Core Viewpoint - The company announced that its subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., received approval for a third indication of its antibody-drug conjugate, sac-TMT (also known as SKB264/MK-2870), for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1] Company Summary - The approved drug, sac-TMT, targets TROP2 and is positioned to address a significant patient population in the NSCLC segment [1] - This approval marks a significant milestone for the company, expanding its product offerings in the oncology space [1] Industry Summary - The approval of sac-TMT aligns with the growing trend of developing targeted therapies for cancer treatment, particularly in the NSCLC market [1] - The NSCLC market is increasingly competitive, with a focus on innovative therapies that can provide options for patients who have limited treatment responses [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。 於2025年3月，蘆 康 沙 妥 珠 單 抗(sac-TMT)已 獲NMPA批准用於EGFR-TKI和 含鉑化療治療後進展 的EGFR基 因 突 變 陽性的局部晚期或轉移性非鱗狀 NSCLC。與 標 準 治 療 相 比，蘆 康 沙 妥 珠 單 抗(sac-TMT)單一療法顯著延長 此 類 患 者 的 總 生 存 期。另外一項 蘆康沙妥珠單抗(sac-TMT)聯合奧希替尼 一線治療EGFR突變的局部晚期或轉移性非鱗狀NSCLC的III期註冊性研究 已 在中國 完成全部患者入組。 關於蘆康沙妥珠單抗(sac-TMT)（佳泰萊®） 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） ...

科伦药业（002422）(002422.SZ)发布公告，公司近日获悉，公司控股子公司四川科伦博泰生物医药股 份有限公司(简称"科伦博泰")靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗 (sac-TMT，亦称SKB264/MK-2870)(佳泰莱)获国家药品监督管理局(NMPA)批准第三项适应症，用于治 疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR基因突变阳性的局部晚期或 转移性非鳞状非小细胞肺癌(NSCLC)成人患者。 芦康沙妥珠单抗(sac-TMT)是迄今为止全球首个且唯一对比含铂双药化疗显示出显著的总生存期(OS)获 益，并且已获批用于仅接受过TKI治疗后进展(2L)的晚期NSCLC的ADC。在预设的OS期中分析中，与 目前含铂双药化疗标准治疗相比，芦康沙妥珠单抗(sac-TMT)单一疗法在无进展生存期和总生存期均具 有显著统计学意义和临床意义的改善，显著延长此类患者的无进展生存期和总生存期。 ...

科伦药业(002422.SZ)发布公告，公司近日获悉，公司控股子公司四川科伦博泰生物医药股份有限公司 (简称"科伦博泰")靶向人滋养细胞表面抗原 2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT， 亦称SKB264/MK-2870)(佳泰莱®)获国家药品监督管理局(NMPA)批准第三项适应症，用于治疗经表皮生 长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞 状非小细胞肺癌(NSCLC)成人患者。 芦康沙妥珠单抗(sac-TMT)是迄今为止全球首个且唯一对比含铂双药化疗显示出显著的总生存期(OS)获 益，并且已获批用于仅接受过 TKI 治疗后进展(2L)的晚期NSCLC 的 ADC。在预设的 OS 期中分析中， 与目前含铂双药化疗标准治疗相比，芦康沙妥珠单抗(sac-TMT)单一疗法在无进展生存期和总生存期均 具有显著统计学意义和临床意义的改善，显著延长此类患者的无进展生存期和总生存期。 ...

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the third indication of the antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1][2] Group 1 - The approval is based on a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study aims to evaluate the efficacy and safety of sac-TMT administered as a monotherapy compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who progressed after EGFR-TKI and platinum-based chemotherapy [2] - The monotherapy with sac-TMT significantly extended the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [2]

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the third indication of the antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1][2] Group 1 - The approval is based on a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will present its findings at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered as a monotherapy compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to standard platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who progressed after EGFR-TKI and platinum-based chemotherapy [2] - The monotherapy with sac-TMT significantly extended the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [2]

Core Viewpoint - Kelong Pharmaceutical's subsidiary, Sichuan Kelong Botai Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate, sac-TMT (also known as SKB264/MK-2870), for a third indication in treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1] Group 1 - Kelong Pharmaceutical's subsidiary, Sichuan Kelong Botai, has developed an ADC targeting TROP2 [1] - The newly approved indication is specifically for EGFR gene mutation-positive NSCLC patients [1] - This approval marks the third indication for sac-TMT, enhancing its therapeutic applications [1]

Core Viewpoint - Kolon Pharmaceutical's subsidiary, Kolon Biotech, has received acceptance for the marketing application of the new drug, Furmasan Lunbotin Capsules, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults [1][4]. Group 1: Drug Development and Clinical Trials - Lunbotin (A400/EP0031) is a second-generation small molecule selective RET inhibitor developed by Kolon Biotech, showing broad activity against common RET gene fusions and mutations, which may help overcome resistance seen with first-generation inhibitors [4]. - Kolon Biotech has conducted several key clinical studies for Lunbotin, including pivotal trials for first-line and second-line treatment of advanced RET fusion-positive NSCLC, as well as studies for RET fusion-positive medullary thyroid carcinoma (RET + MTC) and solid tumors [4]. Group 2: Market Trends and Company Performance - The anti-tumor drug market is experiencing robust growth, with sales in hospitals projected to exceed 120 billion yuan in 2024, reflecting a year-on-year increase of 6.15% [7]. - Kolon Biotech has successfully developed and commercialized several anti-tumor and immune modulators, including the first-class new drug, Tagolizumab Injection (PD-L1), and the antibody-drug conjugate, Lukanosatuzumab Injection [9]. - In the first half of 2025, Kolon Biotech reported revenues of 950 million yuan, with self-commercial sales amounting to 310 million yuan, representing 32.6% of total revenue [12].

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., has received acceptance from the National Medical Products Administration (NMPA) for a New Drug Application (NDA) for the RET small molecule kinase inhibitor A400 (also known as EP0031) for the treatment of RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1][2]. Drug Overview - The KL400-I/II-01 study includes two key Phase II cohorts assessing the efficacy and safety of A400/EP0031 at a dosage of 90 mg orally once daily for treating RET fusion-positive locally advanced or metastatic NSCLC patients, both treatment-naive and previously treated [1]. - The primary efficacy endpoints of the two key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in NSCLC patients, including those previously treated with immunotherapy or with brain metastases [1]. - A400 is a next-generation selective RET inhibitor aimed at treating NSCLC, medullary thyroid carcinoma (MTC), and other solid tumors with high prevalence of RET mutations [2]. Clinical Development - Kelun Botai is currently conducting a Phase 1b/2 clinical study in China targeting RET+ MTC and solid tumors [2]. - The Phase I study results for A400/EP0031 in advanced RET-mutant MTC patients were presented at the 2025 ASCO Annual Meeting [2]. - In March 2024, A400/EP0031 received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of RET fusion-positive NSCLC, and in April 2024, it was approved to enter Phase 2 clinical development, with trials ongoing in the U.S., U.K., EU, and UAE [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） – 1 – （股份代號：6990） 自願公告 A400/EP0031新藥上市申請獲國家藥品監督管理局受理 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 轉 染 過 程 中 重 排(RET)小分子激酶抑制劑項目A400（亦 稱 EP0031）的 一 項 新 藥 上 市 申 請(NDA)已獲中國國家藥品監督管理局(NMPA)藥 品 審評中心(CDE)受 理，用 於 治 療RET融合陽性局部晚期或轉移性非小細胞肺癌 (NSCLC)成 人 患 者。本 次 受 理 是 基 於KL ...