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].

2025.08. 02 今年3月底，礼来的多奈单抗正式在中国进入临床治疗，复旦大学附属华山医院郁金泰教授对第一财 经记者表示，最新的LTE研究未纳入中国数据，因为该药物在中国刚上市不久，在中国患者人群中的 长期有效性还有待进一步验证。 本文字数：1288，阅读时长大约2分钟 作者 | 第一财经 钱童心 近两年来，针对阿尔茨海默病的创新药物在全球范围内获批，为应对阿尔茨海默疾病负担提出了新的 解决方案，但这些药物的长期随访疗效及副作用值得关注。 日前，在多伦多举办的2025年阿尔茨海默病协会国际会议（AAIC）上，礼来公布一项三期临床研究 的长期扩展（TRAILBLAZER-ALZ 2 LTE）结果。数据显示，接受其创新阿尔茨海默病药物疗法多 奈单抗注射液治疗的研究参与者相比未经治疗的队列，疾病进展显著减缓，且该获益在三年间持续显 现。 但研究强调，阿尔茨海默病患者在发病早期使用药物获益更为显著。三年随访结果显示，与较晚开始 接受治疗的延迟治疗组患者相比，早期使用多奈单抗可将疾病进展至下一阶段的风险降低27%，这 也再次证实了早期阿尔茨海默病干预的长期价值。 此前研究显示，超过75%的早期使用多奈单抗的患者在接 ...

Core Insights - Early use of the drug Donanemab significantly benefits Alzheimer's patients, reducing the risk of disease progression to the next stage by 27% compared to those who start treatment later [1] Group 1: Drug Efficacy - Over 75% of early users of Donanemab achieved amyloid clearance within 76 weeks of treatment [2] - The rate of amyloid plaque re-deposition in patients who completed treatment was approximately 2.4 CL/year over a maximum observation period of 2.5 years [2] - Long-term follow-up showed no new safety signals during the extended phase of the study [2] Group 2: Safety Concerns - Previous treatments targeting amyloid have shown imaging-related abnormalities (ARIA), including edema/exudate (ARIA-E) and bleeding/hemosiderin deposition, which may lead to severe symptoms [2] - Brain swelling and bleeding related to amyloid-clearing drugs primarily occur within the first six months of treatment [2] Group 3: Market Context - Donanemab was officially introduced for clinical treatment in China at the end of March this year, with ongoing validation of its long-term efficacy in the Chinese patient population [2] - Another Alzheimer's drug, Lecanemab, has been in clinical use in China for over a year, showing a 34% slower cognitive decline compared to untreated patients after four years [3] - China has approximately 9.83 million Alzheimer's patients, with an estimated 20% being in the early stages of the disease, potentially benefiting from innovative treatments [3]

Core Viewpoint - The National Health Commission of China has banned the use of "Lymphatic-Venous Anastomosis (LVA)" for the treatment of Alzheimer's disease due to a lack of long-term, statistically significant safety and efficacy data [1][2][15]. Group 1: Background of LVA Surgery - LVA surgery is not a new procedure; it was originally developed in the late 20th century for treating lymphatic diseases like lymphedema [2][12]. - The application of LVA for Alzheimer's treatment began in 2018 by Dr. Xie Qingping, leading to its widespread adoption in various medical institutions [2][12]. - Prior to the ban, over a hundred hospitals had been performing LVA surgeries, with total cases exceeding a thousand [7][12]. Group 2: Financial Aspects and Demand - The cost of LVA surgery ranges from tens of thousands to over 210,000 yuan, with many hospitals charging between 20,000 to 50,000 yuan [12][9]. - The financial burden of long-term care for Alzheimer's patients often makes LVA surgery an attractive option for families, as it can be more cost-effective compared to ongoing care [12][9]. - Hospitals have been motivated to promote LVA surgery due to the potential for significant revenue generation, especially in light of financial struggles faced by many medical institutions [12][13]. Group 3: Regulatory and Clinical Concerns - The rapid promotion of LVA surgery occurred in a regulatory vacuum, with many institutions conducting the procedure without sufficient clinical trial data to support its safety and efficacy [14][15]. - The National Health Commission's ban highlights the need for rigorous clinical trials and ethical guidelines for new treatments, as many hospitals had been charging for a procedure that lacked proper validation [15][16]. - There are currently only 12 registered clinical trials for LVA surgery in Alzheimer's treatment, indicating a significant gap in clinical research [15][16].

Core Viewpoint - The production of the Alzheimer's drug "Jiuyiqi" by Green Valley Pharmaceutical has been halted due to the expiration of its license, prompting concerns among patients about when it will resume production. The drug is required to supplement its Phase III clinical data, which has been deemed insufficient [1][2]. Group 1: Clinical Trial and Regulatory Issues - The initial Phase III clinical trial for "Jiuyiqi" was conducted over a period of only 9 months, which has raised significant concerns regarding its adequacy compared to international standards that typically require two parallel trials [1][2]. - The drug was conditionally approved in November 2019, with the understanding that additional data, including a long-term carcinogenicity study in rats, would be submitted within three months. This data has since been provided, showing no carcinogenic risk [2]. - Due to the COVID-19 pandemic, the originally planned global clinical trials were reduced to a smaller scale conducted domestically, which has led to questions about the rigor of the trial design [3]. Group 2: Market Context and Competitive Landscape - Since the launch of "Jiuyiqi," it has been included in the medical insurance system, significantly reducing the monthly treatment cost from over 1500 RMB to under 300 RMB [4]. - In the past year, new Alzheimer's treatments such as Lecanemab and Donanemab have been approved, but they come with high annual treatment costs of around 200,000 RMB and are not yet covered by insurance [4]. - There is a strong call within the industry for domestic manufacturers to continue investing in innovative Alzheimer's drug development to address the substantial unmet clinical needs, as existing treatments are either expensive or ineffective for late-stage diseases [4].

Core Viewpoint - The recent supply shortage and price increase of the Alzheimer's drug Ganluo Sodium (Jiuqi Yi) have raised concerns among patients and the public, prompting discussions about its availability and pricing [1][2][5]. Group 1: Supply Issues - Multiple regions, including Beijing, Shanghai, Guangdong, Shandong, and Heilongjiang, are experiencing shortages of Ganluo Sodium, with patients reporting difficulties in obtaining the medication [2][3]. - The manufacturer, Green Valley (Shanghai) Pharmaceutical Technology Co., has acknowledged the supply issues and is in communication with relevant authorities to address the situation [1][5]. - Over 6,000 patients have registered their demand for the drug amid the supply crisis [5]. Group 2: Price Increases - Online prices for Ganluo Sodium have surged significantly, with reports indicating a rise from approximately 300 yuan to over 540 yuan per box within a month [2][3]. - Various online platforms, including Taobao and JD.com, show prices ranging from 425 yuan to 699 yuan per box, reflecting the impact of the supply shortage on pricing [3][5]. - The company has stated that it is aware of the rapid price increases in some self-paid purchasing channels and is working to mitigate this issue [5]. Group 3: Drug Background and Controversy - Ganluo Sodium was conditionally approved for marketing in November 2019, becoming the first new drug for Alzheimer's disease approved globally since 2003 [6][9]. - The drug has been included in the national medical insurance directory and has benefited over 500,000 patients since its launch [6]. - Despite its approval, the drug has faced criticism regarding its efficacy, with ongoing clinical trials required to confirm its long-term safety and effectiveness [6][7]. Group 4: Clinical Research and Development - Green Valley has reported positive mid-term results from post-marketing clinical studies, showing cognitive and daily living improvements in patients after one year of treatment [7]. - The international multi-center Phase III clinical trial for Ganluo Sodium was prematurely terminated in 2022 due to funding issues and the impact of the pandemic, with plans to restart when conditions allow [8][9]. - The pharmaceutical industry faces significant challenges in Alzheimer's drug development, with a high failure rate and substantial investment required, highlighting the ongoing need for effective treatments [9][10].