剑医见诵 〖亿欧智库 | | 报告背景 | | --- | --- | | ● | 本报告聚焦先进的数据采集技术，确保所获取的销售信息真实、及时且全面，力图从海量数据中提炼出有价值的行业 | | | 趋势与消费洞察，为医药行业的从业者、投资者以及政策制定者提供一份详实可靠的参考依据，助力各方在市场竞争 | | | 中找准定位，优化决策策略。 | | | 数据涵盖范围 药店数据维度 | | | ● 本报告通过监测全国13.5万余家药店，构建了庞大的数据样本库，全面覆 订单量 | | | 盖了不同地区、类型和规模的药店，为分析提供了广泛的代表性。 订单内处方药销量 | | | 订单发生时间 ● 在数据收集过程中,我们成功获取了1400万人次的处方药采购订 | | | 订单所在省份 单信息，这些订单涵盖了各类处方药和中药品种的购买行为，真实反映了 | | | 市场动态和消费者需求。 订单对应的病症 | | | 订单对应病症采购的药品 ● 通过运用先进的数据分析技术,本报告从涵盖10余个分析维度的多 | | | 采购药品对应规格 角度深入剖析数据,包括但不限于销售趋势、地域差异、产品类别、消费 | | | 者行为等， ...

2025 年11月处方药销售全景洞察： 数据驱动・精准破局 亿欧智库 https://www.iyiou.com/research Copyright reserved to EO Intelligence, December 2025 2025 年 1-11 月全国线下药店处方药订单量呈波动上升态势，11 月订单指数达 23.7，增长势头良好。省份分布差异 明显，广东、四川、山东等经济发达、人口密集省份订单占比领先，西藏、青海等西部省份占比极低，反映出区域 药品需求与医疗资源配置的差异。且各省份订单量同比无大幅波动，市场格局相对稳定。 报告数据描述 | | 报告背景 | | | --- | --- | --- | | • | 本报告聚焦先进的数据采集技术，确保所获取的销售信息真实、及时且全面，力图从海量数据中提炼出有价值的行业 趋势与消费洞察，为医药行业的从业者、投资者以及政策制定者提供一份详实可靠的参考依据，助力各方在市场竞争 | | | | 中找准定位，优化决策策略。 | | | | 数据涵盖范围 | 药店数据维度 | | • | 本报告通过监测全国13.5万余家药店，构建了庞大的数据样本库，全面覆 | ...

Core Insights - The recent surge in drug notification letters from the National Medical Products Administration (NMPA) indicates a tightening of approval processes for generic drugs in China, with 167 drugs involved since December, including 102 generic drug applications being rejected or withdrawn, doubling the number from November [2][6]. Group 1: Drug Approval Trends - A total of 102 generic drug applications were either rejected or voluntarily withdrawn in December, primarily affecting cardiovascular, metabolic, neurological, respiratory, anti-infective, oncology, ophthalmology, dermatology, and digestive system treatments [2][5]. - The most affected drug was Bilastine, with six manufacturers, including Shandong Langnuo Pharmaceutical and Jiangsu Hechen Pharmaceutical, facing difficulties in their applications [3][5]. - Other notable drugs with multiple applicants facing rejection include the antipsychotic drug Brexpiprazole and the antibiotic Levofloxacin, with three companies involved in each case [3]. Group 2: Regulatory Changes - The NMPA has signaled a tightening of approval standards, as evidenced by the release of draft guidelines addressing major deficiencies in the pharmaceutical research of chemical generics and bioequivalence studies [7][8]. - The new guidelines indicate that applications with significant deficiencies will not be allowed to supplement their materials, leading to more rejections based on existing documentation [8]. Group 3: Market Dynamics - The approval tightening comes amid a backdrop of increasing competition in the generic drug market, with over 60 companies previously obtaining approvals for common drugs like Amlodipine Besylate [5][10]. - The Chinese generic drug market is characterized by a high level of competition, with a significant increase in the number of similar products, leading to market saturation and reduced profitability for generic manufacturers [10][11]. - The market share of chemical generics is projected to remain at 50% in 2024, with a notable increase in the number of products evaluated or deemed equivalent, rising from 543 in 2021 to 914 in 2024 [10].

Core Viewpoint - The recent surge in drug notification letters from the National Medical Products Administration indicates a tightening of approval processes for generic drugs in China, with a significant increase in rejected or withdrawn applications in December compared to November [1][5]. Group 1: Drug Approval Trends - As of December 19, 2023, a total of 167 drug notification letters were issued, with 102 related to generic drug applications, marking a doubling in rejections or withdrawals compared to November [1]. - The therapeutic areas affected include cardiovascular, metabolic diseases, nervous system, respiratory, anti-infection, oncology, ophthalmology, dermatology, and digestive systems, with specific drugs like sacubitril/valsartan and sitagliptin/metformin among those impacted [1]. - Multiple manufacturers faced challenges with the same drug, such as the allergy treatment bilastine, which had six companies involved in unsuccessful applications [2]. Group 2: Reasons for Rejections - Some companies, like Jiutian Pharmaceutical, have publicly stated that their withdrawal was due to the need for further data refinement after discussions with the National Drug Review Center [3]. - Manufacturers of rejected generic drugs indicated that the primary issues were related to raw materials rather than the formulations themselves [3]. Group 3: Regulatory Changes - The approval process for generic drugs is tightening, as indicated by the recent drafts of guidelines from the National Medical Products Administration, which outline significant deficiencies in pharmaceutical research and bioequivalence studies [5][6]. - The new guidelines suggest that applications with major deficiencies will not be allowed to supplement their materials, leading to more rejections based on existing documentation [5]. Group 4: Market Dynamics - The Chinese generic drug market is facing increased competition, with a significant number of companies vying for approval of similar products, leading to market saturation [7]. - The report from the Chinese Academy of Medical Sciences indicates that by 2024, generic drugs will still account for 50% of the overall pharmaceutical market, with a notable increase in the number of approved generic varieties [7]. - The market concentration remains low, with the top ten companies holding around 22% of the market share, indicating ongoing challenges for profitability in the generic sector [7]. Group 5: Industry Insights - Industry experts have noted that the increasing number of generic drug projects, often with lower development costs compared to innovative drugs, contributes to market saturation and competition [8]. - Concerns about "internal competition" in the generic drug sector have prompted calls for regulatory adjustments to optimize the approval process and reduce unnecessary resource expenditure [8].

Core Viewpoint - The article highlights the significant risks associated with medication management among the elderly, emphasizing the need for better support systems to ensure safe medication practices [1][9]. Group 1: Medication Safety Issues - Many elderly individuals have disorganized medicine cabinets filled with expired or inappropriate medications, leading to potential health risks [2][8]. - Instances of medication misuse, such as taking multiple doses or mixing similar medications, are common among the elderly, resulting in dangerous health consequences [3][4]. - The lack of clear labeling and understanding of medication instructions exacerbates the problem, as many elderly individuals struggle with vision and memory issues [5][6]. Group 2: Healthcare Provider Challenges - Healthcare providers face challenges in ensuring elderly patients adhere to medication regimens, often finding that patients forget instructions shortly after receiving them [3][4]. - Community health services attempt to provide regular check-ups and personalized medication advice, but many elderly patients still encounter difficulties in managing their medications effectively [3][4]. - Pharmacists also report difficulties in communicating with elderly patients, who may not accurately describe their medication needs or understand the implications of their choices [5][6]. Group 3: Societal Responsibility - The article calls for a collective effort from community hospitals, pharmacies, and families to improve medication safety for the elderly [9]. - There is a need for clearer guidance and ongoing support to help elderly individuals manage their medications safely, transforming their medicine cabinets from potential health risks into effective health management tools [8][9].

Macro Highlights - The State Council issued an opinion to release the potential of sports consumption and promote high-quality development of the sports industry, proposing 6 key measures with 20 specific actions [1] - The measures include expanding the supply of sports products, stimulating consumer demand, strengthening sports enterprises, fostering growth points in the sports industry, enhancing support for industry elements, and improving service levels [1] - The National Standardization Administration plans to revise and formulate over 4,000 national standards focusing on key areas such as artificial intelligence and the Internet of Things to support the transformation and upgrading of the manufacturing industry [1] Company News - Jiahe Meikang announced that Hongyun Jiukang plans to reduce its stake in the company by no more than 1% [4] - Bolong Technology's supervisory board chairman intends to reduce his stake by no more than 0.75% [4] - Lianhuan Pharmaceutical received a drug registration certificate for Amlodipine Besylate Tablets [4] - Tianyu Co., Ltd. obtained a drug registration certificate for Candesartan Cilexetil Tablets [4] - Kebo Da plans to acquire 60% of Kebo Da Intelligent Technology for 345 million yuan [4] - Youyan Powder Materials reported that its newly developed heat dissipation copper powder cannot be used as a 3D printing material [4] - Southeast Network Frame won the bid for the joint development project of Wuyuan Street [4] - Lepu Medical completed the first dosing of the Phase II clinical trial for MWN105 injection [4] - Zhonghaidah clarified that its designated robot company is not UBTECH [4] - Information Development aims to expand cooperation opportunities with the Robotaxi industry chain [4] Additional Company News - Jingong Steel Structure's subsidiary won a land bid in Shanghai for 546 million yuan [5] - Fuyuan Pharmaceutical received a drug registration certificate for Amlodipine Benazepril Capsules [5] - Ningbo Construction's subsidiary won construction projects totaling 1.117 billion yuan [5]

Group 1 - The first domestically developed pediatric influenza antiviral drug, Maduonosawei granules, has had its market application accepted, targeting the treatment of influenza A and B in children aged 2 to 11 without complications. This marks a significant milestone for the Chinese pharmaceutical industry [1] - The approval of this pediatric drug is expected to provide a new growth point for Xiansheng Pharmaceutical and enhance its competitiveness in the influenza drug market, while also showcasing the innovative drug development capabilities of Antikang Bio [1] Group 2 - Huasheng Technology announced plans to re-list the transfer of a 51% stake in its subsidiary, Tibet Kangyu Pharmaceutical Co., Ltd., with a listing price of 42.5 million yuan. The company has not yet found a suitable buyer after two rounds of bidding, indicating potential market valuation discrepancies [2] - The failure to attract qualified buyers may reflect concerns regarding the future development, competitive landscape, and financial status of Kangyu Pharmaceutical, making the outcome of the re-listing uncertain [2] Group 3 - Lianhuan Pharmaceutical's subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has received domestic approval for its Amlodipine Besylate tablets, a commonly used medication for regulating vascular pressure, with annual sales expected to reach 1.216 billion yuan in 2024 [3] - This approval enhances the product line of the company and its subsidiaries, improving market competitiveness, although the market is already crowded with numerous participants [3] Group 4 - Medisi's wholly-owned subsidiary, Medisi Puya Pharmaceutical Technology (Shanghai) Co., Ltd., has been sued for 159 million yuan due to a technical service contract dispute, with the case already filed but not yet heard [4] - The uncertainty surrounding this lawsuit may increase operational risks for the company and could lead to investor concerns regarding its future development [4] Group 5 - Shanghai Laishi announced that several executives, including the vice chairman and general manager, plan to increase their shareholdings in the company, with a total investment of no less than 6 million yuan sourced from personal funds [5] - Executive share purchases are generally viewed as a positive signal in the capital market, potentially attracting more investor interest and driving up stock prices, although the effectiveness of this plan will depend on market conditions and the company's actual performance [5]

Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. announced that its subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Amlodipine Besylate Tablets from the National Medical Products Administration, which is expected to enhance the company's product line and market competitiveness [1][2]. Drug Registration Details - The drug registered is Amlodipine Besylate Tablets, available in dosages of 5mg and 10mg, classified as a chemical drug of category 4, and is a prescription medication [1][2]. - The sales revenue for Amlodipine Besylate Tablets in hospitals across China reached 1.216 billion yuan in 2024 [2]. R&D Investment and Production - As of the announcement date, the R&D investment for Amlodipine Besylate Tablets by Changle Pharmaceutical is approximately 3.83 million yuan (unaudited) [2]. - Changle Pharmaceutical has obtained four production licenses for the drug as of the announcement date [2]. Impact on the Company - The acquisition of the Drug Registration Certificate is expected to enrich the product line of the company and its subsidiaries, thereby enhancing their market competitiveness [2]. - The impact on the company's recent operating performance is not expected to be significant [2].

Group 1 - The core point of the article is that Lianhuan Pharmaceutical (600513) announced the approval of a drug registration certificate for Amlodipine Besylate Tablets by the National Medical Products Administration [1] Group 2 - The approved drug is Amlodipine Besylate Tablets, which is a medication used to treat high blood pressure and other cardiovascular conditions [1]

Group 1 - The core point of the article is that Lianhuan Pharmaceutical has received approval from the National Medical Products Administration for its product "Amlodipine Besylate Tablets" through its subsidiary [1] - Lianhuan Pharmaceutical's revenue composition for the year 2024 is as follows: 59.36% from pharmaceutical distribution, 40.38% from pharmaceutical manufacturing, and 0.26% from other businesses [1] - As of the report date, Lianhuan Pharmaceutical has a market capitalization of 6 billion yuan [1]