Core Insights - The article highlights the significant advancements in the ADC (Antibody-Drug Conjugate) sector, particularly focusing on the achievements of Kelun-Botai, which has successfully developed innovative drugs that are gaining international recognition [1][2][3]. Group 1: ADC Developments - Kelun-Botai's TROP2 ADC, Lukan-Satuzumab, has shown promising results in clinical trials, particularly for second-line treatment of EGFR-mutant non-small cell lung cancer (NSCLC), demonstrating significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard chemotherapy [2][3]. - The ESMO conference showcased multiple ADC products from Kelun-Botai, including TROP2, HER2, and CLDN18.2 ADCs, indicating the company's strong research and development capabilities [1][2]. - The company aims to fill critical treatment gaps in oncology, with Lukan-Satuzumab potentially becoming a cornerstone drug for both breast cancer and lung cancer [3][4]. Group 2: Clinical Trial Highlights - The OptiTROP-Lung04 study presented at ESMO demonstrated that Lukan-Satuzumab significantly improves PFS and OS for patients with EGFR-mutant NSCLC who have failed prior treatments [2][3]. - Another study for HER2 ADC, A166, showed significant improvements in PFS compared to T-DM1 for HER2-positive breast cancer, supporting its potential as a leading treatment option [4]. - The introduction of SKB315, targeting CLDN18.2 for gastric cancer, marks a significant expansion into a high-incidence cancer type, with initial clinical data showing promising efficacy [5]. Group 3: Strategic Positioning - Kelun-Botai's strategy focuses on leveraging its proprietary OptiDC™ technology platform to optimize drug design and enhance therapeutic efficacy, positioning itself as a leader in the ADC market [8][9]. - The company is committed to developing large indications and aims to create significant products within major cancer types, ensuring a comprehensive treatment approach from second-line to first-line therapies [9][10]. - Kelun-Botai is also exploring next-generation DC technologies, including dual-antibody ADCs and other innovative mechanisms, to address challenges such as tumor resistance and heterogeneity [12][13]. Group 4: Future Outlook - The company is expanding its pipeline to include diverse therapeutic areas beyond oncology, indicating a strategic move towards a more comprehensive biopharma portfolio [14][15]. - Kelun-Botai is enhancing its global presence through partnerships and clinical trials, aiming to establish itself as a competitive player in the international biopharma market [17][18]. - The ongoing development of innovative products and a sustainable business model positions Kelun-Botai for long-term success and growth in the global pharmaceutical landscape [18].

Core Viewpoint - Kolon Biotech Inc. (06990) experienced a significant increase in stock price, rising by 5.37% to HKD 483, with a trading volume of HKD 1.5939 million, following the announcement 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 - Kolon Biotech announced the presentation of several clinical research results at the ESMO conference [1]. - The research included data on targeted antibody-drug conjugates (ADCs) such as sac-TMT (佳泰莱), A166 (舒泰莱), and SKB315 [1]. - The focus of the studies was on TROP2, HER2, and Claudin18.2 [1].

消息面上，科伦博泰生物-B发布公告，本公司已在于10月17日至21日在德国柏林举行的2025年欧洲肿瘤 内科学会(ESMO)大会上公布多项临床研究成果，涵盖靶向人滋养细胞表面抗塬2(TROP2)抗体偶联药物 (ADC)芦康沙妥珠单抗(sac-TMT)(佳泰莱)、靶向人类表皮生长因子受体2(HER2)ADC博度曲妥珠单抗(亦 称A166)(舒泰莱)以及Claudin18.2 (CLDN18.2) ADC SKB315的相关数据。 智通财经APP获悉，科伦博泰生物-B(06990)高开逾5%，截至发稿，涨5.37%，报483港元，成交额 159.39万港元。 ...

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, focusing on various antibody-drug conjugates (ADCs) targeting specific cancer markers [1] Group 1: Clinical Research Results - The company presented data on the TROP2-targeted ADC sac-TMT (佳泰莱) [1] - The company showcased results for the HER2-targeted ADC A166 (舒泰莱) [1] - The company also reported findings related to the Claudin18.2-targeted ADC SKB315 [1]

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 company presented data on the targeted antibody-drug conjugate (ADC) sac-TMT (佳泰莱®), which targets trophoblast cell surface antigen 2 (TROP2) [1] - The company also showcased results for the HER2-targeted ADC A166 (舒泰莱®) [1] - Additionally, data related to the Claudin18.2 (CLDN18.2) ADC SKB315 was presented [1]

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 Insights - Keren Biotechnology's antibody-drug conjugate (ADC) A166 (also known as "Shutailai") has received approval from the National Medical Products Administration (NMPA) for use in adult patients with HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] - The approval is based on a Phase III clinical trial (KL166-III-06) that demonstrated significant improvement in progression-free survival (PFS) compared to T-DM1, with a trend towards improved overall survival (OS) [1] Company Developments - Keren Biotechnology has initiated a Phase II clinical study for A166 targeting HER2-positive breast cancer patients who have previously received topoisomerase inhibitor ADC therapy [2] - A166 is the second ADC approved by Keren Biotechnology, indicating a growing portfolio in the ADC space [1] Industry Context - The HER2-targeted ADC market is currently dominated by international pharmaceutical companies, with Roche's T-DM1 and Daiichi Sankyo/AstraZeneca's DS-8201 leading the market [2] - DS-8201 was first approved in China in February 2023 and has multiple indications, including breast cancer, gastric cancer, and lung cancer, and is included in the national medical insurance directory [2] - Other domestic ADCs, such as Rongchang Biotech's trastuzumab deruxtecan, have also gained approval for various HER2-related indications, contributing to a competitive landscape [3] - The timeline for A166's inclusion in the national medical insurance directory may be challenging, as the preliminary review for the 2025 adjustments has already been completed [3]

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) Bodo-Tuzumab (A166) by the National Medical Products Administration (NMPA) for the treatment of HER2-positive breast cancer represents a significant advancement in targeted therapy for patients with previously treated, unresectable, or metastatic conditions [1][2]. Group 1: Product Approval - The NMPA has approved Bodo-Tuzumab for adult patients with HER2-positive breast cancer who have received one or more prior anti-HER2 therapies [1]. - The approval is based on the results of a multicenter, randomized, open-label, controlled Phase III study (KL166-III-06) comparing Bodo-Tuzumab to Trastuzumab Emtansine (T-DM1) [2]. Group 2: Clinical Study Results - The study demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) for Bodo-Tuzumab compared to T-DM1, as assessed by blinded independent central review (BICR) [2]. - A trend towards improved overall survival (OS) with Bodo-Tuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [2]. Group 3: Product Characteristics - Bodo-Tuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [3]. - The drug specifically targets HER2 on tumor cells, leading to internalization and release of the cytotoxic agent Duo-5, which induces cell cycle arrest and apoptosis in tumor cells [3]. - Bodo-Tuzumab also exhibits antibody-dependent cell-mediated cytotoxicity (ADCC) activity and inhibits HER2-mediated signaling pathways [3].

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].