Core Insights - Sichuan Kelun-Botai Biopharmaceutical Co., Ltd. (Kelun-Botai) won the "Outstanding Hong Kong Stock Company Golden Bull Award" at the 2025 Xiamen Industry Development Conference, recognizing its exceptional management, market performance, and innovation in the biopharmaceutical sector [1][2] Company Performance - The "Outstanding Hong Kong Stock Company Golden Bull Award" is the highest honor in the evaluation, aimed at companies excelling in financial performance, corporate governance, social responsibility, industry leadership, and investor returns [2] - Since its IPO on the Hong Kong Stock Exchange in July 2023 at an issuance price of HKD 60.6, Kelun-Botai's stock price surged to HKD 434.2 as of November 5, 2025, with a market capitalization exceeding 100 billion [2] Commercialization Progress - Kelun-Botai focuses on the research, manufacturing, and commercialization of innovative drugs in oncology, immunology, and other therapeutic areas, being a pioneer in antibody-drug conjugates (ADC) with over 10 years of experience [3] - The company has successfully launched four leading products, including the world's first approved TROP2 ADC for lung cancer and the first PD-L1 monoclonal antibody for nasopharyngeal carcinoma [3] - In the first half of this year, Kelun-Botai achieved a revenue of 950 million, with its core product generating over 300 million, demonstrating strong commercial performance [3] Future Outlook - Several brokerage reports suggest that Kelun-Botai is expected to reach a profitability inflection point by 2027, driven by successful commercialization and global clinical research progress [4] - The company aims to continue advancing the research, registration, and commercialization of innovative drugs, focusing on unmet clinical needs globally while creating long-term value for stakeholders [4]

Core Viewpoint - The company announced the presentation of multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1: Clinical Research Results - The clinical studies include data on the antibody-drug conjugate (ADC) targeting Trophoblast Cell Surface Antigen 2 (TROP2), sac-TMT (佳泰莱®) [1] - The research also covers the ADC targeting Human Epidermal Growth Factor Receptor 2 (HER2), known as A166 (舒泰莱®) [1] - Additionally, data on Claudin18.2 (CLDN18.2) ADC SKB315 is presented [1]

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。 OptiTROP-Lung04 共 有376名患者被隨機(1:1)分配接受蘆康沙妥珠單抗(sac-TMT)治療或化 療。於 數 據 截 止 時 間（2025年7月6日），中 位 隨 訪 時 間 為18.9個 月。蘆康沙 妥珠單抗(sac-TMT)組的中位無進展生存期(PFS)為8.3個 月，化 療 組 為4.3個 月。蘆康沙妥珠單抗(sac-TMT)較化療顯著改善了PFS，疾 病 進 展 或 死 亡 風 險降低51%（風 險 比(HR) 0.49；95%置信區間(CI): 0.39-0.62；P<0.0001）。在 預 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 ...

Core Viewpoint - Kelong Pharmaceutical's subsidiary, Kelong Botai, received approval for its HER2-targeted antibody-drug conjugate, Boduocutuzumab (舒泰莱®), for treating adult patients with HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [2] Group 1 - The drug Boduocutuzumab has shown significant statistical and clinical improvement in progression-free survival (PFS) compared to T-DM1 in a pre-specified interim analysis [2] - There is a trend observed in the overall survival (OS) benefit for Boduocutuzumab [2] - Kelong Botai has initiated a Phase II open-label, multicenter clinical study for Boduocutuzumab in patients with HER2-positive, unresectable, or metastatic breast cancer who have previously received effective payloads of topoisomerase inhibitor ADC therapy [2]

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) A166 (also known as 博度曲妥珠单抗) by the National Medical Products Administration (NMPA) for treating HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 therapies marks a significant advancement in the treatment landscape for this patient population [1]. Group 1: Drug Approval and Clinical Study - The NMPA has approved A166 for use in patients with unresectable or metastatic HER2-positive breast cancer who have previously undergone treatment with one or more anti-HER2 drugs [1]. - The approval is based on a multicenter, randomized, open-label, controlled Phase 3 study (KL166-III-06) that evaluated the efficacy and safety of A166 compared to T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer [1]. - The interim analysis showed that A166 significantly improved progression-free survival (PFS) compared to T-DM1, with a notable trend towards improved overall survival (OS) [1]. Group 2: Future Research and Development - The company has initiated an open-label, multicenter Phase 2 clinical study of A166 for treating HER2-positive unresectable or metastatic breast cancer previously treated with topoisomerase inhibitor ADCs [2].