Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the interim analysis results of the KN026 combined chemotherapy for HER2+ GC (including GEJ) in a Phase III clinical trial, showing significant clinical benefits compared to the control group [1][2]. Group 1: Clinical Trial Results - The interim analysis demonstrated that KN026 combined chemotherapy achieved clinically meaningful and statistically significant benefits in progression-free survival (PFS) and overall survival (OS) compared to the placebo group [2]. - The median follow-up time for the Anlotinib group was 9.7 months, while the control group had a median follow-up of 9.8 months [2]. Group 2: Patient Characteristics - The baseline characteristics of patients in both groups were generally balanced, with a median age of approximately 64 years in the Anlotinib group and 61 years in the control group [1]. - Over 80% of patients in both groups had an ECOG PS score of 1, and nearly all patients were diagnosed with stage IVB disease at enrollment [1]. Group 3: Mechanism of Action - KN026 aims to be a next-generation HER2-targeted therapy, capable of dual binding to two clinically validated HER2 epitopes (epitopes II and IV) while retaining the wild-type Fc region [2]. - This mechanism allows KN026 to dual-block HER2-related signaling pathways, enhance binding to HER2 receptors, reduce surface HER2 protein, and improve tumor-killing effects through complete antibody-dependent cellular cytotoxicity [2]. Group 4: Ongoing Clinical Trials - Multiple Phase III clinical trials are currently underway in China, including KN026 combined with docetaxel for first-line treatment of HER2+ breast cancer, and KN026 combined chemotherapy for second-line and above treatment of HER2+ GC/GEJ [3].

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the interim analysis results of the KN026 combined chemotherapy for HER2+GC (including GEJ) in a Phase III clinical trial, indicating significant clinical benefits in progression-free survival (PFS) and overall survival (OS) compared to the control group [1][2]. Group 1: Clinical Trial Results - The interim analysis presented at the 2025 ESMO conference showed that KN026 combined with chemotherapy demonstrated clinically meaningful and statistically significant benefits in PFS and OS compared to the placebo group [2]. - The median follow-up time for the Anlotinib group was 9.7 months, while the control group had a median follow-up of 9.8 months [2]. Group 2: Patient Characteristics - The baseline characteristics of patients in both groups were generally balanced, with a median age of approximately 64 years in the Anlotinib group and 61 years in the control group [1]. - Over 80% of patients in both groups had an ECOG PS score of 1, and nearly all patients were diagnosed with stage IVB disease at enrollment [1]. Group 3: Mechanism of Action - KN026 aims to be a next-generation HER2-targeted therapy, capable of dual binding to two clinically validated HER2 epitopes (epitopes II and IV) while retaining the wild-type Fc region [2]. - This mechanism allows KN026 to dual-block HER2-related signaling pathways, enhance binding to HER2 receptors, reduce surface HER2 protein, and improve tumor-killing effects through complete antibody-dependent cellular cytotoxicity [2]. Group 4: Ongoing Clinical Trials - Multiple Phase III clinical trials are currently underway in China, including KN026 combined with docetaxel for first-line treatment of HER2+BC, KN026 combined chemotherapy for second-line and above treatment of HER2+GC/GEJ, and KN026 combined with docetaxel for neoadjuvant treatment of BC [3].

Core Viewpoint - The interim analysis of the KN026 clinical trial indicates that KN026 combined with chemotherapy shows clinically meaningful and statistically significant benefits in progression-free survival (PFS) and overall survival (OS) compared to placebo combined with chemotherapy, suggesting it as a potential new treatment option for HER2+GC/GEJ patients who have progressed after prior trastuzumab-based therapy [2]. Group 1: Clinical Trial Details - The KN026-001 trial, a Phase III clinical study, involves HER2+GC/GEJ patients who progressed after trastuzumab-based treatment, randomized to receive either KN026 combined with chemotherapy or placebo combined with chemotherapy [1]. - Baseline characteristics of both patient groups were balanced, with a median age of approximately 64 years for the KN026 group and 61 years for the control group, and over 80% of patients in both groups having an ECOG PS score of 1 [1]. Group 2: Mechanism and Future Trials - KN026 is designed to be a next-generation HER2-targeted therapy, capable of binding to two different clinically validated HER2 epitopes while retaining the wild-type Fc region, allowing for dual blockade of HER2-related signaling pathways and enhanced tumor-killing effects [2]. - Multiple Phase III clinical trials are currently underway in China, including studies of KN026 combined with docetaxel for first-line treatment of HER2+ breast cancer and for second-line treatment of HER2+GC/GEJ [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 1 結論：期中分析顯示，與安慰劑聯合化療相比，KN026聯合化療在PFS和OS方 面均取得具有臨床意義和具有統計學顯著性的獲益，且具有良好可控的安全性特 徵。該等結果表明，對於既往接受過曲妥珠單抗為基礎的治療後出現疾病進展的 HER2+ GC/GEJ患者，KN026聯合化療可作為一種有潛力的新治療選擇。 關於KN026 KN026旨在成為全球性新一代HER2靶向療法。憑藉其創新的結構，可同時結合 至兩種不同的經臨床驗證的HER2表位（表位II及IV），並保留野生型Fc區。這使 得KN026能夠(i)雙重阻斷HER2相關信號通路，(ii)增強與HER2受體的結合，(iii) 減少細胞表面的HER2蛋白，及(iv)通過完整的抗體依賴性細胞介導的細胞毒性增 強對腫瘤的殺傷效果。該等結合機制使KN026表現出卓越的腫瘤抑制作用。 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has announced the acceptance of a new drug application for KN026 in collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group Co., Ltd. This application targets HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma patients who have failed at least one systemic treatment, including trastuzumab combined with chemotherapy [1][2]. Group 1 - The new drug application is based on a pivotal Phase II/III clinical trial, which demonstrated that KN026 combined with chemotherapy significantly improves clinical efficacy compared to existing standard treatments, extending progression-free survival (PFS) and overall survival (OS) without new safety risks [1]. - KN026 has received breakthrough therapy designation from the National Medical Products Administration (NMPA) and has been granted priority review qualification, with the application date set for August 28, 2025 [1]. Group 2 - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, making KN026 the first anti-HER2 bispecific antibody drug in China to achieve positive results in this indication [2]. - The Phase II clinical trial results, to be presented at the 2024 European Society for Medical Oncology (ESMO) annual meeting, show an objective response rate of 40.0% and a median PFS of 8.6 months as assessed by an independent review committee [2]. - KN026 aims to become a next-generation HER2-targeted therapy globally, utilizing an innovative structure that binds to two different clinically validated HER2 epitopes, enhancing tumor-killing effects through various mechanisms [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 KN026關鍵性II/III期臨床試驗期中分析 達到PFS主要終點 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，本公司與石藥集團有限公司（股份 代號：1093）附屬公司上海津曼特生物科技有限公司合作開發的KN026（「KN026- 001」）聯合化療二線及以上治療HER2陽性GC（包括GEJ）的II/III期臨床試驗已完 成首個期中分析及期中分析結果達到PFS主要終點。 KN026-001的第2部分是一項隨機、雙盲、安慰劑對照的III期研究，旨在評估 KN026聯合化療用於一線標準治療失敗的HER2陽性晚期不可切除或轉移性GC （包 ...