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]

Core Insights - HUTCHMED's New Drug Application (NDA) for fanregratinib has been accepted and granted priority review by the China National Medical Products Administration (NMPA) for treating advanced intrahepatic cholangiocarcinoma (ICC) patients with FGFR2 fusion/rearrangement who have previously undergone systemic therapy [1][3]. Company Overview - HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [5]. - The company retains all global rights to fanregratinib, which is a selective oral inhibitor targeting FGFR 1, 2, and 3 [4]. Industry Context - ICC is the second most common form of liver cancer, accounting for 8.2-15.0% of primary liver cancers, with a rising incidence and a 5-year overall survival rate of approximately 9% [2]. - About 10-15% of ICC patients globally have tumors with FGFR2 fusions or rearrangements, indicating a specific target for fanregratinib [2]. Clinical Data - The NDA is supported by a Phase II registration study in China, which met its primary endpoint of objective response rate (ORR) and showed positive results in secondary endpoints such as progression-free survival (PFS) and overall survival (OS) [3].

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。 ― 僅次於肝細胞癌的第二大常見肝癌類型，長期生存率一般相對較差 ― 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或 「HUTCHMED」）今日宣佈凡瑞格拉替尼 （fanregratinib ，HMPL-453） 用於既往接受過系統性治療，且具有成纖維細胞生長因子受體（「FGFR」）2融合或重排的晚期、轉移性或不可手 術切除的肝內膽管癌（ICC）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。 凡瑞格拉替尼是一種新型、選擇性的FGFR1 、2和3口服抑制劑。肝內膽管癌是一種起源於肝內膽管上皮的具有高度 侵襲性的惡性腫瘤，佔原發性肝癌的約8.2%至15.0% ，是繼肝細胞癌之後第二常見的肝癌類型。近年來，肝內膽管 癌發病率呈持續上升趨勢，5年總生存率約9%。1 全球肝內膽管癌患者中約有10-15％伴有FGFR2融合或重排。2,3 一項在中國開展的單臂、多中心、開放標 ...

Core Insights - 2025 marks a pivotal year for China's innovative pharmaceuticals, with a significant increase in international collaborations and licensing agreements, indicating a shift from a pharmaceutical giant to a stronghold in the industry [1][3] - The total amount of outbound licensing agreements exceeded $100 billion, with upfront payments reaching $8.1 billion, showcasing a transition to multi-layered cooperation models [1][3] - China's biopharmaceutical market remains the second largest globally, with innovative drugs accounting for approximately 30% of global research, reflecting a critical leap from following to competing on a global scale [1][3] Internationalization - The internationalization of China's pharmaceutical industry saw explosive growth in 2025, highlighted by a surge in business development (BD) transactions and the popularity of "A+H" listings [3][4] - The total amount of outbound licensing for innovative drugs reached over $100 billion, a 75% increase from 2024, indicating a shift from merely selling products to actively engaging in global markets [3][4] - Notable BD transactions include significant agreements between major Chinese pharmaceutical companies and international firms, such as a $12.5 billion deal between Hengrui Medicine and GSK [3][4] Innovation - In 2025, advancements in cutting-edge technologies such as antibody-drug conjugates (ADC) and dual antibodies have shown promising results in cancer treatment [7][8] - The third-generation ADC technology has become mainstream, with significant efficacy demonstrated in treating solid tumors [7] - The dual antibody sector continues to lead, with Chinese companies achieving remarkable results in clinical trials, such as a 91% improvement in progression-free survival compared to existing treatments [8] Policy Support - The policy support for innovative drugs in China has reached unprecedented levels, with a notable increase in the number of approved innovative drugs [10][11] - The National Medical Products Administration approved 69 innovative drugs in 2025, a 44% increase from the previous year, covering various therapeutic areas [10] - The payment system for innovative drugs has been significantly upgraded, enhancing accessibility and affordability for patients [10][11] Mergers and Acquisitions - The pharmaceutical sector has seen a surge in mergers and acquisitions, with over 400 transactions announced globally, totaling approximately $111 billion, marking a 50% increase from 2024 [13][14] - Domestic mergers also showed strong activity, with significant deals indicating a shift towards quality improvement and resource consolidation among leading companies [13][14] - The trend reflects a transition from scale expansion to enhancing quality and efficiency, with companies focusing on high-value clinical pipelines [14]