Home GSK Announces Positive Phase III Results for Linerixibat in Cholestatic Pruritus Associated with Primary Biliary Cholangitis

GSK Announces Positive Phase III Results for Linerixibat in Cholestatic Pruritus Associated with Primary Biliary Cholangitis

May 13, 2025 22:25 CST Updated 22:25
GSK

Pharmaceutical R&D Manufacturer

Livzon

Pharmaceutical R&D, Manufacturing, and Sales Enterprises

Report Summary

Market Performance:

On May 8, 2025, the pharmaceuticals sector rose and fell by -0.24%, underperforming the CSI 300 Index by 0.07 percentage points, with its rise and fall ranking 10th among the 31 Shenwan sub-industries. Among various pharmaceutical sub-sectors, offline pharmacies (+1.07%), other biologics (-0.07%), and in vitro diagnostics (-0.47%) performed at the top, while hospitals (-2.00%), vaccines (-1.24%), and blood products (-0.76%) were at the bottom. In terms of individual stocks, the top three gainers were Hehua Co., Ltd. (+10.02%), KeHua Biological (+9.84%), and Taien Kang (+7.20%); the top three losers were Yongan Pharmaceuticals (-10.01%), Aipeng Medical (-9.28%), and Haochen Medical (-6.55%).

Industry News:

Recently, GSK announced positive results from the Phase 3 clinical trial GLISTEN. The trial evaluated the efficacy of the investigational drug linerixibat, which targets the ileal bile acid transporter (IBAT), in adult patients with cholestatic pruritus and primary biliary cholangitis (PBC). Data showed that patients receiving linerixibat (n=119) experienced significant improvement in pruritus over 24 weeks compared to the placebo group (n=119). Assessed using the Worst Itch Numerical Rating Scale (WI-NRS), the least squares mean difference between the two groups was -0.72 (95% CI: -1.15, -0.28, p=0.001).

(Source: GSK, Pacific Securities Research Institute)

Company News:

Livzon Group (000513): The company announced that its subsidiary, Livzon Microspheres, has received the "Drug Registration Certificate" (Certificate No.: 2025S01188) issued by the National Medical Products Administration. The drug, Aripiprazole Microspheres for Injection, has been approved for marketing. It is indicated for adult schizophrenia, administered once a month, which can improve medication adherence and help reduce relapse and hospitalization rates.

Hengrui Medicine (600276): The company announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for the SHR-1316(sc) injection. Clinical trials will be carried out soon for the indication of first-line treatment in combination with carboplatin and etoposide for extensive-stage small cell lung cancer.

Zhifei Biological (300122): The company announced that its subsidiary, Zhifei Longcom, has developed a quadrivalent influenza virus split vaccine (ZFA02 adjuvant), which is currently undergoing Phase I/II clinical trials in Hebei Province. The indication is for the prevention of influenza caused by vaccine-related strains of the influenza virus.

Lepu Medical (300003): The company announced that its subsidiary, Minwei Biotech, has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA). The clinical trial application for MWN109 tablets submitted by Minwei Biotech has been approved.

Risk Warning: The R&D and market launch of new drugs may not meet expectations; risks from intensified market competition, etc.

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