KN035(恩沃利单抗注射液)是重组人源化抗程序性死亡配体1("PD-L1")单域抗体Fc融合蛋白，由本公司 自主研发，2016年起与思路迪(北京)医药科技有限公司("思路迪医药")合作开发。于2020年3月30日，公 司全资附属公司江苏康宁杰瑞生物制药有限公司("江苏康宁杰瑞")、江苏先声药业有限公司("江苏先 声"，为先声药业集团有限公司(其股份于联交所上市，股份代号：2096)的附属公司)及思路迪医药订立 一份合作协议。根据先声协议，江苏先声获授予KN035于中国大陆内的肿瘤适应症的独家市场推广权及 对外许可或转让下的优先受让权。 于2024年1月，公司与思路迪医药及Glenmark Specialty S.A.("Glenmark")订立许可协议，据此思路迪医药 与本集团同意向Glenmark授予KN035肿瘤适应症的独家许可及再授权，以(其中包括)在印度、亚太区(新 加坡、泰国及马来西亚除外)、中东及非洲、俄罗斯、独联体国家及拉丁美洲在肿瘤所有使用领域开发 及商业化KN035。 此外，其作为全球首个皮下注射PD-L1抑制剂，已于2021年11月获得国家药监局批准上市用于不可切除 或转移性微卫星高度不 ...

智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，中国国家药品监督管理局已正式受理KN035(恩沃 利单抗注射液)(商标名：恩维达®)联合吉西他滨和奥沙利铂方案，用于一线治疗不可切除或转移性胆道 癌的新药上市申请。 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BTC患者设 计的随机、平行对照、多中心III期临床试验。试验旨在评估 KN035联合GEMOX方案对比单纯GEMOX 方案的疗效与安全性。 ...

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之內容概不負責，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。 關於KN035（恩沃利單抗注射液）（商標名：恩維達®） KN035（恩沃利單抗注射液）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，由本公司自主研發，2016年起與思路迪（北京）醫藥科技有限 公司（「思路迪醫藥」）合作開發。於2020年3月30日，本公司全資附屬公司江蘇 康寧傑瑞生物製藥有限公司（「江蘇康寧傑瑞」）、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（其股份於聯交所上市，股份代號：2096）的 附屬公司）及思路迪醫藥訂立一份合作協議（「先聲協議」）。根據先聲協議，江蘇 先聲獲授予KN035於中國大陸內的腫瘤適應症的獨家市場推廣權及對外許可或 轉讓下的優先受讓權。於2024年1月，我們與思路迪醫藥及Glenmark Specialty S.A.（「Glenmark」）訂立許可協議，據此思路迪醫藥與本集團同意向Glenmark授 予KN035腫瘤適應症的獨 ...

Group 1 - The core viewpoint of the report is that Guangfa Securities is optimistic about the differentiated biopharmaceutical platform of CStone Pharmaceuticals-B (09966) and the development potential of its ADC drugs, which have shown preliminary clinical efficacy [1] - The company was established in 2015 and focuses on the development, production, and commercialization of innovative anti-tumor biologics, with a highly differentiated internal pipeline covering anti-tumor drugs at various research stages [1] - The first product, KN035 (Envafolimab injection), was launched in November 2021, marking the company's entry into the commercialization phase [1] Group 2 - CStone Pharmaceuticals has developed several globally leading biopharmaceutical technology platforms, including glycoengineered conjugation platform, linker payload platform, bispecific antibody platform, and subcutaneous high-concentration formulation platform, which have differentiated therapeutic advantages [1] - The glycoengineered conjugation platform reduces the production cost of ADC drugs while effectively minimizing toxin release in the circulatory system, enhancing drug safety [1] - Products developed based on this platform, JSKN003 and JSKN016, have entered clinical stages, and the company has upgraded the dual payload technology platform with corresponding products expected to enter clinical trials [1] Group 3 - The HER2 bispecific antibody KN026 is undergoing registration clinical studies for second-line gastric cancer, first-line breast cancer, and neoadjuvant therapy, with a promising path to market [2] - The HER2 bispecific ADC JSKN003 is in phase III clinical trials for breast cancer and platinum-resistant ovarian cancer, demonstrating competitive efficacy in early clinical studies [2] - The HER3/TROP2 bispecific ADC JSKN016 has initiated clinical trials for lung cancer and breast cancer, indicating a broad potential market, while new generation ADCs like JSKN021 (dual payload) and JSKN022 are expected to advance to clinical stages quickly [2]