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 JSKN021的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。 於2025年美國癌症研究協會年會發佈的臨床前數據顯示，JSKN021能有效抑制 HER3陽性、EGFR陽性或雙陽性腫瘤細胞的生長。此外，在多種CDX模型中， JSKN021的腫瘤抑制效果顯著優於單載荷ADC藥物。有關進一步詳情，請參閱本 公司日期為2025年4月30日的公告。 關於JSKN021 JSKN021是一款全球首創的雙抗雙載荷ADC，由靶向EGFR/HER3雙特異性抗體 與新型拓撲異構酶I抑制劑（「T01」）及甲基澳瑞他汀E（「MMAE」）偶聯而成。該 藥物通過精確調控雙抗結合親和 ...

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]

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]

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]

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 ...