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China CDE clears the IND application for WhiteOak/Haichang's HC0301/WGI-0301

 China's CDE has cleared the IND application for WGI-0301/HC0301, which is a lipid nanoparticle (LNP) formulation of an AKT-1 antisense oligonucleotide that binds to AKT-1 mRNA discovered by WhiteOak, a subsidiary of Haichang Biotech. This clearance is for use in patients with hepatocellular carcinoma. The product (RX-0301), along with WGI-0201/HC0201 (RX-0201) and WGI-0047 (RX-0047), was licensed from Rexahn Pharmaceuticals (now Ocuphire Pharma) in 2018. WGI-0301 X-0301 is a nano-liposomal formulation of RX-0201, an antisense oligonucleotide compound designed to enhance delivery to target mRNA encoding Akt-1. RX-0201 works by binding to the mRNA, thereby inhibiting its transcription and the subsequent production of Akt-1 protein.  RX-0201 Rexahn explored the clinical use of RX-0201 in patients with pancreatic cancer and renal cell cancer before 2018.  The median PFS in evaluable patients with mRCC treated with RX-0201 in combination with everolimus was 4.9 months, which is compar