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 ...

Group 1 - The core viewpoint of the article highlights significant movements in the Hong Kong stock market, with notable gains in specific stocks such as卓悦控股 (Joy City Holdings) and石药集团 (Stone Pharmaceutical Group) due to strategic partnerships and upcoming IPOs [1][3] - 卓悦控股 (00653) has seen its stock price double over the past five trading days, with a recent announcement of a strategic partnership with紫元元 (Ziyuan) to expand cross-border business and new retail markets [1] - 石药集团 (01093) has increased over 5% following the submission of an IPO application for its subsidiary,石药创新 (Stone Innovation), to list on the Hong Kong Stock Exchange [1][3] Group 2 - The technology sector is under pressure, with major companies like阿里巴巴 (Alibaba) and腾讯 (Tencent) experiencing declines, influenced by a drop in U.S. tech stocks [1] - The airline sector continues to show growth, with stocks like首都机场 (Capital Airport) and东方航空 (China Eastern Airlines) rising, supported by a report indicating that public and commercial demand is a key factor affecting ticket prices [1][2] - The mining sector, particularly新疆新鑫矿业 (Xinjiang Xin Mining), has seen a rise of over 6.8% due to a significant reduction in Indonesia's nickel ore production targets for 2026 [2] Group 3 - 微创医疗 (MicroPort) shares rose over 8% after the approval of a merger agreement at a special shareholders' meeting [2] - The introduction of foreign participants in the new round of duty-free bidding at major airports like上海浦东 (Shanghai Pudong) and北京首都 (Beijing Capital) has positively impacted首都机场 (Capital Airport) stock [2] - The fiber optic sector, represented by长飞光纤光缆 (Yangtze Optical Fiber and Cable), has seen significant price increases attributed to AI-driven demand, despite previous expectations of a price decline [2]

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]

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]

Market Overview - US stock market continues to rise with increasing expectations of interest rate cuts, leading to a slight opening increase in Hong Kong stocks, with the Hang Seng Index up 0.17% at 25,804.01 points [1] - Major technology stocks mostly rose, with Alibaba down 0.33%, Tencent down 0.16%, JD.com up 0.61%, Xiaomi up 0.3%, NetEase up 0.32%, Meituan up 0.94%, and Kuaishou up 0.07% [1] - The innovative drug concept opened high, with Gilead Sciences up over 3% and BeiGene up 3.1% [1] - Real estate stocks were active, with China Oceanwide Holdings up over 1% [1] - The non-ferrous metals sector performed actively, with Chalco International up 7.17% and Luoyang Molybdenum up 3.43% [1] - Airline stocks opened lower, with China Eastern Airlines down over 1% [1] - Robotics concept stocks opened high, with Sanhua Intelligent Control up 5.67% and Yujian up 4.06% [1] Company News - InnoCare Pharma (02577.HK) has reached a strategic cooperation agreement with ON Semiconductor to accelerate the development of the GaN industry ecosystem [2] - The collaboration aims to integrate InnoCare's advanced GaN manufacturing capabilities with ON Semiconductor's expertise in system packaging and integration, potentially generating hundreds of millions in GaN sales over the next few years [2] - Agile Group (03383.HK) reported a total pre-sale amount of approximately 8.08 billion, a year-on-year decrease of 45.2% [3] - Jingrui Holdings (01862.HK) reported a cumulative contract sales amount of approximately 876 million, a year-on-year decrease of 54.1% [4] - China Aluminum International (02068.HK) announced that its subsidiary won a bid for a new 394,000 tons/year electrolytic aluminum project in Shanxi, with a total contract price of 3.03 billion [4] - Stone Pharmaceutical Group (01093.HK) received clinical trial approval for a selective 5-HT2A receptor agonist in the US [5] - Fosun Pharma (02196.HK) received clinical trial approval for its subsidiary's FXS887 tablets [6] - Zai Lab (02617) had its Tislelizumab tablets included in the priority review list by the National Medical Products Administration [7] - Deking Pharma (06996) received approval in Hong Kong for its Hivio® to treat two new indications: multiple myeloma and diffuse large B-cell lymphoma [7] - Kaisa Group (01813) has postponed its liquidation hearing to December 8 [8] Industry Insights - According to CCB International, domestic demand policies are being promoted, and the market is focusing on the "New Year" expectations [9] - After the consolidation in November, the Hong Kong stock market is expected to welcome a layout window for the year-end rally in December [9] - The focus is shifting from external environments to internal policies, with attention on the Central Economic Work Conference scheduled for mid-December [9] - Tianfeng Securities reported that most northern provinces have begun implementing staggered production during the heating season, with over 85% of clinker lines in a shutdown state [9] - The overall staggered production efforts have strengthened, with Hunan planning a month-long shutdown in December due to environmental pressures [9] - The bottom profitability support for cement is strong in the short term, with head enterprises starting to address overproduction capacity indicators [9]

Group 1: Company Announcements - JD Industrial (07618) plans to globally issue 211 million shares, with an expected listing date of December 11 [1] - China Gas (00384) adheres to its "green city operator" strategy, building a multi-energy complementary energy system and ecological collaboration, signing a strategic cooperation agreement with EVE Energy [1] - China Nuclear International (02302) indirectly controlled parent company China Uranium Industry officially listed on the Shenzhen Stock Exchange, highlighting its enhanced capital market position [1] - Innoscience (02577) and ON Semiconductor have reached a strategic cooperation agreement to accelerate the development of the gallium nitride industry ecosystem [1] - Innoscience (02577) won a lawsuit against Infineon, with the ITC ruling that the two involved patents were not infringed [1] - Wangshan Wangshui-B (02630) and Ascletis Pharma (02096) signed a licensing agreement for the new indication of VV116 [1] - China Biopharmaceutical (01177) received approval for the launch of the Rotigotine patch [1] - Dechra Pharmaceuticals-B (06996) received approval in Hong Kong for the use of Hivio® in treating multiple myeloma and diffuse large B-cell lymphoma [1] - Xianruida Medical-B (06669) received approval from the National Medical Products Administration for the registration application of the microcatheter V-otter [1] - Jiajie Ankang-B (02617) had its Tiengogatin tablets approved for inclusion in the priority review list by the National Medical Products Administration [1] - Yuexiu Transportation Infrastructure (01052) plans to acquire 85% equity of Shandong Qinbin Expressway for 1.1535 billion yuan [1] Group 2: Share Buybacks and Holdings - Tencent Holdings (00700) repurchased 1.04 million shares for 636 million HKD on December 3 [2] - Xiaomi Group-W (01810) spent approximately 302 million HKD to repurchase 7.5 million shares on December 3 [2] - Midea Group (00300) repurchased 121.27 million A-shares for 99.9984 million yuan on December 3 [2] - SF Express (06936) repurchased 163.86 million A-shares for 62.1907 million yuan on December 3 [2] - COSCO Shipping Holdings (01919) repurchased 3 million shares for 41.3725 million HKD on December 3 [2] - China Feihe (06186) repurchased 400,000 shares for 16.7927 million HKD on December 3 [2] - Galen Pharmaceuticals-B (01672) repurchased 130.6 million shares for 15.9275 million HKD on December 3 [2] - Fenbi (02469) repurchased 453.05 million shares for 14.359 million HKD on December 3 [2] - Jieli Trading Treasure (08017) saw Chairman and Executive Director Liu Yong increase holdings by 1 million shares [2] - Yiming Anke-B (01541) had Executive Director Tian Wenzhi increase holdings by 50,000 H-shares [2] - Dongfang Electric (01072) announced that Senior Vice President Wang Jun plans to reduce holdings by no more than 6,250 shares [2] - Red Star Macalline (01528) shareholder Hangzhou Haoyue plans to reduce holdings by no more than approximately 131 million shares [2] Group 3: Operating Performance - Agile Group (03383) reported a total pre-sale amount of approximately 8.08 billion yuan in the first 11 months, a year-on-year decrease of 45.2% [2]