A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of SCB-313, Recombinant Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand-Trimer Fusion Protein, for the Treatment of Malignant Pleural Effusion

To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of SCB-313.

开始日期2020-01-08

申办/合作机构

四川三叶草生物制药有限公司

CTR20191991 / Completed临床1期

评价SCB-313用于治疗恶性胸水患者的安全性、耐受性和药代动力学的I期临床试验

1）通过一次胸腔注射给药的方式，评估SCB-313的单次给药的安全性和耐受性； 2)通过每天一次胸腔注射给药，连续给药3天的方式，评估SCB-313的重复给药的安全性和耐受性，确定SCB-313的最大耐受剂量（MTD）。

开始日期2019-12-02

申办/合作机构

四川三叶草生物制药有限公司

NCT03869697 / Completed临床1期

A Phase I Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of SCB-313, a Fully-Human TRAIL-Trimer Fusion Protein, for the Treatment of Malignant Pleural Effusions

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and PK/PD of SCB-313 (recombinant human TRAIL-Trimer fusion protein) administered once via intrapleural injection (SAD) and once daily over 2 to 3 days (MAD)for the treatment of cancer patients with symptomatic malignant pleural effusions requiring drainage.

开始日期2019-11-20

申办/合作机构

Clover Biopharmaceuticals Aus Pty Ltd.

100 项与重组人肿瘤坏死因子相关凋亡诱导配体–三聚体融合蛋白(四川三叶草生物制药有限公司) 相关的临床结果

登录后查看更多信息

100 项与重组人肿瘤坏死因子相关凋亡诱导配体–三聚体融合蛋白(四川三叶草生物制药有限公司) 相关的转化医学

登录后查看更多信息

100 项与重组人肿瘤坏死因子相关凋亡诱导配体–三聚体融合蛋白(四川三叶草生物制药有限公司) 相关的专利（医药）

登录后查看更多信息

124

项与重组人肿瘤坏死因子相关凋亡诱导配体–三聚体融合蛋白(四川三叶草生物制药有限公司) 相关的文献（医药）

2022-04-01·Journal of cancer research and therapeutics

Enhanced expression of death receptor 5 is responsible for increased cytotoxicity of theophylline in combination with recombinant human TRAIL in MDA-MB-231 breast cancer cells

Article

作者: Tapadar, Poulami ; Pal, Ambika ; Pal, Ranjana ; Dutta, Siddhartha

Background::

Theophylline has been reported to induce cytotoxicity and cell cycle arrest in cancer cells. On the other hand, TRAIL, a secretory ligand, is known for its unique ability to induce cell death only in tumor cells. In the present study, we elucidated the mechanism behind the cytotoxic effect of theophylline in combination with recombinant human TRAIL (rhTRAIL) on cancer cell line MDA-MB-231.

Materials and Methods::

Cytotoxicity of theophylline in combination with TRAIL was measured via trypan blue assay and MTT assay. Protein levels were assessed using Western hybridization. Reactive oxygen species (ROS) levels were measured using 2',7'–dichlorofluorescin diacetate and mitochondrial membrane potential (MMP) assay was conducted using tetramethylrhodamine, ethyl ester.

Results::

We observed theophylline in combination with rhTRAIL to be significantly cytotoxic to the cancer cells in comparison to theophylline and rhTRAIL alone. Next, western hybridization showed combination treatment to upregulate cleaved form of caspase-8, 9 and 3, in comparison to the cells treated with rhTRAIL and theophylline alone. Theophylline in combination also increased the levels of ROS and reduced MMP. Interestingly, combination treatment increased the protein level of death receptor 5 (DR5), sensitizing the cells towards TRAIL-induced apoptosis.

Conclusion::

Theophylline in combination with TRAIL significantly increases cytotoxicity in the MDA-MB-231 breast cancer cell line when compared to theophylline and rhTRAIL alone via upregulation of DR5 levels.

2020-12-01·Anticancer research4区 · 医学

Nitric Oxide Inhibits NF-κB-mediated Survival Signaling: Possible Role in Overcoming TRAIL Resistance

4区 · 医学

Article

作者: Lindner, Daniel J ; Bauer, Joseph A ; Didonato, Joseph A ; Lupica, Joseph A

BACKGROUND/AIM:

Chemoresistance is a major consequence of multicycle chemotherapy and can be attributed to constitutive activation of pro-survival signaling pathways. Nitric oxide is a ubiquitous signaling molecule which has been shown to inhibit several pathways involved with survival signaling in cancer cells. We have previously demonstrated the anti-tumor activity of a nitric oxide-donor, nitrosylcobalamin (NO-Cbl), mediated by increased expression of tumor necrosis factor-related apoptosis-inducing ligand (Apo2L/TRAIL) and its receptors in human tumors. We also demonstrated that a functional Apo2L/TRAIL receptor is necessary for the induction of cell death by NO-Cbl and the Apo2L/TRAIL death receptor DR4 (TRAIL R1) is S-nitrosylated. The aim of the study was to examine the effects of nitric oxide (NO) on nuclear factor kappa B (NF-κB) and determine whether nitric oxide could sensitize drug-resistant melanomas to Apo2L/TRAIL via inhibition of NF-κB or inhibitor kappa B kinase (IKK).

MATERIALS AND METHODS:

Antiproliferative effects of NO-Cbl and Apo2L/TRAIL were assessed in malignant melanomas and non-tumorigenic melanocyte and fibroblast cell lines. Athymic nude mice bearing human melanoma A375 xenografts were treated with NO-Cbl and Apo2L/TRAIL. Apoptosis was measured by the TUNEL assay. The activation status of NF-κB was established by assaying luciferase reporter activity, the phosphorylation status of IκBα, and in vitro IKK activity.

RESULTS:

NO-Cbl sensitized Apo2L/TRAIL-resistant melanoma cell lines to growth inhibition by Apo2L/TRAIL, but had minimal effect on normal cell lines. NO-Cbl and Apo2L/TRAIL exerted synergistic anti-tumor activity against A375 xenografts. NO-Cbl suppressed Apo2L/TRAIL- and TNF-α-mediated activation of a transfected NF-κB-driven luciferase reporter. NO-Cbl inhibited IKK activation, characterized by decreased phosphorylation of IκBα.

CONCLUSION:

NO-Cbl treatment rendered Apo2L/TRAIL-resistant malignancies sensitive to the anti-tumor effects of Apo2L/TRAIL in vitro and in vivo. The use of nitric oxide to inhibit NF-κB and potentiate the effects of chemotherapeutic agents, such as Apo2L/TRAIL, represents a promising anti-cancer combination based on recent clinical investigations of anti-TRAIL antibodies for cancer treatment strategies.

2020-12-01·Investigational new drugs3区 · 医学

Glioma progression is suppressed by Naringenin and APO2L combination therapy via the activation of apoptosis in vitro and in vivo

3区 · 医学

Article

作者: Chen, Fenghua ; Ma, Yujie ; Song, Tao ; Wang, Ying ; Wu, Jun ; Zhang, Mingyu ; Dai, Zhijie

Naringenin (NG) is a natural antioxidant flavonoid which is isolated from citrus fruits, and has been reported to inhibit colon cancer proliferation. However, the effects of NG treatment on glioma remain to be elucidated. The present study aimed to explore the effects of NG on glioma in vitro and in vivo. Also, the interactions between NG and APO2 ligand (APO2L; also known as tumor necrosis factor-related apoptosis-inducing ligand) were investigated in glioma. A synergistic effect of NG and APO2L combination on apoptotic induction was observed, though glioma cells were insensitive to APO2L alone. After NG treatment, glioma cells resumed the sensitivity to APO2L and cell apoptosis was induced via the activation of caspases, elevation of decoy receptors 4 and 5 (DR4 and DR5) and induction of p53. Coadministration of NG and APO2L decreased levels of anti-apoptotic B cell lymphoma 2 (Bcl-2) family members Bcl-2 and Bcl-extra large (Bcl-xL), while increased levels of proapoptotic factors Bcl-2-associated agonist of cell death (Bad) and Bcl-2 antagonist/killer 1 (Bak). Furthermore, an in vivo mouse xenograft model demonstrated that NG and APO2L cotreatment markedly suppressed glioma growth by activating apoptosis in tumor tissues when compared with NG or APO2L monotherapy. The present study provides a novel therapeutic strategy for glioma by potentiating APO2L-induced apoptosis via the combination with NG in glioma tumor cells.

项与重组人肿瘤坏死因子相关凋亡诱导配体–三聚体融合蛋白(四川三叶草生物制药有限公司) 相关的新闻（医药）

2024-04-29

·PRNewswire

Malignant Ascites Market to Observe Growth at a CAGR of 1.2% by 2034 | DelveInsight

The malignant ascites pipeline possesses only two drugs in mid-stage developments to be approved in the near future. The major key players include Clover Biopharmaceuticals and Wuhan YZY Biopharma which hold the potential to create a significant positive shift in the malignant ascites market size. LAS VEGAS, April 29, 2024 /PRNewswire/ -- DelveInsight's Malignant Ascites Market Insights report includes a comprehensive understanding of current treatment practices, malignant ascites emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Malignant Ascites Market Report According to DelveInsight's analysis, the market size for malignant ascites reached USD 1.9 billion in 2020 across the 7MM, which is anticipated to rise to USD 2.3 billion by 2034. In 2020, the total incident cases of malignant ascites-associated cancers were ~1.6 million in the 7MM. Leading malignant ascites companies such as LINDIS BIOTECH, WUHAN YZY BIOPHARMA CO., LTD., CLOVER BIOPHARMACEUTICALS, BINHUI BIOPHARMACEUTICAL, PHARMACYTE BIOTECH INC., and others are developing novel malignant ascites drugs that can be available in the malignant ascites market in the coming years. The promising malignant ascites therapies in the pipeline include CATUMAXOMAB, M 701, SCB-313, VAK, and CYPSCAPS PLUS IFOSFAMIDE, among others. Wuhan YZY Biopharma's M701 is the first and only EpCAM × CD3 BsAb that has entered into a Phase II clinical trial for the treatment of M701 globally. Even with the new therapies coming in the market, still the mainstay treatment for Malignant Ascites will remain chemotherapy over the years. Out of the novel treatments, the highest revenue is expected to be generated by CATUMAXOMAB with 10.54% of share of the total market in 2034, followed by KM-CART with 5.07% and OK-432 with 2.21% of market share, respectively. Discover which therapies are expected to grab the major malignant ascites market share @ Malignant Ascites Market Report Malignant Ascites Overview Malignant ascites is a pathological condition stemming from various primary abdominal and non-abdominal cancers. It stands as a significant source of illness, presenting numerous complexities and treatment obstacles. It serves as an indicator of peritoneal carcinomatosis, denoting the presence of cancerous cells within the peritoneal cavity. Carcinomatosis-causing tumors are frequently secondary malignancies affecting the peritoneal surface, such as those from ovarian, colorectal, pancreatic, and uterine origins; as well as extraperitoneal tumors originating from lymphoma, lung, and breast cancers, alongside smaller proportion of unidentified primary tumors. The origins of fluid accumulation within the abdomen are diverse and may include cirrhosis, congestive heart failure, nephrosis, pancreatitis, peritonitis, primary malignancies, or liver metastases. Differentiating between benign and malignant ascites solely through physical examination or radiographic methods is not feasible. Invasive procedures are required to distinguish between the two types. Ascitic fluid analysis through abdominal paracentesis can typically identify malignant causes of ascite production; however, laparoscopic tissue sampling might be necessary in certain cases. Malignant Ascites Epidemiology Segmentation The malignant ascites epidemiology section provides insights into the historical and current malignant ascites patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The malignant ascites market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Ascites in Selected Indications (Ovarian, Colorectal, Gastric, and Others) Incident Cases of Malignant Ascites in Selected Indications Total Treated Cases of Malignant Ascites Malignant Ascites Treatment Market The available treatments for malignant ascites consist of various strategies designed to ease symptoms and enhance quality of life. These methods include draining fluids through paracentesis, using chemotherapy to combat cancer cells and lessen ascite formation, employing targeted therapy tailored to particular cancer types, opting for surgical procedures like tumor removal or shunt insertion, and incorporating supportive measures such as diuretics and nutritional assistance. The selection of treatment is determined by factors such as the specific cancer type and the severity of symptoms, with the main objective being the management of symptoms and the improvement of overall well-being. Malignant ascite treatments aimed at causing a reduction in malignant ascites mainly consist of systemic chemotherapy, targeted therapy, or surgical procedures designed to decrease or remove the cancerous tumors accountable for the development of ascites. These methods focus on the fundamental cause of ascites by dealing with the underlying cancer, intending to slow down the advancement of the disease and enhance the outcomes for the patient. With just two accepted treatments, OK-432 and KM-CART, available in Japan, many patients are left with only palliative care, which often falls short of addressing their needs. Various methods exist to relieve symptoms linked with malignant ascites. However, due to a lack of understanding of ascites' natural progression, there is limited data on these approaches and their impact on quality of life. Assessing the effectiveness of current treatments is challenging. Common traditional methods for handling malignant ascites encompass sodium-restricted diets, diuretic treatment, repeated paracentesis, and peritoneovenous shunting. To know more about malignant ascites treatment guidelines, visit @ Malignant Ascites Management Malignant Ascites Pipeline Therapies and Key Companies CATUMAXOMAB: LINDIS BIOTECH M 701: WUHAN YZY BIOPHARMA CO., LTD. SCB-313: CLOVER BIOPHARMACEUTICALS VAK: BINHUI BIOPHARMACEUTICAL CYPSCAPS PLUS IFOSFAMIDE: PHARMACYTE BIOTECH INC. Learn more about the FDA-approved drugs for malignant ascites @ Drugs for Malignant Ascites Treatment Malignant Ascites Market Dynamics The dynamics of the malignant ascites market are expected to change in the coming years. SCB-313 utilizes distinctive, patented protein trimerization technology to precisely target and activate the triple-dependent mechanism of tumor cell apoptosis, fostering collaboration among oncologists, surgeons, researchers, and other healthcare professionals to develop effective management strategies, identification of novel therapeutic targets through advanced molecular analyses, and an emphasis on patient-centered care and improved symptom management to enhance the overall quality of life for patients with malignant ascites. Furthermore, many potential therapies are being investigated for the treatment of malignant ascites, and it is safe to predict that the treatment space will significantly impact the malignant ascites market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the malignant ascites market in the 7MM. However several factors may impede the growth of the malignant ascites market. Tackling malignant ascites poses ongoing difficulties in clinical management, with the current focus primarily on alleviating symptoms rather than achieving a definitive cure, due to the absence of universally accepted treatment protocols stemming from limited evidence and patient heterogeneity; consequently, malignant ascites also presents research obstacles, with only a few attempts made to develop medications for the condition, and the potential hindrance of access to emerging therapies once approved by the availability of off-label therapies. Moreover, malignant ascites treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the malignant ascites market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the malignant ascites market growth. Scope of the Malignant Ascites Market Report Therapeutic Assessment: Malignant Ascites current marketed and emerging therapies Malignant Ascites Market Dynamics: Key Market Forecast Assumptions of Emerging Malignant Ascites Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Malignant Ascites Market Access and Reimbursement Discover more about malignant ascites drugs in development @ Malignant Ascites Clinical Trials Table of Contents Related Reports Malignant Ascites Pipeline Malignant Ascites Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant ascites companies, including Clover Biopharmaceuticals, YZY Biopharma, Sorrento Therapeutics, Inc., Simcere, PharmaCyte Biotech, Linton Pharm, among others. Malignant Ascites Epidemiology Forecast Malignant Ascites Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted malignant ascites epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Ascites Market Ascites Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ascites companies, including Grifols Therapeutics LLC, Sanofi, Regeneron Pharmaceuticals, Sequana Medical N.V, Protgen Ltd, Healthgen Biotechnology Corp, Sichuan Clover Biopharmaceuticals Inc, Movetis, BioVie Inc., Ocelot Bio Inc, Novartis, among others. Ascites Pipeline Ascites Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ascites companies, including Grifols Therapeutics LLC, Sanofi, Regeneron Pharmaceuticals, Sequana Medical N.V, Protgen Ltd, Healthgen Biotechnology Corp, Sichuan Clover Biopharmaceuticals Inc, Movetis, BioVie Inc., Ocelot Bio Inc, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

临床2期

2022-12-06

·佰傲谷BioValley

两天四家，多款新冠疫苗被纳入紧急使用

在过去的两天内，有四家公司和科研机构的新冠疫苗别纳入紧急使用，分别是北京万泰生物、北京神州细胞、三叶草生物以及四川大学华西医院等。4款疫苗均覆盖了新冠原始毒株和变异毒株。除了万泰生物的鼻喷新冠疫苗是鼻喷流感病毒载体疫苗，其余3款均为重组蛋白疫苗。多家新冠疫苗获批，现有新冠疫苗生产企业智飞生物、康希诺等股票大幅下跌。令人意外的是，万泰生物、神州细胞、三叶草生物股价也同时下跌。显然是疫苗竞争和内卷的结果。国内新冠疫苗的加速获批，可能与国内防疫政策的逐步放松有关。上海市政府建议市民尽快接种疫苗，当好自己健康的第一责任人。神州细胞新冠疫苗 12月4日晚间，神州细胞披露，神州细胞控股子公司神州细胞工程有限公司（以下简称“神州细胞工程”）收到国家有关部门的函件，公司自主研发的重组新冠病毒 2 价（Alpha/Beta 变异株）S 三聚体蛋白疫苗（项目代号：SCTV01C）经国家有关部门论证被纳入紧急使用。据披露，SCTV01C 是神州细胞工程针对新冠病毒变异快、以原始株为基础的国内外第一代疫苗对变异株中和抗体滴度和保护率下降等问题自主研发的新一代 2 价变异株重组蛋白疫苗，去年11 月获得国家药监局应急批准进行临床试验。已有临床前及临床研究数据显示，SCTV01C 与灭活苗接种后的安全性高度相似。在免疫原性方面，针对当前流行的奥密克戎（Omicron）BA.1 和 BA.5 变异株均能诱导出均一的、超高的真病毒中和抗体滴度，分别达到了对比灭活苗的预设优效终点指标和对比辉瑞 mRNA 疫苗的预设非劣终点指标，展示出了突出的广谱交叉保护优势和对未来可能出现的新变异株的高效防感染潜力。此外，使用 SCTV01C 进行加强免疫后 12 个月时中和抗体滴度值仍可维持在 170—678 的较高区间，展示出 SCTV01C 突出的免疫持久性。神州细胞每年都会投入重金进行研发。2018年至今年前三季度，不到5年时间里，公司的研发投入合计为29亿元。去年7月，公司研发了14年的首个国产重组八因子产品（安佳因）上市，新冠疫苗是神州细胞第二款获批上市的产品。随着安佳因的上市，神州细胞的经营状况才得到大幅改善。2021年以前，公司基本上没有营业收入，2021年的营业收入为1.34亿元，今年前三季度为6.50亿元。三叶草生物新冠疫苗 12月5日，三叶草生物宣布，其新冠疫苗SCB-2019（CpG1018╱铝佐剂）已获中国有关部门评估并在中国被纳入紧急使用。SCB-2019是由SCB-2019抗原联合两种佐剂，即Dynavax的CpG1018佐剂及氢氧化铝（铝佐剂）组成，以预融合构象形式保留S蛋白的天然三聚体结构，这对于引发针对SARS-CoV-2病毒的保护性免疫非常重要。全球2/3期临床试验SPECTRA评估了SCB-2019的有效性、安全性和免疫原性。数据显示SCB-2019对SPECTRA中任何SARS-CoV-2毒株引起的重度COVID-19有100%疗效，对COVID-19住院治疗100%有效，对中度至重度COVID-19的有效率为84%。针对全球占主导地位的Delta变体，SCB-2019对SPECTRA中任何严重程度的COVID-19的疗效为79%。作为既往接种灭活疫苗的异源加强针数据，SCB-2019显示了广谱的中和作用。针对奥密克戎BA.5和其他亚型（BA.1,BA.2），与三针灭活疫苗相比，SCB-2019作为第三针异源加强剂，中和抗体水平高5-6倍，针对原始新冠毒株的免疫反应高12倍。为了集中资源去推进新冠疫苗的开发，三叶草于今年6月调整了研发管线，暂停了SCB-313、SCB-808、SCB-420的继续开发。四川大学新冠疫苗 12月5日，四川大学在其微博及网站披露：近期，经国家相关部门批准四川大学华西医院研发的重组新型冠状病毒蛋白疫苗（Sf9细胞）威克欣纳入紧急使用，为中国和世界新冠疫情预防控制贡献力量。这是中国首个获批紧急使用的昆虫细胞技术平台生产的重组蛋白新型冠状病毒蛋白疫苗，也是我国高校牵头研发的首个获批紧急使用的新冠疫苗。数据显示，威克欣能够明显诱导针对新冠病毒原型株及变异株的中和抗体，并且在现有疫苗免疫的基础上序贯加强免疫能获得更强的免疫反应。在制备技术上，威克欣使用国际上先进的生产技术，将新冠病毒的基因引入昆虫细胞，制备新冠病毒S蛋白，诱导人体产生抗体阻断病毒感染，已实现大规模生产。四川大学华西医院积极支持该疫苗的产业化，在成都高新区成立了成都威斯克生物有限责任公司推进该疫苗的产业化。万泰生物鼻喷式新冠疫苗 12月5日晚间，万泰生物宣布，其联合厦门大学、香港大学合作研发的鼻喷流感病毒载体新冠肺炎疫苗获国家药监局组织论证同意紧急使用。这是国内首款被纳入紧急使用的鼻喷式新冠疫苗，此前康希诺的吸入式新冠疫苗获批使用。这款鼻喷新冠疫苗于2022年10月完成完成III期临床试验的主数据分析，并获得了关键性数据。数据表明，不论用于无免疫史人群的基础免疫还是有免疫史人群的序贯加强免疫，鼻喷新冠疫苗对于Omicron突变株感染导致的COVID-19均可产生良好的保护效力，60岁以上人群保护效力不弱于18-59岁人群，同时，具有很好的安全性。根据研发团队负责人、厦门大学夏宁邵教授披露，该疫苗对住院及以上严重疾病的保护效力为100%；在既往无其它新冠疫苗免疫史人群中，对症状较明显病例（具有3个及以上新冠相关症状）的保护效力为67%；对包括仅有轻微症状者在内的所有症状性感染的保护效力为55%；在既往有新冠灭活疫苗免疫史的人群中，序贯加强鼻喷苗与用安慰剂加强相比，对症状较明显病例的相对保护效力为63%。竞争白热化根据WHO的统计，截至2022年12月2日，全球已获批附条件上市或紧急使用的新冠疫苗产品已超过50个，国内已有10个新冠疫苗获得国家药监局批准附条件上市或纳入紧急使用。截至2022年8月，我国完成COVID-19疫苗基础接种率约90%，加强针接种率约72%，其中，60岁以上老年人约为68%，80岁以上老年人约为38%。据不完全统计，新冠疫苗附条件上市的厂商包括科兴生物、国药集团中国生物、康希诺等等，而新冠疫苗被纳入紧急使用的厂商包括智飞生物、丽珠集团、神州细胞、万泰生物、三叶草生物等等。参考来源：1.https://www.163.com/money/article/HNRDFT5U00258105.html2.https://baijiahao.baidu.com/s?id=1751391260552400880&wfr=spider&for=pc3.http://stock.10jqka.com.cn/20221206/c643402978.shtml

疫苗上市批准加速审批信使RNA

2022-12-05

·医药笔记

孤注一掷，三叶草新冠疫苗纳入紧急使用

▎Armstrong2022年12月5日，三叶草生物宣布其新冠三聚体蛋白疫苗SCB-2019在中国获纳入紧急使用。三叶草生物新冠疫苗采用三聚体蛋白设计，更符合新冠病毒S蛋白的天然构象。三期临床中，SCB-2019作为异源加强针，相对于三针灭活疫苗，对Omicron变异株诱导中和抗体提高了5-6倍，对原始株的免疫反应提高12倍。商业化方面，三叶草生物从四季度开始即开展筹备活动，其中与Gavi的协议进行了修订，之前收到的2.24亿美元预付款，转为Gavi在延长的四年间可酌情行使的选择权。总结今年6月，三叶草生物宣布调整研发管线，暂停了SCB-313、SCB-808、SCB-420的继续开发，集中资源推进新冠疫苗的开发。随着新冠疫情的持续，蛋白疫苗在国内仍有较大的市场机会，丽珠生物（干扰素分子内佐剂）、神州细胞（水包油新型佐剂）、三叶草生物（CpG1018佐剂）等先后获批，作为异源加强针仍有一定的优势。----------------------感兴趣的读者可以加入“医药笔记”知识星球。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

疫苗引进/卖出临床3期信使RNA抗体药物偶联物

100 项与重组人肿瘤坏死因子相关凋亡诱导配体–三聚体融合蛋白(四川三叶草生物制药有限公司) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
恶性胸腔积液	临床1期	澳大利亚	Clover Biopharmaceuticals Aus Pty Ltd.	2019-11-20
恶性腹水	临床1期	中国	四川三叶草生物制药有限公司	2019-08-05
腹膜癌	临床1期	澳大利亚	Clover Biopharmaceuticals Aus Pty Ltd.	2018-06-18

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04123886 \| NCT03869697 (CSCO2022)	临床1期	恶性胸腔积液	18	SCB-313 5mg	壓廠願構鬱獵鬱繭鹽壓(壓範觸蓋積選鬱選簾襯) = 醖夢選醖觸顧簾築齋憲遞積築範窪繭淵構獵構 (積餘顧鹽餘鹽襯築願廠 )	-	2022-09-21
NCT04123886 \| NCT03869697 (CSCO2022)	临床1期	恶性胸腔积液	18	SCB-313 10mg	壓廠願構鬱獵鬱繭鹽壓(壓範觸蓋積選鬱選簾襯) = 獵憲網鑰繭選獵膚鹹選遞積築範窪繭淵構獵構 (積餘顧鹽餘鹽襯築願廠 )	-	2022-09-21
NCT03443674 \| NCT04051112 (AACR2022)	临床1期	恶性腹水	19	SCB-313	膚構鬱獵鏇繭範選鑰蓋(製簾範夢壓顧艱艱齋憲) = 齋蓋衊襯衊淵鬱襯淵壓憲願積醖餘範繭積鹽艱 (艱襯鹽簾齋範觸繭窪構 )	-	2022-06-15