Core Viewpoint - Hutchison China MediTech Limited (00013.HK) announced that its Syk inhibitor, Solipnib, has achieved the primary endpoint of durable hemoglobin (Hb) response during the treatment period of weeks 5 to 24 in the Phase III registration study ESLIM-02 for adult patients with warm antibody autoimmune hemolytic anemia [1] Group 1 - The ESLIM-02 study is focused on the treatment of adult patients suffering from warm antibody autoimmune hemolytic anemia [1] - The primary endpoint achieved indicates a significant milestone in the development of Solipnib for this specific patient population [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 和黃醫藥宣佈索樂匹尼布 (sovleplenib) 用於治療溫抗體型自身免疫性溶血性貧血的 ESLIM-02中國研究的III期階段取得陽性頂線結果 索樂匹尼布是一種新型、研究性的選擇性口服小分子Syk抑制劑 。Syk作為B細胞受體和Fc受體信號傳導通路中的 一個關鍵蛋白，是多種亞型的B細胞淋巴瘤及自身免疫疾病的成熟治療靶點。 攜帶免疫球蛋白Fc-gamma受體（FcγR）的巨噬細胞加速清除被抗體包裹的紅細胞被認為是溫抗體型自身免疫性 溶血性貧血的致病機制。6 被激活的Syk會介導吞噬細胞中活化的Fc受體的下游信號傳導，導致對紅細胞的吞噬作 用。7 此外，活化的Syk通過B細胞受體介導B淋巴細胞的激活並分化為能分泌抗體的漿細胞。8 抑制Syk可通過抑 制吞噬作用和減少 ...

Core Insights - HUTCHMED announced that the Phase III registration part of the ESLIM-02 clinical trial for sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) has met its primary endpoint of durable hemoglobin response rate within weeks 5 to 24 of treatment [1][3] Group 1: Clinical Trial Results - The ESLIM-02 study is a randomized, double-blind, placebo-controlled trial focusing on adult patients with primary or secondary wAIHA who have relapsed or are refractory to at least one prior line of standard treatment [2] - Results from the Phase II part of the study showed an overall response rate of 43.8% compared to 0% in the first 8 weeks, and 66.7% during the 24 weeks of treatment with sovleplenib, indicating a significant hemoglobin benefit [2][3] - The positive topline results suggest that sovleplenib could provide rapid and durable hemoglobin responses for patients with limited treatment options [3] Group 2: Drug Information - Sovleplenib is a novel, investigational selective small molecule inhibitor targeting spleen tyrosine kinase (Syk), which plays a crucial role in B-cell receptor and Fc receptor signaling [4] - The mechanism of action involves the inhibition of phagocytosis and reduction of antibody production, which may be beneficial in treating wAIHA [5] - In addition to wAIHA, sovleplenib is also being studied for immune thrombocytopenia (ITP), with positive results from a Phase III trial in China [6] Group 3: Future Plans - HUTCHMED plans to submit a New Drug Application (NDA) for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026 [3] - Full results of the ESLIM-02 study will be presented at an upcoming scientific conference, indicating ongoing commitment to transparency and scientific communication [3]

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 ...

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]