birelentinib(DZD8586)
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Dizal Pharmaceutical Co., Ltd.(H0342) - Application Proof (1st submission)
2026-01-22 16:00
The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of DIZAL PHARMACEUTICAL CO., LTD. 迪哲(江蘇)醫藥股份有限公司 (the "Company") (A joint stock company incorporated in the People's R ...
迪哲医药(688192.SH):高瑞哲和 Birelentinib 最新研究数据在第67届美国临床血液学会(ASH)发布
Ge Long Hui A P P· 2025-12-09 07:56
Core Viewpoint - The company, DIZH Medical (688192.SH), announced significant advancements in two globally innovative drugs at the 67th American Society of Hematology (ASH) conference, focusing on treatments for T-cell and B-cell lymphomas [1] Group 1: Drug Developments - The high-selectivity JAK1 inhibitor, Golixtin (generic name: Golixtin capsules), has made multiple new progressions in the field of T-cell lymphoma [1] - The non-covalent LYN/BTK dual-target inhibitor, birelentinib (DZD8586), has presented the latest clinical data for the treatment of B-cell lymphoma [1]
迪哲医药:高瑞哲和Birelentinib最新研究数据在第67届美国临床血液学会发布
Zhi Tong Cai Jing· 2025-12-09 07:52
Core Insights - The company announced the latest research results of two globally innovative drugs at the 67th American Society of Hematology (ASH) conference, highlighting advancements in T-cell lymphoma and B-cell lymphoma treatments [1] Group 1: Drug Development - The high-selective JAK1 inhibitor, Golixtin (generic name: Golixtin capsules), has made significant progress in the field of T-cell lymphoma [1] - The non-covalent LYN/BTK dual-target inhibitor, birelentinib (DZD8586), has shown promising clinical data in the treatment of B-cell lymphoma [1] Group 2: Clinical Trial Results - In the Phase III recommended dose (RP3D) of 50mg, the overall response rate (ORR) was 84.2% [1] - Tumor remission was observed in patients who had previously received BTK inhibitors, Bcl-2 inhibitors, or BTK degraders, including those with classic BTK resistance mutations (C481X) or other BTK mutations [1] - The anti-tumor efficacy was durable, and safety was good, with no new safety issues reported during the follow-up period [1]
迪哲医药:高瑞哲 和Birelentinib最新研究数据在第67届美国临床血液学会(ASH)发布
Zheng Quan Shi Bao Wang· 2025-12-09 07:52
Core Viewpoint - The company DiZhe Pharmaceutical (688192) announced significant advancements in two innovative drugs at the 67th American Society of Hematology (ASH) conference, focusing on treatments for T-cell and B-cell lymphomas [1] Group 1: Drug Developments - The high-selectivity JAK1 inhibitor, Goli Siti Ni (generic name: Golisitini capsules), has made multiple new progressions in the field of T-cell lymphoma [1] - The non-covalent LYN/BTK dual-target inhibitor, birelentinib (DZD8586), has presented the latest clinical data for the treatment of B-cell lymphoma [1]
迪哲医药(688192.SH):高瑞哲和Birelentinib最新研究数据在第67届美国临床血液学会发布
智通财经网· 2025-12-09 07:51
Core Insights - The company, Dizhi Pharmaceutical, announced the latest research results of its two globally innovative drugs at the 67th American Society of Hematology (ASH) conference, highlighting advancements in T-cell lymphoma and B-cell lymphoma treatments [1] Group 1: Drug Development - The high-selective JAK1 inhibitor, Golixtin (generic name: Golixtin capsules), has made significant progress in the T-cell lymphoma field [1] - The non-covalent LYN/BTK dual-target inhibitor, birelentinib (DZD8586), has shown promising clinical data in the treatment of B-cell lymphoma [1] Group 2: Clinical Trial Results - In the Phase III recommended dose (RP3D) of 50mg, the overall response rate (ORR) was 84.2% [1] - Tumor remission was observed in patients previously treated with BTK inhibitors, Bcl-2 inhibitors, or BTK degraders, including those with classic BTK resistance mutations (C481X) or other BTK mutations [1] - The anti-tumor efficacy was durable, and safety was good, with no new safety issues reported during the follow-up period [1]
每周股票复盘:迪哲医药(688192)舒沃哲高瑞哲进医保加速放量
Sou Hu Cai Jing· 2025-11-08 18:28
Core Viewpoint - Dize Pharmaceutical (688192) has experienced a decline in stock price, closing at 59.77 yuan, down 6.17% from the previous week, with a current market capitalization of 27.459 billion yuan, ranking 15th in the chemical pharmaceutical sector and 692nd in the A-share market [1] Group 1: Company Performance - For the first three quarters of 2025, the company achieved revenue of 586 million yuan, representing a year-on-year growth of 73% [5] - The company's core products, Shuwozhe (舒沃哲) and Gao Ruizhe (高瑞哲), have been successfully included in the national medical insurance directory, maintaining rapid growth post-inclusion [5][6] - The company is currently in a loss-making state but aims to expedite the launch of more products or indications to achieve profitability sooner [3] Group 2: Product Development and Market Position - Shuwozhe is the first and only domestically developed innovative drug approved in the U.S. for EGFR Exon20ins NSCLC, and it has been included in the NCCN guidelines for non-small cell lung cancer [4] - Gao Ruizhe is the first drug targeting the JAK/STAT pathway for peripheral T-cell lymphoma (PTCL), showing significant clinical benefits and the longest median overall survival (mOS) among single-agent treatments for relapsed/refractory PTCL [4] - The company has established a competitive clinical product pipeline with seven products, including Shuwozhe and Gao Ruizhe, which are expected to enhance the company's international standing in the innovative drug industry [4] Group 3: Research and Development Initiatives - The global registration clinical study "JCKPOT8 B part" for Gao Ruizhe has reached its primary research endpoint, and the company is actively validating the new drug application for overseas markets [3] - Birelentinib (DZD8586) has initiated a Phase III clinical study for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with active participant recruitment [3] - The company is assessing various overseas collaboration models for Shuwozhe, focusing on global commercialization capabilities and pipeline synergy [2]
迪哲医药高瑞哲和Birelentinib多项研究入选第67届ASH大会
Bei Jing Shang Bao· 2025-11-04 09:47
Core Insights - DiZhe Pharmaceutical (688192) will present multiple latest research findings on its key lymphoma treatment products, Golixty (generic name: Golixty capsules) and Birelentinib (DZD8586), at the 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] Group 1: Product Developments - The ASH conference will showcase Golixty's exploration and progress in monotherapy and combination therapy strategies for r/r PTCL, first-line treatment, and rare subtypes, highlighting its broad application potential in T-cell lymphoma treatment [1] - Birelentinib is a globally innovative non-covalent dual-target inhibitor of LYN/BTK that can fully penetrate the blood-brain barrier, with the latest data from I/II clinical studies in CLL/SLL patients previously treated with covalent or non-covalent BTK inhibitors and BTK degraders to be presented [1]
迪哲医药:产品多项研究入选第67届美国临床血液学会大会
Zheng Quan Shi Bao Wang· 2025-11-04 09:27
Core Viewpoint - The company, DIZHE Pharmaceutical (688192), will present multiple research findings on its key lymphoma treatment products, Golitinib (generic name: Golitinib capsules) and Birelentinib (DZD8586), at the 67th American Society of Hematology Annual Meeting from December 6 to 9 [1] Group 1 - The company has 15 abstracts accepted for presentation at the conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]
迪哲医药(688192.SH):高瑞哲®和Birelentinib多项研究入选第67届美国临床血液学会(ASH)大会
智通财经网· 2025-11-04 09:20
Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present multiple research findings on its key lymphoma treatment products at the upcoming 67th American Society of Hematology (ASH) conference from December 6 to 9, showcasing its robust pipeline and research potential in the field of hematologic oncology [1] Group 1 - The company will unveil research results for two core products: Golitiximab (highly regarded as 高瑞哲®) and birelentinib (DZD8586) [1] - A total of 15 abstracts from the company have been accepted for presentation at the ASH conference, highlighting its extensive pipeline in blood cancer treatment [1] - The participation in this prestigious conference reflects the company's commitment to advancing research in hematologic malignancies [1]
迪哲医药:高瑞哲 和Birelentinib多项研究入选第67届美国临床血液学会(ASH)大会
Zhi Tong Cai Jing· 2025-11-04 09:19
Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present significant research findings on its core lymphoma treatment products, Golixty (generic name: Golitinib capsules) and birelentinib (DZD8586), at the 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] Group 1 - The company has 15 abstracts accepted for presentation at the ASH conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]