8月29日晚，万邦德（002082）公告称，全资子公司万邦德制药集团有限公司的2.2类新药石杉碱甲控释 片用于治疗轻、中度阿尔茨海默病型痴呆的II/III期关键注册临床试验，于近日完成首例受试者入组。 公告显示，石杉碱甲是用于改善认知功能的胆碱酯酶抑制剂，临床前研究展现出延缓阿尔茨海默病疾病 进展的潜力及广泛的综合获益，包括对β淀粉样蛋白的降低作用，抗炎、抗氧化应激以及神经元保护作 用，有望成为具有广谱抗阿尔茨海默病型痴呆的药物。 石杉碱甲控释片是万邦德自主研发的用于治疗轻、中度阿尔茨海默病型痴呆的2.2类新药，采用双相控 释技术，平缓药物释放峰谷曲线，并延长药物体内释放时间，从而实现快速起效，减少不良反应，提升 给药剂量与良好的安全性。同时，控释技术支持每天一次给药，提高患者的用药便利性和长期依从性。 值得注意的是，本次开展的II/III期临床研究，是中国目前已知规模最大的阿尔茨海默病注册研究。研究 采用多中心、随机、双盲双模拟的设计，同时设有安慰剂和阳性药双对照，更加全面地评价疗效与安全 性。 据悉，万邦德深耕医疗大健康产业，已形成医药制造与医疗器械板块双头并进的格局。2025年上半年， 公司实现营业收入 ...

Core Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].

Financial Performance - The company's investment income increased by 593.87% compared to the same period last year, primarily due to the termination of recognition of financial assets measured at amortized cost as investment income [1] - Fair value changes resulted in a loss of 4.7671 million yuan, an increase compared to the same period last year, mainly due to changes in the fair value of other non-current financial assets [1] - Asset impairment losses increased by 149.00% year-on-year, mainly due to the impairment provision for intangible assets (trademarks and patents) of the subsidiary Kangci Medical [1] - Credit impairment losses decreased by 103.81% year-on-year, mainly due to changes in the provision for bad debts of receivables [1] - Asset disposal income increased by 15.6225 million yuan, primarily from the disposal of land and properties of the subsidiary Kangci Medical located in Jiangshan [1] - Non-operating income decreased by 6.7666 million yuan compared to the same period last year, mainly due to a decrease in other non-operating income [1] Cash Flow Analysis - The net cash flow from operating activities increased by 193 million yuan year-on-year, mainly due to an increase in the recovery of accounts receivable and an increase in the use of payable notes for purchasing goods [4] - Cash inflow from investment activities increased by 317.55% year-on-year, primarily due to the disposal of land and properties of the subsidiary Kangci Medical [4] - The net cash flow from financing activities decreased by 557.32% year-on-year, mainly due to an increase in debt repayment during the reporting period [4] Profit Distribution Plan - The company plans not to distribute profits for the 2024 fiscal year, which includes no cash dividends, no bonus shares, and no capital reserve conversion to share capital, with the remaining undistributed profits carried forward to the next year [8][9] - The decision is based on the company's current operational development plans and the need to ensure funding for ongoing projects and R&D [8][9] Asset Impairment Provision - The company plans to recognize an asset impairment provision of 26.2414 million yuan for the fiscal year 2024, following a comprehensive review of various asset categories [10][19] - The provision includes specific amounts for receivables, inventory, and intangible assets, reflecting a cautious approach to financial reporting [12][14][16] Credit and Financial Support - The company intends to apply for a comprehensive credit limit of up to 2.1 billion yuan for 2025 to meet the funding needs of its various business developments [23] - The company also plans to provide financial assistance to its subsidiary, Kangci Medical, with a borrowing limit of up to 50 million yuan at an interest rate of 4% [46][48]