Core Viewpoint - The report from Dongfang Securities predicts that the revenue of Hengrui Medicine (00013) will reach $600 million, $706 million, and $797 million for the years 2025-2027, respectively, and assigns a target price of HKD 33.29 for 2026 based on a PS ratio of 5.29 times [1] Group 1: ATTC Platform and Innovation - The original ATTC platform is set to initiate a new wave of innovative drug development, combining monoclonal antibodies with targeted small molecule inhibitors for enhanced synergistic effects [1] - Unlike traditional ADC platforms, drugs based on the ATTC platform demonstrate superior efficacy while reducing off-target toxicity, achieving both efficacy and safety [1] Group 2: Candidate Drug HMPL-A251 - HMPL-A251, the first candidate drug from the ATTC platform, shows comprehensive anti-tumor activity by targeting both HER2 and PI3K pathways [2] - Preclinical data indicates that HMPL-A251 exhibits strong anti-tumor activity in HER2-positive and low-expressing tumor models, achieving better or comparable efficacy to the mainstream HER2 ADC, Trastuzumab [2] - The company plans to initiate clinical development for HMPL-A251 by the end of this year, exploring its potential across various tumor types with different HER2 and PAM alteration statuses [2] Group 3: Core Pipeline Progress - The company has announced the completion of patient enrollment for the global Phase III study of Savolitinib in combination with Osimertinib for second-line treatment of EGFR-mutant non-small cell lung cancer, known as the SAFFRON study [3] - Top-line data from this study is expected to be released in the first half of next year, with plans to submit a marketing application to the FDA based on the results, indicating potential market expansion [3]

Investment Rating - The report maintains a "Buy" rating for the company [3][6]. Core Insights - The company has introduced a new ATTC platform that enhances innovation in drug development, particularly in cancer and immune disease treatments [10]. - The first candidate drug from the ATTC platform, HMPL-A251, shows promising anti-tumor activity and is expected to enter clinical development by the end of the year [10]. - The company's core pipeline is progressing steadily, with key data readouts for the drug Savolitinib anticipated soon, which could lead to market expansion [10]. Financial Forecasts and Investment Recommendations - Projected revenues for the company from 2025 to 2027 are $600.43 million, $705.84 million, and $796.91 million respectively, with a target price of HKD 33.29 for 2026 [3][5]. - The company is expected to see significant growth in net profit, with a forecasted increase of 1110.15% in 2026 [5]. - The report highlights a projected net profit margin of 76.12% in 2026, indicating strong profitability potential [5].

Core Viewpoint - The ATTC platform developed by Hutchison China MediTech Limited (HCM) aims to overcome the toxicity and resistance issues associated with traditional antibody-drug conjugates (ADCs), with potential for combination therapy with chemotherapy as a first-line standard treatment [1][6]. Summary by Sections ATTC Platform - The ATTC platform is designed to link targeted therapeutic agents with antibodies, producing candidate drugs that can target specific driver mutations, potentially reducing chemotherapy toxicity and enabling combination therapy with standard treatments [1][6]. HMPL-A251 - HMPL-A251 is the first candidate drug from the ATTC platform to enter clinical stages, composed of a PI3K/PIKK inhibitor and a HER2 antibody. It is expected to enter Phase 1 clinical trials in Q4 2025 [1][2][6]. - Preclinical data shows that HMPL-A251 exhibits effective endocytosis in HER2-positive cells and demonstrates HER2 expression-dependent cell growth inhibition, overcoming HER2 heterogeneity through a bystander killing effect [2]. PAM Pathway - The PAM (PI3K-AKT-mTOR) pathway plays a crucial role in cell growth, proliferation, differentiation, and apoptosis, with alterations in this pathway closely linked to various human tumors. Overactivation of PI3K is frequently reported in multiple cancer types [3]. - Existing PAM-targeted therapies have limited clinical benefits due to toxicity associated with PI3K/mTOR inhibition, which restricts the safety window for targeted treatments [3]. Future Pipeline - HCM anticipates two additional ATTC candidates (HMPL-A580 and HMPL-A830) to enter global clinical stages in 2026 [3]. - Clinical data for the first-line treatment of PDAC with surufatinib will be presented at the ESMO Asia conference, and the SAFFRON study of savolitinib combined with osimertinib has completed patient enrollment [1][6]. Investment Recommendation - The new generation ATTC platform from HCM is worth attention, with a smoothly advancing pipeline, maintaining an "outperform" rating [1][6].

Company Updates - The company announced the completion of patient enrollment for the global Phase III clinical trial SAFFRON for savolitinib on November 5 [1] - On October 31, the company participated in the 2025 R&D Day, where management shared progress on the next-generation antibody-drug conjugate (ATTC) platform [1] Clinical Trial Insights - SAFFRON is a pivotal trial for savolitinib's registration in the U.S., with top-line results expected in 1H26 [1] - Savolitinib, in combination with osimertinib, has already been approved in China for MET mutation EGFRm NSCLC patients based on the Phase III trial SACHI [1] - Successful results from SAFFRON could support U.S. approval for savolitinib, opening significant commercialization opportunities [1] ATTC Platform Development - The first candidate molecule HMPL-A251 was showcased at the R&D Day, demonstrating early potential [2] - HMPL-A251 is a high-efficiency PI3K/PIKK inhibitor combined with trastuzumab targeting HER2, showing strong efficacy in blocking PAM and PIKK signaling pathways [2] - The company plans to advance HMPL-A251 to Phase I clinical trials in 4Q25 for HER2+ PAM+/- or HER2 low-expressing PAM+ breast cancer [2] - Additional ATTC molecules A580 and A830 are expected to enter U.S.-China Phase I studies in 1H26 and 2H26, respectively [2] Financial Forecast and Valuation - The company maintains its net profit forecasts for 2025 and 2026 at $366 million and $35 million, respectively [2] - The company retains an outperform rating based on a DCF model, with a target price of HKD 30, indicating a 23.9% upside from the current stock price [2]

Investment Rating - The investment rating for the company is "Outperform the Market" (maintained) [1][6][24] Core Insights - The new generation ATTC platform is expected to address the toxicity and resistance issues associated with traditional ADCs, with potential for combination therapy with chemotherapy as a first-line standard treatment [2][3][23] - HMPL-A251 is the first candidate drug from the ATTC platform expected to enter clinical trials in Q4 2025, combining PI3K/PIKK inhibitors with HER2 antibodies [2][7][23] - The PAM pathway is identified as a promising target for broad tumor treatment, and the ATTC platform aims to expand the therapeutic window for targeted therapies [2][12][23] - The company's later pipeline is progressing smoothly, with clinical data for surufatinib in first-line PDAC expected to be presented at the ESMO Asia conference, and the SAFFRON study of savolitinib combined with osimertinib has completed patient enrollment [2][23] Summary by Sections ATTC Platform - The ATTC platform aims to overcome the toxicity and resistance challenges of traditional ADCs by targeting specific mutations, potentially reducing chemotherapy toxicity and enabling combination therapy [3][23] - HMPL-A251, the first clinical candidate from the ATTC platform, is designed to effectively inhibit the PAM pathway and has shown strong anti-tumor activity in HER2-positive models [7][8][12] Clinical Development - HMPL-A251 has received IND approval in the US, with the Chinese IND under review, and is expected to start Phase 1 clinical trials in Q4 2025 [8][12] - The clinical strategy includes enrolling HER2-positive or low-expressing patients and retrospective testing for PAM status [8][10] Future Pipeline - Besides HMPL-A251, two additional ATTC candidates (HMPL-A580 and HMPL-A830) are expected to enter global clinical stages in 2026 [12][23] - The PAM pathway is highlighted as a significant target due to its role in various cancers, with existing therapies showing limited clinical benefits due to associated toxicity [12][15]

Core Insights - The SAFFRON study has completed patient enrollment, focusing on the combination therapy of savolitinib (ORPATHYS) and osimertinib (TAGRISSO) for treating advanced non-small cell lung cancer (NSCLC) with specific genetic mutations [1][2] - This combination therapy offers a promising oral treatment option without chemotherapy for patients who have progressed after prior EGFR TKI treatment [1] Group 1: Study Overview - The SAFFRON study is a global Phase III, open-label, randomized trial assessing the efficacy of the combination of savolitinib and osimertinib compared to platinum-based doublet chemotherapy [2] - The primary endpoint is progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to RECIST 1.1 criteria [2] - The study involves 338 patients from over 230 research centers across 29 countries [2] Group 2: Expected Outcomes - Top-line results from the SAFFRON study are anticipated to be released in the first half of 2026, with plans to submit findings to relevant academic conferences [2] - If results are favorable, the data may support regulatory submissions for the combination therapy to global regulatory authorities [2]

Core Insights - The SAFFRON study has completed patient enrollment, focusing on the combination therapy of savolitinib (ORPATHYS®) and osimertinib (TAGRISSO®) for treating advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations and MET overexpression or amplification after progression on prior TAGRISSO® treatment [1][2] - This combination therapy offers a promising oral treatment option without chemotherapy for patients who have progressed after one EGFR TKI treatment, having received approval in China based on results from the SACHI study [1] Group 1 - The SAFFRON study is a global Phase III, open-label, randomized trial assessing the efficacy of the combination therapy compared to platinum-based doublet chemotherapy in patients with advanced or metastatic NSCLC [2] - The primary endpoint of the study is progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to RECIST 1.1 criteria, with secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety [2] - A total of 338 patients from over 230 research centers across 29 countries have been randomized in the SAFFRON study, with top-line results expected to be announced in the first half of 2026 [2] Group 2 - If the results are favorable, the data from the SAFFRON study may support regulatory submission for the combination therapy to global regulatory authorities [2]

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 和黃醫藥宣佈沃瑞沙®和泰瑞沙®聯合療法用於治療泰瑞沙®治療後疾病進展的伴有 MET過表達和/或擴增的特定肺癌患者的SAFFRON全球III期研究完成患者入組 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或「HUTCHMED」）今天宣佈SAFFRON研究已完成患者入組。 SAFFRON是一項全球III期研究，旨在評估沃瑞沙® （ORPATHYS® ，賽沃替尼/ savolitinib）和泰瑞沙® （TAGRISSO® ， 奧希替尼/ osimertinib）的聯合療法用於治療既往泰瑞沙®治療後疾病進展的表皮生長因子受體（「EGFR」）突變、 伴有MET過表達和/或擴增的局部晚期或轉移性非小細胞肺癌患者 。該研究的最後一名患者已於2025年10月31日完 成入组。 該聯合 ...

Core Insights - HUTCHMED has completed patient enrollment for the SAFFRON Phase III study, which investigates the combination of ORPATHYS and TAGRISSO for treating advanced non-small cell lung cancer (NSCLC) with specific genetic mutations [1][3][16] - The combination therapy is a promising chemotherapy-free, all-oral treatment option that has already received approval in China based on previous trial results [2][15] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases [18] - The company has successfully brought drug candidates from discovery to market, with its first three medicines approved in China and one also approved globally [18] Study Details - The SAFFRON study is a global, open-label, randomized trial involving 338 patients across 29 countries, aiming to assess the efficacy and safety of ORPATHYS in combination with TAGRISSO compared to traditional chemotherapy [3][4][16] - The primary endpoint of the study is progression-free survival (PFS), with additional endpoints including overall survival (OS) and objective response rate (ORR) [3][4] Market Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases, and a significant portion of patients exhibiting EGFR mutations [5][6] - The combination of ORPATHYS and TAGRISSO addresses resistance mechanisms in patients who have progressed on EGFR TKI therapy, with a notable percentage of these patients presenting with MET aberrations [14][15] Product Information - ORPATHYS (savolitinib) is a selective MET TKI approved in China for specific NSCLC patients, while TAGRISSO (osimertinib) is a third-generation EGFR TKI with proven efficacy in NSCLC [7][10][11] - The combination therapy has shown promising results in previous studies, leading to the initiation of multiple Phase III trials, including SAFFRON [14][15]

Company Overview - HUTCHMED is presenting at Deutsche Bank's Virtual Investor Conference, highlighting its innovative drug FRUZAQLA [1][2] - The company has experienced significant growth, with FRUZAQLA sales increasing by 25% in the first half of the year [4] Leadership and Team - David Ng serves as the Head of Investor Relations and Capital Strategies for HUTCHMED, accompanied by Matthew Kwong, VP of Finance [2] Future Direction - The presentation aims to provide insights into HUTCHMED's past performance, current status, and future direction, emphasizing the company's commitment to global commercial success [4]