Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: An Open, Multi-center, Prospective, Single-arm Phase II Clinical Study

This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.

开始日期2023-12-01

申办/合作机构

Beijing Friendship Hospital

[+1]

NCT06024356 / Not yet recruitingN/AIIT

Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer: a Single-center, Retrospective, Controlled Study

It is a single-center, retrospective, controlled study to investigate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.

开始日期2023-09-20

申办/合作机构

Beijing Friendship Hospital

NCT06178146 / Recruiting临床4期IIT

A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events

Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).

开始日期2023-09-01

申办/合作机构

山东省千佛山医院

100 项与胸腺法新相关的临床结果

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100 项与胸腺法新相关的转化医学

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100 项与胸腺法新相关的专利（医药）

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868

项与胸腺法新相关的文献（医药）

2024-02-06·International journal of molecular sciences

Enhanced Immunomodulatory Effects of Thymosin-Alpha-1 in Combination with Polyanionic Carbosilane Dendrimers against HCMV Infection.

Article

作者: María de la Sierra Espinar-Buitrago ; Esmeralda Magro-López ; Elena Vázquez-Alejo ; María Ángeles Muñoz-Fernández

Resistance and toxicity associated with current treatments for human cytomegalovirus (HCMV) infection highlight the need for alternatives and immunotherapy has emerged as a promising strategy. This study examined the in vitro immunological effects of co-administration of Thymosin-alpha-1 (Tα1) and polyanionic carbosilane dendrimers (PCDs) on peripheral blood mononuclear cells (PBMCs) during HCMV infection. The biocompatibility of PCDs was assessed via MTT and LDH assays. PBMCs were pre-treated with the co-administered compounds and then exposed to HCMV for 48 h. Morphological alterations in PBMCs were observed using optical microscopy and total dendritic cells (tDCs), myeloid dendritic cells (mDCs), and plasmacytoid dendritic cells (pDCs), along with CD4+/CD8+ T cells and regulatory T cells (Treg), and were characterized using multiparametric flow cytometry. The findings revealed that Tα1 + PCDs treatments increased DC activation and maturation. Furthermore, increased co-receptor expression, intracellular IFNγ production in T cells and elevated Treg functionality and reduced senescence were evident with Tα1 + G2-S24P treatment. Conversely, reduced co-receptor expression, intracellular cytokine production in T cells, lower functionality and higher senescence in Treg were observed with Tα1 + G2S16 treatment. In summary, Tα1 + PCDs treatments demonstrate synergistic effects during early HCMV infection, suggesting their use as an alternative therapeutic for preventing virus infection.

2024-02-06·Microbial cell factories

Construction of recombinant Lactococcus expressing thymosin and interferon fusion protein and its application as an immune adjuvant.

Article

作者: Zengqi Liu ; Suhua Zhang ; Hongjiao Hu ; He Wang ; Yu Qiu ; Mingqi Dong ; Muping Wang ; Ziyang Cui ; Hongyu Cui ; Yunfeng Wang ; Gaoming He

BACKGROUND:

In recent years, biosafety and green food safety standards have increased the demand for immune enhancers and adjuvants. In the present study, recombinant food-grade Lactococcus lactis (r-L. lactis-Tα1-IFN) expressing thymosin Tα1 and chicken interferon fusion protein was constructed.

RESULTS:

The in vitro interactions with macrophages revealed a mixture of recombinant r-L. lactis-Tα1-IFN could significantly activate both macrophage J774-Dual™ NF-κB and interferon regulator (IRF) signaling pathways. In vitro interactions with chicken peripheral blood mononuclear cells (PBMCs) demonstrated that a mixture of recombinant r-L. lactis-Tα1-IFN significantly enhanced the expression levels of interferon (IFN)-γ, interleukin (IL)-10, CD80, and CD86 proteins in chicken PBMCs. Animal experiments displayed that injecting a lysis mixture of recombinant r-L. lactis-Tα1-IFN could significantly activate the proliferation of T cells and antigen-presenting cells in chicken PBMCs. Moreover, 16S analysis of intestinal microbiota demonstrated that injection of the lysis mixture of recombinant r-L. lactis-Tα1-IFN could significantly improve the structure and composition of chicken intestinal microbiota, with a significant increase in probiotic genera, such as Lactobacillus spp. Results of animal experiments using the lysis mixture of recombinant r-L. lactis-Tα1-IFN as an immune adjuvant for inactivated chicken Newcastle disease vaccine showed that the serum antibody titers of the experimental group were significantly higher than those of the vaccine control group, and the expression levels of cytokines IFN-γ and IL-2 were significantly higher than those of the vaccine control group.

CONCLUSION:

These results indicate that food-safe recombinant r-L. lactis-Tα1-IFN has potential as a vaccine immune booster and immune adjuvant. This study lays the foundation for the development of natural green novel animal immune booster or immune adjuvant.

2024-01-31·Alternative therapies in health and medicine

Mortality Study of Patients with Omicron Infection Before and After the Implementation of the New Crown Standard.

Article

作者: Wei Liu ; Chun Liu ; Aimin Wang ; Xinhua Ma ; Yang Sun ; Chunhui Li ; Lina Zhang ; Yong Lu

Objective:

To investigate the mortality rate of patients with Omicron infection before and after the implementation of the new crown standard, and to evaluate the impact of new treatment protocols on the mortality rate of patients with Omicron infection.

Methods:

Clinical data of 1419 Omicron-infected patients treated in our hospital from April 10, 2022 to June 3, 2022 were collected(Patients diagnosed with Omicron infection who met the diagnostic criteria in the "Diagnosis and treatment protocol for novel coronavirus pneumonia (trial version 9)"15 and whose nasal/pharyngeal swab samples were typed as Omicron variants by laboratory viral genotyping). They were divided into the observation group (April 25 2022 - June 3 2022) and the control group (April 10 2022 - April 24 2022) before and after the implementation criteria. Clinical data of 1419 patients were collected and compared between the two groups on whether to use anticoagulant drugs, whether to use antiplatelet drugs, gender, whether to use new drugs of thymosin/thymus method, age, whether to use herbal medicine, whether to use Fuzheng prescription, blood routine, liver function, kidney function indicators, mortality of patients.

Results:

A total of 1419 patients were initially selected; 501 patients with incomplete information were excluded, and finally, 918 patients were included. According to the time period before and after the application criteria, they were divided into an observation group (586 cases) and a control group (332 cases). There were no statistically significant differences in gender, age, antiplatelet drug use, and herbal medicine use between the two groups (P < .05). However, there were significant differences in the use of anticoagulant drugs, thymidine/thymidine drugs, and Fu Zhengfang between the two groups. It was statistically significant that the mortality rate in the observation group (2.39)% was significantly lower than that in the control group (5.12)%. P < .05 White blood cell count, red blood cell ratio, lymphocyte count, hemoglobin, neutrophil count, and neutrophil ratio were not significantly different between the two groups (P < .05) .In comparison to the control group (4.92±8.00)10^9/L, the platelet count in the observation group (4.77±3.41)109/L was considerably lower. The difference was statistically significant (P < .05). The comparison of total bilirubin, total protein values and alkaline phosphatase values between the two groups was not significant (P < .05). In the observation group, albumin (38.71±6.39) g/L, glutamate transaminase (23.93±26.03) U/L, glutathione transaminase (26.12±25.53) U/L, gamma-glutamyltransferase (34.28±52.3) U/L, globulin values (28.13±5.55) g/L were significantly lower than those of the control group (36.66±7.08) g/L, (30.36±65.77) U/L, (33.29±49.72) U/L, (43.76±80.23) U/L, (29.85±5.67) g/L, the difference was statistically significant (P < .05). Between the two groups, there were no significant differences in the values of uric acid or creatinine (P > .05). Levels and uric acid readings did not differ significantly, P > .05. The difference between the urea values of the observation group (7.44±6.34 mmol/L) and the control group (8.75±7.51 mmol/L) was statistically significant (P < .05).

Conclusion:

After the implementation of the treatment protocol for COVID-19 (Trial Version 9), the number of death cases among patients with Omicron variant infection has significantly decreased. The treatment protocol is safe and feasible and can be widely applied in clinical settings..And it will further promote the development and administration of vaccines to prevent and control the spread of the novel coronavirus, reducing the occurrence of patients and death cases.

项与胸腺法新相关的新闻（医药）

2024-03-29

·Pharmaceutical Technology

Gilead’s Vemlidy expands label to treat paediatric chronic HBV

Vemlidy is approved to treat patients six years and older for chronic HBV. Credits: Sundry Photography/Shutterstock.com Soon after GSK gained traction with a US Food and Drug Administration (FDA) fast track designation for its investigational treatment bepirovirsen for chronic hepatitis B virus (HBV), Gilead Sciences has strengthened its position in the indication with an FDA approval for Vemlidy (tenofovir alafenamide) to treat paediatric patients. The once daily 25mg tablets have been greenlit to treat patients with chronic HBV with compensated liver disease that are six years and older and weigh at least 25kg. The supplemental new drug application (sNDA) approval was based on data from the ongoing Phase II Study 1092 (NCT02932150), comparing the safety and efficacy of 25mg Vemlidy to placebo in 88 treatment-naïve and treatment-experienced patients with chronic HBV. As per a 28 March press release, patients treated with Vemlidy and those that switched to open-label Vemlidy after week 24 demonstrated “progressive increases in rates of virological suppression” by week 96. “The expanded indication for Vemlidy for the treatment of children as young as six years old is a testament to the safety, tolerability and efficacy profile of this therapy,” said Dr. Frank Duff, Gilead’s senior vice president of the virology therapeutic area, in the announcement. The pharma giant aims to continue addressing unmet treatment needs for children, he added. Vemlidy, a small molecule nucleoside analogue reverse transcriptase inhibitor, was first FDA approved in 2016 as a treatment for adults with chronic HBV and gained its first label expansion in 2022 to treat patients aged 12 years and older with compensated liver disease. The product is marketed with a boxed warning for post-treatment severe acute exacerbation of hepatitis B. See Also: Angelini gets grant for method for labelling reels using robot and application roller Rohto Pharmaceutical gets grant for ophthalmic composition for treating myopia with crocetin and ginkgo leaf GlobalData’s drugs database forecasts that the hepatitis B treatment market will significantly increase over the next six years to reach $10.5bn in 2029, with analysts predicting a compound annual growth rate of 30%. According to the analysts, 71% of the sales in 2022 were attributed to Vemlidy and SciClone Pharmaceuticals’ Zadaxin, a synthetic polypeptide, indicating market dominance. GlobalData’s consensus forecasts predict that Vemlidy will generate $873m in sales in 2024. GlobalData is the parent company of Pharmaceutical Technology .

上市批准临床结果临床2期快速通道

2024-03-28

·E药经理人

突发！溢价17%，港股又一百亿市值药企被私有化

撰文| 润屿编辑| 彡氜 Erin今日，德福资本及赛生药业联合公告称，3月19日，要约人(Silver Pegasus Investment Limited)根据公司法第86条以协议安排方式将赛生药业私有化，要求董事会向计划股份持有人提呈建议，其中涉及注销计划股份，作为代价，就每股计划股份以现金向计划股东支付注销价（以换取每股计划股份现金18.8港元），并撤销股份于联交所的上市地位。公告还显示，注销价18.8港元较不受干扰日期收市价每股14.04港元溢价约33.90%，较最后交易日(2024年3月18日)收市价每股16.04港元溢价约17.21%，市值超过百亿港元。另外，公司将于计划生效后，立即根据上市规则第6.15(2)条向联交所申请撤销股份于联交所的上市地位。值得关注的是，赛生将于4月2日复牌交易。同一天，赛生药业还发布了2023年财报，并宣布联席公司秘书陈倩敏已辞任（2021年被委任）。财报显示，2023年，赛生药业全年营收为31.56亿元，同比增长约为14.8%，自2017年集团重组以来年复合增长率实现双位数增长；净利润同比增长增31.2%至11.2亿元。对此，有了解赛生的投资人评论：作为一家专注于肿瘤及重症感染疾病治疗领域并拥有产品开发和商业化集成平台的国际生物制药公司，赛生药业的业绩表现不错，私有化很有底气，估计是有“回A”的想法。而且在此时机，完成私有化是一笔划算的交易。推荐阅读 * 2024年港股第一家私有化药企来了！是位"大家伙"…* 亲历Biotech退市潮：始于不合规，终于直面死亡的勇气这并不是赛生第一次私有化。赛生药业的前身是SciClone US公司（1990年成立），专注于药品收购及开发业务。1992年，SciClone US在纳斯达克上市，之后按照私有化计划，接受了中国财团约6亿美元的私有化收购要约，美股退市时间为2017年。据了解，当时，由GL Trade Investment L.P.及GL Glee Investment Limited（受德福资本创始合伙人及首席执行官李振福共同控制）领导，另由鼎晖投资、上达资本、中银集团投资有限公司等关联实体组成的财团依据财团协议成立，专门处理SciClone US收购及私有化有关事宜。此后，在一系列重组之后，形成了现在的赛生药业，手握一款自研上市产品——注射用胸腺法新（商品名为“日达仙”），临床上用于治疗慢性病毒感染、肿瘤及免疫缺陷病人的辅助治疗，还可作为疫苗增强剂，此前，赛生药业超8成收入都来自该产品。2021年，赛生药业在港交所上市，彼时官方信息显示，赛生药业的非执行董事为德福资本李振福。而就在1个月前，中国中药宣布超150亿港元私有化，现在赛生药业又被知名资本私有化。港股药企私有化的趋势似乎愈演愈烈，下一个，又会是谁？精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

并购财报疫苗高管变更

2024-03-21

·赛柏蓝

上海医药高层大调整 | 新董事长确认、副董事长辞职

作者 | 陈芋来源 | 赛柏蓝01上海医药领导层大调整新董事长确认、副董事长辞职 3月20日，上海医药发布公告，其在第八届董事会第七次会议上审议通过了《关于推选第八届董事会董事长的议案》，同意杨秋华担任公司第八届董事会董事长，任期至第八届董事会届满时止。这一自上任董事长于去年11月辞职后一直由副董事长代任的职务，在空缺4个月后终于尘埃落定。在正式担任董事长前，杨秋华已任上海医药党委书记一职。公布新董事长上任同日，上海医药还发布了一起公告，原副董事长姚嘉勇因工作调动辞去上海医药董事、副董事长等全部职务，辞任后，不在上海医药及下属企业担任任何职务。资料显示，杨秋华生于1972年8月，华东理工大学制药工程硕士，高级工程师，担任上海医药党委书记、董事长、执行董事的同时，也是现任上海实业（集团）有限公司副总裁、上海实业控股有限公司副行政总裁。此前，杨秋华还曾任上海三维制药有限公司党委书记、总经理，上海实业投资有限公司副董事长、总经理，香港天厨有限公司董事长，上实投资(上海)有限公司副总裁，南洋兄弟烟草股份有限公司董事长，永发印务有限公司董事长等职务。上海医药是上实集团医药业务的唯一载体，此次由在上实系统内有过多年工作经验的杨秋华接棒上海医药董事长一职，也属于其内部的一次人事调整。近半年，上海医药高管层经历了不小的动荡。去年11月20日盘前，上海医药公告称，周军因个人原因辞去公司董事长、非执行董事、董事会战略委员会召集人及委员等全部职务。028个产品过评2款创新药临床试验获批截至3月21日，上海医药暂未公布2023年年报，其最新的第三季度报显示，2023年前9个月，上海医药实现营业收入1975.08亿元，同比增长13.11%，其中医药工业实现销售收入208亿元，同比增长5.09%；医药商业实现销售收入1767.08亿元，同比增长14.14%。尽管管理层变动不断，上海医药近半年产品及临床相关工作仍在有序推进中。从去年9月至今，上海医药共8个产品通过仿制药一致性评价，包括注射用美罗培南、替米沙坦氢氯噻嗪片、双氯芬酸钠缓释片、阿普唑仑片、阿昔洛韦片、注射用胸腺法新、胞磷胆碱钠注射液、重酒石酸去甲肾上腺素注射液，覆盖抗感染、降血压、解热镇痛等多个领域。临床方面，上海医药去年新增的两款创新药产品——WST04和I035均已获得国家药监局临床试验批准，前者是一种口服微生态活菌制剂，拟用于治疗晚期恶性实体瘤；后者是一款免疫调节剂，能抑制肠道的炎症反应和增强肠道的免疫调节。另外值得注意的是，上海医药在研发与销售方面的费用支出差距较为悬殊。其财报显示，上海医药在2023年前三季度的研发费为14.7亿元，较上年同期的13.9亿元上涨约5.8%，占总营收的不足1%，占其医药工业销售收入的7%左右；同期，上海医药前三季度销售费达104.7亿元，同比增长约1.3%，占上海医药总营收的5.3%左右。 Wind数据显示，医药（中信）成份项下460家上市公司（剔除4家退市公司），2022年销售费用共计约3397.3亿元，按销售费用排名，2022年医药上市公司Top10的销售费用均超过50亿元。不过，随着医药反腐常态化，医疗机构和药企都受到了更严格的监管，除新品上市后为打开市场而必需投入的正规学术推广费用外，诸多“灰色销售费用”存在的空间将进一步被压缩。END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

高管变更一致性评价

100 项与胸腺法新相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06116	-	A05A	DB04900

研发状态

适应症	最高研发状态	国家/地区	公司
慢性乙型肝炎	批准上市	中国更多	四川源基制药有限公司更多
乙型肝炎	批准上市	-	-
丙型肝炎	批准上市	-	-
晚期恶性实体瘤	临床2期	中国更多	SciClone Pharmaceuticals LLC 更多
终末期肾脏病	无进展	意大利更多	Alfasigma SpA 更多

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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


NCT04487444 (Pubmed)	临床2期	新型冠状病毒感染	49	Thymalfasin (Tα1)	(鏇網製艱遞夢蓋構壓壓) = Nine serious adverse events among treated patients were deemed not related to Tα1. 鬱齋鑰顧願鬱範壓鹹糧 (鏇顧簾顧鏇襯蓋鏇鹹襯 ) 更多	积极	2022-09-03
				Thymalfasin (Tα1) (Standard of care)
Pubmed \| J Cardiothorac Surg	临床4期	-	160	Single-dose group (TA1)	齋廠膚願蓋觸獵顧製醖(構壓積範窪顧窪鹽簾鏇) = 14 (8.8%) had acute kidney failure 廠淵顧鹽鏇構壓積衊鏇 (齋鏇膚艱壓齋鹽醖遞簾 ) 更多	-	2011-10-14
				Double-dose group (TA2)
ASCO2005	N/A	晚期乳腺癌	18	thymalfasin (Group 1)	(鹹憲淵廠窪鹽餘鑰襯衊) = 選餘鹽獵積選齋夢顧積糧襯顧窪選膚願繭膚顧 (鬱積膚艱鹹衊齋衊獵艱 )	-	2005-06-01
				thymalfasin (Group 2)	(衊獵顧齋廠構簾餘膚艱) = 艱齋憲淵選製鑰餘鏇夢鹽繭鬱窪壓鏇艱選鬱製 (遞積簾壓鏇鏇艱鹹獵繭 )