Boundless Bio：Bepirovirsen was not approved by the NMPA recently.
Recently, on May 25, 2026, the NMPA (National Medical Products Administration) released the latest drug notification letter delivery information, which included GlaxoSmithKline’s (GSK) investigational new drug Bepirovirsen injection (Bepirovirsen, GSK3228836, GSK836) for the treatment of chronic hepatitis B, with acceptance number JXHS2600033.
On March 27, 2026, the drug was accepted and published by the NMPA CDE and was granted priority review. According to data from Yaorongquan, it is speculated that the drug may have been withdrawn for resubmission (due to CMC issues or the need to narrow the indication scope), resulting in the failure of the initial marketing application. The indication for the first submission was for the limited-course treatment of chronic hepatitis B virus infection in adult patients with the following characteristics: currently on nucleos(t)ide analog therapy, HBsAg ≤3000 IU/mL, and without cirrhosis.
Bepirovirsen is an antisense oligonucleotide (ASO), originally developed by IONIS under the development code IONIS-HBVRx. In mid-March 2026, the drug was submitted for marketing authorization in the EU, and in April 2026, an NDA was submitted in the US, with a PDUFA target date of October 30, 2026.
On May 11, 2026, GSK also announced an exclusive strategic collaboration with China Biopharmaceuticals’ Chia Tai Tianqing Pharmaceutical Group under a CSO (Contract Sales Organization) cooperation model.
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