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东吴证券:维持康宁杰瑞制药-B“买入”评级 核心管线上市申报中
Zhi Tong Cai Jing· 2026-01-23 02:37
Core Viewpoint - Dongwu Securities maintains a "Buy" rating for Corning Jereh Pharmaceutical-B (09966), anticipating multiple ADC pipelines to complete preclinical development by 2025, leading to adjustments in R&D expense forecasts and net profit estimates for 2025-2027 [1] Group 1: Pipeline Developments - The company has submitted a listing application for KN026, a HER2 bispecific monoclonal antibody, which is expected to receive approval by the end of 2026 or in 2027 [1] - JSKN003, the company's first ADC pipeline, is expected to submit a domestic listing application for HER2-positive breast cancer in 2026, with promising efficacy data presented at the 2025 ESMO conference for ovarian and colorectal cancers [2] Group 2: Clinical Progress and Efficacy Data - For JSKN003, the objective response rate (ORR) for platinum-resistant ovarian cancer patients was 32.0%, with a disease control rate (DCR) of 72.0%, and a median progression-free survival (PFS) of 4.1 months [2] - In colorectal cancer patients, JSKN003 achieved an ORR of 71.0%, a DCR of 100%, a median duration of response (DoR) of 9.89 months, and a median PFS of 11.04 months [2] Group 3: R&D Platform and Future Prospects - The company's self-developed platform continues to yield new pipelines, with the PD-L1/ITGB6/8 multifunctional ADC JSKN022 starting Phase I clinical trials in October 2025, and the PD-L1/VEGFR2 dual-target ADC JSKN027 having received IND approval in December 2025, with Phase I trials expected in 2026 [3]
东吴证券:维持康宁杰瑞制药-B(09966)“买入”评级 核心管线上市申报中
智通财经网· 2026-01-23 02:36
Core Viewpoint - Dongwu Securities maintains a "Buy" rating for Kangning Jereh Pharmaceutical-B (09966), anticipating multiple ADC pipelines to complete preclinical development by 2025, leading to adjustments in R&D expense forecasts and net profit estimates for 2025-2027 [1] Group 1: Financial Projections - The forecast for net profit attributable to the parent company is adjusted to -115 million yuan for 2025 and -97 million yuan for 2026, down from 14 million yuan and 63 million yuan respectively; a new forecast for 2027 is set at -26 million yuan [1] - The company is expected to gradually reduce losses as products like KN026 are anticipated to be launched domestically, with JSKN003 also nearing its application for market approval [1] Group 2: Product Pipeline Developments - KN026, a HER2 bispecific monoclonal antibody, has had its application for marketing approval accepted by NMPA, with expectations for approval by the end of 2026 or in 2027; the domestic rights have been granted to CSPC Pharmaceutical Group, while the company retains exclusive production rights [1] - JSKN003, the company's first ADC pipeline, is expected to submit a domestic application for HER2-positive breast cancer in 2026, with promising efficacy data presented at the 2025 ESMO conference for ovarian and colorectal cancers [2] Group 3: Research and Development Advancements - The company's self-developed platform continues to yield new pipelines, with the PD-L1/ITGB6/8 multifunctional ADC JSKN022 showing superior internalization efficiency and cytotoxic activity, having initiated Phase I clinical trials in October 2025 [3] - The PD-L1/VEGFR2 bispecific ADC JSKN027 has integrated multiple mechanisms and has received acceptance for its IND application, with Phase I clinical trials expected to commence in 2026 [3] - Additional ADCs, such as EGFR/HER3 bispecific dual-load ADC JSKN021, are anticipated to enter clinical development stages [3]
康宁杰瑞制药-B(09966.HK):核心管线上市申报中 新分子即将进入临床
Ge Long Hui· 2026-01-23 01:59
Core Insights - The company has submitted a listing application for KN026, a HER2 dual-target monoclonal antibody, which is expected to be approved for gastric cancer treatment by the end of 2026 or in 2027 [1] - The company has granted domestic rights for KN026 to CSPC Pharmaceutical Group, which will handle commercialization, while the company retains exclusive production rights [1] - The first ADC pipeline, JSKN003, is progressing rapidly, with a domestic listing application expected in 2026 for its indication in HER2-positive breast cancer [1] - JSKN003 has shown promising efficacy data in ovarian and colorectal cancer, with an objective response rate (ORR) of 32.0% and a disease control rate (DCR) of 72.0% in platinum-resistant ovarian cancer patients [1] - The company’s self-developed platform continues to produce new ADC molecules, with JSKN022 and JSKN027 entering clinical trials in 2025 [2] - Revenue forecasts for 2025-2026 are maintained at 414 million and 471 million yuan, with an additional forecast of 563 million yuan for 2027 [2] Financial Projections - The company has adjusted its R&D expense forecasts, leading to a downward revision of net profit estimates for 2025 and 2026 to -115 million and -97 million yuan, respectively [3] - The net profit forecast for 2027 is also revised to -26 million yuan [3] - Despite the losses, the company is expected to gradually reduce its losses as KN026 approaches market entry and JSKN003 is set to apply for listing [3] - The company maintains a "buy" rating based on the positive development cycle of its R&D capabilities and the upcoming clinical stages of its pipeline [3]
国金证券:首予康宁杰瑞制药-B(09966)“买入”评级 目标价14.30港元
智通财经网· 2025-12-22 02:10
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]
国金证券:首予康宁杰瑞制药-B“买入”评级 目标价14.30港元
Zhi Tong Cai Jing· 2025-12-22 02:08
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]
港股异动丨多重利好叠加,康宁杰瑞大涨超11%
Ge Long Hui· 2025-10-17 03:41
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]
康宁杰瑞制药-B:JSKN022 IND申请获CDE正式受理
Zhi Tong Cai Jing· 2025-08-03 10:09
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]
康宁杰瑞制药-B(09966):JSKN022 IND申请获CDE正式受理
智通财经网· 2025-08-03 10:09
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]
康宁杰瑞制药-B(09966.HK):JSKN022 IND申请获CDE正式受理
Ge Long Hui· 2025-08-03 10:09
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]
康宁杰瑞制药:JSKN022 IND申请获CDE正式受理
news flash· 2025-08-03 10:03
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]