JSKN027
Search documents
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]
港股午评:恒指跌0.44%、科指跌1.26%,科网股、锂电池股及新消费概念股集体走低,航空股逆势走高
Jin Rong Jie· 2025-12-18 04:10
Market Overview - The Hong Kong stock market opened lower but rebounded before closing down, with the Hang Seng Index falling by 0.44% to 25,357.69 points, the Hang Seng Tech Index down 1.26% to 5,389.3 points, and the National Enterprises Index down 0.6% to 8,790.55 points [1] - Major technology stocks experienced declines, including Alibaba down 1.58%, Tencent down 0.58%, and Xiaomi down 3.11% [1] - Airline stocks continued to rise, with Capital Airport increasing by over 7% [1] - Lithium battery stocks saw significant declines, with CATL down over 3% [1] - New consumption concept stocks weakened, with Pop Mart down over 2% [1] Corporate News - CICC (03908.HK) is planning a stock swap to absorb and merge with Dongxing Securities (601198.SH) and Cinda Securities (601059.SH), with resumption of trading on December 18 [2] - Ronshine China (03301.HK) reported a total contract sales of approximately 3.492 billion yuan for the first 11 months, a year-on-year decrease of 49.6% [3] - Wanbang Investment (00158.HK) reported revenue of 164 million HKD for the year ending September 30, 2025, a year-on-year increase of 1.6%, but a loss of 640 million HKD, widening by 309.61% [3] - Corning Jereh Pharmaceutical-B (09966.HK) had its IND application for JSKN027 officially accepted by the CDE [4] - China CNR (01766.HK) signed significant contracts totaling approximately 53.31 billion yuan over the past three months [5] - Bofull Property (00225.HK) reported a loss attributable to shareholders of 216 million HKD, a year-on-year decrease of 63.88% [6] - SenseTime (00020.HK) plans to issue shares at a discount of over 8% to raise approximately 3.15 billion HKD [7] - Minth Group (00425.HK) entered into a strategic cooperation agreement with a robotics company [8] - XunCe (03317.HK) is offering 22.5 million H-shares for subscription starting today until next Tuesday [9] - Budweiser APAC (01876.HK) appointed Bernardo Novick as CFO, effective April 1, 2026 [10] - China Metallurgical Group (01618.HK) plans to repurchase up to 2 billion A-shares and 500 million H-shares [11] - Kuaishou-W (01024.HK) repurchased 1.283 million shares for 83.037 million HKD at prices between 63.9 and 65.55 HKD [12] - Tencent Holdings (00700.HK) repurchased 1.057 million shares for 636 million HKD at prices between 595 and 605.5 HKD [13] - Techtronic Industries (00669.HK) repurchased 500,000 shares for 44.91 million HKD at prices between 89.35 and 90.50 HKD [14] - Country Garden Services (06098.HK) repurchased 3.697 million shares for 23.1748 million HKD at prices between 6.22 and 6.33 HKD [15] - Giga Bio (02367.HK) repurchased 400,000 shares for 13.9713 million HKD at prices between 34.62 and 35.22 HKD [16] Institutional Insights - According to CICC, the recent weakness in the Hong Kong market is attributed to southbound capital returning to A-shares due to new public fund benchmark regulations, concerns over IPO financing, and the upcoming peak of lock-up expirations [17] - Huatai Securities noted that while the market's downside is controllable, the upside potential remains limited, with sentiment indicators in a pessimistic range [18] - Ping An International expects the market to maintain a volatile trend in the short term, with investment strategies focusing on a "technology + dividend" barbell approach [18] - Jianyin International recommends buying on dips before the spring market in early 2025, focusing on high-yield stocks and sectors like technology, high-end manufacturing, and new energy [19]
康宁杰瑞制药-B涨超4% 新药JSKN027临床试验申请获受理
Zhi Tong Cai Jing· 2025-12-18 02:45
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) saw a significant increase of over 4%, currently trading at HKD 10.68 with a transaction volume of HKD 2.7829 million, following the announcement of its new drug clinical trial application acceptance by the National Medical Products Administration (NMPA) [1] Group 1: Company Developments - Corning Jereh announced that its self-developed PD-L1/VEGFR2 bispecific antibody drug conjugate (ADC) JSKN027 has received formal acceptance for clinical trial (IND) application by the NMPA [1] - The company is set to initiate Phase I clinical research for JSKN027, targeting advanced malignant solid tumors [1] - JSKN027 is the first PD-L1/VEGFR2 bispecific ADC to enter clinical research globally, with preclinical data showing significant tumor suppression activity in both in vitro and in vivo models [1] Group 2: Industry Context - Currently, there are no ADCs targeting VEGFR2 alone or simultaneously targeting both PD-L1 and VEGFR pathways in clinical research worldwide [1]
港股异动 | 康宁杰瑞制药-B(09966)涨超4% 新药JSKN027临床试验申请获受理
智通财经网· 2025-12-18 02:38
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a stock increase of over 4%, currently trading at 10.68 HKD with a transaction volume of 2.7829 million HKD, following the acceptance of its IND application for the dual-targeting ADC JSKN027 by the NMPA [1] Group 1: Company Developments - Corning Jereh has announced that its self-developed PD-L1/VEGFR2 dual-specific antibody conjugate drug (ADC) JSKN027 has received formal acceptance for clinical trial (IND) application by the National Medical Products Administration (NMPA) [1] - The company is set to initiate Phase I clinical research for JSKN027, aimed at treating advanced malignant solid tumors [1] - JSKN027 is the first ADC globally to enter clinical research that targets VEGFR2 alone or simultaneously targets both PD-L1 and VEGFR pathways [1] Group 2: Clinical Data - Preclinical data indicates that JSKN027 demonstrates significant tumor suppression activity in both in vitro and in vivo models [1]
康宁杰瑞制药-B:JSKN027 IND申请获CDE正式受理
Zhi Tong Cai Jing· 2025-12-17 10:23
Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a dual-targeting antibody-drug conjugate (ADC) aimed at treating advanced malignant solid tumors [1] Group 1: Drug Development - JSKN027 targets both Programmed Death Ligand 1 (PD-L1) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2), making it the first ADC to enter clinical research that specifically targets these pathways [1] - The planned Phase I clinical study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of JSKN027, as well as determine the maximum tolerated dose and/or recommended dose for Phase II [1] Group 2: Market Position - Currently, there are no ADCs targeting VEGFR2 alone or simultaneously targeting both PD-L1 and VEGFR2 in clinical research globally [1] - Preclinical data indicates that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models [1] Group 3: Safety and Efficacy - Good tolerability was observed in GLP toxicology studies at the highest dose [1] - JSKN027 is expected to provide new treatment options for various solid tumors due to its multiple mechanisms of action, including cytotoxicity, anti-angiogenesis, and immune modulation [1]
康宁杰瑞制药-B(09966):JSKN027 IND申请获CDE正式受理
智通财经网· 2025-12-17 10:17
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 JSKN027, a dual-specific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, aimed at treating advanced malignant solid tumors [1] Group 1: Clinical Trial Details - The company plans to conduct a Phase I clinical study of JSKN027 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced malignant solid tumors [1] - The study will also determine the maximum tolerated dose and/or recommended dose for Phase II trials [1] Group 2: Unique Positioning and Preclinical Data - JSKN027 is the first PD-L1/VEGFR2 dual-targeting ADC to enter clinical research globally, with no other ADCs targeting VEGFR2 alone or both pathways simultaneously currently in clinical studies [1] - Preclinical data shows that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models [1] - GLP toxicology studies indicate good tolerability of the drug at the highest doses [1] Group 3: Mechanism of Action and Potential Impact - JSKN027 is expected to provide new treatment options for various solid tumors due to its multiple mechanisms of action, including cytotoxicity, anti-angiogenesis, and immune modulation [1]