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]

Market Overview - The Hong Kong stock market indices collectively rose, with the Hang Seng Index increasing by 1.44% to close at 26,608.48 points, and a total trading volume of HKD 306.23 billion [1] - The Hang Seng Tech Index saw a significant rise of 3.1%, closing at 5,863.2 points, indicating a strong performance in the technology sector [1] Blue-Chip Stocks Performance - Meituan-W (03690) surged by 6.6% to HKD 105, contributing 57.12 points to the Hang Seng Index, with a trading volume of HKD 11.31 billion [2] - Alibaba Health (00241) rose by 10.23% to HKD 6.36, contributing 6.17 points to the index [2] - Kuaishou-W (01024) increased by 7.43% to HKD 80.25, contributing 26.89 points [2] - Other notable movements included a decline in Shenzhou International (02313) by 2.8% and Hansoh Pharmaceutical (03692) by 2.31%, which negatively impacted the index [2] Sector Highlights - The AI sector experienced a significant surge, with stocks like Maifushi (02556) rising by 32.09% and Zhipu (02513) by 31.4%, reflecting a growing interest in AI applications [3][4] - The commercial aerospace sector also saw gains, with Asia Pacific Satellite (01045) increasing by 18.16% and China Technology Group (01725) by 16.84% [5] - Gold stocks were active, with the price of gold surpassing USD 4,600, leading to increases in companies like China Silver Group (00815) and Lingbao Gold (03330) [5][6] Lithium Battery Sector - Lithium battery stocks showed mixed performance, with Ganfeng Lithium (01772) rising by 4.69% while CATL (03750) fell by 2.45% [6] - The recent adjustment in export tax policies for battery products is expected to impact the sector, with potential short-term benefits due to increased export orders before the tax changes take effect [7] Notable Stock Movements - Haowei Group (00501) debuted with a significant increase of 16.22%, closing at HKD 121.8, following its IPO pricing at HKD 104.8 [8] - Baiaosaitu-B (02315) reached a new high, rising by 10.03% to HKD 39.5, following a licensing agreement aimed at accelerating the development of bispecific antibody drug conjugates [9] - COSCO Shipping Energy (01138) continued to rise, up by 9.03% to HKD 11.47, driven by increased shipping demand in the Middle East [10]

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical industry [4] Core Insights - The pharmaceutical index rose by 7.81% from January 5 to January 9, outperforming the CSI 300 index by 5.03%. The brain-machine interface and AI medical sectors are expected to remain active in Q1 2026, with a strong rebound in innovative drugs, particularly small nucleic acids [5][25] - The report highlights the potential for significant advancements in small nucleic acids in 2026, driven by breakthroughs in liver-targeted delivery technologies and a surge in clinical data readouts [8][22] - The report emphasizes the importance of selecting innovative drug stocks with strong fundamentals and suggests focusing on companies that have undergone sufficient adjustments [5][49] Summary by Sections Industry Performance - The pharmaceutical index saw 443 stocks rise and 25 fall during the week, with notable gainers including Innovative Medical (+61.04%) and Sanbo Brain Science (+56.15%). Conversely, Baohua Pharmaceutical saw a decline of -21.65% [5][26][27] Small Nucleic Acids - 2026 is projected to be a pivotal year for the small nucleic acid sector, with advancements in liver-targeted delivery technologies and a high frequency of clinical data readouts expected [8][22] - Arrowhead's delivery platform has shown promising results in clinical trials, validating the feasibility of RNAi therapies for obesity and other conditions [9][11] Investment Recommendations - The report suggests focusing on companies with leading platform capabilities and differentiated pipeline layouts, such as Rebio Biotech, Yuyuan Pharmaceutical, and Frontier Biotech [20][24] - It also recommends a diversified investment approach, including innovative drugs, brain-machine interfaces, and AI medical technologies [47][48] Market Trends - The report notes that the aging population and increasing healthcare demands are driving growth in the pharmaceutical sector, with a focus on chronic diseases and innovative medical technologies [47] - The report highlights the ongoing trend of domestic companies enhancing their capabilities in the global market, particularly in innovative drug development and medical devices [46][47] Key Companies to Watch - Recommended stocks include China National Pharmaceutical Group, Rebio Biotech, Shanghai Yizhong, and Yuyuan Medical [49]

Group 1 - The core point of the news is that Hansoh Pharmaceutical announced the approval of a fifth indication for Amelot (Ametinib Mesylate Tablets) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1] - The approval is based on the AENEAS2 Phase III clinical study, which demonstrated that Amelot 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 in the study, which included only Chinese patients [1] Group 2 - Since its initial approval in March 2020, Amelot has expanded from a single indication to five, with all previous indications included in the national medical insurance catalog, enhancing its clinical position and providing high-level evidence for the treatment of lung cancer in China [2] - The previously approved indications include postoperative adjuvant therapy for EGFR-mutant NSCLC, maintenance therapy after chemoradiotherapy for unresectable locally advanced NSCLC, and first-line and second-line treatments for advanced NSCLC [2]

Group 1: Acquisition and Strategic Moves - Eli Lilly announced the acquisition of Ventyx Biosciences for $1.2 billion, with a premium of 62%, to enhance its NLRP3 inhibitor pipeline, expected to complete in the first half of 2026 [1] - Bangyao Biotech appointed Xiang Yu as CEO starting January 1, 2026, who brings 17 years of experience in the pharmaceutical and healthcare sectors, aiming to accelerate the commercialization of CGT pipelines [2] Group 2: Market Performance and Product Approvals - Jingfeng Medical's stock surged over 30% on its first day of trading in Hong Kong, reflecting strong market confidence in its surgical robot technology and global strategy [3] - Luye Pharma's innovative drug Ruoxinlin received acceptance for a new indication application in China, targeting generalized anxiety disorder, with a clinical efficacy rate exceeding 80% [4] - Hansoh Pharmaceutical's Amivantamab was approved for a new indication in combination with chemotherapy for advanced non-small cell lung cancer patients with specific EGFR mutations, reinforcing its position in the EGFR-TKI market [5]

Major Events - GCL-Poly Energy (00451) plans to issue 186.5 million subscription shares to partner with Pharos to accelerate the integration of Web3 and the renewable energy industry [1] - Hansoh Pharmaceutical (03692) receives drug registration certificate from the National Medical Products Administration for the fifth indication of Amelot (Ametinib Mesylate Tablets) [1] - Green Leaf Pharmaceutical (02186) has its application for the new indication of the innovative drug Ruoxinlin for the treatment of generalized anxiety disorder accepted in China [1] - Xianjian Technology (01302) receives formal registration approval from the National Medical Products Administration for the G-iliacTM Pro iliac artery covered stent system [1] - Meirui Health International (02327) plans to acquire 100% equity of Jiangsu Yide for 125 million yuan [1] - Century International (00959) joint venture signs a memorandum of understanding with WPT to jointly develop, operate, and commercialize mobile applications [1] Operating Performance - Fast Retailing (06288) reports first-quarter earnings with a net profit attributable to shareholders of 147.445 billion yen, an increase of 11.7% year-on-year [1] - Agile Group (01813) reports December pre-sale amount of 420 million yuan, a decrease of 56.7% year-on-year [1] - Baolong Real Estate (01238) projects total contract sales of approximately 7.272 billion yuan for 2025, a decrease of 43.13% year-on-year [1] - China General Nuclear Power (01816) expects total on-grid electricity of approximately 2,326.48 billion kilowatt-hours for 2025, an increase of 2.36% year-on-year [1] - Lingbao Gold (03330) issues a profit warning, expecting net profit for the 2025 fiscal year to be approximately 1.503 to 1.573 billion yuan, an increase of about 115% to 125% year-on-year [1]