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]

Financial Performance - The company's revenue for 2024 reached RMB 12,260,814, an increase of 21.4% compared to RMB 10,103,806 in 2023[9] - Gross profit for 2024 was RMB 11,155,406, reflecting a gross margin of approximately 91%[9] - The company reported a net profit of RMB 4,371,825 for 2024, up 33.4% from RMB 3,277,503 in 2023[9] - The company recorded a revenue of approximately RMB 12.261 billion for the year ending December 31, 2024, representing a year-on-year growth of about 21.3%[22] - Profit for the same period was approximately RMB 4.372 billion, an increase of about 33.4% compared to the previous year[22] - The company achieved a basic earnings per share of approximately RMB 0.74, reflecting a year-on-year increase of about 33.3%[22] Assets and Liabilities - Total assets as of 2024 amounted to RMB 31,657,849, while total liabilities decreased to RMB 2,977,935[9] - The asset-liability ratio was approximately 9.4% as of December 31, 2024, down from 21.9% the previous year[61] - The company maintained a cash and bank deposit balance of RMB 22.622 billion as of December 31, 2024, compared to RMB 22.435 billion a year earlier[61] Research and Development - Research and development expenses for 2024 were RMB 2,701,650, representing a significant investment in innovation[9] - The company is conducting over 60 clinical trials for innovative drugs, with 8 new candidates entering clinical research stages during the reporting period[38] - The company has established a robust R&D platform with over 1,800 researchers across multiple centers, focusing on innovative drug development[37] - The company plans to continue increasing R&D investments due to market changes and innovation efforts[141] Product Development and Approvals - The company received clinical trial approval for its new drug HS-10501, aimed at treating type 2 diabetes and adult obesity[11] - A licensing agreement was established with Pumis for the global development and commercialization of HS-20117, a bispecific ADC product[11] - The company has submitted multiple New Drug Applications (NDAs) for its innovative drug Amelior, targeting specific NSCLC patient populations[12] - The company received breakthrough therapy designation from the FDA for GSK5764227 (HS-20093) for the treatment of ES-SCLC patients[13] - The company’s innovative drug HS-20110 received clinical trial approval from NMPA for advanced solid tumors[14] - The company’s innovative drugs have all been included in the national medical insurance catalog as of December 31, 2024[24] Market Strategy and Partnerships - The company aims to expand its market presence through strategic partnerships and new product developments in the coming years[11] - The company will continue to focus on innovative drug development and internationalization strategies, particularly in oncology, central nervous system, metabolism, and autoimmune disease treatment areas[82] - The company plans to strengthen business development collaborations to optimize its global market layout[82] Corporate Governance - The board of directors consists of three executive directors and three independent non-executive directors as of December 31, 2024[87] - The company has established five specialized committees within the board to oversee various aspects of governance, including audit and remuneration[85] - The company has adopted a high standard of corporate governance to protect shareholder interests and enhance corporate value[84] Risk Management - The company identified major risks including industry competition and technological changes, emphasizing the need for continuous R&D investment to maintain product competitiveness[74] - Regulatory changes in the Chinese pharmaceutical industry may pose challenges to short-term business operations and cost structures, requiring the company to adapt to new regulations[75] - The company employs risk assessment tools such as risk matrices and sensitivity analysis to scientifically classify risks and implement corresponding control strategies[81] Employee and Talent Management - Attracting and retaining key talent is critical for enhancing organizational capabilities, with established mechanisms for talent retention and training[80] - The group’s employees are considered the most valuable asset, with compensation linked to performance and regular training provided to enhance productivity[153] Environmental, Social, and Governance (ESG) - The company maintained an MSCI ESG rating of AA and ranked first in the S&P Global Corporate Sustainability Assessment for the Chinese pharmaceutical industry[15][17] - The company is committed to identifying and mapping climate risks to its future strategies and business activities, focusing on carbon neutrality goals[81] - The group plans to publish an Environmental, Social, and Governance (ESG) report in conjunction with its annual report, as per listing rules[151] Shareholder Information - The company reported a proposed final dividend of HKD 0.1353 per share for the year ending December 31, 2024, compared to HKD 0.1422 in 2023, resulting in a total annual dividend of HKD 0.3363 per share[132] - As of December 31, 2024, major shareholders include Stellar Infinity and Sunrise Investment, each holding 3,900,000,000 shares, representing 65.70% of the total shares[170] Financial Management - The company has established a robust internal control system and conducted an annual review of its risk management and internal control systems, which the board believes are effective and adequate[121] - The company has adopted a dividend policy that considers its operating performance, cash flow, financial condition, and other relevant factors when declaring dividends[129]

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]

Core Insights - A total of 10 first-class innovative drugs have received clinical trial approval in China from April 14 to April 19, covering various types including small molecules, antibody-drug conjugates (ADC), gene therapy, and cell therapy, targeting conditions such as advanced solid tumors, type 1 diabetes, spinal cord injury, Duchenne muscular dystrophy (DMD), and paroxysmal nocturnal hemoglobinuria [1] Group 1: Company-Specific Developments - Hansoh Pharmaceutical's HS-10529, a KRAS G12D small molecule inhibitor, has been approved for clinical trials to treat advanced solid tumors with KRAS G12D mutations, showing good preclinical efficacy and safety [2] - Kanghong Pharmaceutical's KH815, a TROP2-targeted dual-payload ADC, has received clinical approval for treating advanced solid tumors, demonstrating potential to overcome drug resistance [3] - Innovent Biologics' IBI3020, a CEACAM5-targeted dual-payload ADC, has been approved for clinical trials aimed at treating unresectable, locally advanced, or metastatic solid tumors [4] - Xinneng Pharmaceutical's BBM-D101, an AAV gene therapy drug, has been approved for clinical trials to treat Duchenne muscular dystrophy (DMD), aiming for long-term efficacy with a single administration [5] - Zhixin Haosheng's E-islet 01, a universal allogeneic islet regeneration product, has received clinical approval for treating type 1 diabetes, utilizing advanced cell reprogramming techniques [6] - Shizhe Biotechnology's XS228, an iPSC-derived neural precursor cell injection, has been approved for clinical trials to treat subacute spinal cord injury (SCI) [7] - Baili Pharmaceutical's BL-M09D1, an ADC drug, has been approved for treating locally advanced or metastatic solid tumors, sharing technology with another ADC [8] - Renfu Innovation's HWS116, a biological product, has received clinical approval for treating advanced solid tumors, although specific mechanisms are not yet disclosed [9]

Group 1 - The core index of the CSI Hong Kong Stock Connect Biotechnology Theme Index closed at 1134.61 points, with a decline of 3.59% over the past month, an increase of 24.05% over the past three months, and a year-to-date increase of 20.15% [1] - The index consists of 50 listed companies involved in biopharmaceuticals, pharmaceuticals, and biotechnology services, reflecting the overall performance of biotechnology theme companies within the Hong Kong Stock Connect [1] - The index was established on December 28, 2018, with a base point of 1000.0 [1] Group 2 - The top ten weighted companies in the index include: BeiGene (15.69%), WuXi Biologics (11.81%), Innovent Biologics (10.68%), CanSino Biologics (8.36%), CSPC Pharmaceutical Group (6.36%), China Biologic Products (5.81%), Hansoh Pharmaceutical (3.68%), Zai Lab (3.48%), 3SBio (3.22%), and WuXi AppTec (2.82%) [1] - The index's holdings are entirely composed of companies listed on the Hong Kong Stock Exchange, with a 100% allocation [1] Group 3 - In terms of industry composition, biopharmaceuticals account for 52.00%, chemical drugs for 25.67%, pharmaceutical and biotechnology services for 19.19%, and medical devices for 3.14% [2] - The index samples are adjusted semi-annually, with adjustments occurring on the next trading day after the second Friday of June and December each year, with a sample adjustment ratio generally not exceeding 20% [2] - Special adjustments may occur under certain circumstances, such as delisting or significant corporate actions like mergers or acquisitions [2]

Core Insights - The 34th Asia-Pacific Association for the Study of the Liver (APASL 2025) conference highlighted the academic achievements of Hansoh Pharmaceutical's oral antiviral drug, TMF (Amitriptyline), which is the first original research drug for hepatitis B in China [1][2] - TMF demonstrated significant efficacy in chronic hepatitis B patients, with a 95% cumulative HBV DNA suppression rate and a 68% HBeAg seroconversion rate over five years, the highest among current NAs [1] - The drug's safety profile remained stable, with no new drug-related adverse events reported during the study period [1] Group 1 - TMF's Phase IV study showed sustained benefits for chronic hepatitis B patients, particularly in virological response and HBeAg seroconversion [1] - The cumulative incidence of virological resistance after five years of treatment with TMF was 0% [1] - The immunological mechanism study indicated TMF's potential to modulate T cell responses and reduce viral load, contributing to its antiviral efficacy [1] Group 2 - Over 20 additional studies related to TMF were presented, covering its application in various subpopulations, including the elderly, pregnant women, and patients with liver cirrhosis and liver cancer [2] - A systematic review and network meta-analysis indicated TMF's superiority in ALT normalization and delaying liver fibrosis progression compared to other new-generation NAs [2] - TMF was shown to have good maternal-fetal safety and efficacy in treating hepatitis B in pregnant women, successfully preventing HBV mother-to-child transmission [2]

Core Insights - The study published in the International Journal of Molecular Sciences reveals that the GLP-1 receptor agonist, polyethylene glycol-liraglutide (brand name: Fulaimei), accelerates diabetic wound healing through a dual mechanism: systemic anti-inflammatory regulation and restoration of endothelial progenitor cell (EPC) function [1][2]. Group 1: Research Findings - Diabetes is a leading cause of death and disability globally, with vascular complications such as chronic wound healing delays posing significant clinical challenges [1]. - The research utilized a mouse model to compare wound healing in diabetic mice treated with Fulaimei, untreated diabetic mice, and normal mice, demonstrating that Fulaimei improves metabolic disorders, accelerates wound healing, regulates systemic inflammation, and restores EPC function [2]. - Previous in vitro studies indicated that liraglutide can improve EPC damage and mitochondrial dysfunction via the SIRT3/Foxo3 signaling pathway [2]. Group 2: Clinical Implications - The study provides theoretical support for the use of Fulaimei in treating diabetic vascular complications and offers a new strategy for chronic wound treatment in diabetes [2]. - The findings expand the clinical application prospects of GLP-1 receptor agonists, suggesting potential use in other diseases related to mitochondrial dysfunction [2]. - Future research will further explore the efficacy and molecular regulatory networks of Fulaimei in human subjects [2].

Core Insights - Hansoh Pharmaceutical reported a total revenue of approximately 12.261 billion RMB for 2024, representing a year-on-year growth of about 21.3%, and a net profit attributable to shareholders of 4.372 billion RMB, up 33.4% year-on-year [1] - The proportion of innovative drugs in total revenue increased significantly from less than 20% at the time of the company's Hong Kong listing to 77.3% in 2024, highlighting the successful transition to an innovation-driven pharmaceutical company [1][5] - The company achieved revenue of 9.477 billion RMB from innovative drugs and collaborative products, marking a year-on-year increase of 38.1% [1] Revenue Breakdown - In 2024, revenue from various therapeutic areas included approximately 8.122 billion RMB from oncology, 1.464 billion RMB from anti-infection, 1.379 billion RMB from central nervous system disorders, and 1.296 billion RMB from metabolic and other diseases, accounting for 66.2%, 11.9%, 11.3%, and 10.6% of total revenue respectively [1] R&D Investment - The company invested 2.702 billion RMB in R&D, which accounted for 22% of total revenue, focusing on major disease areas such as oncology, central nervous system disorders, metabolism, and autoimmune diseases [2] - Key products in development include the lung cancer treatment Amelot, which has three indications entering NDA stage, and other drugs like HS-20094 and HS-10374 progressing to Phase III clinical trials [2] Business Development (BD) Cooperation - In 2024, revenue from BD cooperation reached 1.573 billion RMB, including a 185 million USD upfront payment from GSK for HS-20093 [4] - The company secured a global exclusive license for an oral GLP-1 small molecule from Merck, receiving an upfront payment of 112 million USD and potential milestone payments of up to 1.9 billion USD [4] - Collaborations with international pharmaceutical companies like GSK and Merck are aimed at accelerating global market expansion [4] Strategic Direction - The company aims to continue its transformation from generics to innovative drugs, leveraging R&D and international strategies while enhancing BD cooperation to optimize its global market presence [5]

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company has shown significant results in its innovative transformation, with internationalization accelerating. The revenue from innovative products is growing rapidly, and the core product, Amivantamab, is expected to reach peak sales of 8 billion yuan. The company continues to benefit from overseas licensing agreements, contributing positively to its performance [5][8]. Financial Performance Summary - For the fiscal year 2024, the company reported total revenue of 12.261 billion yuan, a year-on-year increase of 21.3%. Product sales revenue was 10.688 billion yuan, while collaboration and licensing income was 1.573 billion yuan. The net profit attributable to shareholders was 4.372 billion yuan, reflecting a year-on-year growth of 33.4% [6]. - The company’s operating income and profit both achieved double-digit year-on-year growth, with product sales revenue increasing by 13.65% compared to 9.403 billion yuan in 2023 [6]. Revenue and Profit Forecast - The company’s revenue forecast for 2025 is 13.604 billion yuan, with a projected growth rate of 10.95%. The net profit attributable to shareholders is expected to be 4.421 billion yuan, with a growth rate of 1.14% [7]. - The earnings per share (EPS) for 2025 is projected to be 0.74 yuan, with a return on equity (ROE) of 13.4% [7]. Innovative Product Performance - The revenue from innovative drugs grew by 38.1% year-on-year, reaching 9.477 billion yuan in 2024, accounting for 77.3% of total revenue. The sales of innovative drugs, excluding licensing income, are expected to reach approximately 8 billion yuan, reflecting a year-on-year increase of 28.5% [8]. - The company has a rich pipeline of innovative products, with several expected to be approved soon, providing long-term support for its innovative transformation [8]. Market Position and Future Outlook - The company is well-positioned for future growth, with expectations that the proportion of revenue from innovative drugs will exceed 80% by 2025. The sales of Amivantamab are projected to reach 6 billion yuan, with an upward revision of peak sales to 8 billion yuan [8].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 25.00 [6][8][17] Core Insights - The company's revenue for 2024 is expected to increase by 21.3% to RMB 12.26 billion, with a net profit growth of 33.4%, exceeding expectations [1][6] - The oncology drug segment is projected to contribute 61.2% of the total product sales revenue in 2024, driven by strong performance from the core product Amelot, which is expected to see sales growth of 19.9% [2] - The company has established a partnership with Merck for the development and commercialization of a GLP-1 receptor agonist, which is expected to enhance its capabilities in the metabolic field [4] - The company is currently developing 40 innovative drugs, with several in late-stage clinical trials, indicating a promising pipeline for future growth [5] Financial Summary - The company's revenue is projected to grow from RMB 10.10 billion in 2023 to RMB 12.26 billion in 2024, with a compound annual growth rate (CAGR) of 21.3% [7][14] - Shareholder net profit is expected to rise from RMB 3.28 billion in 2023 to RMB 4.37 billion in 2024, reflecting a growth rate of 33.4% [7][14] - The gross margin is anticipated to improve by 1.2 percentage points, while sales and administrative expenses as a percentage of product sales revenue are expected to decrease [1][7] Product and Market Developments - The oncology drug business is expected to grow from approximately RMB 6.55 billion in 2024 to RMB 10.97 billion by 2027, with a CAGR of 18.8% [2] - The anti-infection drug revenue is projected to increase by 15.0% to RMB 1.46 billion in 2024, primarily driven by the strong sales of the hepatitis drug Hengmu [3] - The company has received multiple recommendations for its products in clinical guidelines, which is expected to support future sales growth [3]