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].

Core Insights - The company Kolonbo Tai Biotech-B (06990) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Bodo Trastuzumab) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have previously received one or more anti-HER2 therapies [1][2] Group 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 Bodo Trastuzumab compared to T-DM1 in HER2-positive patients with unresectable or metastatic BC who had previously received trastuzumab and taxane treatments [1] - In the pre-specified interim analysis, Bodo Trastuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to T-DM1, as assessed by blinded independent central review (BICR) [1] - A trend towards improved overall survival (OS) with Bodo Trastuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [1] Group 2 - The company has initiated an open-label, multicenter Phase 2 clinical study of Bodo Trastuzumab for the treatment of HER2-positive unresectable or metastatic BC previously treated with an effective payload of topoisomerase inhibitor ADC [2] - Bodo Trastuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [2] - The drug specifically binds to HER2 on the surface of tumor cells, leading to internalization and release of the cytotoxic molecule Duo-5, which induces cell cycle arrest in the G2/M phase and triggers apoptosis in tumor cells [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。 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 份 代 號：6990） 自願公告 核心產品博度曲妥珠單抗治療2L+ HER2+乳腺癌 獲國家藥品監督管理局批准上市 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，本 公 司 靶 向 人 類 表 皮 生 長 因 子 受 體2(HER2)的抗體偶聯 藥 物(ADC)博 度 曲 妥 珠 單 抗（亦 稱A166）（舒泰萊®）獲 國 家 藥 品 監 督 管 理 局 (NMPA)批准用於既往接受過一種或一種以上抗HER2藥物治療的不可切 除 ...

Group 1 - A-shares and Hong Kong stocks in the innovative pharmaceutical sector have rebounded, with significant gains in related stocks and ETFs [1][3][5] - The largest medical ETF in A-shares (512170) saw a trading volume of 589 million yuan, recovering 1.34% on the day [1] - The innovative drug sector is experiencing a collective rise, with notable stocks like Huahai Pharmaceutical increasing by 7.59% [3] Group 2 - The Hong Kong innovative drug ETF (520880) rose by 2.12%, with 35 out of 37 constituent stocks gaining, led by Green Leaf Pharmaceutical with an 8.31% increase [5][7] - Recent funding trends indicate a significant inflow into the innovative drug sector, with over 1.29 billion yuan added in the last three days [7] - Upcoming catalysts include the European Society for Medical Oncology (ESMO) annual meeting, which may showcase significant research results from Chinese innovative drugs [7] Group 3 - Investment strategies suggest focusing on innovative drugs, with specific ETFs like the Hong Kong innovative drug ETF (520880) and the A-share drug ETF (562050) highlighted for their potential [8] - The medical ETF (512170) is noted for its inclusion of CXO companies, which account for 26.77% of its weight [8] - The medical ETF is the largest in the market, with a scale of 26.4 billion yuan, while the drug ETF is the only one tracking the China Pharmaceutical Index [9]

Core Viewpoint - The innovative drug sector experienced a significant rally, with the innovative drug index rising by 2.35% as of the midday close on October 15, 2025, driven by strong performances from various companies [1][2]. Group 1: Market Performance - The innovative drug index (886015.TI) closed at 1366.835, reflecting a gain of 2.35%, equivalent to an increase of 31.422 points [2]. - Notable stock performances included Guangshentang, which surged by 20% to 122.65, and several other companies such as Shutaishen and Anglikang, which saw gains of 14.4% and 10.01%, respectively [2][3]. Group 2: Upcoming Events - The European Society for Medical Oncology (ESMO) conference is set to take place from October 17 to 21, 2025, in Berlin, Germany, where significant clinical research results and data are expected to be disclosed [3][4]. Group 3: Business Development Opportunities - There is growing market anticipation for the release of clinical data from domestic innovative drugs and business development (BD) collaborations, with 83 overseas BD transactions recorded in the first eight months of 2025, totaling 845 billion yuan, marking a 62.81% increase compared to the entire year of 2024 [4]. Group 4: Company Earnings Forecast - Several innovative drug companies are expected to report strong earnings for the third quarter of 2025, with Shengnuo Bio projecting a net profit of 114 million to 140 million yuan, representing a year-on-year increase of 100.53% to 145.10% [5]. - Boteng Co. anticipates a net profit of 73.2 million to 88.2 million yuan, indicating a turnaround from losses, driven by a 17% to 21% increase in revenue [5]. Group 5: Industry Outlook - Analysts express optimism regarding the innovative drug sector, anticipating stabilization and rebound due to upcoming catalysts such as BD and medical insurance negotiations [6]. - Long-term trends indicate that the Chinese pharmaceutical industry has transitioned to new growth drivers, particularly in innovative drugs, which are expected to significantly contribute to the growth of Chinese pharmaceutical companies over the next 5 to 10 years [7].