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华源证券:维持和黄医药(00013)“买入”评级 关注ATTC平台价值
智通财经网· 2025-11-11 07:07
Core Viewpoint - Huadong Medicine (00013) has significant potential in its innovative pipeline, with a "Buy" rating maintained by Huayuan Securities, projecting total revenues of $567 million, $676 million, and $816 million for 2025-2027 respectively. The calculated fair equity value of the company is HKD 26.9 billion based on a DCF model with a perpetual growth rate of 2% and a WACC of 9.43% [1] Group 1: Breakthrough ATTC Platform and Pipeline Potential - The ATTC platform is a proprietary cancer precision therapy drug development platform that connects monoclonal antibodies with patented targeted small molecule inhibitors, aiming for dual action mechanisms. This platform is expected to offer superior anti-tumor activity and safety compared to traditional ADCs [2] - The first potential pipeline from this platform is HMPL-A251, a PAM-HER2 ATTC that combines a highly selective and potent PI3K/PIKK inhibitor with a humanized anti-HER2 IgG1 antibody via a cleavable linker. Preclinical studies have shown promising anti-tumor efficacy and tolerability, with plans to advance HMPL-A251 into clinical development by the end of 2025 [2] Group 2: Ongoing Late-Stage Projects and Future Prospects - The FRUSICA-2 study on fruquintinib combined with sintilimab for second-line treatment of renal cell carcinoma will present data at the 2025 ESMO conference, showing a median progression-free survival (mPFS) of 22.2 months and an overall response rate (ORR) of 60.5% [3] - The SANOVO China Phase III study for savolitinib in first-line treatment of EGFR-mutant non-small cell lung cancer (NSCLC) with MET overexpression has completed patient recruitment, while the SAFFRON global Phase III study for second-line treatment is progressing well, expected to complete recruitment by the end of 2025 [3] - The ongoing Phase II/III study of surufatinib combined with carrelizumab, albumin-bound paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma is progressing smoothly, with Phase II results to be announced at an upcoming scientific conference [3] - The Chinese registration Phase II study of HMPL-453 for advanced intrahepatic cholangiocarcinoma has completed recruitment, with plans to submit a new drug application in the first half of 2026 [3]
和黄医药(00013):关注ATTC平台价值,潜力管线不断开发中
Hua Yuan Zheng Quan· 2025-11-10 11:45
Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The report emphasizes the value of the ATTC platform and the continuous development of potential pipelines [5][7] - The company is advancing innovative treatments for cancer and immune diseases, showcasing its proprietary ATTC platform and the latest progress in late-stage pipeline candidates [7] Financial Performance and Forecast - The company’s projected revenues for 2025, 2026, and 2027 are $567 million, $676 million, and $816 million respectively, with growth rates of -10.0%, 19.2%, and 20.7% [6][8] - The expected net profit for 2025, 2026, and 2027 is $426 million, $94 million, and $138 million respectively, with growth rates of 1029.3%, -78.0%, and 46.7% [6][8] - The report anticipates a reasonable equity value of HKD 26.9 billion based on DCF calculations, assuming a perpetual growth rate of 2% and a WACC of 9.43% [7] Pipeline Development - The ATTC platform is a novel cancer precision therapy development platform that combines monoclonal antibodies with proprietary targeted small molecule inhibitors, aiming for superior anti-tumor activity and safety [7] - The first potential pipeline candidate from this platform is HMPL-A251, which has shown promising anti-tumor efficacy and tolerability in preclinical studies, with plans to enter clinical development by the end of 2025 [7] - Ongoing projects include: 1. FRUSICA-2 study for fruquintinib combined with sintilimab in renal cell carcinoma [7] 2. SANOVO study for savolitinib in non-small cell lung cancer [7] 3. Ongoing studies for surufatinib in pancreatic cancer [7] 4. HMPL-453 for intrahepatic cholangiocarcinoma, with plans for a new drug application in mid-2026 [7]
东方证券:维持和黄医药“买入”评级 全新ATTC平台激发创新活力
Zhi Tong Cai Jing· 2025-11-10 06:39
Core Viewpoint - The report from Dongfang Securities predicts that the revenue of Hengrui Medicine (00013) will reach $600 million, $706 million, and $797 million in 2025, 2026, and 2027 respectively, maintaining a "buy" rating with a target price of HKD 33.29 for 2026 based on a PS ratio of 5.29 times [1] Group 1 - The original ATTC platform initiates a new wave of innovative drug development, combining monoclonal antibodies with targeted small molecule inhibitors for enhanced synergistic effects while reducing off-target toxicity [1] - The first candidate drug HMPL-A251 shows comprehensive anti-tumor activity, targeting both HER2 and PI3K pathways, with preclinical data indicating strong anti-tumor efficacy in HER2-positive and low-expressing tumor models [2] - HMPL-A251 is expected to enter clinical development by the end of this year, with potential for combination therapy with chemotherapy to expand clinical application value [2] Group 2 - The core pipeline of the company is progressing steadily, with the SAFFRON study of savolitinib in combination with osimertinib for second-line treatment of EGFR-mutant non-small cell lung cancer having completed enrollment [3] - Top-line data from the global Phase III study is anticipated to be released in the first half of next year, with plans to submit a marketing application to the FDA based on these results [3]
东方证券:维持和黄医药(00013)“买入”评级 全新ATTC平台激发创新活力
智通财经网· 2025-11-10 06:35
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]
和黄医药(00013):2025年研发日点评:全新ATTC平台激发创新活力
Orient Securities· 2025-11-09 15:22
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].
和黄医药(00013.HK):新一代ATTC平台值得关注 首个候选药物预计25Q4进入临床
Ge Long Hui· 2025-11-07 19:50
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].
和黄医药(00013.HK):SAFFRON完成入组 ATTC即将进入临床
Ge Long Hui· 2025-11-07 19:50
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]
和黄医药(00013):新一代ATTC平台值得关注,首个候选药物预计25Q4进入临床
Guoxin Securities· 2025-11-06 02:35
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]
和黄医药宣布沃瑞沙 和泰瑞沙 联合疗法用于治疗泰瑞沙 治疗后疾病进展的伴有 MET过表达和/或扩增的特定肺癌患者的SAFFRON全球III期研究完成患者入组
Zhi Tong Cai Jing· 2025-11-05 06:09
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]
和黄医药(00013)宣布沃瑞沙®和泰瑞沙®联合疗法用于治疗泰瑞沙®治疗后疾病进展的伴有 MET过表达和/或扩增的特定肺癌患者的SAFFRON全球III期研究完成患者入组
智通财经网· 2025-11-05 00:15
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]