突破性治疗药物认定
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港股异动 | 德琪医药(06996)早盘涨近14% ATG-022竞争力有望加强 机构上调中长期及峰值销售
智通财经网· 2025-08-29 02:54
Core Viewpoint - Dechipher Pharmaceuticals (06996) experienced a significant stock increase of approximately 14% following the announcement of its drug ATG-022 receiving breakthrough therapy designation from the National Medical Products Administration for treating CLDN18.2 positive, HER2 negative unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma [1] Group 1: Stock Performance - Dechipher Pharmaceuticals' stock rose by 14.18%, reaching HKD 6.28, with a trading volume of HKD 21.1499 million [1] Group 2: Drug Development and Market Potential - ATG-022 has been granted breakthrough therapy designation for specific gastric cancer patients, indicating its potential significance in the market [1] - CCB International raised its long-term and peak sales forecast for ATG-022 by nearly 30% and adjusted the company's DCF target price to HKD 8.8, corresponding to a target market value of approximately HKD 6 billion and a peak sales revenue multiple of 2.1x [1] Group 3: Analyst Insights - Goldman Sachs noted that the updated Phase II data for Dechipher Pharmaceuticals in the context of unresectable or metastatic gastric cancer is encouraging, with an increase in patient numbers and extended follow-up time [1] - The firm believes that the efficacy and safety of ATG-022 remain competitive, with the median progression-free survival (mPFS) being a key focus for future updates, which could impact competitor comparisons and potential accelerated approval pathways [1]
德琪医药-B:ATG-022就治疗胃癌/胃食管结合部腺癌获授予突破性治疗药物认定
Zhi Tong Cai Jing· 2025-08-19 04:31
Core Viewpoint - The company announced that its internally developed Claudin18.2 antibody-drug conjugate (ADC) ATG-022 has received breakthrough therapy designation from the China National Medical Products Administration (NMPA) for the treatment of patients with CLDN18.2 positive, HER2 negative unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma who have previously received at least two treatments [1] Group 1 - The breakthrough therapy designation is a significant regulatory milestone for the company, indicating the potential of ATG-022 in addressing unmet medical needs in gastric cancer treatment [1] - The targeted patient population includes those with specific biomarkers (CLDN18.2 positive and HER2 negative), which may enhance the drug's efficacy and marketability [1] - The designation may expedite the development and review process for ATG-022, potentially leading to earlier market access [1]
德琪医药-B(06996):ATG-022就治疗胃癌/胃食管结合部腺癌获授予突破性治疗药物认定
智通财经网· 2025-08-19 04:25
Core Viewpoint - The company, DQ Medical-B (06996), announced that its internally developed Claudin 18.2 antibody-drug conjugate (ADC) ATG-022 has received breakthrough therapy designation from the China National Medical Products Administration (NMPA) for the treatment of CLDN18.2 positive, HER2 negative unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) patients who have previously received at least two treatments [1]. Group 1 - The breakthrough therapy designation is a significant regulatory milestone for the company, indicating the potential of ATG-022 in addressing unmet medical needs in a challenging patient population [1]. - The targeted patient group includes those with CLDN18.2 positive and HER2 negative conditions, highlighting the specificity of the treatment [1]. - The designation may facilitate expedited development and review processes for ATG-022, potentially leading to faster market access [1].
德琪医药(06996) - 自愿公告ATG-022就治疗胃癌╱胃食管结合部腺癌获授予突破性治疗药物认...
2025-08-19 04:01
(於開曼群島註冊成立的有限公司) (股份代號:6996) 自願公告 ATG-022就治療胃癌╱ 胃食管結合部腺癌獲授予突破性治療藥物認定 本公告由德琪醫藥有限公司(「本公司」,連同其附屬公司統稱為「本集團」)自願 作出,以向本公司股東及有意投資者提供有關本集團的最新業務發展資料。本公 司董事會(「董事會」)欣然宣佈,本公司內部研發的Claudin 18.2抗體藥物偶聯物 (ADC) ATG-022就治療既往接受過至少兩種治療的CLDN18.2陽性、HER2陰性不 可切除或轉移性胃癌或胃食管結合部腺癌(GC/GEJ)患者獲中國國家藥品監督管理 局(NMPA)藥品審評中心(CDE)授予突破性治療藥物認定。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 德琪醫藥有限公司 香港,2025年8月19日 於本公告日期,董事會包括執行董事梅建明博士及龍振國先生;及獨立非執行董 事錢晶女士、唐晟先生及Ra ...