翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 康寧傑瑞生物製藥 呈交日期： 2025年12月31日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | | 佔有關事件前 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for treating patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]

康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN033的一項II期臨床試驗的IND申請獲CDE正式受理 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司，統稱「本集團」）自願 作出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 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。 ALPHAMAB ONCOLOGY 關於JSKN033 JSKN033是本集團開發的全球首個由HER2雙特異性ADC(JSKN003)及PD-L1單 抗（恩沃利單抗）組成的皮下注射複方製劑。JSKN003是一種靶向HER2雙表位 ADC，其中一種拓撲異構酶I抑制劑通過糖基定點偶聯技術與抗體KN026（一種重 組人源化抗HER2雙特異性抗體）的N糖基化位點連接。恩沃利單抗是重組人源化 PD-L1單域抗體和人免疫球蛋白G1 Fc片段組成的Fc融合蛋白，作為全球首個皮下 注射PD-L1抑制劑，已於2021年11月 ...

Core Viewpoint - Corning Jereh's Envafolimab has received Orphan Drug Designation from the FDA for the treatment of gastric cancer and gastroesophageal junction cancer, marking its third orphan drug designation after advanced biliary tract cancer and soft tissue sarcoma [1][2]. Group 1: Product Development - Envafolimab is a subcutaneously administered PD-L1 single-domain antibody Fc fusion protein developed by Corning Jereh [2][3]. - The product has been in collaboration with Sorrento Therapeutics since 2016, with a strategic partnership established in March 2020 involving Corning Jereh, Sorrento Therapeutics, and Ascletis Pharma [2][3]. - Envafolimab was approved for marketing in China in November 2021 for use in unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors [2][3]. Group 2: Regulatory Milestones - The FDA's Orphan Drug Designation for Envafolimab is significant as it provides incentives for the development of treatments for rare diseases [1]. - Prior to this designation, Envafolimab had already received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for treating high tumor mutational burden (TMB-H) unresectable or metastatic solid tumors [2][3].

Group 1 - The core focus of the event is the announcement of the "Annual Innovation Award" winners, recognizing companies with significant breakthroughs and innovations in the capital market [1] - The awarded companies include Guangfeng Technology, Corning Jereh Pharmaceutical-B, KEEP, Mindray Medical, Ruihe Zhizhi, AAC Technologies, 37 Interactive Entertainment, Tongwei Co., Xinghuan Technology-U, and Ginkgo Bioworks, with no specific ranking [1] - The "Annual Innovation Award" aims to highlight companies that excel in innovation across various dimensions, including technology research and development, products, and business models [1] Group 2 - The "Golden Award" evaluation is designed to create a reference list of the most valuable listed companies and unicorns in the investment community, covering all listed companies on major exchanges [2] - The evaluation includes companies listed on the Hong Kong Stock Exchange, Shanghai Stock Exchange, Shenzhen Stock Exchange, New York Stock Exchange, American Stock Exchange, and NASDAQ [2]

康宁杰瑞 20251222 摘要 康宁杰瑞的 KN026 预计 2026 年获批用于二线及以上 HER2 阳性胃癌， 疗效超越现有临床指南药物，销售峰值预期超 30 亿元。一线乳腺癌及 新辅助临床数据也将在 2026 年读出并申报上市。 GSK003 是一种 HER2 双表位 ADC，采用糖基化定点偶联技术，疗效 和安全性优于 TDM1 等单靶 ADC。预计 2026 年二线 HER2 阳性乳腺 癌数据读出并申报上市，销售峰值预期超 25 亿元。 康宁杰瑞拥有糖基化定点偶联和皮下注射给药两大技术平台。糖基化平 台效率高于 Synaffix，皮下注射平台提升患者依从性。KN035 销售收 入和对外授权许可费是主要营收来源，公司 2024 年已扭亏为盈。 ADC 市场快速发展，康宁杰瑞专注于新一代 ADC 治疗范式，其糖基化 定点偶联平台产出的 ADC 疗效与安全性优于现有单靶 ADC，差异化靶 点布局带来 BD 机遇。公司管线包含多款创新型双抗和复方制剂。 KN026 在 HER2 阳性胃癌的临床试验中，mPFS 和 MOS 均优于现有疗 法，HR 值低于 0.3，可显著降低疾病进展和死亡风险。一线治疗 MOS ...

Core Insights - The "Annual Innovation Award" recognizes companies with breakthrough and innovative capabilities in the capital market, emphasizing the importance of innovation in technology research and development, products, and business models [1][2] - The award selection process involved quantitative data analysis and expert review to determine the final results [1] Group 1: Award Winners - Ten companies were awarded the "Annual Innovation Award," including Guangfeng Technology, Corning Jereh Pharmaceutical-B, KEEP, Mindray Medical, Ruihe Smart, AAC Technologies, 37 Interactive Entertainment, Tongwei Co., Xinghuan Technology-U, and Ginkgo Bioworks [1] - The award aims to highlight companies that are committed to exploring cutting-edge technology and paving new paths for development, thereby leading the industry and promoting social progress [1] Group 2: Evaluation Scope - The "Golden Award" evaluation covers all listed companies and unicorns on major exchanges, including the Hong Kong Stock Exchange, Shanghai Stock Exchange, Shenzhen Stock Exchange, New York Stock Exchange, and NASDAQ [2]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a stock increase of over 6%, currently trading at HKD 11.57, with a transaction volume of HKD 12.83 million. The rise is attributed to the FDA granting breakthrough therapy designation for JSKN003, aimed at treating specific types of advanced ovarian cancer in patients previously treated with bevacizumab [1]. Group 1 - Corning Jereh Pharmaceutical announced that its product JSKN003 has received breakthrough therapy designation from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in adults who have previously been treated with bevacizumab [1]. - JSKN003 is a self-developed HER2 dual antibody ADC, with ongoing Phase III clinical trials in China for multiple indications. The efficacy and safety of JSKN003 have shown superior characteristics compared to Enhertu in the platinum-resistant ovarian cancer population [1]. - The company expects to complete data readout for JSKN003 by 2027 and plans to submit a New Drug Application (NDA) to the CDE for 2L HER2-positive breast cancer in 2026. Additionally, a Phase III clinical trial for HER2-positive metastatic colorectal cancer is set to start in October 2025, with projected sales for JSKN003 estimated at 0.05 billion, 0.57 billion, and 1.08 billion for the years 2027, 2028, and 2029 respectively [1].

消息面上，康宁杰瑞制药公布，JSKN003已获美国食品药品监督管理局(FDA)授予突破性疗法认定，用 于治疗既往接受过贝伐珠单抗治疗的晚期或转移性人表皮生长因子受体2有表达(IHC 1+、2+和3+)铂耐 药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌成年患者。 国金证券发布研报称，JSKN003为公司自研HER2双抗ADC，该产品针对多适应症的III期临床试验在中 国有序推进：在铂类耐药卵巢癌全人群适应症中，其疗效与安全性已展现出优于Enhertu的特征，预计 2027年完成数据读出并报产；预计2026年向CDE提交2L HER2阳性乳腺癌的NDA；2025年10月启动中 国HER2阳性转移性结直肠癌适应症III期临床，该行预期JSKN003预期27/28/29年销售分成为 0.05/0.57/1.08亿元。 （原标题：港股异动 | 康宁杰瑞制药-B(09966)再涨超6% JSKN003用于治疗PROC获得FDA突破性疗法认 定） 智通财经APP获悉，康宁杰瑞制药-B(09966)午前涨超6%，截至发稿，涨6.05%，报11.57港元，成交额 1283.17万港元。 ...