This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

开始日期2020-11-30

申办/合作机构

Swedish Orphan Biovitrum AB

NCT04513366

/ Completed临床3期

A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy will be performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

开始日期2020-08-18

申办/合作机构

Swedish Orphan Biovitrum AB

NCT03905512

/ Completed临床2期

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

开始日期2019-05-07

申办/合作机构

Selecta Biosciences, Inc.

100 项与 SEL-212 相关的临床结果

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100 项与 SEL-212 相关的转化医学

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100 项与 SEL-212 相关的专利（医药）

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项与 SEL-212 相关的文献（医药）

2024-04-02·Rheumatology (Oxford, England)

The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout

Article

作者: DeHaan, Wesley ; Azeem, Rehan ; Traber, Peter G ; Kivitz, Alan J ; Choi, Hyon K ; Baraf, Herbert S B ; Strand, Vibeke ; Terkeltaub, Robert ; Keenan, Robert T ; Dalbeth, Nicola ; Khanna, Puja P

Abstract:

Objectives:

Serum urate (SU) lowering with PEGylated uricases in gout can reduce flares and tophi. However, treatment-emergent anti-drug antibodies adversely affect safety and efficacy and the currently approved PEGylated uricase pegloticase requires twice-monthly infusions. Investigational SEL-212 therapy aims to promote uricase-specific tolerance via monthly sequential infusions of a proprietary rapamycin-containing nanoparticle (ImmTOR) and pegadricase.

Methods:

COMPARE was a randomized, phase 2, open-label trial of SEL-212 vs pegloticase in adults with refractory gout. SEL-212 [ImmTOR (0.15 mg/kg) and pegadricase (0.2 mg/kg)] was infused monthly or pegloticase (8 mg) twice monthly for 6 months. The primary endpoint was the proportion of participants with SU <6 mg/dl for ≥80% of the time during 3 and 6 months. Secondary outcomes were mean SU, gout flares, number of tender and/or swollen joints and safety.

Results:

During months 3 and 6 combined, numerically more participants achieved and maintained a SU <6 mg/dl for ≥80% of the time with SEL-212 vs pegloticase (53.0% vs 46.0%, P = 0.181). The percentage reductions in SU levels were statistically greater during months 3 and 6 with SEL-212 vs pegloticase (−73.79% and −47.96%, P = 0.0161). Reductions in gout flare incidence and number of tender and/or swollen joints were comparable between treatments. There were numerical differences between the most common treatment-related adverse events of interest with SEL-212 and pegloticase: gout flares (60.2% vs 50.6%), infections (25.3% vs 18.4%) and infusion-related reactions (15.7% vs 11.5%), respectively. Stomatitis (and related terms) was experienced by eight participants (9.6%) with SEL-212 and none with pegloticase. Stomatitis, a known event for rapamycin, was associated with ImmTOR only.

Conclusions:

SEL-212 efficacy and tolerability were comparable to pegloticase in refractory gout. This was associated with a substantial reduction in treatment burden with SEL-212 due to decreased infusion frequency vs pegloticase.

Clinical trial registration:

NCT03905512.

2024-01-01·Journal of molecular graphics & modelling

Theoretical investigation of asphaltene molecules in crude oil viscoelasticity enhancement

Article

作者: Cui, Peng ; Yuan, Shideng ; Zhang, Heng ; Yuan, Shiling

Understanding the mechanisms of viscosity enhancement in crude oil phases is crucial for optimizing extraction and transportation processes. The enhanced viscosity mechanism of crude oil phase can be attributed to the intricate intermolecular interactions between asphaltene molecules. However, the molecular mechanism of the viscosification of asphaltene molecules in crude oil is not yet to be fully understood. In this work, molecular dynamics simulations were employed to investigate the dynamic behavior and viscosification mechanism of asphaltene molecules in complex oil phases. Research suggests that the neutral surface of asphaltenes features abundant positive and negative electrostatic potential regions, facilitating complementary pairing between these areas. This significantly augments electrostatic interactions among asphaltene molecules. Besides, the expansive nonpolar expanse on the normal asphaltene surface facilitates interactions between asphaltenes and crude oil molecules. This leads the crude oil viscosity of the system containing normal asphaltene is higher than that of the system containing acidic asphaltene under the same mass fraction (382 μ Pa·s for AAsp and 416 μ Pa·s for NAsp). This work provides insight into the viscosity enhancement mechanisms in crude oil phases and is helpful in improving the efficiency of crude oil extraction and transportation.

2023-08-01·Rheumatology and therapy

Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110).

Article

作者: Choi, Hyon ; Kivitz, Alan ; Kishimoto, Takashi K ; Rhodes, Sheri ; Leung, Sheldon S ; DeHaan, Wesley ; Johnston, Lloyd ; Traber, Peter G ; Azeem, Rehan ; Park, Justin ; Nicolaou, Savvas ; Inshaw, Jamie ; Sands, Earl

INTRODUCTION:

SEL-212 is a developmental treatment for uncontrolled gout characterized by serum uric acid (sUA) levels ≥ 6 mg/dl despite treatment. It comprises a novel PEGylated uricase (SEL-037; also called pegadricase) co-administered with tolerogenic nanoparticles containing sirolimus (rapamycin) (SEL-110; also called ImmTOR^®), which mitigates the formation of anti-drug antibodies (ADAs) against uricase and SEL-037 (PEGylated uricase), thereby enabling sustained sUA control (sUA < 6 mg/dl). The aim of this study was to identify appropriate dosing for SEL-037 and SEL-110 for use in phase 3 clinical trials.

METHODS:

This open-label phase 2 study was conducted in adults with symptomatic gout and sUA ≥ 6 mg/dl. Participants received five monthly infusions of SEL-037 (0.2 or 0.4 mg/kg) alone or in combination with three or five monthly infusions of SEL-110 (0.05-0.15 mg/kg). Safety, tolerability, sUA, ADAs, and tophi were monitored for 6 months.

RESULTS:

A total of 152 adults completed the study. SEL-037 alone resulted in rapid sUA reductions that were not sustained beyond 30 days in most participants due to ADA formation and loss of uricase activity. Levels of ADAs decreased with increasing doses of SEL-110 up to 0.1 mg/kg, with anti-uricase titers < 1080 correlating with sustained sUA control and reductions in tophi. Overall, 66% of evaluable participants achieved sUA control at week 20 following five monthly doses of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg, whereas only 26% achieved sUA control at week 20 when SEL-110 was withdrawn after week 12. Compared to other dose combinations, SEL-037 0.2 mg/kg + SEL-110 0.15 mg/kg achieved the greatest sUA control at week 12 and was well-tolerated with no safety concerns.

CONCLUSION:

Results provide continued support for the use of multiple monthly administrations of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg in clinical trials for SEL-212.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT02959918.

项与 SEL-212 相关的新闻（医药）

2025-05-30

·E药经理人

暴涨200%！儿药老牌首亏后，靠痛风新药掀桌

创新升级不是一个靠一个产品一笔交易就能完成的，他的建设任重道远。靠一款痛风新药真的能改变一品红吗？资深分析师：彡氜编审：苏叶想象力应该如何估价？当一家名不见经传的老牌药企，押中一款市场大药，再碰上另一家老牌药企释放天价交易利好，再燃起一把BD预期的火。连一向低调的投资人都忍不住在朋友圈晒一晒：“这次绝对不会再错过了！”市场对一品红的笃定，就像持续冲破预期的估值——从四月至今，一品红的股价不仅创了历史新高，而且又涨了87%。另一面是，一品红2024年营收大幅下滑、归母净利润首次亏损，即便这样自其业绩预告之日至今，他仍然上涨了200%。对比起疫苗赛道的惨淡现实，市场告诉我们：一家创新公司短期内不必靠现实活着，靠预期就能风生水起。这无疑给到，很多曾经被市场放弃的企业希望，成为他们向上的动力。不过我这样描述，并不是说鸡犬都能升天，而是在描述创新药走进了大时代——水大鱼大。抛开强预期的痛风新药，一品红本身也算是一家不错的标的：业绩稳健增长（收入在2023年之前连续保持了十年的增长），疾病领域相对聚焦（儿科和慢病），毛利率高有一定的稀缺性。股价是最好的反映，自其上市以来已经上涨600%多。随着一品红市值一次又一次的冲高，目前是215亿元，他是否被高估？是否有成为十倍股的潜力？对于我们从传统药企中发掘潜力股有极大的价值。CM10医药研究中心将从他的潜力产品及基本盘来一探究竟。痛风大药的BD预期痛风正在成为创新药的又一座金矿。在全球，当安进的Krystexxa在2024年销售突然爆发，冲破10亿美元大关（销售额11.85亿美元，同比增长336%），长久被忽视的痛风领域再度引爆资本市场——以痛风大药为估值核心的一品红，三个多月上涨2倍。痛风是一种尿酸过度沉积导致的疾病，并且新发患者逐渐年轻化。这一领域市场相当可观：预计到2030年，全球高尿酸血症和痛风患病人数达到14.2亿，中国将达到2.4亿。根据疾控中心报告，目前国内存量痛风患者超过8000万人。但是，偌大的市场上市新药很少。目前国内已经上市治疗高尿酸/痛风的药物主要有三类：1）抑制尿酸生成的XO抑制剂（如别嘌醇和非布司他）；2）促尿酸排泄的URAT1抑制剂（如丙磺舒、苯溴马隆和雷西纳德）；3）尿酸氧化酶类似物等。痛风治疗以XO抑制剂为一线选择，URAT1抑制剂成为治疗新热点，但都有一定的局限性：别嘌醇的过敏风险，非布司他被FDA黑框警告心血管风险，苯溴马隆因为严重肝毒性陆续在一些国家撤市，雷西纳德同样受肾脏毒性被FDA黑框警告。显然，痛风市场亟待一个安全性与疗效性俱佳的好药。市场大，参与者当然不少。截至2025年3月底，国内外在研的URAT1抑制剂痛风药品就有37个。卫材的多替诺雷（已上市）和恒瑞的Ruzinurad处于国内第一梯队，后者于今年1月向CDE提交了上市申请。接下来，就是一品红的AR882、上海璎黎的YL-90148和信诺维的XNW3009等均已在国内进入III期临床。很快，痛风领域即将涌入一波新药。一品红的AR882，国际临床进展最快，并展现出了全球同类最佳尿酸降低药物的潜力，尤其受到投资者青睐。具体来看，这是一款基于苯溴马隆改造的URAT1靶向创新药，具备降低血尿酸治疗痛风、溶解痛风石及治疗慢性肾病三大适应症。根据其一项关键临床，75mg的AR882可将89%患者血清尿酸含量（sUA）水平降至<6mg/dL，同时安全性良好，显现出高潜力。临床进度提前。随着AR882国际三期试验REDUCE2提前完成受试者入组，有望于2026年上半年完成，进度领先同类竞品；国内方面，与非布司他在治疗痛风伴高尿酸血症的头对头三期临床也在近期启动了。另一让投资者笃定的要素是，对AR882运作团队的判断：联合创始人及首席执行官负责过痛风药物雷西纳德和维利纳德的临床药理学相关研究，首席医学官曾担任杜克大学医学中心痛风与晶体关节病诊所主任和杜克大学医学院风湿病与免疫学系医学副教授，为风湿领域专家，首席商务官曾主导过痛风药物SEL-212相关商业化工作。在BD交易中，对人的判断通常是排在产品之外的靠前因素。此关键性阶段，是估值提升的最佳窗口，尤其资本市场冀望一品红的AR882能做出一个漂亮的大BD。今年2月以来，他的股价上涨接近2倍。可以总结的是，在国内“有大市场，强临床需求，自身是Better甚至Best的新药，再加上好的排位，以及中国已形成的良好BD基础”，不大会被淹没了。聪明的普通药企可以说，痛风大药像灯塔一样，给了一品红创新转型的信心。2002年成立的一品红，在押中AR882前实际上是一家不折不扣的传统药企——转型步调节奏趋稳。但不同的是，一品红足够聚焦，这让他的转型包袱没那么大。2018年，一品红开始筹备创新药的研发布局，4月审议通过在美国设立了子公司，为布局全球化创新做铺垫。不过在当时的蓝图中，一品红对自己的战略定位仍然是，“一家儿童药创新药公司”。对于慢病领域，2019年年报中，一品红的描述是着重发展缓控释制剂技术平台。在研的口服缓控释高端制剂矩阵很大：有RDH029控释片、RDH052缓释胶囊、RDH055肠溶胶囊、RDH057双释放肠溶胶囊等9个产品。由此可见，他是想从高端制剂出发，慢慢跨入创新领域。集采加速了他的转型决心。2019年末开展的集采，慢病药品成为首当其冲的领域，尽管对于一品红的影响在两三年后才逐渐显现，但是一品红已经感觉到危机。数据：同花顺2020年时，一品红第一次在年报中提出“慢病谋创新”的战略定位，并提出“三转”战略：加快完成从传统产品创新向高端制剂及新靶点创新的转型，积极布局创新药研发；加快完成从华南市场向全国市场转型；加快完成以业务驱动发展向以技术创新驱动发展的企业升级转型。这个转折点很关键：一品红一方面看到了集采的威胁，另一方面看到了当时创新药的潜力，2020年正值创新药受到资本市场吹捧的高光之年。说干就干，一品红在接下来的两年内完成了创新布局的基本建构：一方面沿着高端制剂继续布局，另一面延伸布局了Protac、AI新药以及小分子创新药等新技术，此外还有新型疫苗。2021年时，一品红密集进行了8笔对外创新投资，来快速补充其自主创新上的产品缺口。如果不评价交易质地，这出手速度其实是相当快的。数据：一品红年报其中就包括了对痛风新药AR882的这笔投资。这是一品红当年最核心的一个项目，金额之大合作之深，也能看到他对这笔投资的笃定成分。简单回顾下这笔合作：2021年7月底，一品红通过全资子公司投资3.83亿元与美国Arthrosi Therapeutics达成深度战略合作——包括一品红对Arthrosi的投资，以及双方在广州成立合资公司瑞安博医药，提供研发资金以支持痛风领域创新药的成果转化，由此获得了最重要的资产就是AR882。这笔交易其实很超前的，可以看成一个反向的Newco，把海外资产拿进中国，专门成立子公司去运营它。保留了对创新权益的选择权，同时又可以较大程度隔绝掉失败的风险，建立起防火墙。这两年随着AR882的临床进展，一品红也一步一步将该创新成果体内化，最大化资本层面的价值。2024年，子公司瑞奥生物以7268 万元受让合资公司瑞安博少数股东Arthrosi24.05%的股权。交易完成后，一品红对瑞安博的股权比例从60.70%上升至 84.75%。2025年5月，一品红再度增资4900万元，将广州瑞安博变为公司全资子公司，将AR882资产的权益完全并表。通过对这笔交易的复盘，我们也可以总结出：一品红到底是如何获得了这款痛风新药的。一是战略上的相对聚焦，一品红的战略一直是聚焦儿童药和慢病领域，这已然超过很多企业。二是策略上的“分散投资”，小额切入，持续加码，对于重点项目的投资可以适当倾斜，敢于下注。这一策略适合绝大多数传统药企转型创新，“在擅长的领域去做投资，在做投资的时候分散风险，步步深入。”你也可以看到，一品红的投资也不都是十分成功的。比如2021年，一品红下重注投资的疫苗，金额也达到了1.85亿元。到2024年，这笔投资等于宣告“失败”，因为一品红将该项目权利转让给了丽珠单抗，交易总额是2.1亿元，含首付款500万元，产品商业化后有销售额提成，总额不超过20亿元。这一“失败”是指作为战略投资的一种失策，因为最后没有达成战略的结果。来到拐点时刻接下来的问题是，一品红有没有能力去承接这份创新成果的落地，这是他市值持续突破的评估指标。回答这一问题，要看这家公司的基因和相关经验沉淀的能力。如果你去复盘，外部合作恰恰是这家公司的基因，我们提到的是广义BD，一品红早年间的资产积累是靠外部代理做起来的，2010-2011年，他通过并购引进了53项产品技术；2013-2014年，他又并购引进了85项产品技术；2015年他还收购了2个独家儿童新药。通过外部并购给一品红的更多是吃到甜头，营收从2013年的5.08亿元到2023年的25亿元；2013-2022年进入资产扩张积累期，到2023年逐渐稳定下来到44亿元。数据：同花顺这一基因离不开掌权人李捍雄，李捍雄背景是做金融，他十分擅长资源的整合和运作，并且了解资本市场的偏好，注重资源配置效率最大化。如果不计算2024年的拐点，一品红的人均创收在A股化学制药板块排名前20%。净资产收益率常年维持在15%以上。所以即便之前没有痛风新药的资产，一品红的股价也从6元一路上涨到20元区间，原因就是长达十年的业绩稳健增长的支撑。底子很好，但也有失手时刻。2024年对于一品红来说是一个拐点之年：一方面是业绩塌方式的下滑，营收24年下滑42%，利润从同比下滑到首次亏损5.4亿元；另一面是痛风新药全面进入到关键的3期临床，研发投入占到营收的22.4%。造成去年拐点的主因是集采冲击，7个品种中标但部分违规被暂停资格至2025年2月，此外需退回医保资金2.66亿元。短期对一品红的利润和现金流都造成了冲击，集采资格恢复后，销售可能有所修复，但需要时间。接下来一品红仍将面临的，第一资金压力增加，资产负债率24年攀升到56%，虽然这并不是不可解决的核心问题。第二基本盘何时恢复。长期来看，一品红的收入结构将是“儿童药+慢病药+创新药”，并且儿童药和慢病药作为基本盘，是提供稳定现金流，支撑创新药研发的关键阵地。业务何时能够恢复才是重中之重。2024年慢病药收入下滑52%，儿童药收入下滑39%。当前市场对儿童药的价值认可度不高，资本市场上的儿药标的如健民集团、葫芦娃等公司都处于低估值状态，儿药空间亟待发掘。一品红的儿童药年营收在10亿左右，贡献了三分之二的营收，离头部药企还有差距。核心产品芩香清解口服液市占率已达18%，有机构预计该板块未来三年CAGR将保持在12%以上。第三创新药方面，可以期待的是AR882三期临床数据披露，以及BD的好消息。此外口服小分子GLP-1，APH01727的临床进展，不过GLP-1已然是一片红海。而即便是AR882上市了，一品红仍然面临创新药的商业化挑战，尤其是在区域上的大扩围。显而易见的是在接下来的两三年内，一品红仍将继续承受新旧产品迭代的撕裂之痛，在此过程重建新的增长曲线所需能力，对实现阶梯式跃升是必要的。我们不否认，一品红在创新转型上给行业带来的借鉴意义。但是我们也要提醒，对于任何一家公司来说，创新升级不是一个靠一个产品一笔交易就能完成的，他的建设任重道远。在此期间，我们需要平衡考虑基本盘的稳定性和创新产品的可持续性，来给予相对合理的估值。一审| 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疫苗财报

2025-05-30

·BiG生物创新社

对标K药，三生制药赢麻了

作者｜momo2025年5月，三生制药以一场震撼行业的“王炸级”操作赢麻了，60.5亿美元天价BD交易刷新国产创新药出海天花板，其PD-1/VEGF双抗SSGJ-707凭借“Best-in-Class”临床数据成为“下一个K药”有力竞争者。 01 天价BD，孕育下一个K药2025年5月20日，中国生物医药行业迎来历史性时刻——三生制药宣布与辉瑞达成总额60.5亿美元的授权协议，将其PD-1/VEGF双抗SSGJ-707的全球（除中国内地）权益授予辉瑞。这一交易以12.5亿美元首付款刷新国产创新药出海纪录，远超此前康方生物AK112与Summit Therapeutics达成的50亿美元总交易规模（图1）。三生制药SSGJ-707正在PD-1赛道上演与K药的“王座继承战”。图1.三生制药与辉瑞达成总额60.5亿美元的授权协议SSGJ-707的成功源于其独特的技术设计与临床数据优势。作为三生制药基于专有CLF2平台开发的双抗药物，其采用天然IgG4结构设计，通过消除ADCC和CDC效应，显著降低了免疫系统误伤正常组织的风险，从而在安全性上优于同类竞品。这一差异化设计使其在临床中展现出“Best-in-Class”潜力。图2.SSGJ-707 临床早期数据2025年JPM大会披露的II期数据显示，在单药一线治疗PD-L1阳性非小细胞肺癌（NSCLC）患者中，SSGJ-707的客观缓解率（ORR）达70.8%，疾病控制率（DCR）为100%；联合化疗时，鳞癌患者ORR更飙升至81.3%，且3级及以上不良反应发生率仅为23.5%（图2）。相比之下，康方生物的AK112在III期临床试验中ORR为50%，安全性数据亦稍逊（3级及以上不良反应发生率29.4%）。尽管两者尚未开展头对头试验，但SSGJ-707的疗效与安全性组合已为其赢得“BIC”标签。图3.PD-(L)1/VEGF双抗全球研发进展PD-1/VEGF双抗的崛起源于其能够同时抑制免疫检查点PD-1和促血管生成因子VEGF“双重抗癌机制”。康方生物AK112于2024年9月公布的HARMONi-2 III期研究数据首次在头对头试验中击败默沙东的K药，成为该赛道的引爆点。此后，全球药企加速布局，而三生制药凭借SSGJ-707的快速推进（全球进度第二）抢占先机。目前，全球在研PD-(L)1/VEGF双抗达35款，其中中国占据20款（图3），但仅康方AK112上市，三生（SSGJ-707）、礼新（LM-299）、普米斯（PM8002）等紧随其后。辉瑞选择SSGJ-707而非进度更早的AK112，既因其临床数据亮眼，亦与其适应症拓展潜力及联合疗法开发空间密切相关。 02 展开合作，扩大治疗领域近年来，三生制药通过密集的对外合作与产品引进，持续拓宽治疗领域边界，逐步构建起覆盖多疾病领域的创新产品管线（图4）。在肿瘤领域，三生制药通过ADC、双抗等前沿技术组合探索治疗潜力。2025年2月，三生制药与百利天恒达成合作，共同推进其PD-1/VEGF双抗SSGJ-707与百利天恒全球首创的EGFR×HER3双抗ADC药物BL-B01D1的联用研究。BL-B01D1作为全球唯一进入临床阶段的靶向EGFR×HER3双抗ADC，已在中美开展约30项临床试验，覆盖非小细胞肺癌、乳腺癌等适应症，其中联合奥希替尼用于一线非小细胞肺癌的III期试验已完成首例受试者入组。此外，2025年1月，三生制药引进映恩生物HER2 ADC药物DB-1303，获得其在中国内地及港澳的商业化权利。DB-1303采用拓扑异构酶-1抑制剂载荷，已获FDA及NMPA突破性疗法认定，针对HER2低表达乳腺癌的III期临床试验全球领先，疾病控制率（DCR）高达94.1%。图4.公司近年来开展的合作项目（部分）在血液疾病领域，三生制药聚焦中国高发的急性髓性白血病（AML）。2024年11月，三生制药获得东阳光药第二代FLT3抑制剂苯磺酸克立福替尼的独家商业化权利。该药物针对FLT3-ITD突变型AML，其III期临床试验数据显示更强的靶点抑制活性及更低脱靶风险，有望成为国内首个上市的国产高选择性FLT3抑制剂。 2024年5月，三生蔓迪与翰宇药业合作开发司美格鲁肽注射液，切入千亿减重市场（图5）。该产品是国内首个进入III期临床的国产司美格鲁肽类似物，依托三生制药的营销网络，有望在超重/肥胖率超50%的中国市场快速渗透。同时，公司在痛风领域从EnzymeRx 引进的SEL-212（Pegsiticase）已于2024年7月向FDA提交生物制品许可申请（BLA），其通过重组酶代谢尿酸的机制为顽固性痛风患者提供新选择，潜在市场空间达百亿级。三生制药在剂型革新上亦取得显著进展。2024年10月，三生获得海和药物紫杉醇口服溶液（柏瑞素）的独家商业化权利（图5）。该产品采用脂质自乳化技术（DH-LASED），突破紫杉醇传统注射限制，生物利用度提升且过敏风险降低，无需预处理即可居家服用，极大提升晚期胃癌患者依从性。其针对HER2阴性乳腺癌的国际多中心III期研究已进入随访阶段，未来适应症拓展潜力显著。图5.三生制药在多个领域展开密集合作在血小板减少症领域，三生制药与则正医药合作的艾曲泊帕乙醇胺干混悬剂（特艾升）于2024年12月获批上市。该干混悬剂型适口性更佳，支持精准剂量调整，尤其适合儿童及吞咽困难患者，进一步巩固了公司在骨髓保护产品线的领导地位（图5）。更令人关注的是，三生制药通过引进Cosmo 附属公司 Cassiopea 旗下Winlevi（柯拉特龙乳膏）进一步切入痤疮治疗领域。作为40年来首个新机制外用雄激素受体抑制剂，Winlevi在美国市场处方量已超109万张，其在中国内地的III期桥接试验预计2025年完成，有望成为国内首个AR拮抗剂类痤疮药物，覆盖中重度患者群体。 03 发力自免，创造第二增长曲线随着全球自身药物市场加速扩容，三生制药控股子公司三生国健作为国内自免领域先行者，已构建覆盖IL-17A、IL-4R、IL-5、IL-1β等核心靶点的产品矩阵，并前瞻性布局BDCA2、TL1A等下一代靶点，推动自免业务成为继肿瘤领域后的第二增长曲线。其中，SSGJ-608是是国内进度第二的IL-17A单抗，针对斑块状银屑病，为全新的氨基酸序列，在体外和体内动物模型中显示出和同靶点抗体Cosentyx 和 Taltz 相当的生物活性。其针对中重度斑块状银屑病的III期临床试验显示，12周主要疗效数据优异，短期内快速起效、疗效优势明显、维持治疗期，SSGJ-608给药间隔延长至Q4W或Q8W疗效持续维持高位，有望在PsO上实现更长给药间隔（图6）。图6.SSGJ-608 III期临床研究数据相较于已上市的司库奇尤单抗（诺华）和依奇珠单抗（礼来），SSGJ-608通过优化氨基酸序列实现更高生物活性，并计划拓展中轴型脊柱炎适应症，预计2025年递交NDA，成为国产IL-17A领域的重要竞争者。此外，SSGJ-611是全球第三款靶向IL-4Rα的生物制剂。它通过精准阻断IL-4/IL-13炎症信号通路，抑制2型免疫反应过度激活，从而快速缓解瘙痒、修复皮肤屏障。在特应性皮炎（AD）II期临床中（图7），300mg每两周给药组的EASI-75应答率达72.5%，优于度普利尤单抗同阶段数据（67%），并计划于2026年提交NDA。其适应症布局覆盖AD、COPD及慢性鼻窦炎伴鼻息肉（CRSwNP），目标患者群体超1.6亿人，有望复制度普利尤单抗“一药多适应症”的放量路径。图7.SSGJ-611 II期临床研究数据值得注意的是，针对急性痛风性关节炎的重组抗白介素1-β（IL-1β）人源化单克隆抗体SSGJ-613的II期临床结果显示，使用SSGJ-613治疗12周复发率仅8.3%，显著低于阳性对照组倍他米松（28.6%），且疼痛评分降幅达70%以上。目前国内尚无IL-1β单抗上市，长春高新的金纳单抗虽已递交NDA，但SSGJ-613凭借更优疗效数据和三生国健在风湿科的渠道优势，有望在2025年NDA后快速抢占市场。与此同时，三生国建持续布局BDCA2、TL1A等自免领域前沿靶点。BDCA2靶点通过抑制浆细胞样树突状细胞（pDC）产生干扰素α/β，直击红斑狼疮核心病理机制。三生国健的SSGJ-626已在中美同步获批IND，进度仅次于Biogen的Litifilimab（III期临床中），有望成为全球第二款进入临床的BDCA2单抗（图8）。图8.SSGJ-626有望成为全球第二款进入临床的BDCA2单抗另外，TL1A靶点在溃疡性结肠炎、克罗恩病等适应症中展现突破性潜力，辉瑞、默沙东等跨国药企已通过BD交易押注该赛道。三生制药的SSGJ-627于2025年1月获准IND，成为国内首个进入临床的TL1A单抗，有望在消化系统自免领域建立先发优势。结语三生制药凭60.5亿美元天价BD交易、SSGJ-707强劲数据及肿瘤、自免多线布局实力“赢麻”，以创新硬实力与前瞻战略，在出海与本土市场双制霸，成国产药企“顶流”标杆！参考资料[1]https://www.3sbio.com/ImgUpload/files/202501/2025012104430567755.pdf[2]https://www.3sbio.com/ImgUpload/files/202408/2024082206294824405.pdf[3]三生制药官网、官微、国盛证券研报、中泰证券研报、各种公开资料等共建Biomedical创新生态圈！如何加入BiG会员？

2025-01-08

·PRNewswire

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

疫苗临床3期免疫疗法

100 项与 SEL-212 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
慢性痛风	申请上市	美国	Swedish Orphan Biovitrum AB	2024-07-02
痛风性关节炎	临床3期	美国	Swedish Orphan Biovitrum AB	2020-08-18
痛风	临床3期	美国	Selecta Biosciences, Inc.	-
高尿酸血症	临床2期	美国	Selecta Biosciences, Inc.	2016-10-01

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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


NCT04596540 \| NCT04513366 (DISSOLVE II, EULAR 12024 \| EULAR 22024) 人工标引	临床3期	痛风	265	SEL-212 0.15 mg/kg (high-dose)	齋積製蓋鏇積壓窪衊齋(壓鏇齋築築窪獵觸繭窪) = 廠襯鑰廠鬱選觸願積製壓糧選遞膚積觸憲簾願 (鹽鏇夢蓋蓋夢蓋選獵簾, 9.5) 更多	积极	2024-06-14
				SEL-212 0.1 mg/kg (low-dose)	齋積製蓋鏇積壓窪衊齋(壓鏇齋築築窪獵觸繭窪) = 蓋蓋鏇襯繭範鏇艱憲鏇壓糧選遞膚積觸憲簾願 (鹽鏇夢蓋蓋夢蓋選獵簾, 9.4) 更多
NCT04513366 (DISSOLVE I, EULAR2024)	临床3期	痛风	38	SEL-110 at 0.15 mg/kg + SEL-037 at 0.2 mg/kg	築醖網窪鹽鬱獵顧獵窪(願餘獵廠艱構蓋餘顧製) = The most common adverse event of special interest across all three treatment arms was gout flare 製鹹鑰膚繭構齋鬱窪積 (鏇餘願窪築蓋觸膚膚壓 ) 更多	积极	2024-06-05
				SEL-110 at 0.1 mg/kg + SEL-037 at 0.2 mg/kg
NCT03905512 (COMPARE, CTgov)	临床2期	痛风 \| 慢性痛风 \| 痛风性关节炎	170	SEL-212 (SEL-212)	鑰鑰網獵糧獵網窪蓋積 = 選鹽鹹鏇鹹鹽製窪選壓遞窪憲築餘構壓蓋鏇網 (鏇顧範窪醖窪窪醖憲窪, 夢襯餘淵衊鹹鏇餘鬱選 ~ 鹽鏇蓋築選範構蓋範遞) 更多	-	2023-10-17
				KRYSTEXXA® (KRYSTEXXA)	鑰鑰網獵糧獵網窪蓋積 = 衊窪醖遞醖糧窪廠蓋簾遞窪憲築餘構壓蓋鏇網 (鏇顧範窪醖窪窪醖憲窪, 鹹選壓構築鹽積鏇鹽壓 ~ 窪艱齋廠構餘顧醖遞顧) 更多
NCT03905512 (COMPARE, Corporate Publications) 人工标引	临床2期	慢性痛风	170	SEL-212	繭鑰簾淵糧齋網積壓壓(夢鏇遞鹹醖顧選選艱糧) = 積鬱鏇鏇簾觸製齋鑰廠製窪襯憲選範觸蓋網衊 (襯淵夢鬱壓築壓壓憲艱 ) 更多	积极	2020-09-30
				Pegloticase	繭鑰簾淵糧齋網積壓壓(夢鏇遞鹹醖顧選選艱糧) = 鬱膚鹽壓餘鬱餘遞鹹鏇製窪襯憲選範觸蓋網衊 (襯淵夢鬱壓築壓壓憲艱 ) 更多
NCT02959918 (ACR2019) 人工标引	临床2期	痛风	152	SEL-212	鹽蓋醖鏇顧餘積壓壓窪(艱築顧鹽憲醖顧構壓獵) = 構構願築蓋願構願觸積願簾積鬱齋網糧鏇鑰醖 (窪艱繭顧壓餘壓觸鬱簾 ) 更多	积极	2019-11-11
				Pegadricase	-
SEL-212 (EULAR2019)	临床2期	痛风	152	SEL-212 (0.1 mg/kg ImmTOR + 0.2 mg/kg pegadricase)	窪積遞鏇糧鹽鏇築鑰遞(選觸簾艱壓糧壓積蓋鏇) = All evaluable patients receiving 0.1 or 0.15 mg/kg ImmTOR administered with 0.2 mg/kg pegadricase who achieved three months of SUA control maintained SUA control in months four and five of combination treatment 鑰鹽襯繭鑰網襯鹹獵願 (鑰壓膚齋夢繭遞觸願願 ) 更多	-	2019-06-12
				SEL-212 (0.15 mg/kg ImmTOR + 0.2 mg/kg pegadricase)
ACR2017	临床2期	痛风	60	SEL-212 (0.4mg/kg pegsiticase + 0.08mg/kg SVP-R)	簾夢窪壓選窪糧淵簾壓(積廠窪鹽壓獵築襯膚顧) = Of 7 observed serious infusion reactions, 4 were associated with patients receiving pegsiticase alone or the lowest dose of SEL-212, as expected, and two were related to dosing errors 顧觸積網鑰願窪積製範 (憲鑰構鹽範構範衊鬱襯 )	积极	2017-11-07
				Pegsiticase alone (0.4mg/kg)
FOCIS2017	临床1期	高尿酸血症	5	SVP-R alone	選齋壓簾鏇獵窪願蓋糧(窪鹹選繭築觸鑰繭願夢) = 淵窪醖襯積積獵構廠鑰願衊範願鹹膚構憲繭糧 (夢顧繭鬱鹹獵糧窪選鬱 )	积极	2017-06-14
FOCIS2017	临床2期	-	38	SEL-212 (SVP-R + pegsiticase)	築願衊衊蓋艱構網繭網(築襯淵蓋糧鏇觸餘獵齋) = 網鬱遞憲選鹹鹽鬱獵襯繭齋範積網築襯觸網鏇 (顧鏇糧蓋鬱鹹積蓋鹽簾 )	积极	2017-06-14
				Pegsiticase alone	築願衊衊蓋艱構網繭網(築襯淵蓋糧鏇觸餘獵齋) = 鏇餘齋觸簾膚鑰範鹹製繭齋範積網築襯觸網鏇 (顧鏇糧蓋鬱鹹積蓋鹽簾 )