Core Viewpoint - The Chinese innovative drug sector is experiencing rapid growth, positioning itself as a global leader in drug development, with significant investments and collaborations from major pharmaceutical companies [2][8][30]. Group 1: Market Dynamics - The price of experimental monkeys has surged from 3,000 yuan to 100,000 yuan, indicating a high demand in the innovative drug sector [1]. - By 2025, China is projected to rank second globally in new drug clinical trials, with its pipeline accounting for 30% of the global total [2]. - In 2024, Chinese innovative drug companies completed 94 overseas licensing transactions, representing 44% of the national total, with over 100 transactions exceeding $100 billion in the first ten months of 2025 [6][30]. Group 2: Challenges in Traditional Pharmaceutical Sector - The generic drug sector is facing significant challenges, with a projected 5.5% decline in revenue for 2024 and over 30% of companies experiencing losses [5]. - Major pharmaceutical companies are increasingly collaborating with Chinese innovative drug firms to mitigate the risks associated with patent expirations, which could lead to a revenue gap exceeding $300 billion in the next five years [10][30]. Group 3: Advantages of Chinese Innovative Drugs - China offers a cost-effective and efficient environment for drug development, with clinical trial costs significantly lower than in the U.S. [20][21]. - The average time for clinical trial approvals in China has been reduced from 60 to 30 working days, and the average new drug application approval time has decreased to approximately 130 days [14]. - Chinese pharmaceutical companies are increasingly moving from "me-too" and "me-better" drugs to original innovations, with a notable increase in the number of innovative drug projects [27]. Group 4: Global Positioning and Future Outlook - Despite the rapid growth of Chinese innovative drugs, the overall market value of Chinese biotech companies remains significantly lower than their U.S. counterparts, capturing only 5% to 10% of global new drug revenues [30][31]. - Chinese companies are establishing commercial centers in global pharmaceutical hubs to enhance their commercialization capabilities, marking a shift towards becoming major players in the global market [37][38]. - The transition from biotech firms to large multinational pharmaceutical companies is seen as a critical step in the global battle for market share and innovation [38].

Core Insights - The Hong Kong Wealth Management Summit and the 12th Hong Kong Stock Top 100 Awards recognized Hansoh Pharmaceutical as an "Annual Medical Innovation Pioneer" and included it in the "Top 100 Comprehensive Strength" list, highlighting its status as a core benchmark for innovation in the Hong Kong pharmaceutical sector [1] Group 1: Company Performance - In the first half of 2025, Hansoh Pharmaceutical achieved revenue of 7.434 billion yuan, representing a year-on-year growth of 14.3%, with innovative drugs and collaborative product sales accounting for 82.7% of total revenue, serving as the main driver of growth [2] - The company has established four R&D centers in Shanghai, Lianyungang, Changzhou, and Maryland, USA, employing over 1,900 specialized R&D personnel, thus creating a complete innovation system from compound screening to clinical research [2] Group 2: Global Expansion - Hansoh Pharmaceutical successfully obtained two marketing approvals for Amelot® in the UK, marking it as the first Chinese original third-generation EGFR-TKI to enter the mainstream European market, laying a solid foundation for future expansion into the EU [3] - The company announced a collaboration with Indian pharmaceutical company Glenmark for exclusive rights to Amelot® across multiple regions, with a total potential value exceeding 1 billion USD, further demonstrating its achievements in internationalization [3] - Hansoh has established a global innovation network through bilateral business development collaborations, having introduced 12 cooperative projects, with 10 entering clinical stages and 2 achieving commercialization, forming a dual innovation model of "independent R&D + external collaboration" [3] Group 3: Industry Context - The domestic innovative drug industry is entering a critical phase of "commercialization and global breakthrough," with policy support, explosive overseas transactions, and the emergence of profitability points creating vast opportunities for industry development [3] - Recognition as an "Annual Medical Innovation Pioneer" reflects the capital market's acknowledgment of Hansoh's past achievements and expectations for its future growth potential [3]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Viewpoints - The US tumor gene testing industry is accelerating, and there are positive domestic opportunities. The market for gene testing has low penetration rates but high growth potential, particularly in colorectal cancer early screening, treatment selection, and minimal residual disease (MRD) testing, which are all billion-dollar markets [3][8] - The report emphasizes the importance of innovation in the pharmaceutical sector, highlighting that the Chinese pharmaceutical industry has completed a transition from old to new growth drivers, particularly in innovative drugs. Companies like Heng Rui Medicine and Han Sen Pharmaceutical have made significant strides in innovation [5][41] - The report suggests that the aging population and the increasing demand for healthcare services will continue to drive growth in the pharmaceutical industry, supported by a multi-layered payment system and advancements in technology such as AI and brain-computer interfaces [41][42] Summary by Sections Market Performance - From January 12 to January 16, the pharmaceutical index fell by 0.68%, with 202 stocks rising and 261 falling. The top gainers included Baolait (up 48.76%) and Hualan Biological (up 32.72%), while the biggest losers were Sunflower (down 37.48%) and *ST Changyao (down 33.33%) [5][25][27] Gene Testing Industry - The report highlights the rapid development of the US tumor gene testing industry, with companies like Natera and Guardant Health showing impressive revenue growth. Natera's Q4 2025 revenue reached $660 million, a 39% year-on-year increase, while Guardant Health's revenue for the same period was $280 million, also up 39% [8][9] - The report notes that the domestic gene testing market is expected to grow rapidly, with companies like BGI and Edan Diagnostics actively positioning themselves in the MRD and early screening sectors [24][22] Investment Recommendations - The report recommends focusing on strong fundamentals and undervalued stocks in the innovative drug sector, including companies like Xinyi Tai, Zecjin Pharmaceutical, and Shanghai Yizhong. It also suggests monitoring emerging technologies in healthcare, such as AI and brain-computer interfaces, which are expected to see significant advancements in 2026 [5][45][44] - Specific investment combinations for January include Xinyi Tai, China Biologic Products, and Sanofi Pharmaceutical, among others [45]

近日，由国家传染病医学中心、中华医学会感染病学分会及《中华传染病杂志》编辑委员会共同制定的 《中国高危人群乙型肝炎病毒再激活防治指南(2026年版)》(以下简称：《指南》)正式发布，为我国高 危人群乙型肝炎病毒(HBV)再激活的管理提供了系统、权威的循证实践指导建议。翰森制药自主研发的 中国首个原研口服抗乙型肝炎病毒药物——艾米替诺福韦(恒沐，TMF)作为新一代核苷(酸)类HBV抗病 毒药物，在《指南》中被明确列为预防HBV再激活的推荐用药之一。 HBV再激活是临床上面临的重要问题，尤其在接受免疫抑制治疗、免疫检查点抑制剂、嵌合抗原受体T 细胞治疗(CAR-T)以及器官移植等高危人群中，可能导致肝炎活动甚至肝衰竭，危及生命。因此，科 学、规范的药物预防至关重要。《指南》基于国内外最新循证证据，结合中国临床实际，对不同免疫抑 制方案下的预防策略进行了系统梳理与推荐，具有重要的临床指导价值。 其中，关于"选择哪种抗病毒药物预防乙肝病毒再激活？"这一临床问题，《指南》推荐选择高耐药基因 屏障药物进行预防性抗乙肝病毒治疗，并列举了包括艾米替诺福韦在内的几种核苷(酸)类药物，推荐等 级为强推荐，且证据质量高。 上市以来 ...

Core Insights - Hansoh Pharmaceutical Group Limited announced the approval of a fifth indication for Amelotex (Ametinib Mesylate Tablets), which is now indicated for first-line treatment in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][2] Group 1: Product Approval and Clinical Data - The approval is based on the AENEAS 2 Phase III clinical study, which demonstrated that Amelotex combined with chemotherapy significantly extends progression-free survival (PFS) compared to monotherapy, with a hazard ratio (HR) of 0.47, indicating a 53% reduction in the risk of disease progression or death [1] - The median PFS was extended to 28.9 months, with an objective response rate (ORR) of 93.2%, and no new safety risks were identified [1] - The study included only Chinese patients, highlighting the efficacy and safety of the original EGFR-TKI in this demographic [1] Group 2: Product Background and Market Position - Amelotex is the first original third-generation EGFR-TKI in China, approved for five indications since its initial launch in March 2020 [2][3] - Previous indications include postoperative adjuvant therapy for EGFR mutation NSCLC, maintenance therapy after chemoradiotherapy for unresectable locally advanced NSCLC, and first-line and second-line treatments for advanced NSCLC [2] - The drug has established a strong clinical position in treating lung cancer in China, providing high-level evidence for its use [2] Group 3: Company Overview - Hansoh Pharmaceutical is a leading innovation-driven pharmaceutical company in China, focusing on major disease areas such as oncology, anti-infection, central nervous system, metabolism, and autoimmune diseases [4] - The company has a strong revenue stream from innovative drugs, with over 80% of its income derived from this segment, and has established a rich R&D pipeline [4] - Hansoh Pharmaceutical has been recognized as one of the top global pharmaceutical companies and is listed on the Hong Kong Stock Exchange under the stock code 03692.HK [4]

每经AI快讯，翰森制药(03692.HK)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 received approval from the National Medical Products Administration (NMPA) for its innovative drug Amelot (Ametinib Mesylate Tablets) to be used 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 specific EGFR mutations. This marks the fifth indication approved for Amelot [1][1][1]. Group 1 - Hansoh Pharmaceutical's stock rose over 4% and was trading at HKD 42.12 with a transaction volume of HKD 97.62 million at the time of reporting [1][1][1]. - The newly approved indication for Amelot targets adult patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations [1][1][1]. Group 2 - Recent research published in the prestigious oncology journal Lancet Oncology indicates that Amelot significantly improves disease-free survival (DFS) in patients with completely resected stage II-III B EGFR-mutant NSCLC, demonstrating good safety [1][1][1].

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: Regulatory Approval - On January 8, Hansoh Pharmaceutical announced that the National Medical Products Administration (NMPA) of China has issued a drug registration certificate for Amelot, 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 indication approved for Amelot [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, with good safety profiles [1]

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]