strategies[1]. - Gross profit increased by 2.1% to RMB 192.9 million from RMB 188.9 million for the same period in 2024, with a gross profit margin of 92.2% compared to 91.5% in 2024[37]. User Growth and Market Expansion - User data showed a 30% increase in active users, reaching 1.2 million by the end of the reporting period[1]. - The company plans to expand its market presence in Southeast Asia, targeting a 15% market share within the next two years[1]. - The company is focusing on accelerating product development and commercialization processes to enhance operational efficiency and bring forward novel medicines[198]. - The company aims to strategically collaborate with partners to expand into emerging markets for the development and commercialization of 恩維達®[200]. Research and Development - Research and development efforts focused on the new PD-L1 inhibitor, ENWEIDA, which is expected to enter clinical trials in Q3 2025[1]. - The company is involved in the research and development of PD-1 and PD-L1 related therapies, targeting non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC)[9]. - The company has advanced a proprietary 177Lu-labeled PSMA-targeted RDC, which is now in the investigator-initiated trial (IIT) stage[29]. - The ongoing development of Envafolimab includes multiple clinical trials demonstrating its efficacy and safety across various cancer types[26][27]. - The company has established a comprehensive nucleic acid drug development system, including drug design, preparation, and preclinical research, with a focus on tumor neoantigen vaccines and the development of the 3D-PreciseAg antigen prediction system[115]. Product Development and Commercialization - The company has commercialized Envafolimab, which is now sold in over 3,000 hospitals and 760+ pharmacies across 30 provinces in China[133]. - Envafolimab achieved sales revenue of RMB 209.2 million in China for the first half of 2025, contributing to a total sales of approximately RMB 1.9 billion[58]. - The company is developing a new mRNA therapeutic cancer vaccine, 3D124, which targets multiple tumor-specific antigens and has shown strong anti-tumor effects in pre-clinical studies[95]. - The production capacity expansion for Envafolimab Injection received official approval from the National Medical Products Administration (NMPA) in the first half of 2025, enhancing manufacturing capabilities to meet growing market demand[125]. Strategic Partnerships and Acquisitions - A strategic acquisition of a local biotech firm was announced, which is expected to enhance the company's product pipeline and capabilities[1]. - The company has initiated a partnership with a leading pharmaceutical company to co-develop new therapies, aiming for a launch by 2026[1]. - The company has established a licensing agreement with Glenmark and is actively pursuing overseas licensing opportunities for Envafolimab in additional countries and regions[62]. Financial Position and Cash Flow - Cash and bank balances as of June 30, 2025, were RMB 660.5 million, down from RMB 864.3 million as of December 31, 2024[34]. - The net cash used in operating activities for the six months ended June 30, 2025, was RMB 205.8 million, compared to RMB 179.7 million for the same period in 2024[170]. - The Group's total revenue increased by approximately 1.3% compared to the corresponding period in 2024, driven by improved market conditions and strong sales execution[58]. - Total current assets decreased by RMB 185.2 million to RMB 802.6 million as of June 30, 2025, from RMB 987.8 million as of December 31, 2024[165][167]. Corporate Governance and Structure - The company has undergone changes in its board of directors, with new appointments and resignations effective June 30, 2025[12]. - The principal bank for the company is Bank of Communications, indicating a stable banking relationship for financial operations[15]. - The company is registered in the Cayman Islands, with its corporate headquarters located in Qingdao, Shandong, PRC[15]. Employee and Operational Insights - The Group had 183 full-time employees as of June 30, 2025, with total employee benefits expenses of approximately RMB 63.4 million for the six months ended June 30, 2025[192]. - Employee recruitment is based on various factors, including work experience and educational background, with ongoing training programs provided to enhance skills and knowledge[197]. - The company is building differentiated commercial capabilities in mainland China and plans to expand these capabilities in the global market[199].

Core Viewpoint - Sillodic Pharmaceuticals (01244) shares rose over 10%, currently up 13.96% at HKD 9.06, with a trading volume of HKD 17.58 million [1] Company Summary - Sillodic Pharmaceuticals recently announced that its self-developed nuclear medicine platform's first radiolabeled drug, 177Lu-PSMA-3D1015 injection, has completed the first patient dosing in the IIT study [1] - The study aims to evaluate the safety and preliminary efficacy of 3D1015 in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) [1] - The company believes that 177Lu-PSMA-3D1015 injection has the potential to become a "best-in-class" nuclear medicine product, providing a safer and more effective treatment option for prostate cancer patients globally [1] Industry Summary - According to MEDraysintell, the global nuclear medicine market is expected to reach nearly USD 39 billion by 2032 [1] - The advancement of 177Lu-PSMA-3D1015 is seen as a step towards elevating China's nuclear medicine research to an internationally leading level [1]