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AstraZeneca Shares Rise 3% as CDSCO Approves Sale of Tremelimumab

AstraZeneca halts development of Crohn's disease drug.

AstraZeneca Pharmaceuticals India shares rose more than 3% in morning trade on June 2 after the CDSCO approved the sale and distribution of Tremelimumab (Imjudo) concentrate in India at a concentration of 20 mg/ml (25 mg/1.25 ml and 300 mg/ml). mg/15 ml in single-dose vials), the company said in a release. The intravenous route will administer the solution, it added.

AstraZeneca Pharmaceuticals India has received approval from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, to import Tremelimumab (Imjudo) concentrate for sale and distribution in India on Form CT-20, using Indications for specific uses. Tremelimumab is combined with durvalumab (Imfinzi) to treat unresectable hepatocellular carcinoma (uHCC) patients.

The company said obtaining this clearance paves the way for the drug’s launch in India for specific indications, subject to obtaining relevant statutory approvals, if any.

Last month (May 3), the company received a license from the CDSCO to import and sell Trastuzumab Deruxtecan, also known as Enhertu, for treating HER2-positive breast cancer.

In the quarter ended March 203, the company posted a net profit of Rs 172.7 crore compared to Rs 278.8 crore year-on-year.

Revenue was at Rs 284.70 crore compared to Rs 231.96 crore year-on-year. The company’s board of directors has recommended a dividend of Rs 16 per share for FY22-23.

AstraZeneca was quoted at Rs 3,561.30 at 9:23 am, up Rs 61.75, or 1.76% on the BSE.

The stock hit a 52-week high of Rs 3,619.70 and a 52-week low of Rs 2,650 on November 9, 2022, and June 20, 2022, respectively. Currently, it is trading 1.61% below its 52-week high and 34.39% above its 52-week low.

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