Core Viewpoint - Heng Rui Medicine (600276) has received conditional approval from the National Medical Products Administration for its innovative drug, Zemeituosita Tablets (SHR2554), aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma (R/RPTCL) who have previously undergone at least one line of systemic treatment [1] Group 1: Company Developments - Heng Rui Medicine's stock rose by 3.21%, reaching HKD 82.05, with a trading volume of HKD 206 million [1] - The Zemeituosita Tablets are the first EZH2 inhibitor developed independently in China, marketed under the name Airi Jing [1] - The company has invested approximately CNY 213 million in the research and development of Zemeituosita Tablets to date [1] Group 2: Product Details - Zemeituosita Tablets effectively inhibit both wild-type and mutant EZH2 enzyme activity by precisely binding to the SET catalytic domain of EZH2, blocking the abnormal generation of H3K27me3 [1] - The drug reactivates tumor suppressor genes and initiates the apoptosis program in tumor cells, while also improving the tumor microenvironment and restoring the body's immune surveillance and clearance capabilities against tumor cells [1]

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]

Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its innovative drug, Zemeituosita Tablets, which is the first self-developed EZH2 inhibitor in China, providing a new treatment option for adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) [1][2] Company Summary - Heng Rui Medicine has developed Zemeituosita Tablets, a highly selective oral EZH2 inhibitor, which works by inhibiting histone methyltransferase EZH2, reversing abnormal epigenetic programming in tumor cells, and inducing cell cycle arrest and early apoptosis [2] - The company has successfully launched 24 first-class innovative drugs in China, with over half being anti-tumor drugs, and has more than 100 self-innovated products in clinical development, along with over 400 clinical trials ongoing domestically and internationally [2] Industry Summary - Peripheral T-cell lymphoma (PTCL) accounts for approximately 25-30% of non-Hodgkin lymphoma patients in China, significantly higher than in Western countries, with a median onset age of 52-57 years [2] - The clinical treatment of PTCL is challenging, as most patients experience relapse or become refractory after initial treatment, with a recent study showing a median progression-free survival of only 5.2 months for patients entering second-line treatment [2] - The approval of Zemeituosita Tablets highlights the need for innovative treatment options in the R/R PTCL patient population, which currently lacks standardized treatment protocols and effective therapeutic options [2]

Group 1 - The core point of the article is that Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, for adult patients with relapsed or refractory peripheral T-cell lymphoma who have previously undergone at least one line of systemic therapy [1] Group 2 - SHR2554 tablets are the first self-developed EZH2 inhibitor in China, representing a new, efficient, and selective oral EZH2 inhibitor [2] - The global sales of Tazverik, an EZH2 inhibitor developed by Epizyme, are projected to reach approximately $51 million in 2024 [2] - The cumulative R&D investment for SHR2554 tablets has reached approximately 213 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, which is the first EZH2 inhibitor independently developed in China, aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma who have received at least one line of systemic therapy [1] Group 1: Product Development - SHR2554 tablets are a new, highly efficient, and selective oral EZH2 inhibitor developed by the company [1] - The drug is positioned to address a significant unmet medical need in the treatment of R/RPTCL [1] Group 2: Market Context - The approval of SHR2554 follows the earlier approvals of similar drugs, such as Tazverik by Epizyme in the US and Ezharmia by Daiichi Sankyo in Japan, indicating a growing market for EZH2 inhibitors [1] - Tazverik is projected to have global sales of approximately $51 million in 2024, highlighting the commercial potential for EZH2 inhibitors [1] Group 3: Investment and R&D - The cumulative R&D investment for the SHR2554 project has reached approximately 213 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, for adult patients with relapsed or refractory peripheral T-cell lymphoma who have received at least one line of systemic therapy [1] Group 1: Product Development - SHR2554 tablets are the first self-developed EZH2 inhibitor in China [1] - The drug is a new, efficient, and selective oral EZH2 inhibitor [1] - The total R&D investment for the SHR2554 project has reached approximately 213 million yuan [1] Group 2: Market Context - In January 2020, the U.S. FDA approved the oral EZH2 inhibitor Tazverik (tazemetostat) developed by Epizyme [1] - In August 2021, Hutchison China MediTech obtained the development and commercialization rights for tazemetostat in Greater China [1] - Tazverik's global sales are projected to be approximately 51 million USD in 2024 according to EvaluatePharma [1]