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Yingsi Intelligent’s world’s first TNIK inhibitor ISM001-055 has achieved positive results in phase IIa clinical trials

·ISM001-055 is an innovative drug driven by generative artificial intelligence and fully developed independently by Insilicon Intelligence. It targets TNIK (Traf2/NCK interacting kinase) and has completed phase IIa clinical trials for the treatment of patients with idiopathic pulmonary fibrosis (IPF); ·This study lasted for 12 weeks, and its preliminary results showed that ISM001-055 exhibited good safety in IPF patients and showed a dose-dependent pharmacological trend in improving lung function indicators in patients; ·The positive clinical trial results of ISM001-055 also provide the first conceptual validation for AI driven drug development. Hong Kong, China, September 18, 2024- Yingsi Intelligent, a clinical stage biotechnology company driven by generative artificial intelligence (AI), announced that its pipeline ISM001-055 has achieved positive preliminary research results in a phase IIa clinical trial. ISM001-055 is a “first in class” small molecule inhibitor driven by generative AI for drug discovery and design, targeting TNIK (Traf2/NCK interacting kinase) for ...
- Source: drugdu
- 114
- September 23, 2024
Yuheng Biotechnology announces the release of APHEXDA (Antifotide) ®, Motixafortide has been approved for marketing by the Macau Drug Administration in China

Motefutide Macau officially approvedOn September 20, 2024, Guangzhou Yuheng Biotechnology Co., Ltd. (referred to as “Yuheng Biotechnology”) announced the world’s first peptide drug, Mortifutide (APHEXDA), targeting the chemokine receptor 4 (CXC chemokine receptor 4, CXCR4) ®， Motixafortide has recently been officially approved for marketing by the Drug Administration of the Macao Special Administrative Region of China. According to the WHO ATC (Anatomical Therapeutic Chemical Classification System) drug classification management system, it has been approved as immune enhancer L03AX23, which is used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for peripheral blood stem cell collection and subsequent autologous transplantation in patients with multiple myeloma (MM). After Boao, Hainan, Macau has become the second region within Yuheng Biotech’s Asia authorized area to receive approval for Motefutide. Motefutide has obtained new drug approval in the United States in September 2023. It is the first approved innovative drug for ...
- Source: drugdu
- 214
- September 23, 2024
Lepu Biotech’s Injection of Vebecotamab Aiming for Priority Review for Nasopharyngeal Carcinoma

On September 19, the National Medical Products Administration (NMPA) released a public notice on its drug evaluation center’s official website, announcing that Lepu Biotech’s injection of Vebecotamab is proposed for priority review. This treatment is intended for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapies. This drug, developed by Lepu Biotech, is an antibody-drug conjugate (ADC) targeting EGFR, with the development code MRG003. It is composed of an EGFR-targeted monoclonal antibody linked to a potent microtubule inhibitor, MMAE, through a vc linker. The molecular design of this drug has the potential to extend its application to a broader range of cancers that overexpress EGFR and may overcome various types of resistance caused by common mutations. In its previously published semi-annual report, Lepu Biotech indicated plans to submit a new drug application (NDA) for MRG003 to the ...
- Source: drugdu
- 109
- September 23, 2024
AstraZeneca’s “Class 1 Anti-heart Failure Chemical Drug” has applied for clinical trials in China

On September 14, according to the official website of CDE, AstraZeneca’s clinical trial application for the Class 1.1 chemical drug AZD5462 tablets was accepted. According to public information, the drug is a relaxin RXFP1 receptor agonist. Relaxin, as an agonist of the relaxin 1 receptor (RXFP1), produces unique and diverse biological effects, including pulmonary and systemic vasodilation, tissue remodeling/fibrosis reversal, and reduced inflammation, and therefore also has potential in cardiopulmonary diseases. significant curative effect. In addition, this substance is also known as the “pregnancy hormone” and is regulated during pregnancy to help the expectant mother’s cardiovascular system meet the increased demands of the developing fetus and remodel tissue and musculoskeletal structure. . AZD5462 is a relaxin RXFP1 receptor agonist developed by AstraZeneca. Preclinical studies on monkey models of heart failure with reduced ejection fraction (HFrEF) showed that cardiac systolic function was improved after 8 weeks of treatment. There was no ...
- Source: drugdu
- 106
- September 23, 2024
Countdown to the National Hospital Inspection

Recently, the State Council Information Office held a series of themed press conferences on “Promoting High-quality Development”. Yan Qinghui, deputy director of the National Medical Insurance Administration, said that so far, a total of 432 designated medical institutions in 30 provinces have been inspected. It is expected that the number of inspected institutions this year will exceed the total of the past five years, and the expansion is relatively large. According to incomplete statistics from Cyber Blue, as of September 18, the national flight inspection team has landed in Hebei, Shanxi, Liaoning, Jilin, Heilongjiang, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Hainan, Sichuan, Guizhou, Yunnan, Shaanxi, Gansu, Qinghai, Inner Mongolia, Guangxi, Tibet, Ningxia, Xinjiang, Beijing, Shanghai and other places (see the attachment at the end of the article for details). According to the work arrangements of the National Medical Insurance Administration, all provinces across the country will complete ...
- Source: drugdu
- 110
- September 23, 2024
Breaking the domestic gap! New Pulse Medical opens a new era in the TAVR market

Domestic companies have created a new situation in the TAVR market and created a new market engine. On August 14, 2024, the State Food and Drug Administration officially approved the domestic Prizvalve transcatheter aortic valve system developed by New Pulse Medical. As the first self-developed balloon-expandable valve launched in China, the Prizvalve valve system is expected to be the first to break the import monopoly, effectively improve the quality of life, and quickly capture market share. Aortic valve disease mainly includes aortic valve stenosis and aortic valve regurgitation. With the deepening of aging, the prevalence of cardiovascular diseases (including aortic valve stenosis) continues to rise, and the number of patients with aortic valve disease in the world and China has increased year by year. This change has not only had a serious impact on the quality of life of patients, but also posed severe challenges to the medical system. Traditional ...
- Source: drugdu
- 67
- September 23, 2024
【EXPERT Q&A】Why should medical device companies make full use of data value under the normalization of collection?

Drugdu.com expert’s response: In the context of normalized centralized procurement, the importance of medical device enterprises leveraging data value has become increasingly prominent. This primarily stems from the following considerations: Ⅰ. Market Trend Insight and Precise Positioning Market Analysis Reports: CRM systems or other data analytics tools can provide detailed market analysis reports, enabling enterprises to promptly understand market size, competitive landscape, and trend changes. This aids enterprises in precisely positioning themselves in the market under centralized procurement policies, adjusting product portfolios and marketing strategies to better align with market demands. Competitive Landscape Analysis: Through data analysis, enterprises can grasp competitors’ dynamics, including their product layouts, market shares, pricing strategies, etc., thereby formulating more targeted competitive strategies. Ⅱ. Customer Demand Response and Satisfaction Enhancement Customer Analysis Reports: Enterprises can gain deep insights into customer preferences, purchasing behaviors, and satisfaction levels, providing data support for product design, customized services, and after-sales ...
- Source: drugdu
- 83
- September 23, 2024
the dawn of treatment for multiple myeloma!

Original Medical Overview Medical Overview September 19, 2024 08:54 Shanghai Multiple myeloma (MM) is a blood cancer that, despite advances in treatment methods in recent years, remains an incurable disease. The traditional treatment options for MM include the combination of proteasome inhibitors (PIs), immunomodulators (IMiDs), and monoclonal antibodies (Mo Abs). Although these methods improve patient survival and progression free survival (PFS), with the emergence of treatment resistant clones, patients will eventually develop resistance to these treatments. Therefore, researchers are exploring new treatment strategies such as CAR-T cell therapy and bispecific antibodies, which activate immune T cells to kill tumor cells. Based on the review of bispecific antibodies and multiple myeloma published in the Blood Cancer Journal this month, let’s talk about the design, mechanism of action, current clinical trials, and future development directions of bispecific antibodies. 01 Bispecific antibodies and therapeutic targets Bispecific antibodies (BsAbs) are antibody constructs with two ...
- Source: drugdu
- 127
- September 21, 2024
Nat Microbiol | Liu Wei/Li Hao reveal new mechanism of bile acid protection against SFTSV (fever with thrombocytopenia syndrome) infection

BioArt September 19, 2024 08:45 Shanghai Bile acids are metabolites produced by the synergistic effect between the host and its gut microbiota. They can regulate various biological functions and affect the host’s susceptibility to viral infections, especially enteroviruses and hepatitis viruses, by activating specific receptors and cellular signaling pathways in intestinal and liver tissues. A small fraction (<10%) of total bile acids can enter the systemic circulation and may play a critical role in antiviral immunity during systemic infections. However, the function and mechanism of bile acids in regulating the host’s immune response to viral systemic infections are still poorly understood, and the association between bile acid metabolism and disease outcomes of viral systemic infections is also unclear. Viral hemorrhagic fever is usually caused by highly pathogenic RNA viruses, which can lead to severe systemic infections, multiple organ failure, and even death. Severe fever with thrombocytopenia syndrome (SFTS) is a ...
- Source: drugdu
- 108
- September 21, 2024
全球及中国在长效术后镇痛制剂领域的市场需求不断增长

近期，科伦药业发布公告，其子公司湖南科伦制药的化学药品“布比卡因脂质体注射液”获得国家药监局批准上市（商品名布瑞科®），按照化药3类获批，视同通过仿制药质量和疗效一致性评价。科伦药业的布瑞科®是我国第二个上市的布比卡因脂质体注射液产品。恒瑞医药的布比卡因脂质体注射液仿制药（商品名：艾恒平）已于2022年11月获批，为全球首仿药，同时也为国内首个上市的长效术后镇痛药物。今年7月，艾恒平获FDA批准上市，成为全球首家在美国获得该品种仿制药批准的厂家。国产药企接连成功突围背后，是全球及中国在长效术后镇痛制剂领域不断增长的市场需求。中国术后疼痛发生率仍然较高术后疼痛（postoperative pain）指手术操作引起的急性创伤和内脏器官的损伤以及神经末梢周围炎性刺激引起的疼痛。术后疼痛自麻醉清醒后出现，疼痛高峰期为术后24至48小时，持续时间一般不超过3到7天。术后疼痛短期内会对病人的心血管功能、呼吸功能、神经内分泌及免疫和心理情绪等方面造成不利影响，如术后疼痛在急性期没有得到有效控制，将有可能发展为慢性术后疼痛，持续时间可达半年甚至数十年。术后疼痛管理是保证术后镇痛效果的重要环节。术后疼痛管理的目标包括在安全的前提下，持续、有效镇痛。目前虽然非药物治疗，如理疗、音乐、分散注意力等方法有不同的治疗效果的研究报道，但手术后急性疼痛治疗仍以药物治疗为主。当前临床术后镇痛使用的主要药物包括：阿片类镇痛药、非甾体类抗炎药和局部麻醉药。其中局部麻醉药通过局部神经阻滞发挥区域镇痛作用，相比其他类型镇痛药物全身系统性不良反应少，但往往作用时间和强度不够，神经阻滞持续时间通常少于8小时，而术后疼痛的管理通常需要数天，临床可应用非连续多次注射局部麻醉药、硬膜外腔或外周神经插入导管连续输注药物、一次性泵等方法实现持续数天的术后镇痛。持续局部麻醉药输注可有效控制疼痛并减少术后阿片类药物的使用，但需要相对昂贵的设备和连续监测，且长期留置导管易引起导管移位和并发症。频繁给药也会增加血药浓度波动、降低患者依从性，给患者造成疼痛和不方便、导致严重的副作用。尽管国内术后疼痛管理开展已有二十余年的历史，国内术后疼痛患者人群数量仍然较大。国家统计局数据显示：2022年，我国医疗卫生机构住院病人手术人次达到8271.75万人。而2023年一项对中国大陆百余医疗中心的横断面研究显示，手术后中重度疼痛的发生率达48.7%，包括32.2%的患者患有严重术后疼痛。这意味着国内不同程度的术后疼痛患者总数可能达到四千万人以上。布比卡因脂质体如何治疗术后疼痛？布比卡因（bupivacaine）是一种酰胺类的局部麻醉药，通过可逆地阻断快速电压门控钠离子通道来阻断神经脉冲的传递，从而达到镇痛效果。其盐酸盐即盐酸布比卡因早在1972年就已经在美国作为局部麻醉药上市，商品名包括Marcain、Marcaine（麻卡因）、Sensorcaine及Vivacaine，主要用于局部浸润麻醉、外周神经阻滞和椎管内阻滞。短效布比卡因制剂麻醉效果能维持3-6小时或更长时间，无法覆盖术后三至四天的疼痛高峰期。在此背景下，2011，FDA批准了Pacira BioSciences公司研制的布比卡因脂质体注射液用于直接注射至手术部位以帮助控制术后疼痛，商品名Exparel，是首个在美国上市的长效术后镇痛药物。2018年，FDA批准其扩大使用范围，包括围术期或术后通过肌间沟臂丛神经阻滞给药以产生手术后局部镇痛。公开数据显示，2023年Exparel全球销售额达到4.8亿美元，折合人民币约34亿，从2012年以来的复合增长率为40%，具体销售额趋势如下图。 Exparel在仅有两个适应症的情况下，产品销售额仍能接近5亿美元，原因主要在于产品独特的作用机制和高昂的价格。多囊脂质体(multivesicular liposomes,MVL)是以储库泡沫技术为基础的非同心脂质体，其内部由许多水性腔室以非同心圆的形式紧密填充构成，在注射部位能够蓄积形成药物储库，通过脂质腔室溶蚀实现药物缓释效果，各个水性腔室之间以脂质双分子层相隔，具有较高的药物包封率和回收率，可以用于小分子药物和蛋白、多肽等高分子药物的包封。多囊脂质体的囊泡较大，载药量大，包封率高，具有较好的生物相容性，目前用于开发长效缓释制剂。布比卡因脂质注射液通过多个囊泡结构的脂质体包裹药物缓释释放，不仅将镇痛效果延长至72小时，还可以减少布比卡因带来的副作用。长效镇痛制剂需要平衡药品的安全性与长效性、起效速度与起效平稳性。作为全球首个获批的长效局麻药，Exparel相关100多项临床试验涉及拇囊炎切除术、痔切除术、前列腺切除术、膝关节置换术、胸腔手术等的术中术后镇痛，以及儿科用药临床试验，临床结果支持Exparel应用于几乎所有手术的局部浸润麻醉以及术后镇痛；对不同手术，可避免使用或减少使用45%～78%阿片类药物；且与普通注射液相比能够在72小时内维持有效血药浓度的同时始终低于CNS毒性限度且没有药物突释行为，没有CNS不良反应病例报道。此外有研究显示布比卡因脂质体的血药浓度峰值低于盐酸布比卡因，或可一定程度上降低中枢及心脏相关毒性风险。 Exparel在美国的用药费用高昂，一瓶20毫升的Exparel售价约为376美元，而相同尺寸的盐酸布比卡因每瓶售价为38美元。未来长效术后镇痛制剂的发展方向长效术后镇痛制剂仍属于有待开拓的药物领域。在Exparel上市后，FDA相继批准上市了四款非阿片类术后长效镇痛药，均为布比卡因的改良制剂。改良型长效局部麻醉药已成为国内术后镇痛药的研发热点。目前恒瑞制药和科伦制药的布比卡因脂质体分别于2022年11月和2024年8月获批上市，另有2个布比卡因活性成分和5个罗哌卡因活性成分长效注射制剂药物进入申报或开展临床阶段。长效术后镇痛制剂这一品类仍有很大的发展空间，布比卡因脂质体作为长效术后镇痛制剂品类中上市的首个药物，相比原研药在美国的高昂用药费用，国产布比卡因脂质体注射液每支价格为382元，并且已成功通过国谈纳入医保药品目录。国内手术数量不断增长驱动布比卡因脂质体需求提升，新适应症的上市将持续推动这一品种的市场空间，且研发壁垒决定了其良好的竞争格局，具有可观的市场潜力。来源：https://news.yaozh.com/archive/44217.html
- Source: drugdu
- 109
- September 21, 2024

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