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]

ALPHAMAB ONCOLOGY 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 JSKN022 IND申請獲CDE正式受理 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份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 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」）╱ 整合素αvβ6雙特異性抗體偶聯藥物（「ADC」）JSKN022新藥臨 床試驗（「IND」）申請，已獲中國國家藥品監督管理局（「NMPA」）藥品審評中心 （「CDE」）正式受理。本公司計劃開展用於治療晚期惡性實體瘤的JSKN022首次人 體臨床研究。 目前全球範圍內尚無靶向整合素αvβ6或PD-L1的ADC上市，相關在研藥物均處於 臨床研究階段。臨床前數據顯示，JSKN022在體外和體內模型中， ...

Group 1 - The core viewpoint of the report is that Guangfa Securities is optimistic about the differentiated biopharmaceutical platform of CStone Pharmaceuticals-B (09966) and the development potential of its ADC drugs, which have shown preliminary clinical efficacy [1] - The company was established in 2015 and focuses on the development, production, and commercialization of innovative anti-tumor biologics, with a highly differentiated internal pipeline covering anti-tumor drugs at various research stages [1] - The first product, KN035 (Envafolimab injection), was launched in November 2021, marking the company's entry into the commercialization phase [1] Group 2 - CStone Pharmaceuticals has developed several globally leading biopharmaceutical technology platforms, including glycoengineered conjugation platform, linker payload platform, bispecific antibody platform, and subcutaneous high-concentration formulation platform, which have differentiated therapeutic advantages [1] - The glycoengineered conjugation platform reduces the production cost of ADC drugs while effectively minimizing toxin release in the circulatory system, enhancing drug safety [1] - Products developed based on this platform, JSKN003 and JSKN016, have entered clinical stages, and the company has upgraded the dual payload technology platform with corresponding products expected to enter clinical trials [1] Group 3 - The HER2 bispecific antibody KN026 is undergoing registration clinical studies for second-line gastric cancer, first-line breast cancer, and neoadjuvant therapy, with a promising path to market [2] - The HER2 bispecific ADC JSKN003 is in phase III clinical trials for breast cancer and platinum-resistant ovarian cancer, demonstrating competitive efficacy in early clinical studies [2] - The HER3/TROP2 bispecific ADC JSKN016 has initiated clinical trials for lung cancer and breast cancer, indicating a broad potential market, while new generation ADCs like JSKN021 (dual payload) and JSKN022 are expected to advance to clinical stages quickly [2]

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 ONCOLOGY 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 於2025年AACR年會呈列的JSKN021及JSKN022的最新研究成果 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，JSKN021及JSKN022臨床前研究 的最新成果已於2025年4月25日至4月30日舉行的2025年AACR年會的壁報展示期 間（摘要展示編號：5450及5451）公佈。此研究結果概述如下。 JSKN021在臨床前研究中的藥理活性 背景：EGFR及HER3均屬於EGFR家族，在人類惡性腫瘤中廣泛過表達，使其成 為極具潛力的腫瘤治療靶點。腫瘤是一種異質性疾病，瘤間與瘤內的異質性被認 為是導致復發、轉移及對當前SO ...