每经记者｜金喆 每经实习记者｜许立波 林姿辰 每经编辑｜宋思艰 到了审批期的最后一个月，美国食品药品监督管理局（FDA）还是决定对这个全球首款延缓阿尔茨海默 症进程的新药放行。 当地时间6月7日，FDA宣布批准渤健/卫材公司Aβ（β淀粉样蛋白）抗体Aduhelm（Aducanumab）用于 治疗早期阿尔茨海默症（AD）患者的生物制品许可（BLA）申请，这是继2003年后FDA批准的首款阿 尔茨海默药。 消息传出后，渤健股价一度暴涨近60%，国内资本市场也跃跃欲试，绿谷制药等多家布局阿尔茨海默病 的国内企业备受市场关注。 不过，《每日经济新闻》记者注意到，与资本市场的热情不同，业界对这款药的态度"冰火两重天"。回 望此前国内获批的阿尔兹海默药，也难逃被质疑的命运。 靶向Aβ药加速审批，临床效益仍需验证 本次Aducanumab获批之所以引爆舆论，或许主要因为两个因素，一个是阿尔茨海默症本身的热度，另 一个是其一波三折的上市之路。 阿尔茨海默病（AD）又称老年痴呆症，是一种起病隐匿的进行性发展的神经系统退行性疾病。根据世 界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000 ...

Group 1 - WuXi AppTec's CAR-T cell therapy, Rikeolunase injection, is expected to be included in the commercial health insurance directory, marking a significant step in China's multi-tiered medical security system [1] - The pricing for Rikeolunase injection is set at 1.29 million yuan per dose, which highlights the potential accessibility of high-cost therapies through the "commercial insurance + innovative drugs" model [1] Group 2 - Green Valley Pharmaceutical was fined 400,000 yuan for illegal promotion of its drug, Ganlutena capsules (Jiuqi Yi), which has faced efficacy controversies since its approval [2] - The fine serves as a significant warning for pharmaceutical companies, especially regarding compliance in marketing practices for new drugs with low public awareness [2] Group 3 - Libang Pharmaceutical has submitted its prospectus for an IPO on the Hong Kong Stock Exchange, focusing on the kidney disease sector with a vertically integrated platform covering R&D, production, and commercialization [3] - The company aims to address the substantial market demand from approximately 850 million kidney disease patients globally, amidst a shortage of innovative therapies [3] Group 4 - Aidi Pharmaceutical's ADC118 tablets, a first-class new drug for HIV, have received clinical approval, representing a significant breakthrough in the development of domestic anti-HIV medications [4] - If clinical trials proceed successfully, ADC118 could disrupt the dominance of imported drugs in the HIV treatment market, providing high-quality domestic options for patients [4] Group 5 - Lepu Biopharma's MRG003 (Vibekotamab) has been approved for marketing, targeting patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitors [5] - MRG003 is the first EGFR ADC new drug approved globally, marking a new milestone for domestic ADC development [5]

Core Viewpoint - The approval process for the first domestically developed Alzheimer's drug, "Jiuyiqi" (Glycyrrhizin Sodium Capsules), has encountered significant setbacks, indicating challenges in the drug's re-registration and the broader difficulties in Alzheimer's drug development in China [1][7]. Approval Challenges - "Jiuyiqi" was conditionally approved in November 2019 for treating mild to moderate Alzheimer's disease, but its re-registration application has not been approved, as indicated by the absence of an approval number in the recent notification from the National Medical Products Administration (NMPA) [1][3]. - The NMPA requires companies to submit a new application for re-registration, and "Jiuyiqi" has faced scrutiny regarding its clinical trial data and the adequacy of its ongoing studies [2][3]. Industry Context - The drug's approval difficulties reflect a global challenge in Alzheimer's drug development, primarily due to the unclear pathogenic mechanisms of the disease and the complexities involved in clinical trials [7][8]. - The pricing of "Jiuyiqi" has made it a more accessible option for patients compared to imported alternatives, which can cost significantly more [7]. Controversies and Legal Issues - "Jiuyiqi" has been surrounded by controversy regarding its efficacy and the reliability of its clinical trials, leading to public debates and legal disputes among key figures in the scientific community [4][5]. - Despite the controversies, the drug was included in the national medical insurance directory, highlighting its perceived value in the market [6]. Future Prospects - The future of "Jiuyiqi" and its potential re-registration remains uncertain, as the company must provide additional data to support its application [7][8]. - The case of "Jiuyiqi" serves as a significant example in the history of original drug development in China, illustrating the complexities and challenges faced by pharmaceutical companies in the Alzheimer's treatment landscape [7][8].

Policy Developments - Shanghai has initiated the online listing for the first batch of traditional Chinese medicine centralized procurement expansion, with the application period from August 12 to August 29, 2025 [1] Drug and Device Approvals - Hualan Vaccine has received approval for clinical trials of its lyophilized Hib conjugate vaccine, which is expected to induce immune response against Hib [2] - Insmed announced that the FDA has approved its first-in-class oral drug Brinsupri for treating non-cystic fibrosis bronchiectasis in patients aged 12 and older [3] - The National Medical Products Administration has received a market application for the intraocular injection of Bevacizumab from Fuhong Hanlin and Eddingpharm, marking the second such application in China [4] - Heng Rui Medicine has received approval for clinical trials of its innovative drug SHR-A2102 in combination with other treatments for recurrent/metastatic head and neck squamous cell carcinoma [5] Capital Market Activities - Inokang Medical Technology has started the listing guidance process with Huatai Securities, as disclosed by the China Securities Regulatory Commission [6] - Inokang was founded in 2014 by returnees and experienced professionals in the medical industry, and it has been recognized as a national high-tech enterprise [7] - Rejuve Bio announced a capital increase of 100 million yuan for its subsidiary ShunJing Biomedical Technology, with the company's stake decreasing from 45.5833% to 43.1842% [8] Industry Events - Zhifei Biological has completed the first nationwide vaccination of its quadrivalent influenza vaccine, highlighting the competitive landscape and market potential in China's influenza vaccine sector [10] - Zhonghui Bio's quadrivalent influenza vaccine has passed the preliminary review for inclusion in the national commercial health insurance innovative drug directory [11] - BeiGene anticipates that its drug Sotucumab will receive its first global approval by the end of 2026, with multiple milestone events expected soon [12] Public Sentiment Alerts - The re-registration application for Green Valley Pharmaceutical's mannitol sodium capsules has not been approved, indicating ongoing challenges for this controversial Alzheimer's drug [14] Shareholder Activities - Former Vice Chairman of Zhaoyan New Drug plans to reduce his holdings by up to 352.45 million shares due to personal financial needs, representing 0.4703% of the company's total share capital [15]

Core Viewpoint - The article discusses the ongoing challenges faced by Green Valley Pharmaceutical regarding its Alzheimer's drug GV-971 (甘露特钠胶囊), which has not received re-registration approval, leading to potential production halts and supply shortages [4][21]. Group 1: Drug Approval and Market Status - GV-971, developed for mild to moderate Alzheimer's disease, was conditionally approved in November 2019, marking the first new Alzheimer's drug approval in 17 years [8]. - The drug has faced significant scrutiny regarding its efficacy and clinical trial data, with notable public disputes among experts [8][9]. - As of May 2023, reports indicated nationwide shortages of GV-971, with prices on e-commerce platforms soaring to 5000 yuan per box, compared to its original price of 296 yuan when included in medical insurance [20]. Group 2: Production and Regulatory Challenges - Green Valley announced in May 2023 that it would halt production of GV-971 due to the expiration of its drug registration certificate, which is typically renewed six months prior to expiration [20][21]. - The failure to secure re-registration approval is believed to be linked to poor clinical trial data or unclear efficacy [21]. - The company has faced criticism for its handling of the drug's international clinical trials, which were suspended in May 2022 [8][9]. Group 3: Patient Impact and Alternatives - Patients have expressed concerns over the potential impact of drug shortages, but experts suggest that the drug's mechanism does not lead to immediate adverse effects upon discontinuation [21]. - Alternatives for patients include symptom-targeting medications and non-pharmacological interventions, although no similar mechanism drugs have been approved [21].

Core Viewpoint - The re-registration application for GV-971 (甘露特钠胶囊) by Green Valley Pharmaceutical has been denied, marking a significant challenge for this Alzheimer's disease drug that has been controversial since its conditional approval in 2019 [1][4]. Company Summary - GV-971, developed by Green Valley, is aimed at improving cognitive function in patients with mild to moderate Alzheimer's disease. It was conditionally approved in November 2019, filling a 17-year gap in new Alzheimer's drug approvals [1][2]. - The drug's approval was based on its unique mechanism targeting the gut-brain axis, using low molecular weight acidic oligosaccharides derived from marine brown algae, differing from the mainstream β-amyloid hypothesis [2]. - Following the denial of the re-registration application, Green Valley's production has been halted, and the drug has faced supply shortages and price increases across various platforms [1][4]. Industry Summary - The denial of GV-971's re-registration reflects the complexities involved in the development and approval of Alzheimer's drugs, highlighting potential issues with clinical trial data and efficacy [4][5]. - The drug's conditional approval required the completion of clinical trials and submission of formal reports, which have not been satisfactorily met, leading to the current situation [2][3]. - There are currently no other drugs with a similar mechanism approved, although alternative symptomatic treatments are available, such as donepezil, which some patients have switched to following GV-971's supply issues [5].

Core Viewpoint - The sudden discontinuation of the Alzheimer's drug, 甘露特钠胶囊 (brand name "九期一"), by Green Valley Pharmaceutical has led to a crisis for patients relying on this medication, with reports of counterfeit drugs flooding the market as a result of the supply shortage [1][2][4]. Group 1: Drug Supply Crisis - The discontinuation of 甘露特钠胶囊 began in early May 2025 and peaked in June, leaving many families of Alzheimer's patients in desperate search for alternatives [1][2]. - Green Valley Pharmaceutical stated that the production halt was due to the expiration of the drug's registration certificate, which is currently awaiting review [4]. Group 2: Counterfeit Drug Market - The shortage of the legitimate drug has led to a surge in counterfeit products being sold online, with misleading names such as "同仁堂甘露特钠胶囊" and "甘露药食同源浓缩丸" appearing on e-commerce platforms [6][11]. - Prices for the legitimate drug have skyrocketed, with reports of it being sold for as much as 5000 yuan per box, compared to the original monthly cost of approximately 296 yuan after insurance [4][2]. Group 3: Brand Misuse and Legal Issues - The issue of brand misuse is not new for 同仁堂, which previously reported 65 instances of its name being used fraudulently in March 2025 [11]. - The sale of counterfeit drugs has been identified as a criminal offense, with a notable case in May 2024 involving a live-streaming fraud scheme that targeted older adults, resulting in a financial loss of 30.89 million yuan [13].

Core Viewpoint - The Chinese innovative drug "Jiuqi Yi" (GV-971) developed by Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd. is facing production suspension due to the expiration of its drug registration certificate and delays in renewal approval, amidst rising investment enthusiasm in China's innovative drug sector [1][4][15]. Group 1: Company Situation - Green Valley announced that as of May 30, 2025, relevant positions for "Jiuqi Yi" have been suspended, with the main reason being the expiration of the drug registration certificate on November 2, 2024, and the failure to complete the renewal process on time [1][4]. - The company has been actively communicating with regulatory authorities regarding the renewal application, which was submitted on October 25, 2024, and is currently in a "waiting for review" status [4][5]. - Green Valley confirmed that the temporary adjustment only affects the "Jiuqi Yi" product line, and employees will receive wages at the minimum wage standard while social security and housing funds will continue to be paid [1][4]. Group 2: Product and Market Context - "Jiuqi Yi" was approved for conditional marketing in November 2019 and is recognized as the first drug targeting Alzheimer's disease in over 16 years, with a sales price of 296 yuan per box [15][16]. - Since its launch, "Jiuqi Yi" has sold 2.13 million boxes and benefited over 500,000 patients [16]. - The drug has faced ongoing academic controversy regarding its efficacy and safety, with critics questioning its mechanism of action and the adequacy of clinical trial durations [17][19]. Group 3: Clinical Research and Efficacy - Green Valley has conducted two post-marketing clinical studies involving 3,300 patients over approximately two years, showing improvements in cognitive function and daily living abilities for initial treatment patients [4][5]. - The company plans to present final data results from these studies at international academic conferences later this year [5]. - Despite the controversies, Green Valley maintains that it has not received negative feedback regarding the quality or efficacy of "Jiuqi Yi" [4][5].

Core Viewpoint - The news highlights the supply issues surrounding GV-971 (甘露特钠胶囊), a drug for Alzheimer's disease, which has led to a significant price increase and potential production halt due to regulatory challenges and cash flow problems faced by the manufacturer,绿谷制药 [1][3][5]. Group 1: Supply and Demand - GV-971 has been experiencing a supply shortage since six months ago, with recent reports indicating complete stockouts, causing prices to surge from 296 yuan to between 830 yuan and 1,033 yuan per box [1]. - Over 9,300 patients have requested the drug, and more than 1,200 doctors have urged the company to ensure continuous supply [1]. - The company is in communication with relevant authorities to expedite the review process for the drug's certification renewal [1][2]. Group 2: Regulatory and Clinical Background - GV-971 was conditionally approved in November 2019, becoming the first drug targeting the "gut-brain axis" mechanism for Alzheimer's treatment [3]. - The drug's approval was contingent upon the submission of long-term carcinogenicity data, which was completed and submitted in December 2019, showing no carcinogenic risk [3]. - The drug has been under review since October 2024, but its approval status remains pending, possibly due to ongoing debates regarding its efficacy [4]. Group 3: Financial Performance and Market Impact - Since its launch, GV-971 has reportedly benefited over 500,000 patients, with sales reaching 2.13 million boxes in 2024 alone [5]. - The drug's sales have grown at a compound annual growth rate of 343.2% since its approval, with hospital sales reaching 170 million yuan and retail sales at 156 million yuan in 2022 [5]. - The company has faced severe cash flow issues, leading to temporary layoffs and reduced salaries for employees [2]. Group 4: Alternative Treatments and Market Landscape - Despite the supply issues with GV-971, other established treatments for Alzheimer's disease, such as cholinesterase inhibitors and NMDA receptor antagonists, remain available [6]. - Newer drugs like Eli Lilly's donanemab and Eisai's lecanemab have also entered the market, providing additional options for patients [7]. - The Alzheimer's drug development landscape is characterized by high investment and risk, with over $100 billion invested globally, yet only one drug successfully launched from over 200 clinical trials [8][9].

Core Viewpoint - The first domestic Alzheimer's disease drug, Ganluotena Capsules (brand name: Jiuqi Yi), is facing a supply shortage due to production halts related to its registration certificate expiration, but the company, Shanghai Green Valley Pharmaceutical Technology, is in the final stages of approval and is optimistic about resuming supply soon [1][2]. Group 1: Product and Market Information - Ganluotena Capsules are priced over 1,000 yuan per box online, with a specification of 150mg and 42 capsules per box, requiring patients to take 6 capsules daily [1]. - The drug was conditionally approved by the National Medical Products Administration (NMPA) in November 2019 and was included in the medical insurance directory at the end of 2021, with the price reduced from 895 yuan to 296 yuan per box [1]. - Since its launch, over 500,000 patients have used Ganluotena, with sales exceeding 2.1 million boxes in 2024 alone [5]. Group 2: Regulatory and Production Status - The production halt is temporary and limited to the Ganluotena product line due to the need for a new registration certificate, with employees receiving minimum wage during this period [2]. - The company submitted supplementary applications for Ganluotena in May and October 2024, which will undergo comprehensive evaluation by the drug review center [3]. Group 3: Scientific and Clinical Background - Ganluotena is the world's first drug targeting the gut-brain axis for Alzheimer's disease, aiming to reshape gut microbiota, inhibit neuroinflammation, and improve cognitive function [4]. - The drug has faced controversy regarding its mechanism and the authenticity of research papers by its main inventor, but legal challenges against these criticisms have been dismissed [4].