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 ...

12月23日，康宁杰瑞宣布，其自主研发的恩沃利单抗（英文通用名：Envafolimab，康宁杰瑞研发代号：KN035）获美国食品药品监督管理局 （FDA）授予孤儿药资格认定（Orphan Drug Designation，ODD），用于治疗胃癌和胃食管结合部癌（GC/GEJ）。这是继晚期胆道癌及软组织肉 瘤之后，恩沃利单抗获得的第3项孤儿药资格认定。 恩沃利单抗是皮下注射PD-L1单域抗体Fc融合蛋白。由康宁杰瑞自主研发，2016年起与思路迪医药共同开发，2020年3月30日，康宁杰瑞、思路迪 医药、先声药业三方达成战略合作，康宁杰瑞作为原研方负责生产和质量，思路迪医药负责肿瘤领域的临床开发，先声药业负责产品在中国大陆 的独家商业推广。恩沃利单抗于2021年11月在中国获批上市，适用于不可切除或转移性微卫星高度不稳定（MSI-H）或错配修复基因缺陷型 （dMMR）实体瘤。此前，已获国家药品监督管理局（NMPA）授予突破性疗法认定，用于治疗高肿瘤突变载荷（TMB-H）不可切除或转移性实 体瘤。 恩沃利单抗是皮下注射PD-L1单域抗体Fc融合蛋白。由康宁杰瑞自主研发，2016年起与思路迪医药共同开发，2020年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 ...

"年度创新力奖"旨在表彰资本市场最具有突破性、创新性的企业。创新是企业的核心竞争力，想要不 凡，就必须在技术研发、产品、商业模式等方面做出创新。本奖项从创新的广度、深度等多维度出发， 甄选出的企业都致力于探索前沿科技，开辟发展新路径，引领行业前行，推动社会进步。本次评选通过 定量数据分析和专家评审团等方式得出最终结果。 格隆汇以"全球视野，下注中国"为初衷，本次评选旨在打造出投资圈中最具参考价值的上市公司及独角 兽公司排行榜。此次"金格奖"上市公司评选覆盖港交所、上交所、深交所、纽交所、美国证券交易所、 纳斯达克证券交易所挂牌上市的全部上市公司及独角兽公司。 12月22日，格隆汇在线上举办"科技赋能·资本破局"分享会。本次分享会，备受瞩目的卓越公司评选榜 单将隆重揭晓，其中格隆汇"金格奖"年度卓越公司评选中，光峰科技(688007.SH)、康宁杰瑞制药- B(09966.HK)、KEEP(03650.HK)、迈瑞医疗(300760.SZ)、瑞和数智(03680.HK)、瑞声科技 (02018.HK)、三七互娱(002555.SZ)、通威股份(600438.SH)、星环科技-U(688031.SH)、云顶新耀 ...

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。 ...

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(IHC1+、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。 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。 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。 ...

Group 1 - The company is a pioneer in antibody technology in China, focusing on the research, production, and commercialization of innovative biopharmaceuticals for oncology, with a core technology platform that includes self-developed bispecific antibodies and ADC technology [2] - The global first PD-L1 subcutaneous injection KN035 was approved for market in November 2021, with expected sales and royalties of 130 million, 128 million, and 125 million yuan for 2025, 2026, and 2027 respectively [2] - The self-developed HER2 bispecific antibody KN026 has shown strong positive efficacy in treating 2L+ HER2-positive gastric cancer, with its application for market approval expected to be accepted by NMPA in September 2025, and anticipated approval in the second half of 2026 [2] Group 2 - JSKN003, a self-developed HER2 bispecific antibody ADC, is advancing in clinical trials for multiple indications in China, showing superior efficacy and safety compared to Enhertu, with data readout expected in 2027 [3] - The company plans to submit an NDA for 2L HER2-positive breast cancer in 2026 and will initiate a Phase III trial for HER2-positive metastatic colorectal cancer in October 2025, with projected sales of 0.05 million, 0.57 million, and 1.08 million yuan for 2027, 2028, and 2029 respectively [3] Group 3 - The company has established a diversified bispecific antibody ADC product matrix through its proprietary glycosylation site-specific conjugation technology platform and differentiated target layout strategy [4] - JSKN016 is the world's first TROP2/HER3 bispecific antibody ADC, currently enrolling over 400 patients for indications in lung and breast cancer, indicating a broad market potential [4] - JSKN022, a first-in-class targeted PD-L1/ITGB6 bispecific antibody ADC, initiated its first patient dosing in October, while JSKN027, which has a triple mechanism of action, is expected to file for IND soon [4]

Group 1 - The core viewpoint of the report is that the company, Corning Jereh Pharmaceutical-B (09966), is projected to experience a significant decline in revenue in 2025, followed by a recovery in the subsequent years, with expected revenues of 4.43 billion, 4.86 billion, and 5.50 billion in 2025, 2026, and 2027 respectively, reflecting a year-on-year change of -30.87%, +9.78%, and +13.22% [1] - The company is recognized as a pioneer in domestic antibody technology, with its HER2 bispecific antibody expected to receive approval soon, focusing on the research, production, and commercialization of innovative biopharmaceuticals in the oncology field [1] - The company’s self-developed PD-L1 subcutaneous injection KN035 was approved for market in November 2021, with projected sales and royalties of 1.3 billion, 1.28 billion, and 1.25 billion for the years 2025, 2026, and 2027 respectively [1] Group 2 - JSKN003, a self-developed HER2 bispecific antibody ADC, is advancing through clinical trials in China, showing superior efficacy and safety compared to Enhertu in platinum-resistant ovarian cancer, with data readout expected in 2027 and NDA submission planned for 2026 for 2L HER2-positive breast cancer [2] - The company is leveraging its proprietary glycosylation site-specific conjugation technology platform and a differentiated target layout strategy to build a diverse product matrix of bispecific antibody ADCs, including JSKN016, the world's first TROP2/HER3 bispecific antibody ADC, which has enrolled over 400 patients in lung and breast cancer indications [3] - JSKN022, a first-in-class targeted PD-L1/ITGB6 bispecific antibody ADC, has initiated patient dosing, while JSKN027, which possesses cytotoxic, anti-angiogenic, and immune-regulatory mechanisms, is expected to file for IND soon [3]