本月底法定/註冊股本總額： USD 150,000,000 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 和黃醫藥（中國）有限公司 呈交日期: 2026年1月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00013 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 1,500,000,000 | USD | | 0.1 | USD | | 150,000,000 | | 增加 / 減少 (-) | | | 0 | | | | USD | | | | 本月底結存 | | | 1,500,000,000 | USD | | 0.1 ...

Market Performance - The Hang Seng Index closed down 0.87% at 25,630.54 points, while the Hang Seng Tech Index fell 1.12% to 5,515.98 points, and the National Enterprises Index decreased by 0.86% to 8,913.68 points [1] - The overall market saw declines in tech stocks, with Alibaba down 1.18%, Tencent down 0.17%, and JD Group down 1.76%, while Bilibili and Baidu saw gains of 0.42% and 1.39% respectively [1] - The annual performance of the Hang Seng Index increased by 27.77%, marking the best performance since 2017, while the Hang Seng Tech Index rose by 23.45%, the best since 2020 [2] Sector Performance - The gold and precious metals sector showed significant gains, with Zhu Feng Gold rising over 1200% and Lingbao Gold increasing by over 570% throughout the year [2] - The semiconductor sector performed well, with Huahong Semiconductor up over 240% and SMIC up over 120% [2] - The aviation sector saw strong performance, with Southern Airlines rising over 4% [1] Company Updates - Zijin Mining (02899.HK) expects a net profit of approximately RMB 51-52 billion for 2025, a year-on-year increase of about 59%-62% due to increased production and sales prices [3] - Xingqian Development (00640.HK) reported a revenue of approximately HKD 835 million for the year ending September 30, 2025, a 13.4% year-on-year increase, with net profit rising by 21.7% to approximately HKD 122 million [3] - Shanghai Electric (02727.HK) plans to sell a 47.4% stake in Electric Guoxuan and waive the right of first refusal for an additional 3.6% stake [4] Investment Insights - Everbright Securities noted that the overall profitability of Hong Kong stocks remains strong, with relatively low valuations despite recent increases, suggesting long-term investment opportunities [13] - Founder Securities highlighted positive signals from government policies aimed at optimizing the automotive industry, indicating potential for improved market conditions and value in leading automotive companies [14] - CITIC Securities projected a 7.9% increase in private residential transactions in Hong Kong for 2026, driven by a favorable interest rate environment and increased asset allocation demand [14]

Core Insights - Chinese companies are projected to conduct approximately 39% of global cancer clinical trials in 2024, surpassing the United States at about 32% [2][8] - The number of clinical trials in China has increased significantly, from around 2% in 2009 to approximately 35% in 2023, indicating a growing dominance in the cancer research field [2][8] - The Chinese government is providing strong support for new drug research, designating it as a key national focus and investing substantial resources [4][8] Clinical Trials and Market Dynamics - In 2024, Chinese enterprises are expected to conduct 896 cancer clinical trials, leading globally, while the U.S. will conduct 720 trials [2][8] - The total number of clinical trials globally is projected to be 5,318, with Chinese companies accounting for 1,669 trials, approximately 30% of the total [7][8] - The increase in patient numbers in China facilitates easier clinical trial execution and drug development [5] Collaborations and Partnerships - Japanese pharmaceutical companies are increasingly collaborating with Chinese firms, with notable agreements in cancer treatment and autoimmune disease therapies [6][7] - In 2023, Takeda Pharmaceutical signed an agreement with a Chinese company for cancer drug licensing, highlighting the advantages of conducting research in China [6][7] - By mid-2025, contracts between Chinese and global pharmaceutical companies are expected to exceed $48.5 billion, indicating a robust partnership trend [7] Intellectual Property and Globalization - China filed over 188,000 drug patents in 2024, significantly outpacing the U.S. with about 53,000 patents, reflecting a rapid enhancement in research capabilities [7][8] - For Chinese drugs to enter international markets, they must undergo rigorous clinical trials and secure regulatory approvals, emphasizing the importance of intellectual property protection [10] - The potential for innovative Chinese drugs to be utilized globally is increasing, necessitating careful management of economic and geopolitical risks [10]

Core Viewpoint - Chinese companies are leading the world in cancer clinical trials, with a projected 39% share in 2024, surpassing the United States at 32% and indicating a significant shift in the global pharmaceutical landscape [1][3]. Group 1: Clinical Trials and Market Position - In 2024, Chinese enterprises are expected to conduct 896 cancer clinical trials, representing 39% of the global total, while the U.S. will account for approximately 32% [3]. - The number of clinical trials conducted by Chinese companies has increased from about 2% in 2009 to 35% in 2023, marking a substantial growth trajectory [3]. - The global market for pharmaceuticals is projected to see China’s drug expenditure reach $166 billion in 2024, constituting 10% of the global market [9]. Group 2: Government Support and R&D Investment - The Chinese government has prioritized new drug research as a key area, providing substantial funding and talent, particularly in the biopharmaceutical sector [7]. - The "Made in China 2025" initiative has identified biomedicine as a critical industry for national revitalization [7]. Group 3: Collaborations and Partnerships - Japanese pharmaceutical companies are increasingly collaborating with Chinese firms, with notable agreements for cancer treatments and other therapeutic areas [8]. - In the first half of 2025, contracts between Chinese and global pharmaceutical companies reached 61, totaling $48.5 billion, indicating a growing trend in international partnerships [9]. Group 4: Innovation and Patent Applications - China applied for over 188,000 drug patents in 2024, significantly outpacing the U.S. with approximately 53,000 applications, showcasing an increase in R&D capabilities [9]. - The quality of drug development in China is improving, with expectations for the emergence of blockbuster drugs and major pharmaceutical companies in the future [9]. Group 5: Global Market Challenges - Despite advancements, Chinese drugs primarily remain within the domestic market, with challenges in gaining approval for international sales [11]. - The need for transparent clinical trial data and intellectual property protection is crucial for Chinese companies aiming for global market entry [12].

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]

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 ...

Market Performance - The Hong Kong stock market showed a positive trend on December 30, with the Hang Seng Index rising by 0.86% to 25,854.6 points, the Hang Seng Tech Index increasing by 1.74% to 5,578.38 points, and the National Enterprises Index up by 1.12% to 8,991.02 points [1] - Major technology stocks experienced gains, with Alibaba up by 0.84%, Tencent Holdings by 0.59%, JD Group by 1.43%, Xiaomi by 2.02%, NetEase by 2.59%, Meituan by 0.1%, Kuaishou by 1.1%, and Bilibili by 0.68% [1] - Semiconductor stocks also saw an increase, with InnoCare rising over 15%, SMIC up over 4%, and Hua Hong Semiconductor increasing nearly 4% [1] - The gold sector faced declines, with Zhu Feng Gold dropping over 6% and Lao Pu Gold down over 5% [1] - The "three oil giants" saw gains, with CNOOC rising nearly 4% [1] - Wind power stocks declined, with leading company Goldwind Technology falling nearly 11% [1] Corporate News - China Energy Construction (03996.HK) announced that its subsidiary won a bid for an ecological comprehensive governance project in Shaanxi Province, with a total contract value of 6.864 billion RMB, covering various construction aspects with a total duration of 36 months [2] - China Shenhua (01088.HK) reported that its second phase of the Qingyuan power plant's Unit 3 has completed a 168-hour trial run and is now in commercial operation, while Unit 4 is on track for commissioning in February 2026 [2] - Bay Area Development (00737.HK) signed a construction contract with Poly Longda for a total price of 775 million RMB [3] - China Railway Construction (01186.HK) completed the issuance of 4.45 billion RMB in corporate bonds [4] - Sichuan Energy Investment Development (01713.HK) entered into a strategic cooperation agreement with Mengsheng Electronics to deepen collaboration in the power industry [5] - China Supply Chain Industry (03708.HK) signed a "Test Version Data Center Agreement" with Shuwi Technology [6] - Stone Pharmaceutical Group (01093.HK) received clinical trial approval for its GLP-1/GIP receptor dual agonist injection in China [6] - Hutchison China MediTech (00013.HK) announced that its application for the new drug listing of HMPL-453 for second-line treatment of intrahepatic cholangiocarcinoma has been accepted and prioritized for review [6] - Fuhong Hanlin (02696.HK) completed the first patient dosing in a Phase I clinical study of HLX37 for advanced/metastatic solid tumors in China [6] - Henxin Technology (01085.HK) announced that its planned 350MW solar thermal power station is ready to commence construction [7] - Runhua Services (02455.HK) expanded its property management services to multiple provinces in western China [8] - Hong Kong International Industries (00480.HK) plans to sell its entire issued share capital of Yue Shan Limited for 452 million HKD [9] - Yimei International Holdings (01870.HK) received formal approval for its 218MW/436MWh electrochemical independent energy storage project in Shaoguan City [9] Institutional Insights - Huatai Securities noted that the volatility of asset performance and frequent style and industry rotations have led to a decrease in clarity regarding market themes, with two main consensus points: solid logic for bulk commodity sectors and a left-side bias in consumer sector allocations due to weak domestic recovery [10] - CITIC Securities highlighted the recent appreciation of the RMB, which benefits RMB-denominated equity assets, and indicated that the central bank's policy tools will be used more flexibly, focusing on domestic demand targets [11] - The outlook for 2026 suggests stable macro-financial conditions pointing to a stable banking operating environment, with expectations for bank interest margins to bottom out and income and profit recovery in the real sector [11]