Buntanetap(Buntanetap) - 药物靶点：ACHE_在研适应症：阿尔茨海默症，帕金森病，路易体病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

(+)-phenserine、(+)-Posiphen、Posiphen

+ [4]

靶点

ACHE

作用方式

抑制剂

作用机制

AChE抑制剂(乙酰胆碱酯酶抑制剂)、TINAPs inhibitors(Neurotoxic aggregating proteins inhibitors)

治疗领域

神经系统疾病内分泌与代谢疾病心血管疾病+ [1]

在研适应症

阿尔茨海默症帕金森病路易体病+ [2]

非在研适应症

认知功能障碍亨廷顿舞蹈病轻度认知障碍+ [2]

原研机构

National Institute on Aging

在研机构

Annovis Bio, Inc.

非在研机构

Cenomed BioSciences LLC

权益机构

National Institute on Aging

Annovis Bio, Inc.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C20H23N3O2

InChIKeyPBHFNBQPZCRWQP-AZUAARDMSA-N

CAS号116839-68-0

关联

7

项与 Buntanetap 相关的临床试验

NCT07284784

/ Recruiting临床2/3期

An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease

This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.

开始日期2026-01-09

申办/合作机构

Annovis Bio, Inc.

[+1]

NCT06709014

/ Recruiting临床3期

A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls

开始日期2025-02-04

申办/合作机构

Annovis Bio, Inc.

[+1]

NCT05686044

/ Completed临床2/3期

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Buntanetap in Participants With Mild to Moderate Alzheimer's Disease

The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimer's disease.
Study details include:
The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home.
The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.

开始日期2023-04-01

申办/合作机构

Annovis Bio, Inc.

100 项与 Buntanetap 相关的临床结果

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100 项与 Buntanetap 相关的转化医学

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100 项与 Buntanetap 相关的专利（医药）

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37

项与 Buntanetap 相关的文献（医药）

2025-12-01·Alzheimers & Dementia

Pharmacokinetic characterization of buntanetap in plasma of patients with early Alzheimer’s and Parkinson’s diseases

Article

作者: Maccecchini, Maria L. ; Fang, Cheng ; Morin, Alexander ; Peterson, Matthew J

Abstract:

Background:

Buntanetap (formerly Posiphen) is an orally bioavailable small molecule that improves cognitive function in patients with early Alzheimer’s (AD) and Parkinson’s (PD) diseases. Buntanetap is lipophilic and has high blood‐brain barrier penetrability and brain uptake (10:1 brain:plasma ratio). In SAD and MAD studies, at all doses, buntanetap showed similar profiles, it was absorbed rapidly and cleared from the circulation bi‐phasically, independent of dose. This analysis aims to further evaluate the pharmacokinetics (PK) of buntanetap in AD and PD populations.

Method:

The following parameters were measured across two RCTs for buntanetap doses ranging between 7.5mg‐30mg: C max , T max , AUC 0‐t , AUC 0‐∞ , t 1/2 . In AD (NCT05686044, Phase II/III, N=351), PK samples were obtained at 0h and then 1h, 2h, and 4h after drug administration (0, 7.5mg, 15 mg, 30mg QD). In PD (NCT05357989, Phase III, N=523), two cohorts of PK samples were obtained: sparse and dense (0, 10 mg, 20mg QD). In the sparse group, PK samples were obtained at 0h and then 1.5h after drug administration. In the dense group, PK samples were obtained at 0h and then 1h, 1.5h, and 2h‐10h (hourly) after drug administration.

Result:

Calculated PK parameters for buntanetap in plasma for AD (Table 1) and PD patients (Table 2) had many similarities. C max and AUC 0‐t for AD and PD (dense) increased at the same rate in a dose‐proportional manner; PD (sparse) increased with dose as well, but its response was more muted overall. Mean T max ranged from 1.34‐1.88h across all doses in both AD and PD patients. Mean t 1/2 was comparable and ranged from 1.55‐1.74h in AD and 2.01‐2.57h in PD. The 30mg dose in AD did not follow the increasing trend for AUC 0‐∞ as in the lower doses for AD and PD (dense), which was likely underpowered by the sampling of this measure ( N =2).

Conclusion:

Analyses from two RCTs confirmed similar mean C max , T max , and AUC 0‐t across doses of 7.5mg‐30mg buntanetap in both patients with early AD and PD. These data confirm fast plasma peak, as seen in all of our previous studies, and dose‐dependent exposure to drug, supporting buntanetap’s PK uniformity across AD and PD indications.

2025-12-01·Alzheimers & Dementia

A dual 6‐month (stage 1) & 18‐month (stage 2) prospective, randomized, placebo‐controlled, double‐blind, pivotal clinical trial investigating efficacy and safety of buntanetap in early Alzheimer's patients

Article

作者: Morin, Alexander ; Gaines, Melissa ; Fang, Cheng ; Peterson, Matthew J ; Maccecchini, Maria L. ; MacCallum, Sarah J

Abstract:

Background:

Annovis Bio initiated a new pivotal clinical trial in early Alzheimer's disease (AD). This Phase III trial is being conducted to determine whether buntanetap, which inhibits the translation of neurotoxic aggregating proteins, is able to a) duplicate the efficacy seen in our phase IIb study and improve symptomatic effects and b) show potential disease‐modifying effects.

Method:

The study started in March 2025 and is progressing at a good pace. In total, 760 participants will be randomized across up to 100 sites. The study is being conducted at both academic and private sites across the US. Participants are being recruited through sites' databases, physician referrals, and word of mouth. We will collect and summarize data as to site opening, patient inclusion using the plasma pTau217 biomarker, and participant enrollment.

Result:

Tables will be featured on the poster showing the status of the following per July 2025:• An update of the recruiting sites and locations• A US map with all site locations shown as pins, to highlight regional study access• pTau217 selection inclusion/exclusion figures• Current enrollment versus Target enrollment of 760 participants• Actual monthly participant accrual versus projected monthly accrual• Estimated timelines for the 6‐month and 18‐month end of study data readouts• Screen failure rate with breakdown of screen failure reasons

Conclusion:

In summary, we will show the ease of using plasma biomarkers to determine the presence of AD. We will provide updates on total enrollment and the 6‐ and 18‐month data readout timepoints.

2025-12-01·Alzheimers & Dementia

Design of Phase III study testing buntanetap efficacy in early Alzheimer's patients based on the insights from previous studies

Article

作者: Maccecchini, Maria L. ; Fang, Cheng ; Sanders, Laurie H ; Gaines, Melissa

Abstract:

Background:

By inhibiting the translation of neurotoxic aggregating proteins ‐ amyloid precursor protein, tau, alpha‐synuclein, and TDP43 etc., buntanetap restores axonal transport, lowers inflammation, and protects nerve cells from dying. Results from our phase II/III dose‐ranging study of buntanetap in mild to moderate Alzheimer’s disease (AD) patients (MMSE14‐24) showed that 30mg buntanetap improved mild AD patients (MMSE 21‐24) cognitive functions. We are validating the findings in a Phase III study in early AD patients (MMSE 21‐28).

Method:

A double‐blind, placebo‐controlled, phase III study is currently underway to test buntanetap’s efficacy and safety in early AD. Patients will be 1 to 1 randomized with either placebo or 30 mg QD buntanetap. A total of 760 patients will be enrolled in the US. Primary endpoints are ADAS‐Cog13 and ADCS‐iADL.

Result:

Biomarker data from our Phase II/III study confirmed the mechanisms of action and showed more insights into the molecular pathway, from neurotoxic proteins, synaptic function, inflammatory responses, and neurodegeneration.The new ongoing pivotal Phase III study incorporates the pTau217 plasma biomarker into patient enrichment/validation. This study has 2 parts. Part 1 is a 6‐month study to confirm buntanetap’s symptomatic effects in improving patients’ cognition. Part 2 is an 18‐month study to test buntanetap’s potential disease modifying effects.

Conclusion:

Based on clinical and biomarker data from our previous studies, we designed a novel Phase 3 study to validate symptomatic improvement and potentially show disease‐modification effects of buntanetap in treating early AD patients.

154

项与 Buntanetap 相关的新闻（医药）

2026-02-12

·丽影淑音

- 帕金森临床进展：二期、三期新药汇总

帕金森前沿速递｜2026最新临床动态二/三期在研药一览今天为大家带来帕金森领域最新消息，不少备受关注的新药正处在关键的二期、三期临床阶段，每一步推进，都在为广大病友点亮新的希望。下面为大家梳理当前最值得关注的临床药物与前沿进展，方便大家及时了解、心中有数。一、三期临床新药（最接近上市） 1. Prasinezumab（普拉西珠单抗）作为靶向α‑突触核蛋白的单克隆抗体药物，主打延缓病情进展，目前处于全球三期临床，有望在2026年进入国内市场。2. Buntanetap口服神经保护类药物，三期临床数据显示，可有效改善运动症状、延缓病程发展，预计2026年下半年国内将有最新消息。3. Tavapadon新型多巴胺受体激动剂，每日只需服用一次，对运动症状改善效果明确，目前已提交FDA审批，即将迎来上市节点。4. Bemdaneprocel干细胞多巴胺神经元修复疗法，直接作用于受损神经元，从根源上改善功能，正在开展全球三期临床试验。二、二期临床新药（前景值得期待） 1. NC201注射液我国自主研发的干细胞药物，一期临床效果亮眼，可显著改善评分、恢复多巴胺功能，目前已正式进入二期临床。2. CPL’36国外新型PDE10A抑制剂，二期临床数据积极，对运动症状有明显改善作用，是未来潜力候选药物之一。三、小结与寄语 2026年是帕金森新药研发的关键一年，三期药物离上市越来越近，国内干细胞疗法也在稳步推进。每一项研究、每一次数据更新，都在为病友们带来更多治疗选择与生活信心。我们一起静待佳音，科学在进步，希望一直在前方。

2026-02-12

·BioSpace

Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial of Buntanetap in Alzheimer’s Disease

MALVERN, Pa., Feb. 12, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that an independent Data and Safety Monitoring Board (DSMB) has issued a positive recommendation regarding the safety of buntanetap at 6 months, supporting the continuation of the ongoing pivotal Phase 3 AD clinical trial without modification. The DSMB is responsible for periodically reviewing accumulated safety data and providing independent recommendations on the conduct and progression of the study. During the open session, Annovis presented an overview of the trial status, including enrollment progress, adverse events, and study timelines. In the closed session, attended exclusively by DSMB voting members to ensure full objectivity and by an unblinded reporting statistician, unmasked safety data were reviewed. Following a comprehensive evaluation, the DSMB concluded that no safety concerns were identified and recommended that the clinical trial continue as planned, without changes. Moreover, the 6-month safety data in Alzheimer’s patients were consistent with those observed in Parkinson’s patients at the same time point. Subsequent safety evaluations are planned at 12 and 18 months. “We are pleased to receive this positive recommendation from the DSMB,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “This response reinforces our confidence in the safety pro buntanetap and allows the clinical program to proceed without interruption. Importantly, due to the alignment of safety outcomes across the Alzheimer’s and Parkinson’s studies, the FDA indicated it may consider accepting combined safety data in a future NDA submission.” The pivotal Phase 3 AD clinical trial of buntanetap ( NCT06709014 ) is currently recruiting patients across the United States and is now 40% complete. The first symptomatic efficacy readout is anticipated in early 2027, followed by a disease-modifying readout expected in early 2028. About Annovis Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients. For more information, visit and follow us on LinkedIn , YouTube , and X . Investor Alerts Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at . Forward-Looking Statements This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law. Contact Information: Annovis Bio Inc. 101 Lindenwood Drive Suite 225 Malvern, PA 19355 Investor Contact: Alexander Morin, Ph.D. Director, Strategic Communications Annovis Bio ir@annovisbio.com ‍

临床3期

2026-02-04

·帕不怕先生

帕金森病未来有哪些新的药物研发计划？

帕金森病的药物研发正在从传统的“控制症状”转向“延缓甚至阻断疾病进程”。下表汇总了重点在研新药的核心信息，帮你快速了解全局。药物/疗法名称类型/作用机制最新研发阶段 (2026年)核心特点与潜在获益靶向FAM171A2的新药小分子化合物/抗体药物临床前研发，计划推向临床试验旨在早期干预，阻断致病蛋白传播，延缓疾病进展，是“对因治疗”的突破性探索。UB-312靶向α-突触核蛋白的主动免疫疗法III期临床试验完成激发人体免疫系统清除有毒蛋白，直击病因，有望实现疾病修饰。Buntanetap减少神经毒性蛋白聚集的口服药物计划开展开放标签延伸研究聚焦神经退行核心机制，同时关注运动和非运动症状（如认知障碍）的改善。奥吡卡朋 (Opicapone)第三代COMT抑制剂已在国内提交上市申请每日一次口服，作为左旋多巴的辅助治疗，能稳定血药浓度，帮助减少 “剂末现象” 。XS411细胞注射液iPS衍生多巴胺能神经前体细胞疗法已获批临床试验，预计2026年推进II期通过细胞移植重建神经功能，为中晚期患者提供新方向，目标是改善运动症状，缩短“开关期”。 💡 新药研发的三大趋势当前的新药进展显示出几个清晰的走向：从“对症”到“对因”的转变：传统药物如左旋多巴主要是补充多巴胺，缓解症状。而像靶向FAM171A2的新药和UB-312这样的疗法，直接瞄准帕金森病的核心病理——α-突触核蛋白的异常聚集和传播，目标是延缓或阻止疾病本身的发展，这被称为“疾病修饰疗法”。追求用药的便捷与稳定：新药在努力延长给药间隔（如每日一次的奥吡卡朋）或采用更便捷的给药方式（如鼻喷雾剂），这能显著提高患者长期治疗的依从性，从而提升生活质量。覆盖疾病全程管理：研发不仅关注早期患者，也注重解决中晚期患者面临的复杂问题，如左旋多巴长期治疗产生的运动并发症。新的辅助治疗药物（如他伐帕顿）和细胞疗法为此带来了希望。💎 重要提醒在为您或家人关注这些新进展时，有几点需要特别留意：上市状态：上述部分药物的临床数据和预期时间点来源于研发机构的发布，其最终能否上市、具体适应症及疗效，必须由国家药品监督管理局（NMPA）等监管部门的最终审评结果为准。个体化差异：帕金森病的病情因人而异，没有任何一种药物对所有患者都有效。选择何种方案需要神经内科医生根据患者的具体病情、疾病分期和个人身体状况来综合判断。理性看待：尤其是细胞疗法、基因疗法等前沿技术，虽然前景广阔，但部分仍处于临床研究阶段，其长期安全性和有效性有待进一步验证。

免疫疗法细胞疗法基因疗法

100 项与 Buntanetap 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15317

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床3期	美国	Annovis Bio, Inc.	2025-02-04
帕金森病	临床3期	美国	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	德国	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	匈牙利	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	意大利	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	波兰	Annovis Bio, Inc.	2022-08-03
帕金森病	临床3期	西班牙	Annovis Bio, Inc.	2022-08-03
帕金森病（青年型、早发型）	临床2期	美国	Annovis Bio, Inc.	2020-08-14
认知功能障碍	临床2期	美国	Annovis Bio, Inc.	2009-05-26
路易体病	临床2期	-	Annovis Bio, Inc.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05686044 (CTgov)	临床2/3期	阿尔茨海默症	351	Placebo (Placebo)	製範鬱範獵憲遞艱艱積(獵齋鹽餘遞積窪窪鏇鏇) = 糧簾繭鑰遞築簾範艱願廠窪膚選鏇餘夢糧顧齋 (簾觸網製繭鬱築鑰獵製, 0.533) 更多	-	2025-04-29
				Buntanetap/Posiphen (7.5mg Buntanetap/Posiphen)	製範鬱範獵憲遞艱艱積(獵齋鹽餘遞積窪窪鏇鏇) = 獵鑰積遞淵膚膚餘繭繭廠窪膚選鏇餘夢糧顧齋 (簾觸網製繭鬱築鑰獵製, 0.526) 更多
NCT05357989 (CTgov)	临床3期	帕金森病	523	Placebo (Placebo)	繭選衊鏇簾構鏇醖蓋範(糧範膚廠憲選顧醖艱廠) = 願壓齋選餘窪襯鑰餘膚鏇齋齋糧鑰蓋鑰範鬱繭 (鹹衊窪鬱艱襯選壓壓齋, 0.311) 更多	-	2025-03-03
				buntanetap/posiphen (10 mg Buntanetap/Posiphen)	繭選衊鏇簾構鏇醖蓋範(糧範膚廠憲選顧醖艱廠) = 窪齋鬱選顧鹽遞鏇衊網鏇齋齋糧鑰蓋鑰範鬱繭 (鹹衊窪鬱艱襯選壓壓齋, 0.312) 更多
NCT05357989 (Biospace) 人工标引	临床3期	帕金森病	-	Buntanetap	願廠襯糧糧網衊糧廠選(廠艱憲壓製醖積網顧顧) = In patients diagnosed with PD for longer than 3 years (MH>3), with measurable declines in MDS-UPDRS Part II, 20mg buntanetap significantly improved MDS-UPDRS Part II, Part III, Part II+III, and Total scores compared to placebo and baseline 鑰窪壓遞齋壓觸觸壓憲 (餘鹽鬱壓繭膚製膚淵鏇 ) 更多	积极	2024-07-02
				Placebo
GlobeNewswire 人工标引	N/A	阿尔茨海默症	-	Buntanetap 15mg	製選簾鹹構壓窪憲築鏇(蓋艱鹽製獵觸築醖餘獵) = 選願鹹繭衊襯餘餘淵壓積壓鏇壓齋蓋構淵廠簾 (鏇構顧簾鏇鏇築顧艱鑰 )	积极	2024-06-11
				Placebo	製選簾鹹構壓窪憲築鏇(蓋艱鹽製獵觸築醖餘獵) = 鏇壓衊築廠衊鏇簾糧繭積壓鏇壓齋蓋構淵廠簾 (鏇構顧簾鏇鏇築顧艱鑰 )
NCT05686044 (Biospace) 人工标引	临床2/3期	阿尔茨海默症	325	Buntanetap 7.5 mg	範壓築窪壓選選構獵構(鏇遞願餘簾觸餘選醖範) = 製獵窪獵糧醖淵齋餘蓋築願顧範鹽築鏇遞廠鬱 (衊衊糧糧蓋積願膚鹽選, 0.87)	积极	2024-05-29
				Buntanetap 15 mg	範壓築窪壓選選構獵構(鏇遞願餘簾觸餘選醖範) = 鏇憲壓糧鏇夢淵衊鑰築築願顧範鹽築鏇遞廠鬱 (衊衊糧糧蓋積願膚鹽選, 0.81)
NCT05686044 (Biospace) 人工标引	临床2/3期	阿尔茨海默症	107	Buntanetap	窪築憲網襯遞選繭憲範(廠襯憲獵獵顧壓鏇築廠) = 鏇鹽獵獵蓋製鏇襯夢壓齋壓淵網夢艱襯鬱顧蓋 (窪艱願襯遞獵選衊願構 )	积极	2023-10-30
NCT04524351 (CTgov)	临床1/2期	帕金森病（青年型、早发型） \| 阿尔茨海默症	75	Posiphen (Posiphen, 80mg (Parkinson's Participants))	鬱醖艱憲獵獵餘繭鬱鹽 = 網鬱繭憲鏇遞醖壓範顧鏇範壓艱獵繭觸齋鹽製 (鏇齋顧夢選顧艱構選廠, 廠夢製範衊製夢窪醖餘 ~ 製壓簾鬱鏇願醖蓋衊齋) 更多	-	2023-02-28
				Posiphen (Posiphen, 40mg (Parkinson's Participants))	鬱醖艱憲獵獵餘繭鬱鹽 = 鹹窪鹹齋蓋選夢餘繭築鏇範壓艱獵繭觸齋鹽製 (鏇齋顧夢選顧艱構選廠, 製蓋壓壓構衊選憲獵餘 ~ 繭蓋蓋鹹願獵遞壓築艱) 更多
NCT02925650 (CTAD2022)	临床1期	轻度认知障碍 CSF Aβ42/40	19	Posiphen	製壓觸膚鬱蓋顧鹹醖網(鑰餘築鏇獵選淵醖獵遞) = 8/19 participants reported headache either during CSF sampling (4),after the procedure (3), or both (1). 5 had blood patches with rapid resolution of headache. 襯選醖淵鹹遞遞積艱齋 (窪製蓋夢顧糧齋構獵願 )	-	2022-12-03