NMPA 批准首个 T 细胞受体 (TCR) T 细胞疗法治疗乙型肝炎病毒 (H

StephenW

NMPA 批准首个 T 细胞受体 (TCR) T 细胞疗法治疗乙型肝炎病毒 (HBV) 相关肝细胞癌 (HCC) 的 IND
2022 年 3 月 12 日，星期六，上午 12:07·3 分钟阅读

新加坡 2022 年 3 月 11 日 /美通社/ -- 总部位于新加坡的领先生物技术公司 SCG 细胞治疗私人有限公司（“SCG”）今天宣布，中国国家药品监督管理局 (NMPA) 已批准其在研新药 (IND ) 申请 SCG101，这是该公司首个针对乙型肝炎病毒抗原的 T 细胞受体 T 细胞疗法。 SCG101是首个获NMPA批准用于治疗肝细胞癌的TCR-T细胞疗法。

“ NMPA 批准我们的 SCG101 IND 申请是我们细胞治疗计划的一个重要里程碑，因为它标志着第一个 TCR-T 产品候选者从我们的治疗管道中推进，这些治疗旨在治疗主要癌症适应症中未满足的需求”，Frank Wang Shuli 说， SCG 细胞疗法首席执行官。

SCG101是一种针对特定乙型肝炎病毒（HBV）表位的自体TCR-T细胞疗法。在HBV感染过程中，HBV DNA与肝细胞基因组的整合很常见，这对整合的肝细胞基因组造成破坏，从而导致HCC的发生。 SCG101可以将T细胞重定向至靶向表达在细胞表面的HBV表位，成为HBV相关HCC的新治疗策略。

乙型肝炎病毒 (HBV) 感染是超过 80% 的亚洲人群发生肝细胞癌 (HCC) 的主要原因。

中国约有 1.2 亿人患有乙型肝炎，即十二分之一的人携带乙型肝炎病毒 (HBV)。在中国每年估计的 466,000 例新发肝癌病例中，由病毒性乙型肝炎（HBV）感染引起的肝细胞癌占 83.77%[1]。

关于SCG101

SCG101是一种针对特定乙型肝炎病毒（HBV）表位的自体T细胞受体（TCR）T细胞疗法，是治疗HBV相关肝细胞癌（HCC）的一种潜在的新型疗法。 HCC是最常见的肝癌类型。在亚洲，HBV 占病毒相关 HCC 病例的 80% 以上。 HCC 通常在其病程晚期被诊断出来，并且与预后不良有关。初步数据表明，SCG101 是一种针对 HBV 相关 HCC 的新型 TCR-T 疗法。 SCG101目前正在临床试验中进行研究。

StephenW

NMPA Clears IND for First T-Cell Receptor (TCR) T Cell Therapy to Treat Hepatitis B virus (HBV) associated hepatocellular carcinoma (HCC)
Sat, March 12, 2022, 12:07 AM·3 min read

SINGAPORE, March 11, 2022 /PRNewswire/ -- Singapore-based SCG Cell Therapy Pte Ltd ("SCG"), a leading biotechnology company, today announced that the China National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for SCG101, the company's first T-cell receptor T-cell therapy targeted hepatitis B viral antigens. SCG101 is the first TCR-T cell therapy approved by the NMPA for the treatment of hepatocellular carcinoma.

"NMPA's clearance of our IND application for SCG101 is an important milestone for our cell therapy program as it marks the first TCR-T product candidate to advance from our pipeline of therapies geared to treat unmet needs in major cancer indications" said Frank Wang Shuli, Chief Executive Officer of SCG Cell Therapy.

SCG101 is an autologous TCR-T cell therapy targeting specific hepatitis B virus (HBV) epitopes. During HBV infection, integration of HBV DNA into the genome of hepatocytes occurs commonly, which causes damages to the integrated hepatocyte genome and leads to the occurrence of HCC. SCG101 can redirect T cells to target HBV epitopes expressed on the cell surface and become a new therapeutic strategy for HBV-associated HCC.

Hepatitis B virus (HBV) infection is the major cause of hepatocellular carcinoma (HCC) in more than 80% of the Asian population.

About 120 million people in China have hepatitis B, or one in twelve people carries the hepatitis B virus (HBV). Hepatocellular carcinoma caused by viral hepatitis B (HBV) infection accounts for 83.77% of the estimated 466,000 new cases of liver cancer in China each year.[1]

About SCG101

SCG101, an autologous T-cell receptor (TCR) T cell therapy targeting specific hepatitis B virus (HBV) epitopes, is a potential novel treatment for HBV-related hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer. In Asia, HBV accounts for more than 80% of virus-associated HCC cases. HCC is typically diagnosed late in its course and is associated with the poor prognosis. Preliminary data indicates that SCG101 is a novel TCR-T therapy against HBV-related HCC. SCG101 currently being investigated in clinical trials.

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MP4

SCG101是中国哪个合作公司？

乙肝人1949

好的，我都同意