翰森制药(03692):升目标价至33.3港元,重申"买入"评级 瑞银华宝 该行对集团的研发能力及合作项目的收入潜力持正面态度，主要受惠于两项对外授权合作(BD)HS-20094及 HS-10535。该行将翰森制药2025至27年的每股盈利预测分别上调16.2%、17.7%及21.3%，收入预测上调6%至 12%，料阿美乐(Aumolertinib)及BD将会是主要推动力，预期阿美乐今年销售额达60亿元人民币，并于2029年 破顶至80亿元人民币。 瑞银发布研报称，即使翰森制药(28.8,-0.05,-0.17%)(03692)股价年初至今已累升53%，但认为集团股价 仍然被低估，将目标价由24港元升至33.3港元，重申"买入"评级。 ...

Investment Rating - The report assigns an "Accumulate" rating for the company, marking it as the first coverage with a target price of HKD 29.50, compared to the current price of HKD 27.2 [5]. Core Viewpoints - The company is recognized as a leading innovation-driven pharmaceutical enterprise, focusing on oncology, anti-infection, central nervous system, metabolic diseases, and autoimmune diseases. It is projected to achieve a revenue of HKD 12.26 billion in 2024, representing a 21% year-on-year growth, and a net profit of HKD 4.372 billion, reflecting a 33% increase [1][5]. - The company has successfully launched multiple innovative drugs, with a strong pipeline that is expected to drive future growth. The sales of innovative drugs are anticipated to continue increasing, with a projected revenue of HKD 9.477 billion in 2024, marking a 38.1% year-on-year growth [16][24]. Summary by Sections 1. Innovation and R&D - The company has established a comprehensive R&D system, employing over 1,800 professionals and creating several national-level research institutions. It has been recognized as a key high-tech enterprise and a national technology innovation demonstration enterprise [14][26]. - The company has eight innovative drugs approved for market, including Amelotin (甲磺酸阿美替尼片) and Fluoromethylnitro (甲磺酸氟马替尼片), which are expected to contribute significantly to revenue growth [16][17]. 2. Market Performance - The sales of Amelotin, the first domestic third-generation EGFR TKI, are projected to grow rapidly, with a compound annual growth rate (CAGR) of 214% from 2020 to 2024, capturing approximately 28% of the total sales of third-generation EGFR TKIs by 2024 [2]. - The company has also seen significant sales growth in Fluoromethylnitro, with a 54% increase in 2023 and a projected 36% growth in 2024 [3]. 3. Future Growth Potential - The company has a robust pipeline with several innovative drugs in various stages of clinical trials, including HS-20089 and HS-20093, which have entered phase II and III trials, respectively [4]. - The company is expanding its market presence through collaborations, such as granting global exclusive licensing rights for HS-10535 to Merck, indicating strong potential for future revenue streams [4][5]. 4. Financial Projections - Revenue forecasts for 2025, 2026, and 2027 are projected at HKD 13.741 billion, HKD 15.567 billion, and HKD 17.374 billion, respectively, with net profits expected to reach HKD 4.746 billion, HKD 5.336 billion, and HKD 5.850 billion [5].

Investment Rating - The report assigns an "Accumulate" rating for the company, marking it as the first coverage with a target price of HKD 29.50, compared to the current price of HKD 27.2 [5]. Core Viewpoints - The company is recognized as a leading innovative pharmaceutical enterprise with a focus on oncology, anti-infection, central nervous system, metabolic diseases, and autoimmune diseases. It has shown robust performance with a projected revenue of HKD 12.26 billion for 2024, representing a 21% year-on-year growth, and a net profit of HKD 4.372 billion, reflecting a 33% increase [1][5]. - The company has successfully launched multiple innovative drugs, with significant sales growth in its key products, particularly in the oncology sector, which is expected to account for 66.24% of total revenue by 2024 [17][24]. Summary by Sections 1. Innovation and R&D - The company has established a comprehensive R&D system with over 1,800 professional researchers, focusing on drug discovery and clinical research. It has been recognized as a national high-tech enterprise and a national technology innovation demonstration enterprise [14][26]. - The company has eight innovative drugs approved for market, including Amelotin (甲磺酸阿美替尼片) and Fluoromethine (甲磺酸氟马替尼片), which have shown strong sales performance [16][17]. 2. Sales Performance - The sales of Amelotin are projected to grow at a compound annual growth rate (CAGR) of 214% from 2020 to 2024, capturing approximately 28% of the total sales for third-generation EGFR TKIs by 2024 [2]. - The sales of Fluoromethine increased by 54% in 2023 compared to the previous year, with a projected growth of 36% in 2024 [3]. 3. Future Growth Potential - The company has a robust pipeline with several innovative drugs in various stages of clinical trials, including HS-20089 and HS-20093, which have entered phase II and III trials, respectively [4]. - The company is expanding its market presence with global licensing agreements for its innovative drugs, indicating strong potential for future revenue growth [4][5]. 4. Financial Forecast - The revenue forecast for the company is set at HKD 13.741 billion, HKD 15.567 billion, and HKD 17.374 billion for the years 2025, 2026, and 2027, respectively, with net profits projected at HKD 4.746 billion, HKD 5.336 billion, and HKD 5.850 billion [5].

Core Viewpoint - Hansoh Pharmaceutical's innovative drug, Amivantamab (Aumseqa®), has been approved for marketing in the UK, marking it as the first innovative drug from the company to enter the overseas market and the first Chinese-origin EGFR-TKI to be launched internationally [1][2]. Group 1: Drug Approval and Market Entry - Amivantamab is approved for use as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activated EGFR mutations, as well as for patients with T790M mutation-positive NSCLC [1]. - The drug has already been approved for four indications in China, making it the most approved indication for a Chinese-origin third-generation EGFR-TKI [2]. Group 2: Market Context and Competitors - As of March 2025, there are seven third-generation EGFR-TKI products available in China, including Amivantamab and others like Osimertinib and Furmonertinib [3]. - The market for NSCLC treatments is significant, with lung cancer accounting for 18.7% of global cancer deaths in 2022, and NSCLC being the most common type, representing approximately 85% of all lung cancer cases [4]. Group 3: Historical Context and Future Prospects - The first-generation EGFR-TKI, Gefitinib, was launched in the early 2000s, followed by second-generation drugs that also faced resistance issues, leading to the development of third-generation EGFR-TKIs like Osimertinib [5]. - Current research is focused on addressing resistance issues associated with third-generation EGFR-TKIs, with innovations such as EGFR/C-MET dual antibodies and ADC drugs being explored [6].

Group 1 - The core point of the article is that Hansoh Pharmaceutical has received approval from the UK Medicines and Healthcare products Regulatory Agency for the marketing of Amivantamab tablets [1]

Core Viewpoint - Hansoh Pharmaceutical has entered into a licensing agreement with Regeneron Pharmaceuticals, granting Regeneron global exclusive rights to develop, manufacture, and commercialize HS-20094, excluding mainland China, Hong Kong, and Macau [1] Group 1: Financial Terms - Hansoh Pharmaceutical will receive an upfront payment of $80 million [1] - The company is eligible to receive up to $1.93 billion in milestone payments based on the product's development, regulatory approval, and commercialization progress [1] - Future potential product sales will generate double-digit percentage royalties for Hansoh Pharmaceutical [1]

Group 1 - The majority of Hong Kong pharmaceutical stocks are experiencing declines, with Hansoh Pharmaceutical falling over 4% [1] - Hansoh Pharmaceutical (03692.HK) decreased by 4.45%, while other companies like Aimeijia Vaccine (06660.HK) and CSPC Pharmaceutical Group (01093.HK) also saw significant drops of 3.98% and 2.72% respectively [1] - Kanglong Chemical (03759.HK) reported a decline of 1.83%, indicating a broader trend of weakness in the sector [1]

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]