Henlius Wins FDA Nod to Begin U.S. Trial of Cetuximab Biosimilar HLX05-N
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Shanghai Henlius Biotech, Inc. has received FDA approval to conduct a phase 1 clinical trial for HLX05-N, a biosimilar to cetuximab, aimed at treating metastatic colorectal cancer. This follows prior approval from China's National Medical Products Administration. The company anticipates entering a lucrative oncology biosimilar market, with global sales projected at USD 1.66 billion by 2025. Analysts rate the stock as a Buy with a target price of HK$99.78, although successful development is not guaranteed.
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