JSKN003用於治療PROC獲得FDA突破性療法認定 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。 本公司董事（「董事」）會（「董事會」）欣然宣佈，JSKN003已獲美國食品藥品監督 管理局（「FDA」）授予突破性療法認定（「BTD」），用於治療既往接受過貝伐珠單 抗治療的晚期或轉移性人表皮生長因子受體2（「HER2」）有表達（IHC 1+、2+和 3+）鉑耐藥復發性上皮性卵巢癌、原發性腹膜癌或輸卵管癌（統稱為「PROC」）成 年患者。此前，JSKN003已獲FDA批准開展一項治療不限HER2表達水平的PROC 的II期臨床試驗，且分別在PROC和結腸直腸癌(CRC)上獲國家藥品監督管理局 （「國家藥監局」）藥品審評中心授予BTD，在PROC上獲FDA授予快速通道資格認 定並在胃╱胃食管結合部癌(GC/GEJ)上獲FDA授予孤兒藥資格認定。此次BTD 的獲授進一步彰顯了國際監管機構對JSKN003的臨床潛力及其作為新型治療候選 藥物重要性的信心。 卵巢癌是女性生殖系統最常見的惡性腫瘤之一。多數患者確診時 ...

（文章来源：每日经济新闻） 每经AI快讯，康宁杰瑞制药-B(09966.HK)涨超4%，截至发稿，涨4.4%，报10.68港元，成交额278.29万 港元。 ...

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]

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]

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]

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]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a bispecific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, aimed at treating advanced malignant solid tumors [1] Group 1 - The company plans to conduct Phase I clinical research for JSKN027 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced malignant solid tumors [1] - JSKN027 is the first PD-L1/VEGFR2 bispecific ADC to enter clinical research globally, with no other ADCs targeting VEGFR2 alone or both PD-L1 and VEGFR pathways currently in clinical studies [1] - Preclinical data shows that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models, and GLP toxicology studies indicate good tolerability at the highest doses [1] Group 2 - The multiple mechanisms of action of JSKN027, including cytotoxicity, anti-angiogenesis, and immune modulation, suggest it may provide new treatment options for various solid tumors [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 JSKN027 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。 本公司董事（「董事」）會（「董事會」）欣然宣佈，公司自主研發的程序性死亡配 體1（「PD-L1」）╱ 血管內皮生長因子受體2（「VEGFR2」）雙特異性抗體偶聯藥 物（「ADC(s)」）JSKN027新藥臨床試驗（「IND」）申請，已獲國家藥品監督管理局 （「NMPA」）藥品審評中心（「CDE」）正式受理。本公司計劃開展JSKN027用於治 療晚期惡性實體瘤的I期臨床研究，旨在評估其在該等患者人群中的安全性、耐受 性、藥代動力學、藥效學特徵以及初步抗腫瘤活性，並確定最大耐受劑量及╱或 推薦II期劑量。 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之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就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 ONC ...

交银国际发表报告指，看好康宁杰瑞制药-B ADC产品矩阵的巨大全球市场潜力，上调2025至2027年收 入预测3%至8%，上调目标价至13港元，上调评级至"买入"。报告指，公司已成功搭建多个生物大分子 药物研发技术平台，持续产出差异化竞争优势显著的早期候选药物、并快速推进临床开发。 ...

交银国际发布研报称，看好康宁杰瑞制药(09966)ADC产品矩阵的巨大全球市场潜力，上调2025-27年收 入预测3-8%，上调目标价至13港元，评级升至"买入"。该行认为，凭借KN026及JSKN003，公司有望实 现在乳腺癌的全线、多亚型覆盖，并拓展其他HER2表达实体瘤的使用，借助差异化布局在HER2赛道拥 有一席之地。 ...