东吴证券发布研报称，维持康宁杰瑞制药-B(09966)"买入"评级，考虑到2025年公司有多款ADC新管线 完成临床前研发，该行提高了对研发费用的预测水平，相应影响归母净利润水平，2025-2026年归母净 利润分别下调为-1.15/-0.97亿元，原值为0.14/0.63亿元，新增2027年归母净利润预测为-0.26亿元。随着 公司后续产品KN026有望国内上市，JSKN003也即将申报上市，该行预计未来公司亏损将逐步缩小。同 时基于公司后备管线的逐步进入临床阶段，公司研发能力进入良性发展循环。 自研平台持续发力，多款新ADC分子即将进入临床 公司自研的技术平台持续产出新管线，在PD-L1靶点管线中，PD-L1/ITGB6/8多功能ADCJSKN022展现 出优于单抗ADC的内吞效率和体内外杀伤活性，该管线目前已经在2025年10月启动了I期临床。PD- L1/VEGFR2双抗ADCJSKN027整合了细胞毒杀伤、抗血管及免疫调节三重机制，公司在2025年12月已 经向中国药监局提交IND申请并获得受理，2026年有望开展针对JSKN027的I期临床研究。后续还有 EGFR/HER3双抗双载荷ADCJSKN ...

智通财经APP获悉，东吴证券发布研报称，维持康宁杰瑞制药-B(09966)"买入"评级，考虑到2025年公司 有多款ADC新管线完成临床前研发，该行提高了对研发费用的预测水平，相应影响归母净利润水平， 2025-2026年归母净利润分别下调为-1.15/-0.97亿元，原值为0.14/0.63亿元，新增2027年归母净利润预测 为-0.26亿元。随着公司后续产品KN026有望国内上市，JSKN003也即将申报上市，该行预计未来公司亏 损将逐步缩小。同时基于公司后备管线的逐步进入临床阶段，公司研发能力进入良性发展循环。 东吴证券主要观点如下： 多款核心管线催化剂密集，KN026已提交上市申请 KN026是公司开发的HER2双表位单抗，其核心适应症之一的联合化疗治疗2L及以上胃癌目前已经获得 NMPA受理，该行预计2026年年底或2027年有望获批上市。公司已经将该产品的国内权益授予石药集 团，未来上市后石药集团将负责相关商业化工作，公司将保留KN026的独家生产权，为石药集团提供产 品。除此之外KN026的乳腺癌1L治疗和新辅助治疗的方案也有望在2026年提交上市申请。 自研平台持续发力，多款新ADC分子即将进 ...

机构：东吴证券 研究员：朱国广/邹行健 考虑到2025 年公司有多款ADC 新管线完成临床前研发，我们提高了对研发费用的预测水平，相应影响 归母净利润水平，2025-2026 年归母净利润分别下调为-1.15/-0.97 亿元，原值为0.14/0.63 亿元，新增 2027年归母净利润预测为-0.26 亿元。随着公司后续产品KN026 有望国内上市，JSKN003 也即将申报上 市，我们预计未来公司亏损将逐步缩小。 多款核心管线催化剂密集，KN026 已提交上市申请：KN026 是公司开发的HER2 双表位单抗，其核心 适应症之一的联合化疗治疗2L 及以上胃癌目前已经获得NMPA 受理，我们预计2026 年年底或2027 年有 望获批上市。公司已经将该产品的国内权益授予石药集团，未来上市后石药集团将负责相关商业化工 作，公司将保留KN026 的独家生产权，为石药集团提供产品。除此之外KN026 的乳腺癌1L 治疗和新辅 助治疗的方案也有望在2026 年提交上市申请。JSKN003 是公司开发的首款ADC管线，其临床进展也较 为迅速，针对2L HER2 阳性乳腺癌的适应症预计有望在2026 年提交国内上市申请。 ...

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]

Core Viewpoint - The biotechnology stocks in Hong Kong are rising against the trend, with Kangning Jereh Pharmaceutical-B (9966.HK) experiencing a significant increase of over 11%, currently priced at HKD 15.26, with a total market capitalization of HKD 14.8 billion [1] Company Summary - Kangning Jereh Pharmaceutical repurchased 400,000 shares for HKD 5.483 million on October 16, indicating confidence in its financial resources to support the buyback plan of up to HKD 20 million [1] - The company announced the clinical approval of JSKN022 for advanced solid tumors, which is a positive development for its product pipeline [1] - Kangning Jereh's research KN026 is among 23 studies from China selected for presentation at the European Society for Medical Oncology (ESMO) conference scheduled from October 17 to 21 in Berlin, highlighting its research significance [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced that its self-developed PD-L1/Integrin αvβ6 bispecific antibody ADC, JSKN022, has received formal acceptance for clinical trial (IND) application by the National Medical Products Administration (NMPA) in China [1] Group 1: Product Development - The company plans to initiate the first human clinical study of JSKN022 for the treatment of advanced malignant solid tumors [1] - Currently, there are no ADCs targeting Integrin αvβ6 or PD-L1 available on the market globally, and related investigational drugs are still in clinical research stages [1] Group 2: Clinical Data - Preclinical data indicates that JSKN022 exhibits anti-tumor activity against tumor cells expressing Integrin αvβ6 and/or PD-L1 in both in vitro and in vivo models [1] - The drug is expected to provide new treatment options for patients with tumors that are resistant to or ineffective against PD-1/PD-L1 inhibitors, such as non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN022, a dual-specific antibody-drug conjugate (ADC) targeting programmed cell death ligand 1 (PD-L1) and integrin αvβ6, aimed at treating advanced malignant solid tumors [1] Group 1 - The company plans to initiate the first human clinical study of JSKN022 for the treatment of advanced malignant solid tumors [1] - Currently, there are no ADCs targeting integrin αvβ6 or PD-L1 available on the global market, with all related investigational drugs still in clinical research stages [1] - Preclinical data indicates that JSKN022 exhibits anti-tumor activity against tumor cells expressing integrin αvβ6 and/or PD-L1 in both in vitro and in vivo models [1] Group 2 - JSKN022 is expected to provide new treatment options for patients with tumors that are resistant to or ineffective against PD-1/PD-L1 inhibitors, such as non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has received acceptance for its IND application for JSKN022, a dual-targeting ADC aimed at treating advanced malignant solid tumors, marking a significant step in the development of innovative cancer therapies [1][2] Group 1: Product Development - JSKN022 is a globally pioneering dual-targeting ADC that simultaneously targets PD-L1 and integrin αvβ6, representing a novel approach in cancer treatment [2] - The drug is based on the company's self-developed Envafolimab and innovatively combines immune mechanisms with ADC technology [2] - JSKN022 utilizes glycosylation site-specific conjugation technology to enhance stability and uniformity, which is crucial for its therapeutic efficacy [2] Group 2: Clinical Research and Market Potential - The clinical trial for JSKN022 aims to provide new treatment options for patients with tumors that are resistant to PD-1/PD-L1 inhibitors or for whom existing treatments are ineffective, such as non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer [1] - Currently, there are no ADCs targeting integrin αvβ6 or PD-L1 available in the global market, with all related investigational drugs still in clinical research stages [1]

Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration (NMPA) of China for its Investigational New Drug (IND) application for JSKN022, a dual-specific antibody-drug conjugate targeting PD-L1 and integrin αvβ6, aimed at treating advanced malignant solid tumors [1] Group 1 - The company is developing JSKN022, which is a dual-specific antibody-drug conjugate [1] - The IND application for JSKN022 has been officially accepted by the NMPA's Center for Drug Evaluation (CDE) [1] - The first human clinical study for JSKN022 is planned to be conducted for the treatment of advanced malignant solid tumors [1]