消息面上，1月8日，翰森制药发布公告，集团创新药阿美乐(甲磺酸阿美替尼片)获中国国家药品监督管 理局("NMPA")签发的药品注册证书，批准增加"阿美乐联合培美曲塞和铂类化疗药物适用于具有表皮生 长因子受体("EGFR")外显子19缺失或外显子21(L858R)置换突变的局部晚期或转移性非小细胞肺癌 ("NSCLC")成人患者的一线治疗"适应症。此为阿美乐获批的第五项适应症。 值得一提的是，据翰森制药官微消息，近日，国际顶级肿瘤学期刊《Lancet Oncology》(中文译名： 《柳叶刀.肿瘤学》，影响因子：35.9)在线重磅发布了翰森制药创新药阿美乐(甲磺酸阿美替尼片， 110mg)用于EGFR突变非小细胞肺癌辅助治疗的最新研究结果。数据显示，阿美乐能够显著改善完全切 除的Ⅱ-ⅢB期EGFR突变NSCLC患者的无病生存期(DFS)，且安全性良好。 翰森制药(03692)午前涨超4%，截至发稿，涨3.64%，报42.12港元，成交额9762.23万港元。 ...

Core Viewpoint - Hansoh Pharmaceutical (03692) has seen a stock price increase of over 4%, currently trading at HKD 42.12, following the announcement of a new indication for its innovative drug Amelot (Ametinib Mesylate Tablets) [1] Group 1: Drug Approval and Indications - On January 8, Hansoh Pharmaceutical announced that its innovative drug Amelot received a drug registration certificate from the National Medical Products Administration (NMPA) in China, approving it for use in combination with pemetrexed and platinum-based chemotherapy for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations [1] - This marks the fifth approved indication for Amelot, highlighting the drug's expanding therapeutic applications [1] Group 2: Research Findings - Recent research results published in the prestigious oncology journal Lancet Oncology indicate that Amelot significantly improves disease-free survival (DFS) in patients with completely resected stage II-III B EGFR-mutant NSCLC, demonstrating good safety [1]

作为中国首个原研三代EGFR-TKI，阿美乐自2020年3月首次获批上市以来，已从单一适应症扩展至五 项，此前获批的四项适应症均已纳入国家医保目录，包括：EGFR突变NSCLC患者的术后辅助治疗、不 可切除局部晚期NSCLC放化疗后的维持治疗，以及晚期NSCLC的一线治疗和二线治疗，在为原研三代 EGFR-TKI治疗中国肺癌人群带来高级别循证医学证据的同时，也夯实了其临床地位，让更多肺癌患者 从中国创新方案中得到生存获益。 本次获批主要基于AENEAS2Ⅲ期临床研究，研究结果曾于2025年美国癌症研究协会(AACR)年会上以全 体大会口头报告形式全球首发。 AENEAS2研究数据证实，在EGFR敏感突变局部晚期或转移性NSCLC患者中，阿美乐联合化疗一线治 疗较单药显著延长患者的无进展生存期(PFS)，HR为0.47，提示相较于单药使用，阿美乐联合化疗可以 降低53%的疾病进展或死亡风险。中位无进展生存时间(mPFS)延长至28.9个月，客观缓解率(ORR)高至 93.2%，未发现新的安全性风险。该研究纳入的均为中国患者，显示了原研EGFR-TKI对国内患者的显 著疗效和可控的安全性。 1月8日，翰森制药集团 ...

翰森制药(03692)发布公告，集团创新药阿美乐(甲磺酸阿美替尼片)获中国国家药品监督管理局 ("NMPA")签发的药品注册证书，批准增加"阿美乐联合培美曲塞和铂类化疗药物适用于具有表皮生长因 子受体("EGFR")外显子19缺失或外显子21(L858R)置换突变的局部晚期或转移性非小细胞肺癌 ("NSCLC")成人患者的一线治疗"适应症。此为阿美乐获批的第五项适应症。 ...

智通财经APP讯，翰森制药(03692)发布公告，集团创新药阿美乐 (甲磺酸阿美替尼片)获中国国家药品监督管理局("NMPA")签发的药品注册证书， 批准增加"阿美乐联合培美曲塞和铂类化疗药物适用于具有表皮生长因子受体("EGFR")外显子19缺失或外显子 21(L858R)置换突变的局部晚期或转 移性非小细胞肺癌("NSCLC")成人患者的一线治疗"适应症。此为阿美乐获批的第五项适应症。 （原标题：翰森制药(03692)：阿美乐® (甲磺酸阿美替尼片)第五项适应症获国家药品监督管理局签发药品注册证书） ...

Core Viewpoint - The mid-term performance announcement of Hansoh Pharmaceutical highlights the company's clear innovation transformation and internationalization strategy, with significant growth in revenue and profit driven by innovative drugs and collaborative products [2][3]. Financial Performance - In the first half of 2025, Hansoh Pharmaceutical reported revenue of approximately RMB 74.34 billion, a year-on-year increase of about 14.3%, and a profit of approximately RMB 31.35 billion, up by about 15.0% [2]. - Basic earnings per share reached approximately RMB 0.53, reflecting a year-on-year growth of about 14.8% [2]. Innovation and Product Sales - Sales revenue from innovative drugs and collaborative products amounted to approximately RMB 61.45 billion, marking a year-on-year increase of 22.1% and accounting for about 82.7% of total revenue [2][3]. - The company has seen a significant shift from "generic-innovative combination" to "innovation-driven" strategies, indicating a successful transformation in response to policy guidance and market demand [2][3]. Collaborative Agreements - In the first half of 2025, Hansoh received a BD licensing fee of USD 112 million from Merck, and in June 2025, it granted Regeneron exclusive overseas licensing rights for the GLP-1/GIP dual receptor agonist HS-20094, receiving an upfront payment of USD 80 million [2]. - The company is also engaged in multiple collaborations, including a partnership with Lupo Pharmaceutical for the BTK inhibitor LP-168, which aims to expand its pipeline for autoimmune diseases [6][7]. Research and Development Investment - Hansoh's R&D expenditure reached RMB 14.41 billion in the first half of 2025, representing a year-on-year increase of 20.4% and accounting for 19.4% of total revenue [6]. - The company is pursuing a dual-track strategy of "introduction and output," enhancing its product pipeline and reducing risks associated with single R&D projects [6][10]. Market Position and Industry Trends - The 82.7% share of innovative revenue significantly exceeds the industry average of 50%-70% for leading domestic pharmaceutical companies [3]. - The Chinese innovative drug sector has seen over 50 BD outbound transactions by June 30, 2025, with a total disclosed cooperation amount of USD 48.448 billion, marking a historic high [9]. Strategic Evolution - The industry is shifting from "single transactions" to "ecosystem co-construction," with deeper collaboration across the pharmaceutical value chain, including partnerships with biotech firms and research institutions [10]. - The trend indicates a move towards strategic binding and shared interests among partners, enhancing long-term value and reducing risks associated with new product development [10].

Core Viewpoint - The mid-term performance announcement of Hansoh Pharmaceutical highlights the company's clear innovation transformation and internationalization strategy, showcasing significant growth in revenue and profit driven by innovative drugs and collaborative products [1][2]. Financial Performance - In the first half of 2025, Hansoh Pharmaceutical reported revenue of approximately RMB 7.434 billion, a year-on-year increase of about 14.3%, and a profit of approximately RMB 3.135 billion, up 15.0% year-on-year [1]. - Basic earnings per share reached approximately RMB 0.53, reflecting a year-on-year growth of 14.8% [1]. Revenue Composition - Sales revenue from innovative drugs and collaborative products amounted to approximately RMB 6.145 billion, representing a year-on-year increase of 22.1% and accounting for about 82.7% of total revenue [1][2]. - The revenue breakdown for the first half of 2025 includes approximately RMB 4.531 billion from oncology, RMB 735 million from anti-infection, RMB 768 million from central nervous system, and RMB 1.400 billion from metabolic and other diseases, with respective contributions of 60.9%, 9.9%, 10.4%, and 18.8% to total revenue [2]. R&D Investment - R&D expenditure for the first half of 2025 was RMB 1.441 billion, a year-on-year increase of 20.4%, constituting 19.4% of total revenue [3]. Strategic Collaborations - Hansoh has adopted a dual-track approach of "introduction and output" in its innovation strategy, signing various collaboration agreements to enhance its product pipeline and reduce risks associated with single R&D projects [3][4]. - Notable collaborations include a partnership with Merck for a BD licensing fee of USD 112 million and exclusive licensing agreements with Regeneron and other companies for innovative drug development [1][3][5]. Industry Trends - The proportion of innovative drug revenue at 82.7% is significantly higher than the industry average of 50%-70%, indicating a successful strategic shift from "generic-innovative combination" to "innovation-driven" [2][6]. - The Chinese innovative drug sector has seen over 50 BD outbound transactions with a total disclosed cooperation amount of USD 48.448 billion, marking a historic high and reflecting the industry's maturation [6][7]. Future Outlook - The trend towards deeper collaboration within the industry is evident, with companies moving from single transactions to ecosystem co-construction, enhancing R&D efficiency and market value [7]. - The shift from financial investment to strategic binding in partnerships is expected to create long-term value and reduce risks associated with new product introductions [7].

Core Viewpoint - Hansoh Pharmaceutical Group announced the approval of Amelot (Ametinib Mesylate Tablets) for a new indication, expanding its application to treat adult non-small cell lung cancer (NSCLC) patients with specific EGFR mutations [1][2] Group 1: Product Approval and Clinical Research - The new indication is for patients with stage II-III B NSCLC who have previously undergone surgical resection and may or may not receive adjuvant chemotherapy [1] - The approval is based on the ARTS (HS-10296-302) Phase III clinical study, which was presented at the 2025 American Association for Cancer Research (AACR) annual meeting [1] - The ARTS study demonstrated a significant improvement in disease-free survival (DFS) for patients receiving Amelot as adjuvant therapy, with a 2-year DFS rate of 90.2% [1] Group 2: Market Position and Expansion - Amelot, as China's first original third-generation EGFR-TKI, has been expanding its treatment areas since its launch five years ago [2] - The recent approval allows Amelot to cover early to mid-stage NSCLC (II-III stage), providing more treatment options for lung cancer patients in China [2]

Core Viewpoint - The 2025 CSCO Guidelines Conference has introduced the 2025 edition of the CSCO Guidelines for the Diagnosis and Treatment of Primary Non-Small Cell Lung Cancer (NSCLC), highlighting the inclusion of Hansoh Pharmaceutical's Amelot (Ametinib Mesylate Tablets) as the first Chinese original third-generation EGFR-TKI to receive a Class I recommendation for consolidation therapy in EGFR mutation-positive stage III unresectable NSCLC patients after chemoradiotherapy [1][2][3] Group 1 - The new recommendation is based on positive results from the POLESTAR study, a nationwide, multicenter, randomized, double-blind, controlled phase III clinical trial assessing the efficacy and safety of Amelot in consolidation therapy for stage III unresectable NSCLC patients with EGFR mutations after chemoradiotherapy [2] - The mid-term analysis of the POLESTAR study, presented at the 2024 World Lung Cancer Conference, showed a median progression-free survival (mPFS) of 30.4 months for the Amelot group, compared to 3.8 months for the placebo group, indicating an 8-fold improvement and an 85% reduction in the risk of disease progression or death [2] - The POLESTAR study exclusively included Chinese patients, demonstrating the significant efficacy of original EGFR-TKIs for domestic patients and providing high clinical relevance for China [2] Group 2 - NSCLC accounts for approximately 85% of all lung cancer cases in China, with nearly one-third being locally advanced (stage III) NSCLC, highlighting the urgent need for more precise and effective treatment options [2] - The rapid development of third-generation EGFR-TKIs represents a significant advancement in targeted therapy, offering more treatment choices to improve the diagnosis and treatment levels of stage III unresectable NSCLC and enhance patient prognosis [2] - The inclusion of Amelot as a Class I recommendation for consolidation therapy in this context confirms its application potential and is expected to guide the development of precision diagnosis and treatment for NSCLC in China, ultimately benefiting patients [3]