Market Overview - The Hong Kong stock market opened slightly lower on December 31, with the Hang Seng Index down 0.21% at 25,801.49 points, the Hang Seng Tech Index down 0.22% at 5,566.24 points, and the National Enterprises Index down 0.23% at 8,970.49 points [1] - Major tech stocks mostly declined, with Alibaba down 0.55%, Tencent down 0.42%, and JD.com down 1.32%. Conversely, Xiaomi rose by 0.86% [1] Company News - Zijin Mining (02899.HK) expects to achieve a net profit of approximately RMB 51-52 billion for the fiscal year 2025, representing a year-on-year increase of about 59%-62% due to increased production and sales prices [2] - Starry Development (00640.HK) reported revenue of approximately HKD 835 million for the fiscal year ending September 30, 2025, a year-on-year increase of 13.4%, and a net profit of approximately HKD 122 million, up 21.7% [2] - Shanghai Electric (02727.HK) plans to sell a 47.4% stake in Electric Guoxuan and waive its preemptive rights to an additional 3.6% stake [3] - CNOOC Services (02883.HK) has recently purchased bank wealth management products totaling HKD 3 billion [4] Clinical Trials and Drug Approvals - Fosun Pharma (02196.HK) has initiated clinical trials for its integrated diagnosis and treatment nuclear medicine project SRT-007 within China [5] - Hutchison China MediTech (00013.HK) announced that its new drug application for Savolitinib, intended for treating gastric cancer patients with MET amplification, has been accepted and prioritized for review [5] Strategic Partnerships - Linkong Biotechnology Group (00690.HK) has established a strategic partnership with Wenzhou Medical University National Engineering Research Center and the Ouhai District People's Government [6] Financing Activities - Youlian International Education Leasing (01563.HK) has entered into a financing lease agreement for energy-saving equipment [7] Stock Buybacks - Tencent Holdings (00700.HK) repurchased 1.062 million shares for HKD 636 million at prices ranging from HKD 594.5 to HKD 600.5 [8] - COSCO Shipping Holdings (01919.HK) repurchased 4.3715 million shares for HKD 61.05 million at prices between HKD 13.86 and HKD 14.06 [9] - China Feihe (06186.HK) repurchased 8.837 million shares for HKD 36.34 million at prices between HKD 4.07 and HKD 4.12 [10] - Kuaishou-W (01024.HK) repurchased approximately 464,000 shares for HKD 29.88 million at prices between HKD 63.75 and HKD 64.75 [10] - Giant Bio (02367.HK) repurchased 400,000 shares for HKD 13.44 million at prices between HKD 33.48 and HKD 33.76 [11] Institutional Insights - Everbright Securities notes that the overall profitability of Hong Kong stocks remains strong, with relatively scarce assets in internet, new consumption, and innovative pharmaceuticals. Despite recent gains, valuations are still considered low, suggesting long-term investment potential [12] - Founder Securities highlights positive signals from government policies aimed at optimizing the "two new" policies, which may enhance the competitive environment in the automotive industry [12] - CITIC Securities anticipates a 7.9% increase in Hong Kong private residential transaction volumes in 2026, driven by a favorable interest rate environment and increased asset allocation demand [12]

Major Events - Cloudtop New Horizon (01952) has its original product, Nanfukang®, protected by patent ZL200980127272.5 in China, which is currently valid [1] - Linkang Biotechnology Group (00690) has reached a strategic cooperation with Wenzhou Medical University National Engineering Research Center and the People's Government of Ouhai District, Wenzhou [1] - Auhua Pharmaceutical (00013) announced that the new drug application for Savolitinib for treating gastric cancer patients with MET amplification has been accepted and included in priority review in China [1] - Fosun Pharma (02196) has initiated Phase I clinical trials for its integrated diagnosis and treatment nuclear medicine project SRT-007 within China [1] - Postal Savings Bank of China (01658) has received approval from the National Financial Supervision Administration for the absorption and merger with Postal Huai Wanjia Bank [1] - MicroPort Cardiac Devices-B (02160) has officially published the one-year follow-up results of the early feasibility study for AltaValveTM [1] Operating Performance - New Fire Technology Holdings (01611) reported an annual loss attributable to shareholders of HKD 9.212 million, a shift from profit to loss year-on-year [1] - Xingqian Development (00640) reported an annual net profit of approximately HKD 122 million, an increase of 21.7% year-on-year [1] - Zijin Mining Group (02899) expects a net profit attributable to shareholders of approximately RMB 51-52 billion for the fiscal year 2025, representing a year-on-year increase of about 59%-62% [1] - Zijin Gold International (02259) issued a profit warning, expecting a net profit attributable to shareholders of approximately USD 1.5-1.6 billion for 2025, a year-on-year increase of about 212%-233% [1]

Core Viewpoint - Hutchison China MediTech Limited (HCM) announced that the new drug application for Savolitinib, intended for adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET gene amplification after failing at least two prior treatments, has been accepted by the National Medical Products Administration (NMPA) of China and granted priority review status [1] Group 1 - The new drug application is based on data from a single-arm, multi-center, open-label Phase II registration study conducted in China, which achieved the primary endpoint of objective response rate (ORR) assessed according to RECIST 1.1 [1] - The study details can be found on clinicaltrials.gov under registration number NCT04923932 [1] - Savolitinib was included in the NMPA's list of breakthrough therapies for this potential indication in 2023, recognizing it as a new treatment for serious diseases with significant advantages over existing therapies [1]

Core Viewpoint - The new drug application for Savolitinib, intended for adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET gene amplification, has been accepted by the National Medical Products Administration of China and prioritized for review [1] Group 1: Company Information - The new drug application is based on a Phase II registration study conducted in China, which demonstrated an objective response rate (ORR) as the primary endpoint according to RECIST1.1 criteria [1] - Savolitinib was included in the breakthrough therapy designation by the National Medical Products Administration in 2023, recognizing its significant advantages over existing treatment options for severe diseases [1] Group 2: Industry Context - Gastric cancer is one of the most common cancers in China and is a leading cause of cancer-related deaths [1] - Approximately 4-6% of gastric cancer patients have MET amplification, with an estimated 18,000 new cases of MET-amplified gastric cancer diagnosed annually in China [1]

Core Insights - The New Drug Application (NDA) for savolitinib has been accepted and granted priority review by the China National Medical Products Administration (NMPA) for treating gastric cancer patients with MET amplification who have failed at least two prior systemic treatments [1][2] - Savolitinib is positioned to be the first selective MET inhibitor in China for MET-amplified gastric cancer, which has a poor prognosis [1][3] - The NDA is supported by positive Phase II registration study data demonstrating a significant objective response rate [2][4] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [7] - Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and it is already approved in China under the brand name ORPATHYS [6][5] - The drug has been included in the National Reimbursement Drug List of China since March 2023, indicating its significance in the market [6] Industry Context - Gastric cancer is one of the most common cancers and a leading cause of cancer death in China, with MET amplification occurring in approximately 4-6% of gastric cancer patients [3] - The annual incidence of MET amplification gastric cancer in China is estimated to be around 18,000 cases [3] - The NMPA granted Breakthrough Therapy Designation to savolitinib in 2023, highlighting its potential advantages over existing therapies [4]

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分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。 HUTCHMED (China) Limited 和黃醫藥（中國）有限公司 （於開曼群島註冊成立的有限公司） （股份代號：13） 自願性公告 和黃醫藥宣佈賽沃替尼 (savolitinib) 用於治療伴有MET擴增的胃癌患者的 中國新藥上市申請獲受理並獲納入優先審評 ― 繼2023年獲納入突破性治療品種後，基於一項在中國患者中開展的II期註冊研究結果提交該新藥上市申請 ― ― 賽沃替尼有望成為中國首個用於MET擴增胃癌的選擇性MET抑制劑 ― 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或 「HUTCHMED」）今日宣佈賽沃替尼（savolitinib）用於經過 至少2種治療後失敗的MET基因擴增的局部晚期或轉移性胃癌或胃食道連接部腺癌成人患者的新藥上市申請已獲 中國國家藥品監督管理局（「國家藥監局」）受理，並獲納入優先審評。 該新藥上市申請是基於一項在中國開展的賽沃替尼用於治療伴有MET擴增的胃癌患者的單 ...

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]