Core Viewpoint - Hutchison China MediTech Limited (00013.HK) announced the appointment of Chen Shaowen as an independent non-executive director and a member of the Technical Committee, effective from October 15, 2025 [1] Group 1 - The appointment of Chen Shaowen is aimed at enhancing the governance and technical expertise within the company [1]

Core Viewpoint - The announcement by Hutchison China MediTech Limited (和黄医药) regarding the appointment of Professor Chen Shaowen as an independent non-executive director and a member of the technical committee, effective from October 15, 2025 [1] Group 1 - Professor Chen Shaowen has been appointed to enhance the company's governance and technical expertise [1]

Core Points - Professor Chen Shaowen has been appointed as an independent non-executive director and a member of the technical committee of Hutchison China MediTech Limited, effective from October 15, 2025 [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） 和黃醫藥宣佈委任獨立非執行董事及董事委員會成員 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或「本公司」）今天宣佈，陳邵文教授獲委任為本公司獨立非執行 董事及技術委員會成員，自2025年10月15日起生效。 陳教授，47歲，在腫瘤學擁有超過20年經驗，主要研究領域針對胸腔、頭頸部惡性腫瘤及藥物開發。他目前擔任新 加坡國家癌症中心（「NCCS」）臨床試驗與流行病學科學部主管，並為醫學腫瘤科的高級顧問。他是杜克－新加坡 國立大學醫學院教授，並擔任新加坡基因組研究院高級臨床科學家。 和黃醫藥主席艾樂德博士表示：「本人謹代表董事會熱烈歡迎陳教授。陳教授在新型療法早期臨床試驗方面的往績 卓越 ，而我們相信，他在標靶治療、生物標記開發及臨床腫瘤學方面的專業知識，將大力支持本公司的策略增長， ...

Core Viewpoint - The FRUSICA-2 study results indicate that the combination of fruquintinib and sintilimab may provide a valuable new treatment option for patients with advanced renal cell carcinoma, addressing significant unmet medical needs in this patient population [1][3]. Group 1: Study Overview - The FRUSICA-2 study is a randomized, open-label, positive-controlled registration trial aimed at evaluating the efficacy and safety of fruquintinib combined with sintilimab compared to axitinib or everolimus monotherapy for second-line treatment of advanced renal cell carcinoma [1]. - A total of 234 patients were randomly assigned to receive either the combination therapy or monotherapy [1]. Group 2: Efficacy Results - The median progression-free survival (PFS) for the fruquintinib and sintilimab group was 22.2 months, compared to 6.9 months for the axitinib/everolimus group, with a stratified hazard ratio (HR) of 0.373 and a p-value of <0.0001 [2]. - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy, with an odds ratio of 4.622 and a p-value of <0.0001 [2]. - The median duration of response (DoR) was 23.7 months for the combination group compared to 11.3 months for the monotherapy group [2]. Group 3: Safety Profile - The combination therapy demonstrated a tolerable safety profile, consistent with known characteristics of the treatments, with 71.4% of patients experiencing grade 3 or higher treatment-emergent adverse events (TEAEs) compared to 58.8% in the axitinib/everolimus group [2]. Group 4: Regulatory Progress - Based on the FRUSICA-2 study data, the National Medical Products Administration of China has accepted the new drug application for the combination therapy for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic treatment [3].

Core Insights - The FRUSICA-2 study results indicate that the combination of fruquintinib and sintilimab may provide a valuable new treatment option for patients with advanced renal cell carcinoma, addressing significant unmet medical needs in this patient population [1][3] Study Overview - The FRUSICA-2 study is a randomized, open-label, positive-controlled registration trial designed to evaluate the efficacy and safety of fruquintinib and sintilimab compared to axitinib or everolimus as second-line treatments for advanced renal cell carcinoma [1] - A total of 234 patients were randomly assigned to receive either the combination therapy or monotherapy with axitinib or everolimus, with a median follow-up time of 16.6 months as of the final analysis cutoff date [1] Efficacy Results - The median progression-free survival (PFS) for the fruquintinib and sintilimab combination was 22.2 months, compared to 6.9 months for the axitinib/everolimus group, with a stratified hazard ratio (HR) of 0.373 and a p-value of less than 0.0001 [2] - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy group, with an odds ratio of 4.622 and a p-value of less than 0.0001 [2] - The median duration of response (DoR) was 23.7 months for the combination therapy compared to 11.3 months for the monotherapy group [2] Safety Profile - The combination therapy demonstrated a tolerable safety profile, consistent with known characteristics of the treatments, with 71.4% of patients experiencing grade 3 or higher treatment-emergent adverse events (TEAEs) compared to 58.8% in the axitinib/everolimus group [2] Regulatory Progress - Based on the FRUSICA-2 study data, the National Medical Products Administration of China has accepted the new drug application for the combination therapy of fruquintinib and sintilimab for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic treatment [3]

Core Viewpoint - The FRUSICA-2 study results indicate that the combination of fruquintinib and sintilimab may provide a valuable new treatment option for patients with advanced renal cell carcinoma, addressing significant unmet medical needs in this patient population [1][3]. Summary by Sections Study Overview - The FRUSICA-2 study is a randomized, open-label, positive-controlled registration trial designed to evaluate the efficacy and safety of fruquintinib combined with sintilimab compared to monotherapy with axitinib or everolimus for second-line treatment of advanced renal cell carcinoma [1]. - A total of 234 patients were randomly assigned to receive either the combination therapy or monotherapy [1]. Efficacy Results - The median progression-free survival (PFS) for the fruquintinib and sintilimab group was 22.2 months, compared to 6.9 months for the axitinib/everolimus group (stratified hazard ratio [HR] 0.373; p < 0.0001) [2]. - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy (odds ratio 4.622; p < 0.0001) [2]. - The median duration of response (DoR) was 23.7 months for the combination group compared to 11.3 months for the monotherapy group [2]. - Efficacy benefits were observed across all prognostic risk groups as defined by the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) [2]. Safety Profile - The combination therapy demonstrated a tolerable safety profile, consistent with known characteristics of the treatments [2]. - The proportion of patients experiencing grade 3 or higher treatment-emergent adverse events (TEAEs) was 71.4% in the fruquintinib and sintilimab group, compared to 58.8% in the axitinib/everolimus group [2]. Regulatory Status - Based on the FRUSICA-2 study data, the National Medical Products Administration of China has accepted the new drug application for the combination therapy for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic treatment [3].

Core Insights - The combination of fruquintinib and sintilimab shows significant improvements in progression-free survival (PFS) for patients with advanced renal cell carcinoma after first-line therapy failure [1][3][5] Study Overview - The FRUSICA-2 trial is a randomized, open-label study comparing fruquintinib and sintilimab combination therapy against axitinib or everolimus monotherapy for second-line treatment of advanced renal cell carcinoma, involving 234 patients [2] - The median follow-up for the final PFS analysis was 16.6 months, with a cutoff date of February 17, 2025 [2] Efficacy Results - The median PFS was 22.2 months for the fruquintinib and sintilimab group compared to 6.9 months for the axitinib/everolimus group, with a stratified hazard ratio of 0.373 (p<0.0001) [3] - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy (Odds Ratio 4.622, p<0.0001) [3] - The median duration of response (DoR) was 23.7 months for the combination compared to 11.3 months for the monotherapy [3] - Efficacy benefits were consistent across all prognostic risk groups as defined by the International mRCC Database Consortium (IMDC) criteria [3] Safety Profile - The safety profile of the fruquintinib and sintilimab combination was tolerable, with treatment-emergent adverse events (TEAEs) of grade 3 or above occurring in 71.4% of patients in the combination group compared to 58.8% in the axitinib/everolimus group [4] Regulatory Developments - A New Drug Application (NDA) for the combination therapy has been accepted for review by the China National Medical Products Administration (NMPA) [5] Market Context - In 2022, approximately 435,000 new kidney cancer cases were diagnosed globally, with around 74,000 cases in China, where renal cell carcinoma accounts for about 90% of kidney tumors [6]

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） 呋喹替尼聯合信迪利單抗的盲態獨立中心閱片（BICR）評估的中位PFS為22.2個月 ，阿昔替尼/依維莫司組則為6.9 個月（分層風險比 [HR] 0.373 ；分層log-rank檢驗 p <0.0001） 。客觀緩解率（ORR）分別為60.5%對比24.3% （優 勢比 4.622 ， p <0.0001），中位緩解持續時間（DoR）分別為23.7個月對比11.3個月。截至數據截止時，總存活期 數據仍在持續積累中，成熟度約為20%。在根據國際轉移性腎細胞癌數據庫聯盟（IMDC）標準劃分的所有預後風 險組中，均觀察到療效獲益。 呋喹替尼和信迪利單抗的聯合療法展示出可耐受的安全性，並與各項治療的已知特徵保持一致。呋喹替尼和信迪利 單抗組患者發生3級或以上治療期間不良事件（TEAE）的比例為71.4% ...

Core Insights - The Chinese innovative pharmaceutical industry is experiencing a golden moment, with significant advancements in global market presence and product approvals [1][2] - The number of innovative drugs in development in China is projected to reach 704 by 2024, making it the global leader in this area [3] - The trend of high-value business development (BD) transactions indicates a shift in international perception of Chinese pharmaceutical capabilities [2][5] Group 1: Market Dynamics - Chinese innovative drugs are increasingly recognized on the global stage, with major international investments and partnerships emerging [2][4] - The total value of License-out transactions for Chinese innovative drugs reached nearly $66 billion in the first half of 2025, surpassing the total for 2024 [2] - The successful launch of products like fuquintinib in over 30 countries demonstrates the growing competitiveness of Chinese pharmaceutical companies [1][3] Group 2: Financial Performance - A significant number of Chinese innovative drug companies are reporting profitability, with 75 out of 157 A-share companies being profitable [5] - The revenue from innovative products is becoming a key driver for profitability, as seen with companies like BeiGene, which reported a 45.8% increase in product revenue [5] - The strategic focus on long-term innovation and global collaboration is yielding positive financial results for companies in the sector [5][6] Group 3: Strategic Shifts - Companies are moving away from one-time BD transactions towards building sustainable capabilities for ongoing development and commercialization [7] - The decision by companies like Hutchison China MediTech to divest non-core assets reflects a commitment to strengthening their innovative drug pipeline [7] - The emphasis on core business focus and deepening source innovation is seen as essential for future growth in the competitive global market [7][8] Group 4: Future Outlook - The industry is encouraged to transition from "borrowing boats to go to sea" to "building boats to go to sea," indicating a need for self-sufficiency and innovation [8][9] - Overcoming barriers related to funding, global teams, and drug development capabilities is crucial for the success of Chinese innovative drug companies [8] - The aspiration remains for a cohort of Chinese innovative drug companies to emerge as global pharmaceutical giants in the future [9]