A Dose-increasing, Randomized, Double-blind, Placebo-controlled, Single-dose/multiple-dose Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection in Healthy Chinese Subjects.

This is a Phase I clinical to evaluate the safety and tolerability of single and multiple intravenous infusions of AAPB at different doses over 7 consecutive days.

开始日期2024-11-14

申办/合作机构

江苏康缘药业股份有限公司

ITMCTR2024000671

/ Suspended临床1期IIT

A dose-escalation randomized double-blind placebo-controlled single/multiple dose phase I trial to evaluate the safety tolerability and pharmacokinetics of an injectable AAPB in healthy Chinese subjects.

开始日期2024-11-14

申办/合作机构

Beijing Tiantan Hospital Affiliated to Capital Medical University

100 项与 AAPB 相关的临床结果

登录后查看更多信息

100 项与 AAPB 相关的转化医学

登录后查看更多信息

100 项与 AAPB 相关的专利（医药）

登录后查看更多信息

项与 AAPB 相关的文献（医药）

2025-02-01·Acta Pharmaceutica Sinica B

A novel anti-ischemic stroke candidate drug AAPB with dual effects of neuroprotection and cerebral blood flow improvement

Article

作者: Zhang, Yihua ; Chang, Xinglong ; Zhu, Jiayi ; Ding, Yang ; Huang, Zhangjian ; Hang, Taijun ; Wang, Zhenzhong ; Chen, Xijing ; Zhong, Yan ; Xu, Yuwen ; Liu, Qiu ; Jiao, Weijie ; Xiao, Wei ; Li, Liang ; Wang, Tuanjie ; Guo, Qingming ; Ji, Duorui ; Wu, Jianbing ; Cao, Yumei ; Sun, Xia ; Jia, Jian ; Ling, Ya

Ischemic stroke (IS) is a globally life-threatening disease. Presently, few therapeutic medicines are available for treating IS, and rt-PA is the only drug approved by the US Food and Drug Administration (FDA) in the US. In fact, many agents showing excellent neuroprotection but no blood flow-improving activity in animals have not achieved ideal clinical efficacy, while thrombolytic drugs only improving blood flow without neuroprotection have limited their wider application. To address these challenges and meet the huge unmet clinical need, we have designed and identified a novel compound AAPB with dual effects of neuroprotection and cerebral blood flow improvement. AAPB significantly reduced cerebral infarction and neural function deficit in tMCAO rats, pMCAO rats, and IS rhesus monkeys, as well as displayed exceptional safety profiles and excellent pharmacokinetic properties in rats and dogs. AAPB has now entered phase I of clinical trials fighting IS in China.

2022-05-01·FASEB JOURNAL

Case Analysis of Accessory Abductor Pollicis Longus Tendons and Brevis Muscles with Implications for Occupational Therapy

Article

作者: Tyce, Alexis ; White, Andrew ; Snow, Ethan

INTRODUCTION:

Variations in muscles to the pollex are relatively common. Abnormal cleavage of the thenar muscles during development can form accessory muscle bellies, and forearm muscles sending long tendons to the pollex can develop extra tendons. While these abnormalities are typically asymptomatic and often go undetected, serious sequelae can result that affect pollex function. Pollex abduction, generated primarily by the abductor pollicis longus (APL) and brevis (APB) muscles, is an essential movement for hand function. APL has been reported with accessory tendons, split muscle bellies, and abnormal attachments, but variations in APB are less common. The addition of an accessory APL (aAPL) tendon in the 1st extensor compartment may cause crowding of APL and extensor pollicis brevis (EPB) tendons and result in inflammation. This condition is known as de Quervain’s tenosynovitis and often generates pain during abduction and extension of the pollex – implications that are pertinent to Occupational Therapy (OT). The objective of this study is to analyze a unique case of bilateral aAPL tendons which distally attach to accessory APB (aAPB) muscles and discuss their implications for OT practice.

METHODS:

Bilateral aAPL tendons distally attaching to aAPB muscles were discovered during routine cadaver dissection at the University of Nebraska Medical Center. The aAPL tendons, aAPB muscles, and surrounding anatomy were cleaned of extraneous tissue to better view the course, structure, and attachments of the anomalies. The bilateral anomalies were comparable, so only the left aAPL tendon and aAPB muscle were photographed in situand post‐evisceration. Bilateral tendon measurements and maximal isometric forces (Fmax) for each muscle were used to determine comparability and thereafter discussed as means. The normal APL and APB were also analyzed bilaterally to gauge accessory muscle impact. A literature review was conducted to discuss rarity and clinical implications of these muscles for OT practice.

RESULTS:

The regular APL tendon displayed a normal insertion on the base of the 1st metacarpal. The aAPL tendon originated from the APL muscle belly and exhibited two distal attachments: the main tendon (137.5 mm length) to the aAPB muscle belly and a short distal branch of the main tendon to the trapezium. Compression of the aAPL tendon in the 1st extensor compartment was grossly visible. The literature consistently references de Quervain’s tenosynovitis as an expected result from similar cases, but no studies describe a distal bifurcation of the aAPL tendon that distinctly attaches to both aAPB and trapezium. Mean Fmax for APB, aAPB, and APL were 12.1 N, 8.2 N, and 40.8 N, respectfully.

CONCLUSIONS & SIGNIFICANCE:

The present study reports a unique case of an aAPL tendon with a distinct bifurcation to an aAPB and the trapezium. The short tendon to trapezium allows aAPB to use the aAPL tendon as an anchor (origin) but limits APL’s ability to abduct the pollex via pull on aAPB. This report may help OT providers better determine the presence of accessory abductor pollicis tendons and/or muscles when treating patients with de Quervain’s tenosynovitis, adapt treatment modalities, and note this in their medical record for possible future use in tendon transfer surgeries.

2007-09-01·FEMS microbiology ecology3区 · 生物学

Dynamics of aerobic anoxygenic phototrophic bacteria in the East China Sea

3区 · 生物学

Article

作者: Yao Zhang ; Nianzhi Jiao

Aerobic anoxygenic phototrophic bacteria (AAPB) are a group of heterotrophic bacteria capable of photosynthesis. The dynamics of AAPB in the East China Sea, a typical marginal sea characterized by diverse physical-chemical and ecological conditions, were investigated from April 2002 to September 2003. The results showed that the abundance of AAPB varied from 0.16 to 7.9 x 10(4) cells mL(-1) and the percentage of AAPB (AAPB%) in the total heterotrophic bacterial abundance varied from 0.5% to 11.6% over a gradient of environmental conditions. The abundance of AAPB and AAPB% was higher in coastal and continental shelf waters than in oceanic waters. An interesting seasonal pattern was observed in the Yangtze River estuary: the abundance of AAPB was highest in summer and lowest in winter; however, AAPB% was higher in winter than in the other seasons. Throughout the investigation period, variation of AAPB abundance with temperature was much less than that of nonAAPB abundance, suggesting that low temperature was not a limiting factor for AAPB in this case. Close correlation between AAPB and chlorophyll a was observed in each season, suggesting that dependence of AAPB on dissolved organic carbon produced by phytoplankton (PDOC) may be one key factor controlling AAPB distribution.

项与 AAPB 相关的新闻（医药）

2025-03-11

·米内网

康缘药业厉害了！手握48个独家中成药，47款1类新药、9个新品冲刺，掘金4200亿市场

精彩内容近日，康缘药业公告称，公司申报的中药1.1类新药固本消疹颗粒获批临床，用于治疗慢性自发性荨麻疹卫表不固证。作为国内中药龙头企业之一，康缘药业手握48个独家中成药，近年来坚持创新驱动发展，目前有33款中药新药、19款化药/生物药新药在研，9款中药新药上市可期。此外，9个品种以新注册分类报产，其中有3个暂无首仿（含剂型首仿）获批。超10亿品种领跑！48个独家中成药亮眼康缘药业是一家集药品研发、生产、销售为一体的大型中药企业，目前拥有药品生产批件200余个，聚焦呼吸与感染疾病、妇科疾病、心脑血管疾病、骨伤科疾病等中医优势领域，覆盖口服液、注射液、胶囊剂、片剂/丸剂、颗粒剂/冲剂、贴剂、凝胶剂等剂型。目前康缘药业手握48个中药独家品种（含独家剂型，不含原料药），不乏金振口服液、热毒宁注射液、银杏二萜内酯葡胺注射液、复方南星止痛膏、杏贝止咳颗粒、桂枝茯苓胶囊、腰痹通胶囊、天舒胶囊、七味通痹口服液等临床畅销品种。目前仅康缘药业拥有生产批文的中成药注：标*为国家医保品种来源：米内网中国上市药品（MID）数据库米内网数据显示，金振口服液、热毒宁注射液2023年在中国三大终端六大市场（统计范围详见本文末）销售额超过10亿元，银杏二萜内酯葡胺注射液销售额接近10亿元，复方南星止痛膏、桂枝茯苓胶囊销售额均超过3亿元。即使手握多款独家优势品种，康缘药业也毫不松懈，始终坚持创新驱动发展，以中医药为主体，同时积极布局化学药、生物药等领域。近年来，公司持续加大研发投入与力度，2023年研发投入约7.8亿元，占总营收比重约16%，2024年前三季度研发费用（不含资本化研发投入）约4.7亿元。在过去的2024年，康缘药业有1款中药新药温阳解毒颗粒，4款化药仿制药吡仑帕奈片、泊沙康唑肠溶片、甲磺酸仑伐替尼胶囊、替米沙坦氨氯地平片顺利获批上市；龙七胶囊、参蒲盆安颗粒2款中药1.1类新药及玉女煎颗粒1款中药3.1类新药提交NDA，4款化药仿制药恩格列净片、呋塞米口服溶液、盐酸左沙丁胺醇雾化吸入溶液、骨化三醇软胶囊以新注册分类报产。此外，羌芩颗粒、七味脂肝颗粒、补髓益智颗粒、固本消疹颗粒、连参更年颗粒5款中药1类新药，KYHY2302乳膏、注射用AAPB、KYHY2303片3款化药1类新药，KYS202002A注射液、KYS202004A注射液、KYS202003A注射液3款生物药1类新药提交IND，除了补髓益智颗粒、连参更年颗粒，其余均已顺利获批临床。猛攻4200亿市场！33款中药新药来势汹汹作为国内中药创新龙头企业，康缘药业自2020年以来保持每年皆有中药新药获批上市的态势，累计拿下筋骨止痛凝胶、银翘清热片、散寒化湿颗粒、苓桂术甘颗粒、济川煎颗粒、温阳解毒颗粒6个中药新药。 3月5日，康缘药业连发公告称：公司申报的中药1.1类新药固本消疹颗粒获批临床，该药处方源于临床经验方，具有益气温阳、祛风固表的功效，可用于治疗慢性自发性荨麻疹卫表不固证；淫羊藿总黄酮胶囊新适应症获批临床，用于治疗血管性痴呆。目前康缘药业有33款中药新药处于申请临床及以上阶段，覆盖呼吸系统、妇科、消化及代谢系统、儿科、心脑血管疾病等中医优势领域。若以中药新注册管理办法计，则中药1类创新药有29个，中药2类改良型新药有2个，古代经典名方中药复方制剂有2个。康缘药业国内在研的中药新药来源：公司公告、米内网综合数据库 9款中药新药上市可期。其中，龙七胶囊（肺癌）、参蒲盆安颗粒（盆腔炎性疾病后遗症-慢性盆腔痛）、玉女煎颗粒（胃热阴虚证）、泻白颗粒（小儿肺热咳喘证）已提交NDA；此外，用于流行性感冒的热毒宁颗粒及双鱼颗粒、用于变应性鼻炎的紫辛鼻鼽颗粒、用于更年期综合征的六味地黄苷糖片、用于支气管哮喘的麻杏止哮颗粒均处于III期临床。除了开发中药新药，康缘药业也在拓展公司已上市品种的新适应症，其中大株红景天胶囊用于预防急性高原反应的新适应症已处于III期临床，金振口服液用于儿童病毒性肺炎的新适应症、杏贝止咳颗粒用于感染后咳嗽风热犯肺证的新适应症均已步入II期临床，苁蓉总苷胶囊用于阿尔茨海默病(AD)轻中度痴呆属髓海不足患者的症状改善治疗的新适应症、淫羊藿总黄酮胶囊用于血管性痴呆的新适应症已获批临床等。米内网数据显示，2023年中国三大终端六大市场中成药销售额接近4200亿元，同比增长约6.5%，2024上半年有略微下滑，销售额超过2100亿元。 18款1类新药在路上，3大品种抢首仿化药/生物药新药方面，2025年至今，康缘药业有1款1类新药KYS202002A注射液获批临床，1款1类新药WXSH0493片提交IND等。为进一步丰富生物药研发管线，康缘药业于2024年11月公告称，公司拟以2.7亿元收购中新医药100%股权。中新医药为生物药新药研发公司，聚焦代谢性疾病及神经系统疾病领域，目前已有4个1类新药步入临床试验阶段。含引进的新药在内，目前康缘药业有19款化药/生物药新药（18款为1类新药）处于获批临床及以上阶段，涵盖抗肿瘤及免疫调节、心脑血管系统、神经系统、消化及代谢系统等治疗领域。康缘药业国内在研的化药及生物药新药来源：米内网综合数据库从研发进度上看，WXSH0493片（痛风）、氟诺哌齐片（阿尔茨海默氏病）、KY0467颗粒（儿童手足口病）、喹诺利辛片（前列腺增生）、SIPI-2011片（室性心律失常）等已处于II期临床阶段。化药仿制药方面，1月8日，康缘药业申报的4类仿制药西格列汀二甲双胍片(Ⅱ)获批生产并视同过评，这是公司首个获批的糖尿病化药，同时也是公司2025年首个获批的产品。截至目前，康缘药业有14个品种过评或视同过评。此外，康缘药业有9个品种以新分类报产在审，若以通用名计，则9个药品2023年在中国三大终端六大市场的销售额合计超过50亿元，不乏骨化三醇、利格列汀等畅销品种。康缘药业新分类报产且在审的品种来源：米内网中国申报进度（MED）数据库 9个品种中，有3个暂无首仿（含剂型首仿）获批上市，包括琥珀酸舒马普坦萘普生钠片、色甘酸钠吸入溶液及布瑞哌唑片，其中前两个由康缘药业首家/独家报产，有望拿下国内首仿。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至3月10日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

临床申请上市批准临床研究

2025-02-28

·米内网

【瞩目】康缘中药1类新药来袭！64亿市场再掀波澜

精彩内容 2月27日，CDE官网显示，康缘药业的中药1.1类新药固本消疹颗粒获得临床试验默示许可，用于治疗慢性荨麻疹。米内网数据显示，2023年中国三大终端六大市场皮肤科中成药销售额超过64亿元。中药1.1类新药固本消疹颗粒具有益气温阳、祛风固表之功效，用于慢性荨麻疹，卫表不固证。该产品的临床申请于2024年12月11日获得CDE承办，2025年2月27日获得临床试验默示许可。米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）皮肤科中成药销售额超过64亿元，同比增长10.58%；2024年上半年其销售额超过34亿元，同比增长8.16%。中国三大终端六大市场皮肤科中成药销售情况（单位：万元）来源：米内网格局数据库 2024年上半年中国三大终端六大市场皮肤科中成药TOP5品牌分别为山东汉方制药的复方黄柏液涂剂、国药同济堂(贵州)制药的润燥止痒胶囊、汕头美宝制药的湿润烧伤膏、北京华洋奎龙药业的皮肤康洗液、重庆希尔安药业的金蝉止痒胶囊。 2024H1中国三大终端六大市场皮肤科中成药TOP5品牌来源：米内网格局数据库作为国内中药创新龙头企业，康缘药业坚持创新驱动，以中医药发展为主体，并积极布局化学药、生物药等领域。近年来公司坚持研发投入，2023年研发费用7.72亿元，2024年前三季度研发费用4.67亿元。 2024年至今，康缘药业已有9款1类创新药获得临床试验默示许可，包括KYS202003A注射液、KYHY2303片、KYHY2302乳膏、KYS202004A注射液、注射用AAPB、KYS202002A注射液、七味脂肝颗粒、羌芩颗粒、固本消疹颗粒。资料来源：米内网数据库、CDE注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

2024-12-12

·思齐俱乐部

新增9款1类新药头次在中国获批临床！涉及康缘药业、恒瑞医药、百济神州等

数据统计，11月18日~11月24日，有9款1类创新药头次在中国获得临床试验默示许可(IND)，涉及药企包括康缘药业、恒瑞医药、百济神州、普利药业等。其中，根据11月18日CDE网站显示，康缘药业的1类新药KYS202003A注射液获得临床试验默示许可，用于治疗晚期实体瘤患者。据悉，康缘药业1类生物创新药KYS202003A注射液用于治疗晚期实体瘤患者，其临床试验申请于2024年8月24日获得CDE承办，11月18日获得临床试验默示许可。据悉，今年以来，康缘药业已有7款1类创新药获得临床试验默示许可，包括KYS202003A注射液、KYHY2303片、KYHY2302乳膏、KYS202004A注射液、七味脂肝颗粒、羌芩颗粒、注射用AAPB。其中，KYHY2303片(治疗复发或难治性恶性血液肿瘤)、KYS202003A注射液(治疗晚期实体瘤患者)均为抗肿瘤药。 11月19日，CDE网站公示，百济神州申报的1类新药BGB-58067片获得临床试验默示许可，拟开发治疗晚期实体瘤患者。根据百济神州公开资料，BGB-58067是一款PRMT5抑制剂，为百济神州未来的核心项目之一。根据CDE查询，这是该产品头次在中国获批临床。资料显示，百济神州研发的BGB-58067为第2代MTA协同PRMT5抑制剂，可选择性杀伤MTAP缺失肿瘤细胞，同时避免影响正常血液细胞。研究表明，在MTAP缺失细胞中具活性和选择性，具有良好的血脑屏障穿透力和颅内药效，拥有理想的半衰期，可以实现每日给药。 11月19日，CDE网站还显示，恒瑞医药注射用SHR-4394获临床许可，拟开展治疗前列腺癌的研究。据悉，作为创新型制药企业，恒瑞医药持续加大创新力度，累计研发投入已超400亿元。当前恒瑞医药已上市17款创新药，公司另有90多个自主创新产品正在临床开发，300多项临床试验在国内外开展。普利药业申报的1类新药注射用PL002也于上周获批临床，拟用于脑胶质瘤患者的术前诊断及术中导航。据悉，这是一款荧光/磁共振双模态造影剂。派金生物1类新药PJ016注射液获批临床，拟开发治疗晚期实体瘤。据悉，PJ016注射液是一种长效聚乙二醇化精氨酸耗竭生物新药。轩竹生物申报的XZP-6924-TS1片获批临床，拟用于实体瘤的治疗。据悉，XZP-6924是一种有效的高选择性USP1抑制剂，具有提高疗效和克服PARP抑制剂耐药性的潜力。此外，原研药港生命科学申报的1类新药PE-003片获批临床，拟开发用于治疗成年男性早泄。昆药集团申报的1类新药KPC000154片获批临床，拟开发用于治疗非酒精性脂肪性肝炎。民为生物1类新药MWN105注射液获批临床，拟开发治疗2型糖尿病、超重或者肥胖。来源：制药网商务合作 130 6172 3098 zakk.cui@siqibest.com 点击阅读原文了解更多

临床获批

100 项与 AAPB 相关的药物交易

登录后查看更多信息