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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-B(06996.HK):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
Ge Long Hui· 2025-08-19 04:12
Core Viewpoint - The company, DQ Medical-B (06996.HK), 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 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 indicates a significant advancement in the treatment options available for patients with specific types of gastric cancer [1] - ATG-022 targets a specific biomarker (Claudin 18.2), which may enhance treatment efficacy for the identified patient population [1] - The designation by NMPA may expedite the development and review process for ATG-022, potentially leading to earlier 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 ...
德琪医药-B(06996)股东将股票存入渣打银行(香港) 存仓市值4.16亿港元
智通财经网· 2025-08-19 00:43
7月28日,德琪医药发布公告,中国国家药品监督管理局(NMPA) 已批准希维奥 (塞利尼索)(与硼替佐米 和地塞米松(XVd)联用)用于治疗既往接受过至少一种治疗的多发性骨髓瘤(MM)成年患者,这是希维奥 的一种新适应症。 香港联交所最新资料显示,8月18日,德琪医药-B(06996)股东将股票存入渣打银行(香港),存仓市值 4.16亿港元,占比9.23%。 ...
德琪医药-B股东将股票存入渣打银行(香港) 存仓市值4.16亿港元
Zhi Tong Cai Jing· 2025-08-19 00:37
Core Insights - The latest data from the Hong Kong Stock Exchange indicates that on August 18, shareholders of Deking Pharmaceutical-B (06996) deposited shares worth HKD 416 million into Standard Chartered Bank (Hong Kong), representing 9.23% of the total shareholding [1] - On July 28, Deking Pharmaceutical announced that the National Medical Products Administration (NMPA) of China has approved the use of Xivio (Selinexor) in combination with Bortezomib and Dexamethasone (XVd) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior therapy, marking a new indication for Xivio [1]
港股午评|恒生指数早盘涨1.88% 恒生生物科技指数大涨3.77%
智通财经网· 2025-08-13 04:09
Group 1: Market Overview - The Hang Seng Index rose by 1.88%, gaining 470 points to close at 25,439 points, while the Hang Seng Tech Index increased by 2.35% [1] - The early trading volume in the Hong Kong stock market reached HKD 143.8 billion [1] Group 2: Biotechnology Sector - The Hang Seng Biotechnology Index surged by 3.77%, driven by a collective rise in pharmaceutical stocks following the debut of the "dual directory" for drug applications [1] - Zhonghui Biotech-B (02627) saw a significant increase of 24%, while Jiuyuan Gene (02566) rose by 8.99%, and Kintor Pharmaceutical (09939) increased by 5.7% [1] - Innovent Biologics (01801) experienced a rise of 7.27%, and He Yu-B (02256) reached a new high with a 7.38% increase, reporting a 59% year-on-year growth in net profit for the first half of the year [1] Group 3: Pharmaceutical Developments - Daqi Pharmaceutical-B (06996) rose over 15% as Claudin 18.2 ADC was proposed for inclusion as a breakthrough therapy [2] Group 4: Technology Sector - Tencent's subsidiaries reported generally better-than-expected earnings, with Tencent Music-SW (01698) rising by 15%, and Reading Group (00772) also increasing by over 15% [2] - Weimeng Group (02013) saw an increase of over 7% [2] Group 5: Industrial and Manufacturing Sector - Chongqing Machinery (02722) rose by 8.9%, with an expected 50% year-on-year growth in net profit due to rapid growth in AIDC engine demand [3] - Zhongyan Hong Kong (06055) increased by over 7%, maintaining its position in the domestic cigarette export tax-free business, with earnings to be announced next Friday [3] Group 6: Technology and Electronics - Qiu Tai Technology (01478) rose by over 8%, reporting a 167% year-on-year increase in net profit for the first half of the year, leading to target price upgrades from multiple institutions [4] - Hong Teng Precision (06088) increased by over 9% post-earnings, with a cumulative rise of over 60% in the month, reporting an 11% revenue growth but a 3% decline in net profit [5] - Minmetals Resources (01208) rose by over 9% after reporting a 15-fold increase in net profit for the first half of the year and lowering cost guidance for its mines [6] Group 7: Performance Review - 361 Degrees (01361) fell by over 10% post-earnings, with institutions stating that the first half performance met expectations, but net profit growth was slightly lower than revenue growth [7]
德琪医药-B涨超14% Claudin 18.2 ADC拟纳入突破性疗法
Zhi Tong Cai Jing· 2025-08-13 02:59
Core Viewpoint - The stock of Deqi Pharmaceutical-B (06996) surged over 14%, reaching a price of 6.1 HKD with a trading volume of 38.14 million HKD, following the announcement of six drugs, including ATG-022, being considered for breakthrough therapy designation [1] Company Summary - ATG-022 is a self-developed Claudin18.2 antibody-drug conjugate by Deqi Pharmaceutical [1] - Recent clinical data presented at the ASCO GI 2025 conference showed an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 95.2% in patients with high Claudin18.2 expression (IHC2+ ≥ 20%) [1] - For patients with low Claudin18.2 expression (IHC2+ < 20%), the ORR was 30.0% and the DCR was 50.0% [1] - The company plans to present the latest research data on ATG-022 at the ESMO annual meeting in October 2025 [1]
港股异动 | 德琪医药-B(06996)涨超14% Claudin 18.2 ADC拟纳入突破性疗法
智通财经网· 2025-08-13 02:57
Core Viewpoint - The stock of Deqi Pharmaceutical-B (06996) has increased by over 14%, currently trading at 6.1 HKD with a transaction volume of 38.14 million HKD, following the announcement of six drugs, including ATG-022, being proposed for breakthrough therapy designation [1] Company Summary - ATG-022 is a self-developed Claudin 18.2 antibody-drug conjugate by Deqi Pharmaceutical [1] - Recent clinical data presented at the ASCO GI 2025 conference showed an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 95.2% in patients with high Claudin 18.2 expression (IHC 2+ ≥ 20%) [1] - For patients with low Claudin 18.2 expression (IHC 2+ < 20%), the ORR was 30.0% and the DCR was 50.0% [1] - The company plans to present the latest research data on ATG-022 at the ESMO annual meeting in October 2025 [1]
药品股集体上扬 “医保双目录”申报药品首次亮相 推动“多层次+创新支持”战略转型
Zhi Tong Cai Jing· 2025-08-13 02:56
Group 1 - Pharmaceutical stocks collectively surged, with notable increases in companies such as Deqi Pharmaceutical-B (up 13.53% to HKD 6.04), Jiuyuan Gene (up 7.89% to HKD 11.76), and others [1] - The National Healthcare Security Administration announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalogs, revealing that 534 drugs passed the basic insurance catalog review and 121 drug generic names passed the commercial insurance innovative drug catalog review [1] - High-priced innovative drugs, including CAR-T therapies, are seeking inclusion in the commercial insurance innovative drug catalog, aiming for diversified payment methods for innovative drugs [1] Group 2 - The core breakthrough of the 2025 plan is the establishment of a "Basic Insurance + Commercial Insurance Innovative Drug" dual-track system, which aims to alleviate pressure on basic insurance funds while meeting multi-tiered demands [2] - The plan includes a new price negotiation mechanism and a team of commercial insurance experts, reflecting policy coordination for innovative drug development, although it also increases process complexity [2] - Overall, this represents a strategic shift in healthcare policy from "basic coverage" to "multi-tiered + innovative support," balancing accessibility and sustainability [2]