Hengrui Medicine gets green light for HRS-5635 trial
Jiangsu Hengrui Medicine Co., Ltd. [SSE:600276] announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for clinical trials of HRS-5635 injection. This drug, a new generation liver-targeted siRNA drug for hepatitis B virus (HBV), will undergo clinical trials to assess its efficacy in combination with Peg-IFNa for chronic hepatitis B treatment. Preclinical studies have demonstrated HRS-5635's potent antiviral activity against all HBV genotypes and a favorable safety profile. As of now, there are no similar drugs approved globally. Hengrui Medicine has invested approximately CNY 13,028 million in the research and development of HRS-5635 to date. The company cautioned that the drug's path to market involves uncertainties and will actively advance the project while fulfilling its disclosure obligations.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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