Core Viewpoint - The stock of药捷安康-B (02617) has dropped over 14% following the unlocking of cornerstone lock-up shares on December 23, leading to a significant decline in its market value [1] Group 1: Stock Performance - As of the report, the stock price of药捷安康-B is down 14.05%, trading at 145 HKD, with a transaction volume of 163 million HKD [1] - The stock reached a historical high of 679.5 HKD per share in mid-September, representing an increase of nearly 51 times from its initial public offering price of 13.15 HKD on June 23 [1] Group 2: Share Unlocking - A total of 5 shareholders of药捷安康 experienced a share unlocking event, with a cumulative total of 9.774 million shares being released [1] - The unlocking of shares is a significant event as it may impact the stock's liquidity and market perception [1]

Core Viewpoint - The announcement indicates that the new drug application for Tienogratinib tablets has been accepted by the China National Medical Products Administration, targeting advanced, metastatic, or unresectable cholangiocarcinoma patients who have previously received at least one systemic therapy and FGFR inhibitor treatment [2] Group 1 - The drug Tienogratinib is intended for adult patients with advanced, metastatic, or unresectable cholangiocarcinoma [2] - The application for Tienogratinib has been included in the priority review and breakthrough therapy lists prior to this acceptance [2]

Core Viewpoint - The new drug application for Tienogratinib tablets has been accepted by the Center for Drug Evaluation of the National Medical Products Administration of China, aimed at treating adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] Group 1 - Tienogratinib tablets are intended for patients with advanced cholangiocarcinoma [1] - The drug has previously been included in the priority review and breakthrough therapy lists [1]

Core Viewpoint - The announcement indicates that the new drug application for Tienogratinib tablets has been accepted by the National Medical Products Administration of China, aimed at treating adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] Group 1 - The drug Tienogratinib is intended for patients with advanced cholangiocarcinoma [1] - The application has been prioritized and included in the breakthrough therapy list [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。 本公司董事會（「董事會」）欣然宣佈，替恩戈替尼片的新藥上市申請已獲中國國家 藥品監督管理局（「NMPA」）藥品審評中心（「CDE」）受理，擬用於治療既往至少 接受過一種系統性治療和FGFR抑制劑治療的晚期、轉移性或不可手術切除的膽 管癌成人患者。此前，替恩戈替尼片此適應症已獲批准納入優先審評品種名單及 突破性治療品種名單。 上市規則第18A.08(3)條規定的警示聲明：無法保證本公司將能最終成功開發及銷 售相關產品。 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 吳永謙博士 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 替恩戈替尼片新藥上市申請獲國家藥品監督管理局受理 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 ...

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，近日，本公司核心產品替恩戈替尼在美國開 展的針對膽管癌的探索性臨床2期結果在《柳葉刀，胃腸病和肝病學》（影響因子 38.6）上發表。 膽管癌是一種侵襲性極強的膽道系統癌症，其發病常由FGFR2融合驅動，這類突 變可通過佩米替尼(pemigatinib)和福替巴替尼(futibatinib)等抑制劑靶向治療。然 而，由於獲得性FGFR2突變的出現，耐藥性往往會頻繁產生。在這項2期、開放 標籤、多中心研究(NCT04919642)中，符合條件的膽管癌患者包括攜帶FGFR2融 合且對FGFR抑制劑存在原發性或獲得性耐藥的患者，或存在其他FGFR基因改變 的患者，以及FGFR野生型患者。替恩戈替尼可克服FGFR2融合陽性膽管癌患者 對FGFR抑制劑的獲得性耐藥，並在其他FGFR基因改變的膽管癌患者中顯示出抗 腫瘤活性。 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 ...

Core Viewpoint - The stock of Jiangsu Hengrui Medicine Co., Ltd. (药捷安康-B) has seen a significant increase, attributed to the approval of its drug, Tienogratinib, for priority review by the NMPA for treating advanced cholangiocarcinoma [1] Group 1: Stock Performance - Jiangsu Hengrui Medicine's stock rose over 9% in early trading and is currently up 4.9%, priced at 179.7 HKD, with a trading volume of 77.964 million HKD [1] Group 2: Regulatory Approval - Tienogratinib has been included in the priority review list by the NMPA, aimed at treating adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] - The drug has also been designated as a breakthrough therapy for cholangiocarcinoma by the NMPA [1] Group 3: Clinical Research - Jiangsu Hengrui Medicine announced the publication of exploratory Phase 2 clinical trial results for Tienogratinib in cholangiocarcinoma in The Lancet Gastroenterology & Hepatology [1] - The Phase 2 study (NCT04919642) included eligible cholangiocarcinoma patients with FGFR2 fusions and those with primary or acquired resistance to FGFR inhibitors, as well as patients with other FGFR gene alterations and FGFR wild-type patients [1] - Tienogratinib demonstrated the ability to overcome acquired resistance in FGFR2 fusion-positive cholangiocarcinoma patients and showed anti-tumor activity in other FGFR gene-altered cholangiocarcinoma patients [1]

每经AI快讯，药捷安康-B(02617.HK)早盘涨超9%，截至发稿涨4.9%，报179.7港元，成交额7796.4万港 元。 ...

Core Viewpoint - The stock of Jiangsu Hengrui Medicine Co., Ltd. (02617) has seen a significant increase, attributed to the approval of its drug, Tienogratinib, by the NMPA for priority review in treating advanced cholangiocarcinoma patients [1] Group 1: Company Developments - Jiangsu Hengrui Medicine's stock rose over 9% in early trading, currently up 4.9% at HKD 179.7, with a trading volume of HKD 77.964 million [1] - The NMPA has included Tienogratinib in its priority review list for patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] - Tienogratinib has also been recognized as a breakthrough therapy for cholangiocarcinoma by the NMPA [1] Group 2: Clinical Research - Jiangsu Hengrui Medicine announced the publication of exploratory Phase 2 clinical trial results for Tienogratinib in cholangiocarcinoma in The Lancet Gastroenterology & Hepatology [1] - The Phase 2 study (NCT04919642) included eligible cholangiocarcinoma patients with FGFR2 fusions and those with primary or acquired resistance to FGFR inhibitors, as well as patients with other FGFR gene alterations and FGFR wild-type patients [1] - Tienogratinib demonstrated the ability to overcome acquired resistance in FGFR2 fusion-positive cholangiocarcinoma patients and showed antitumor activity in other patients with FGFR gene alterations [1]

Core Viewpoint - The stock of Zai Lab Limited (药捷安康-B) has seen a significant increase, attributed to the approval of its drug, Tazemetostat, for priority review by the NMPA for treating advanced cholangiocarcinoma in adult patients [1] Group 1: Regulatory Approval - Tazemetostat has been included in the priority review list by the NMPA for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] - The drug has previously been recognized as a breakthrough therapy for cholangiocarcinoma by the NMPA [1] Group 2: Clinical Trial Results - Zai Lab announced that the exploratory Phase 2 clinical trial results for Tazemetostat in cholangiocarcinoma were published in The Lancet Gastroenterology & Hepatology, which has an impact factor of 38.6 [1] - The Phase 2 study (NCT04919642) included eligible cholangiocarcinoma patients with FGFR2 fusions who had primary or acquired resistance to FGFR inhibitors, as well as patients with other FGFR gene alterations and FGFR wild-type patients [1] - Tazemetostat demonstrated the ability to overcome acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma patients and showed antitumor activity in other cholangiocarcinoma patients with FGFR gene alterations [1]