GLP - 1R和GIPR双激动剂

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江苏恒瑞医药股份有限公司关于获得药品注册批准的公告
Shang Hai Zheng Quan Bao· 2025-09-01 21:28
Group 1: Drug Approval and Development - Jiangsu Hengrui Medicine Co., Ltd. received conditional approval from the National Medical Products Administration for its innovative drug, SHR2554 tablets, which is the first EZH2 inhibitor developed in China, aimed at treating adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) who have undergone at least one line of systemic therapy [1][2] - The drug is classified as a chemical drug of category 1, with a specification of 50mg in tablet form, and is a prescription medication [1][2] - The company has invested approximately 21.3 million yuan in the development of SHR2554 tablets [3] Group 2: Clinical Context and Market Need - Peripheral T-cell lymphoma (PTCL) accounts for about 25-30% of non-Hodgkin lymphoma cases in China, which is significantly higher than in Western countries, with a median age of onset at 52 years [2] - A recent large-scale real-world study indicated that the median progression-free survival (PFS) for patients entering second-line treatment drops sharply from 30.5 months in first-line treatment to just 5.2 months, highlighting the limited treatment options and poor survival benefits for R/R PTCL patients [2] Group 3: Additional Drug Development - The company’s subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its application for HRS9531 injection accepted by the National Medical Products Administration, targeting long-term weight management in adults with a BMI of 28 kg/m² or higher [8][9] - HRS9531 injection has shown significant efficacy in a Phase III clinical trial, with a high-dose group achieving an average weight reduction of 19.2%, and 44.4% of participants losing 20% or more of their body weight [9][11] - The drug is a novel dual agonist targeting GLP-1R and GIPR, designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity [11]