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]