Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has announced that the National Medical Products Administration of China has officially accepted the New Drug Application (NDA) for KN035 (Envafolimab injection) in combination with GEMOX for the 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), which is a randomized, parallel-controlled, multi-center study designed for advanced first-line BTC patients in China [1] - The trial aims to evaluate the efficacy and safety of KN035 in combination with the GEMOX regimen compared to the GEMOX regimen alone [1] Group 2 - KN035 (Envafolimab injection) is a recombinant humanized anti-PD-L1 single-domain antibody Fc fusion protein, developed independently by the company in collaboration with Suzhou Innovent Biologics since 2016 [2] - In March 2020, a cooperation agreement was established between the company's wholly-owned subsidiary Jiangsu Corning Jereh Biopharmaceutical Co., Ltd., Jiangsu Xiansheng Pharmaceutical Co., Ltd., and Suzhou Innovent Biologics, granting Jiangsu Xiansheng exclusive marketing rights for KN035 in oncology indications in mainland China [2] - In January 2024, a licensing agreement was signed with Suzhou Innovent Biologics and Glenmark Specialty S.A., granting Glenmark exclusive licensing and sublicensing rights for KN035 in oncology indications across various regions including India, the Asia-Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East and Africa, Russia, CIS countries, and Latin America [2] Group 3 - KN035 is the world's first subcutaneous PD-L1 inhibitor, which was approved by the National Medical Products Administration in November 2021 for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors [3]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced that the National Medical Products Administration of China has officially accepted the new drug application for KN035 (Envafolimab injection) in combination with gemcitabine and oxaliplatin for first-line treatment of unresectable or metastatic biliary tract cancer [1] Group 1 - The acceptance of the application is based on the results of the Phase III clinical trial (KN035-CN-005) [1] - This trial is a randomized, parallel-controlled, multi-center Phase III clinical study designed for advanced first-line BTC patients in China [1] - The study aims to evaluate the efficacy and safety of 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]