Core Viewpoint - The company announced clinical data for its core product, Tengogatinib, in treating advanced cholangiocarcinoma (CCA) patients at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) [1] Group 1: Clinical Data Presentation - Tengogatinib, a novel FGFR inhibitor, shows potential activity in overcoming acquired resistance to previous FGFR inhibitors in CCA patients [1] - The report includes an analysis of circulating tumor DNA (ctDNA) biomarkers to evaluate the efficacy of Tengogatinib in patients with FGFR2 fusions and primary or acquired resistance to FGFR inhibitors [1] - The study assessed genomic alterations in patient ctDNA and correlated efficacy based on ctDNA mutation status and patient subgroups [1] Group 2: Ongoing Research - The results support further investigation in ongoing Phase III clinical trials by expanding biomarker sampling for deeper analysis [1]

Core Viewpoint - The company announced the presentation of clinical data for its core product, Tengogatinib, at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, highlighting its potential in treating advanced cholangiocarcinoma (CCA) patients [1] Group 1: Clinical Data Presentation - Tengogatinib, a novel FGFR inhibitor, shows promising activity in overcoming acquired resistance to previous FGFR inhibitors in CCA patients with FGFR2 alterations [1] - The report includes an analysis of circulating tumor DNA (ctDNA) biomarkers to evaluate the efficacy of Tengogatinib in patients with primary and acquired resistance to FGFR inhibitors, as well as other FGFR mutations or wild-type FGFR [1] - The assessment of genomic alterations in patient ctDNA and the correlation of efficacy based on ctDNA mutation status and patient subgroups were discussed, supporting further research in ongoing Phase III clinical trials [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，概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 TransThera Sciences (Nanjing), Inc. 藥捷安康（南京）科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2617） 自願性公告 於2026年美國臨床腫瘤學會胃腸道腫瘤研討會公佈 替恩戈替尼單藥治療晚期膽管癌患者的臨床數據 本公告由藥捷安康（南京）科技股份有限公司（「本公司」，連同其附屬公司統稱「本 集團」）自願刊發，以向本公司股東及潛在投資者提供有關本集團的最新業務進 展。 本公司董事會（「董事會」）欣然宣佈，本公司在2026年美國臨床腫瘤學會胃腸道腫 瘤研討會(ASCO GI)上以壁報形式公佈了核心產品替恩戈替尼單藥治療晚期膽管 癌(CCA)患者的臨床數據。 題目：替恩戈替尼在晚期膽管癌中的II期研究：分子應答與耐藥機制分析 展示形式：壁報 壁報編號：Bd D9 承董事會命 藥捷安康（南京）科技股份有限公司 董事長兼首席執行官 展示時間：202 ...

Core Viewpoint - The announcement by Hutchison China MediTech regarding the acceptance of the new drug application for Fruquintinib for advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) patients with FGFR2 fusion or rearrangement has been prioritized for review by the National Medical Products Administration of China [1] Company Summary - Hutchison China MediTech has developed Fruquintinib, a novel selective oral inhibitor targeting FGFR1, 2, and 3 [1] - The drug is aimed at adult patients who have previously undergone systemic treatment and have specific genetic markers related to their cancer [1] Industry Summary - Intrahepatic cholangiocarcinoma (ICC) is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2% to 15.0% of primary liver cancers, making it the second most common type after hepatocellular carcinoma [1] - The incidence of ICC has been on the rise, with a five-year overall survival rate of about 9% [1] - Approximately 10-15% of global ICC patients have FGFR2 fusion or rearrangement, indicating a specific target population for Fruquintinib [1]

Core Viewpoint - The announcement by Hutchison China MediTech Limited (00013.HK) regarding the acceptance of the new drug application for Fanregratinib (HMPL-453) by the National Medical Products Administration of China highlights a significant advancement in the treatment options for advanced intrahepatic cholangiocarcinoma (ICC) patients with FGFR2 fusion or rearrangement [1] Company Summary - Hutchison China MediTech Limited has received acceptance for its new drug application for Fanregratinib, a selective oral inhibitor targeting FGFR1, 2, and 3, specifically for adult patients with advanced, metastatic, or unresectable ICC who have previously undergone systemic therapy [1] - The drug application has been prioritized for review by the National Medical Products Administration, indicating its potential significance in the market [1] Industry Summary - Intrahepatic cholangiocarcinoma (ICC) is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2% to 15.0% of primary liver cancers, making it the second most common type after hepatocellular carcinoma [1] - The incidence of ICC has been on the rise, with a five-year overall survival rate of about 9% [1] - Approximately 10-15% of global ICC patients have FGFR2 fusion or rearrangement, indicating a specific target population for Fanregratinib [1]

Core Viewpoint - The new drug application for Fanregratinib (HMPL-453) for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) has been accepted by the National Medical Products Administration of China and is prioritized for review [1] Company Summary - Hutchison China MediTech Limited (和黄医药) announced the acceptance of the new drug application for Fanregratinib, a selective oral inhibitor targeting FGFR1, 2, and 3 [1] - The drug is aimed at patients who have previously undergone systemic treatment and have FGFR2 fusion or rearrangement [1] Industry Summary - Intrahepatic cholangiocarcinoma (ICC) is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2% to 15.0% of primary liver cancers, making it the second most common type after hepatocellular carcinoma [1] - The incidence of ICC has been steadily increasing, with a 5-year overall survival rate of about 9% [1] - Approximately 10-15% of global ICC patients have FGFR2 fusion or rearrangement [1] Research Summary - A Phase II registration study conducted in China, which was single-arm, multicenter, and open-label, provided data supporting the new drug application [1] - The study achieved the primary endpoint of objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS) also supporting the primary findings [1] - Complete study data is expected to be presented at an upcoming academic conference [1]

Core Viewpoint - The new drug application for Fanregratinib (HMPL-453) for the treatment of advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) in adult patients has been accepted by the National Medical Products Administration of China and is included in priority review [1] Company Summary - Hutchison China MediTech Limited (和黄医药) announced the acceptance of the new drug application for Fanregratinib, a selective oral inhibitor targeting FGFR1, 2, and 3 [1] - The drug is aimed at patients who have previously received systemic treatment and have FGFR2 fusion or rearrangement [1] Industry Summary - Intrahepatic cholangiocarcinoma (ICC) is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2% to 15.0% of primary liver cancers, making it the second most common type after hepatocellular carcinoma [1] - The incidence of ICC has been on the rise, with a 5-year overall survival rate of about 9% [1] - Approximately 10-15% of global ICC patients have FGFR2 fusion or rearrangement [1] Research Summary - A Phase II registration study conducted in China, which was a single-arm, multicenter, open-label trial, provided data supporting the new drug application [1] - The study achieved the primary endpoint of objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS) also supporting the primary findings [1] - Complete study data is expected to be presented at an upcoming academic conference [1]

Core Viewpoint - The stock of ZhiJie AnKang-B (02617) has surged nearly 88%, reaching a high of 204.6 HKD, representing an increase of over 1455% from its IPO price of 13.15 HKD, driven by its inclusion in the Hong Kong Stock Connect list and positive developments regarding its core product, Tiengertinib [1][1][1] Company Developments - ZhiJie AnKang's Tiengertinib is the world's first and only FGFR inhibitor to enter the registration clinical stage for treating patients with recurrent or refractory cholangiocarcinoma [1][1] - The company has received multiple positive updates for Tiengertinib, including the approval for a Phase II clinical trial in China for treating HR+ and HER2- recurrent or metastatic breast cancer, which was granted clinical implied permission on September 10 [1][1] - Tiengertinib is also involved in an open-label, multicenter Phase II clinical study for advanced hepatocellular carcinoma (HCC) in combination with other therapies, with the first patient recently dosed [1][1] - The drug has received Fast Track designation from the FDA for the treatment of metastatic castration-resistant prostate cancer [1][1]

Group 1 - The stock of Yaojie Ankang-B (02617) rose over 10%, reaching a new high of 30.7 HKD, which is an increase of over 130% from the IPO price of 13.15 HKD [1] - As of the report, the stock was up 8.83% at 30.2 HKD, with a trading volume of 24.18 million HKD and a market capitalization that briefly exceeded 12 billion HKD [1] - Yaojie Ankang announced that its self-developed multi-target kinase inhibitor, TT-00420, received Fast Track designation from the FDA for the treatment of metastatic castration-resistant prostate cancer [1] Group 2 - According to Frost & Sullivan, the global CCA drug market is expected to reach 2 billion USD by 2024, with a compound annual growth rate (CAGR) of 16.2% from 2019 to 2024 [2] - The market is projected to grow to 3.2 billion USD by 2027, with a CAGR of 17.1% from 2024 to 2027, and further increase to 4.6 billion USD by 2030, with a CAGR of 12.8% from 2027 to 2030 [2] - The company is a leader in the niche industry, with Tinengotinib being the first and only FGFR inhibitor entering the registration clinical stage for treating recurrent or refractory cholangiocarcinoma patients [2]