Xin Nuowei(300765) announced on the evening of March 4 that its controlling subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd., recently received a "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for emecizumab injection (SYS6053), agreeing to conduct clinical trials as a biosimilar of emecizumab.

SYS6053 is a modified humanized IgG4 monoclonal antibody with a bispecific antibody structure that bridges coagulation factors IXa and X. It is a biosimilar of the original drug, Shuyoule®, and is indicated for patients with hemophilia A. This product is classified as a therapeutic biological product .For Category 3.3 applications, the research and development follows the relevant guidelines for biosimilars. Pharmaceutical and non-clinical research results show that the biosimilar is highly similar to the original reference drug in terms of quality, safety and efficacy, supporting the conduct of subsequent clinical studies.

Xin Nuowei notes that after obtaining clinical trial approval, drugs still need to undergo clinical trials and be approved by national regulatory authorities before they can be marketed and sold. Research and development is characterized by high investment, high risk, and long cycle. There are risks such as clinical trial results falling short of expectations, failure to pass approval, delays in market launch, or sales falling short of expectations after market launch. However, these risks will not have a significant impact on the performance of subsidiaries and the company in the short term.

https://finance.eastmoney.com/a/202603043661962192.html