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]

Core Insights - Infosys collaborates with Telenor Shared Services to standardize HR processes and enhance employee productivity through Oracle Cloud Human Capital Management [1][2] - The partnership aims to unify various management systems on a single platform, improving data quality and decision-making capabilities [2][3] Company Overview - Infosys is a global leader in next-generation digital services and consulting, with over 320,000 employees operating in 59 countries [4] - The company focuses on enabling clients to navigate digital transformation powered by cloud and AI, emphasizing a commitment to sustainability and diversity [4] Collaboration Details - The collaboration will streamline HR operations and integrate Human Capital Management, Financial Management, Supply Chain Management, and Projects Portfolio Management [2][3] - Telenor Shared Services' CEO highlighted the importance of modernizing HR operations to improve efficiencies and employee experience [3]

Core Insights - The report from CMB International highlights the release of the first batch of innovative pharmaceutical technology medical insurance payment incentive catalog by Zhejiang Province, which is expected to alleviate the challenges of innovative drugs entering hospitals [1] - Despite the Trump administration's announcement of a 100% tariff on imported innovative drugs, the overall impact on China's pharmaceutical industry chain is considered manageable, with a recommendation to monitor subsequent developments [1] - The upcoming ESMO conference in mid to late October is noted as a key event, with a focus on companies such as CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (688331.SH) that are expected to release significant data [1] Industry Summary - The Hong Kong pharmaceutical sector has shown relatively flat performance in September, but with increasing industry catalysts such as academic conferences and favorable policy implementations in October, a market rebound is anticipated [1] - The report recommends focusing on specific segments: 1) Innovative drugs: Companies like 3SBio (01530) and Eucure Biopharma-B (06996) have rich short-term catalysts and their valuations do not yet reflect the core value of major products; companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered significantly undervalued with clear long-term growth logic [1] 2) CXO: Leaders in this segment, such as WuXi AppTec (02268), are expected to benefit from high downstream demand and marginal recovery in financing [1]

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9月30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: 2025年10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 | USD | | 150,000,000 | 本月底法定 ...

Core Insights - The public fund industry has experienced a fruitful year in the structural bull market, with active equity funds making a significant comeback, particularly supported by the AI computing and innovative pharmaceutical sectors [1][2]. Group 1: Fund Performance - A total of 53 funds have achieved over 100% returns year-to-date as of September 30, with 42 of these being active equity funds, showcasing the fund managers' effective strategies in high-growth sectors [2][4]. - The top-performing fund, managed by Ren Jie, achieved a return of 194.49%, heavily investing in the overseas computing industry chain, with significant contributions from stocks like Shenghong Technology, which surged 581% this year [2][3]. - Other notable funds include Zhang Wei's fund with a 155.09% return, focusing on Hong Kong's innovative pharmaceuticals, and Feng Ludan's fund with a 140.86% return, both capitalizing on the AI industry chain [3]. Group 2: Commodity Performance - Gold ETFs have emerged as the standout performers in the commodity fund sector, with all 14 gold ETFs showing gains exceeding 40% year-to-date, driven by rising international gold prices [5][6]. - The highest-performing gold ETFs, managed by Zhao Xu and Rong Ying, reported returns of 41.48% and 41.47%, respectively, reflecting strong long-term investment value [5][6]. Group 3: Market Outlook - Looking ahead to Q4, several fund companies suggest maintaining a focus on growth sectors while also considering cyclical and consumer stocks, as the market has already seen significant gains [7][8]. - The ongoing AI technology innovation is expected to provide a premium valuation for related assets, despite potential short-term volatility [8][9]. - The overall market sentiment remains bullish, with continued optimism for emerging technologies and cyclical financial sectors, particularly in the context of the "anti-involution" policies that may enhance competition in the renewable energy sector [9].

Core Insights - Hutchison China MediTech Limited (和黄医药) will present updated research data on its self-developed compounds at the European Society for Medical Oncology (ESMO) 2025 Annual Meeting in Berlin from October 17 to 21, 2025 [1] Group 1: Research Presentations - The FRUSICA-2 registration study results for fruquintinib combined with sintilimab in the second-line treatment of locally advanced or metastatic renal cell carcinoma will be presented in a mini-oral session [1] - Further analysis results of the FRUSICA-1 study on fruquintinib for endometrial cancer, as well as the SACHI and SAVANNAH studies on savolitinib for non-small cell lung cancer, will be showcased in poster presentations [1]