瑞迪博士实验室于周三宣布，已获得印度药品管制局对 Zytorvi 的监管批准。
在10月21日星期三发布的一份证券交易所文件中，该公司表示，其于2023年与君实生物就特瑞普利单抗在21个国家达成了一项许可和商业化协议。
Dr Reddy's Laboratories announced on Wednesday that it has obtained regulatory clearance from the Drugs Controller General of India for Zytorvi .In an exchange filing issued on Wednesday, October 21, the company said it entered into a licensing and commercialisation agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries.
Zytorvi 是一种治疗药物，旨在扩大印度各地晚期食管鳞状细胞癌患者对一线免疫疗法的获取。
Zytorvi is a therapeutic agent designed to broaden patient access to first-line immunotherapy for individuals suffering from advanced oesophageal squamous cell carcinoma throughout India.
这家制药公司在官方声明中披露，该药物已获批与顺铂和紫杉醇联合使用，作为表现为不可切除的晚期、复发性或转移性食管鳞状细胞癌成年患者的一线治疗方案。什么是 Zytorvi ？
这一监管批准代表了 Zytorvi 在该国内部的第二个获批治疗适应症，表明其应用范围已超越了先前获批的鼻咽癌适应症。
The pharmaceutical company disclosed in an official statement that the drug has received approval for use in combination with cisplatin and paclitaxel as a first-line treatment option for adult patients presenting with unresectable advanced, recurrent, or metastatic ESCC. What Is Zytorvi ?This regulatory approval represents Zytorvi's second authorised therapeutic indication within the country, demonstrating expansion beyond its previously approved use in nasopharyngeal carcinoma.
根据该公司声明，食管鳞状细胞癌约占印度记录的所有食管癌病例的80%。
According to the company's statement, ESCC constitutes approximately 80% of all oesophagal cancer cases documented in India.
Zytorvi 采用特瑞普利单抗配制，这是一种单克隆抗体，其作用机制是通过结合 PD-1 并抑制其与 PD-L1 和 PD-L2 的相互作用，从而促进针对恶性细胞的增强型 T 细胞活性。
Zytorvi is formulated with toripalimab, a monoclonal antibody that functions by binding to PD-1 and inhibiting its interaction with PD-L1 and PD-L2, thereby facilitating enhanced T-cell activity directed against malignant cells.
声明还指出，在最终的总生存期分析中，接受特瑞普利单抗联合化疗治疗的患者的中位总生存期时长记录为17.7个月，而接受单药化疗的患者则为12.9个月。股票表现瑞迪博士实验室的股价大体上较为波动；该股下跌了 0.38% 或 4.70 卢比。在过去的交易年里，该股已下跌近 4%。目前的股价已跌至每股 1,237.80 卢比。
During the concluding overall-survival analysis, the median overall survival duration was documented at 17.7 months for patients receiving toripalimab combined with chemotherapy, compared with 12.9 months for those receiving chemotherapy as monotherapy, the statement further indicated. Stock Performance The shares of Dr Reddy's Lab have largely been volatile; the stock has slumped 0.38% or ₹4.70. The stock has fallen nearly 4% in the past year of trading. The current stock price is now down to ₹1,237.80 per share.
