GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

Shots: GSK has reported data from the P-III (B-Well 1 & B-Well 2) trials assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml. Bepirovirsen is under regulatory review in the US, EU, China & Japan Pooled data showed a 19% functional cure rate (1EP) in the overall population (233/1,220…

ByRidhi Rastogi5 hours ago

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GSK Collaborates with Sino Biopharmaceutical to Accelerate Bepirovirsen at Launch

Shots: GSK has entered an exclusive strategic collaboration with Sino Biopharmaceutical, via its subsidiary CTTQ, to support the launch & commercialization of bepirovirsen (under NMPA’s priority review) in mainland China CTTQ will manage importation, distribution, hospital access, and promotional & non-promotional activities in China under a 5.5yr. supply deal with GSK On the other hand,…

ByRidhi RastogiMay 11, 2026

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The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

Shots: The US FDA has accepted NDA & granted priority review as well as BTD to GSK's bepirovirsen for the treatment of adults with chronic hepatitis B (CHB) NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline…

ByRidhi RastogiApril 28, 2026

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GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

Shots: The EMA has accepted MAA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) MAA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml across 29 countries Both trials met…

ByRidhi RastogiMarch 27, 2026

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GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Shots: The Japanese MHLW has accepted the NDA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) NDA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in pts from 29 countries for the treatment of CHB Trials showed statistically significant &…

ByRidhi RastogiFebruary 27, 2026

NEWS

GSK Reports P-III (B-Well 1 & B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B

Shots: GSK has reported P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in over 1,800 pts from 29 countries for the treatment of chronic hepatitis B (CHB) Both trials met the 1EP, with bepirovirsen delivering a statistically significant, clinically meaningful functional cure & showing superior cure rates vs SoC; Results were…

ByRidhi RastogiJanuary 8, 2026

GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

GSK Collaborates with Sino Biopharmaceutical to Accelerate Bepirovirsen at Launch

The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

GSK Reports P-III (B-Well 1 & B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B

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