0证券代码：6004200证券简称：国药现代0公告编号：2025-092 上海现代制药股份有限公司 关于全资孙公司获得化学原料药上市申请批准通知书的公告 申请事项：境内生产化学原料药上市申请 登记号：Y20240000572 通知书编号：2025YS01091 化学原料药注册标准编号：YBY73032025 包装规格：20kg/桶 生产企业：江苏威奇达药业有限公司 企业地址：南通市海门区临江镇临江大道1号 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，上海现代制药股份有限公司（以下简称公司）全资孙公司江苏威奇达药业有限公司(以下简称国 药江苏威奇达)收到国家药品监督管理局核准签发的关于原料药阿戈美拉汀的《化学原料药上市申请批 准通知书》。现将相关情况公告如下： 一、化学原料药基本信息 化学原料药名称：阿戈美拉汀 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准注册。 二、药品研发及市场情况 阿戈美拉汀主要通过对褪黑素受体MT1、MT2的激动及对5-HT2C拮抗的协同作用， ...

北京商报讯（记者 王寅浩 宋雨盈）12月9日，国药现代发布公告称，公司全资孙公司江苏威奇达药业有 限公司收到国家药品监督管理局核准签发的关于原料药阿戈美拉汀的《化学原料药上市申请批准通知 书》，化学原料药注册标准编号为YBY73032025。 公告显示，阿戈美拉汀主要通过对褪黑素受体MT1、MT2的激动及对5-HT2C拮抗的协同作用，而使患 者紊乱的生物节律恢复正常，进而发挥抗抑郁效应，其制剂产品临床主要用于治疗成年抑郁症。 ...

阿戈美拉汀主要通过对褪黑素受体 MT1、MT2 的激动及对5-HT2C拮抗的协同作用，而使患者紊乱的生 物节律恢复正常，进而发挥抗抑郁效应，其制剂产品临床主要用于治疗成年抑郁症。 格隆汇12月9日丨国药现代(600420.SH)公布，公司全资孙公司江苏威奇达药业有限公司(简称国药江苏 威奇达)收到国家药品监督管理局核准签发的关于原料药阿戈美拉汀的《化学原料药上市申请批准通知 书》。 ...

Investment Rating - The report does not explicitly state an investment rating for the antidepressant drug industry Core Insights - Depression disorders are the most common mental disorders, characterized by persistent low mood, loss of pleasure, and decreased energy. The etiology remains unclear, with various hypotheses including the monoamine hypothesis and glutamatergic system abnormalities [5][23] - There are unmet clinical needs in depression treatment, including limited efficacy of current first-line antidepressants, slow onset of action, and the need for precision treatment for different subtypes and special populations [5][27] - The current market for antidepressants in China is substantial, with over 8 billion yuan in hospital sales, where SSRIs and SNRIs account for approximately 60% of the market share [5][6] - New drug development is focusing on deepening monoamine research, exploring amino acid classes, and other mechanisms, with a gradual entry into a harvest period for innovative drugs [5][6] Summary by Sections Unmet Clinical Needs - Current first-line antidepressants like SSRIs have limited efficacy, with about one-third of patients not achieving remission after multiple treatment steps [27] - The onset of current antidepressants is slow, typically requiring 1-4 weeks for initial improvement and 4-8 weeks to reach treatment goals, posing risks for patients during acute phases [27][28] - There is a need for precision treatment for different subtypes of depression and special populations such as children and the elderly [27] Market Overview - The antidepressant market in China saw over 8 billion yuan in sales, with SSRIs leading at 3.58 billion yuan (43.44% market share) and SNRIs at 1.42 billion yuan (17.18% market share) [5][6] - The top-selling antidepressants include escitalopram oxalate, agomelatine, and sertraline [5] Drug Development Trends - The report highlights ongoing research into monoamine neurotransmitter drugs, with 128 clinical-stage products targeting various mechanisms [5][6] - Innovative drugs are gradually entering the market, with one local innovative drug already launched and over twenty in clinical trials [5][6]

Core Viewpoint - The National Drug Centralized Procurement Office has announced the new centralized procurement document, emphasizing principles of clinical stability, quality assurance, prevention of collusion, and reduction of competition pressure in the pharmaceutical industry [1][3]. Summary by Sections Centralized Procurement Announcement - The announcement requires participating drugs to obtain valid domestic registration by September 28 and complete information submission on the National Medical Insurance Service Platform, with the bidding ceremony scheduled for October 21, 2025 [1]. Changes in Procurement Rules - The new procurement rules introduce a "benchmark price" for the same drug category, set at 50% of the average unit comparable price of validly declared companies and the higher value of the lowest unit comparable price. Companies can qualify for selection if their bid is below 1.8 times the benchmark price, a shift from the previous model that focused solely on the lowest price [3]. Participation and Reporting - A total of 46,359 medical institutions participated in the reporting, with 77% reporting by brand name and 23% by generic name. The drug list remains unchanged with 55 varieties, but mainstream specifications and prices have been noted [3]. Sodium Bicarbonate Injection Reporting - The total reported quantity of sodium bicarbonate injection across 31 provinces reached 71.5665 million units, with unspecified brands accounting for 47.45% of the total [5][9]. Manufacturer Performance - Among the specified brands, six manufacturers reported over 1 million units, with Shijiazhuang Fourth Pharmaceutical Company leading at 9.6542 million units, followed by Hebei Tiancai Pharmaceutical Co., Ltd. at 5.6166 million units [7][9]. Regional Preferences - Regional preferences for manufacturers are evident, with Yunnan showing a strong preference for Hebei Tiancai Pharmaceutical, while Shijiazhuang Fourth Pharmaceutical has a balanced national coverage [9][10]. Market Dynamics Ahead of Bidding - As the bidding date approaches, the market dynamics for sodium bicarbonate injection are expected to shift, influenced by brand preferences and the flow of unspecified brands, with companies that possess capacity, quality, and clinical recognition likely to emerge as winners in this round of procurement [10].

Core Insights - The prevalence of insomnia among adults in China is increasing, with the number of affected individuals expected to reach 300 million by 2024 and 330 million by 2030 [1] - The market for insomnia medications in China is projected to grow from 12.28 billion yuan in 2021 to 15.12 billion yuan by 2025, and further to 21.19 billion yuan by 2030 [1] - New dual orexin receptor antagonists (DORAs) have recently been approved for the Chinese market, targeting a broader population of insomnia sufferers [1][3] Market Trends - The sales of traditional hypnotics have shown rapid growth, with sample hospitals reporting sales of 1.641 billion yuan in 2021, and public hospitals spending 5.481 billion yuan on these medications [2] - Despite the growth, over 40% of the population suffers from sleep issues, with less than 30% seeking treatment, indicating a significant unmet demand [2] Drug Development - Traditional insomnia medications, primarily benzodiazepines, have side effects such as daytime drowsiness and cognitive impairment, which DORAs aim to overcome [2][3] - DORAs work by blocking the binding of orexin neuropeptides to their receptors, thus inducing natural sleep without the extensive sedation associated with traditional drugs [2][3] Regulatory and Market Entry - Two new DORA medications, approved in May and June 2023, are now available in hospitals and on e-commerce platforms, with intentions to negotiate for inclusion in the national medical insurance directory [3][4] - The current focus of domestic innovative pharmaceutical companies has been on oncology and autoimmune diseases, leading to fewer developments in insomnia treatments [4] Competitive Landscape - The insomnia medication market is competitive, with various options available, including traditional and herbal remedies [5] - Agomelatine, a melatonin receptor agonist, has shown significant sales growth, reaching 640 million yuan in 2022, a 29.6% increase year-on-year [5] Treatment Recommendations - Non-pharmacological interventions such as relaxation techniques and aerobic exercise are recommended for occasional insomnia, while persistent issues should be evaluated by specialists [6]

Core Insights - The prevalence of insomnia among adults in China is increasing, with the number of affected individuals expected to reach 300 million by 2024 and 330 million by 2030 [1] - The sleep economy market in China is expanding, with the insomnia medication market projected to grow from 12.28 billion yuan in 2021 to 15.12 billion yuan by 2025, and 21.19 billion yuan by 2030 [1] - New dual orexin receptor antagonists (DORAs) have been approved for the Chinese market, targeting the general population suffering from insomnia [1][2] Market Dynamics - The traditional insomnia medication market, primarily consisting of benzodiazepines, has seen rapid growth, with sales in sample hospitals reaching 1.641 billion yuan in 2021 [1] - Despite the growth, a significant portion of the insomnia population remains untreated, with over 40% of the population experiencing sleep issues and less than 30% seeking medical help [2] - DORAs present a new opportunity as they do not fall under the strict regulations of controlled substances, making them more accessible to the general public [2] Product Development - Two new DORA medications, Lemborexant and Daridorexant, were approved in China in May and June 2023, respectively, and are now available on e-commerce platforms and retail pharmacies [3] - Both medications have applied for inclusion in the national medical insurance directory, indicating potential for price negotiations and broader access [3] - Current clinical trials for DORA medications include YZJ-1139 and HEC-83518, indicating ongoing innovation in the insomnia treatment space [3] Competitive Landscape - The insomnia medication market is competitive, with various options available, including traditional medications and newer alternatives like melatonin receptor agonists [4] - Agomelatine, a melatonin receptor agonist, has shown significant sales growth, reaching 640 million yuan in 2022, with a year-on-year increase of 29.6% [4] - The dual orexin receptor antagonists are positioned to address unmet needs in the insomnia treatment market, particularly for patients who have not previously used related medications [3][4] Treatment Approaches - Non-pharmacological interventions such as relaxation training, deep breathing, meditation, and aerobic exercise are recommended for occasional insomnia, reducing the need for medication [5] - For persistent insomnia, a thorough evaluation by a specialist is advised to rule out other underlying issues before considering medication [5]

Group 1: Financial Performance Overview - The company achieved a sales revenue of 427.42 million CNY, a year-on-year increase of 11.88% [2] - Foreign sales amounted to 348.34 million CNY, growing by 6.66%, while domestic sales reached 79.09 million CNY, up by 42.59% [2] - New products generated sales of 195.19 million CNY, reflecting a growth of 7.16%, whereas mature products contributed 232.24 million CNY, increasing by 16.17% [2] - CMO/CDMO business saw a revenue decline of 19.05%, totaling 32.30 million CNY [2] - Net profit was reported at 58.49 million CNY, a decrease of 15.91%, with a net profit margin of 13.68%, down by 4.52 percentage points [2] Group 2: Cost and Profitability Analysis - Gross margin stood at 31.45%, down by 3.08 percentage points [2] - Sales expenses decreased by 8.92%, while management expenses increased by 1.04% [2] - R&D expenses rose by 20.14% due to an increase in R&D personnel [2] - The decline in gross margin was attributed to low prices of mature products and increased depreciation costs [3] Group 3: Market and Product Insights - Non-contract custom business revenue increased by 15.48%, while contract custom project revenue fell by 19.05% [2] - Sales of pharmaceutical raw materials rose by 20.06%, despite a gross margin decline of 3.70 percentage points [3] - Domestic sales saw a significant increase of 42.59%, with a gross margin improvement of 9.30 percentage points [3] - The company plans to enhance its domestic raw material market presence and increase the number of API registrations [4] Group 4: Future Growth Strategies - The company aims to continue launching new products, with a focus on becoming a leading supplier of generic drugs [4] - CMO/CDMO business is expected to grow significantly by 2027-2028, with new projects being actively pursued [6] - The second-phase construction of the second plant is ongoing, expected to contribute to production capacity by 2026 [6] - The company anticipates a total production capacity of 2 billion CNY in the next 3-5 years [10] Group 5: Investor Q&A Highlights - New products are projected to generate 195 million CNY in the first half of 2025, with 160 million CNY from high-end regulated markets [7] - The company is focusing on high-difficulty specialty formulations and will not pursue general solid oral formulations [10] - Future R&D investments will prioritize raw materials, CMO/CDMO, and specialty formulations [11]

Investment Rating - The report maintains a "Buy" rating for the company [1][7] Core Views - The company's Q2 performance exceeded market expectations, driven by new product launches that significantly boosted revenue and profit [1][11] - In H1 2025, the company achieved revenue of 427 million yuan, a year-on-year increase of 11.88%, while net profit attributable to shareholders was 58 million yuan, a year-on-year decrease of 15.91% [4][5] - Q2 2025 saw revenue of 241 million yuan, a year-on-year increase of 36.98%, and net profit of 38 million yuan, a year-on-year increase of 45.08% [4][5] Financial Performance - The gross margin for Q2 2025 was 34.46%, up 2.45 percentage points year-on-year and 6.88 percentage points quarter-on-quarter [4] - The net profit margin for Q2 2025 was 15.68%, an increase of 0.88 percentage points year-on-year and 4.56 percentage points quarter-on-quarter [4] - The company's raw materials and intermediates business generated revenue of 395 million yuan in H1 2025, a year-on-year increase of 15.48% [5] Production Capacity - The first phase of the company's second plant has been operational since 2024, with a potential full production value of 500 million yuan [6] - The company raised 800 million yuan in a private placement to fund the second phase of the second plant, which is expected to have a full production value of 1.9 billion yuan [6] Future Projections - The company anticipates rapid growth in new products in the regulatory market over the next three years, forecasting revenues of 850 million yuan, 980 million yuan, and 1.17 billion yuan for 2025, 2026, and 2027 respectively [7][10] - The projected net profit for 2025, 2026, and 2027 is 131 million yuan, 159 million yuan, and 199 million yuan respectively [10]

Core Viewpoint - The company has received market access approval for its active pharmaceutical ingredients, Agomelatine and Oxycodone, in South Korea, which will positively impact its international market expansion efforts [1] Group 1 - The company announced the receipt of drug registration certificates from the South Korean Ministry of Food and Drug Safety [1] - The approval signifies that Agomelatine and Oxycodone have gained entry into the South Korean market [1] - This development is expected to enhance the company's ability to expand its international business operations [1]