Core Viewpoint - The company, Hutchison China MediTech Limited (和黄医药), has initiated the Phase III portion of a clinical trial for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1]. Group 1 - The study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial aimed at evaluating the efficacy and safety of the S+C+AG regimen compared to the AG regimen in adult patients with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy [2]. - The Phase II portion of the study included 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion [2]. - The primary endpoint of the Phase III portion is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2]. Group 2 - Results from the Phase II portion were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress, showing a median PFS of 8.15 months as of the data cutoff on July 24, 2025 [3]. - The S+C+AG group had a median PFS of 7.20 months compared to 5.52 months for the AG group, indicating a 50.1% reduction in the risk of disease progression or death (HR 0.499, p=0.0407) [3]. - Other key efficacy endpoints showed similar benefits, with an ORR of 67.7% versus 41.9% (p=0.0430) and a DCR of 93.5% versus 71.0% (p=0.0149) [3]. - Although overall survival data is not yet mature, a positive trend has been observed, with 9 events in the S+C+AG group and 15 events in the AG group [3]. - The treatment demonstrated manageable safety characteristics, with 80.6% of patients in the S+C+AG group experiencing grade 3 or higher treatment-emergent adverse events (TEAEs), compared to 61.3% in the AG group [3].

Core Viewpoint - The company announced the initiation of a Phase III portion of a clinical trial for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1] Group 1: Clinical Trial Details - The study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial aimed at evaluating the efficacy and safety of the S+C+AG regimen compared to the AG regimen in adult metastatic pancreatic cancer patients who have not previously received systemic anti-tumor treatment [2] - The Phase II portion included 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion [2] - The primary endpoint for the Phase III portion is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2] Group 2: Phase II Results - The results of the Phase II portion were recently presented at the 2025 ESMO Asia Congress, with a median PFS follow-up time of 8.15 months [3] - The median PFS for the S+C+AG group was 7.20 months, compared to 5.52 months for the AG group, indicating a 50.1% reduction in the risk of disease progression or death (stratified hazard ratio [HR] 0.499, log-rank test p=0.0407) [3] - Other key efficacy endpoints showed similar benefits, including ORR (67.7% vs. 41.9%, p=0.0430) and DCR (93.5% vs. 71.0%, p=0.0149) [3] - Although overall survival data is not yet mature, a positive trend has been observed, with 9 events in the S+C+AG group (N=31) and 15 events in the AG group (N=31) [3] - The treatment demonstrated manageable safety characteristics, with 80.6% of patients in the S+C+AG group experiencing grade 3 or higher treatment-emergent adverse events (TEAEs), compared to 61.3% in the AG group [3]

Core Viewpoint - Hutchison China MediTech Limited (HCM) has announced the initiation of a Phase III portion of a clinical study for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1] Group 1 - The clinical study is a Phase II/III trial focusing on the treatment of metastatic PDAC [1] - The combination therapy includes surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine [1] - The first patient has already commenced treatment as of December 30, 2025 [1]

Core Viewpoint - HUTCHMED has initiated the Phase III part of a clinical trial to evaluate a combination therapy for metastatic pancreatic ductal adenocarcinoma (PDAC), which is a highly aggressive cancer with poor survival rates [1][2]. Group 1: Clinical Trial Details - The trial is a multicenter, randomized, open-label, active-controlled Phase II/III study assessing the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer who have not received prior systemic therapy [2]. - A total of 62 patients were enrolled in the Phase II part, with plans to enroll approximately 400 additional patients in the Phase III part [2]. - The primary endpoint for the Phase III part is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2]. Group 2: Phase II Results - As of July 24, 2025, the median PFS for the S+C+AG regimen was 7.20 months compared to 5.52 months for the AG arm, indicating a 50.1% reduction in the risk of progression or death [3]. - The ORR was 67.7% for the S+C+AG arm versus 41.9% for the AG arm, and the DCR was 93.5% compared to 71.0% for the AG arm [3]. - Although overall survival data were immature, a favorable trend was observed with 9 events in the S+C+AG arm and 15 events in the AG arm [3]. Group 3: Drug Information - Surufatinib is a novel oral angio-immuno kinase inhibitor that targets VEGFRs, FGFR, and CSF-1R, promoting the immune response against tumor cells [4]. - Camrelizumab is a humanized monoclonal antibody targeting the PD-1 receptor, approved in China for multiple cancer indications [5]. - HUTCHMED is an innovative biopharmaceutical company focused on the development and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [6].

HUTCHMED (China) Limited 和黃醫藥（中國）有限公司 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。 （於開曼群島註冊成立的有限公司） （股份代號：13） 自願性公告 和黃醫藥啟動現正進行中的索凡替尼聯合卡瑞利珠單抗用於治療 初治胰腺導管腺癌研究的III期階段 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或 「HUTCHMED」）今日宣佈啟動索凡替尼（surufatinib）聯合 卡瑞利珠單抗（camrelizumab）、白蛋白結合型紫杉醇（nab-paclitaxel）和吉西他濱（gemcitabine）用於一線 治療轉移性胰腺導管腺癌（PDAC）患者的中國II/III期研究的III期部分。首名患者已於2025年12月30日接受首次 給藥治療。 胰腺導管腺癌是一種高度侵襲性的癌症，佔胰腺癌病例的90%以上。全球估計有511,000人被診斷為患有胰腺癌， 於2022年導致約467,000人死亡，平均的五年存活率低於10% 。在中國， ...

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 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]