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德琪医药(06996) - 自愿公告 ATG-022联合KEYTRUDA(帕博利珠单抗)化疗的IB/...
2025-12-02 08:43
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 1 關於德琪醫藥 德琪醫藥有限公司 (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聯合KEYTRUDA® (帕博利珠單抗)±化療的IB/II期研究 於中國獲授予IND批准 本公告由德琪醫藥有限公司(「本公司」,連同其附屬公司統稱「本集團」)自願作 出,以知會本公司股東及潛在投資者有關本集團之最新業務發展。本公司董事會 (「董事會」)欣然宣佈,中國國家藥品監督管理局(國家藥監局)已批准用於評估 ATG-022(CLDN18.2抗體藥物偶聯物ADC)聯合MSD (Merck & Co., Inc., Rahway, NJ, USA)的抗PD 1療法KEYTRUDA® (帕博利珠單抗)以及ATG-022聯合帕博利 珠單抗及化療的Ib/II期CLINCH-2研究的研究性新藥(IND)申請。 承董事會命 德琪醫藥有限公 ...
决胜港股升浪·牛启东方2026——第十届智通财经资本市场年会邀您共赴资本盛宴
智通财经网· 2025-11-18 00:56
Group 1 - The core theme of the upcoming "10th Zhitong Financial Capital Market Annual Conference" is "Winning the Hong Kong Stock Surge: Bullish Outlook for 2026," focusing on the potential of Chinese assets amid a new technology-driven bull market [1] - The Hang Seng Index surged by 28% in a single quarter, while the Hang Seng Tech Index rebounded over 50% year-to-date, indicating a significant capital influx into undervalued Chinese assets [1] - The conference will feature prominent speakers, including economists and fund managers, who will discuss cross-border capital flows and relative valuation opportunities in the Hong Kong stock market [2] Group 2 - The afternoon session will focus on innovative pharmaceuticals, with companies like Deke Pharma and He Yu sharing insights on their latest clinical developments and commercialization strategies [3] - A diverse lineup of over 80 listed companies will participate in roadshows, providing investors with opportunities for in-depth discussions and identifying quality investment targets [4] Group 3 - The "3rd Overseas Fund Summit" will take place on December 4, featuring discussions on global capital allocation strategies and the impact of geopolitical shifts on investment [5] - The event will include four strategic roundtable discussions, addressing topics such as cognitive warfare and the mission of capital in a post-scarcity era [6] - The conference will conclude with the presentation of the New Intelligence Awards, showcasing the evolution of investment strategies from present to future [6] Group 4 - The event will continue in Hong Kong on December 5, maintaining a dual-city format that emphasizes the synergy between technological breakthroughs and global capital trends [6] - The conference aims to explore new patterns, tracks, and dividends arising from the new technological revolution, inviting participants to engage in high-level discussions [6]
德琪医药(06996) - 截至2025年10月31日止月份之股份发行人的证券变动月报表
2025-11-06 09:04
I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06996 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 2,000,000,000 | USD | | 0.0001 USD | | 200,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 2,000,000,000 | USD | | 0.0001 USD | | 200,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 德琪醫藥有限公司(於開曼群島註冊成立的有限公司) 呈交日期: 2025年11月6日 FF301 本月底法 ...
港股德琪医药-B涨超6%
Mei Ri Jing Ji Xin Wen· 2025-10-20 06:24
Core Viewpoint - The stock of Dechra Pharmaceuticals-B (06996.HK) has increased by over 6%, indicating positive market sentiment and trading activity [2] Group 1 - The stock price rose by 6.16%, reaching 5.17 HKD [2] - The trading volume amounted to 12.1859 million HKD [2]
德琪医药-B涨超6% 公布ATG-022的I/II期临床研究最新研究成果
Zhi Tong Cai Jing· 2025-10-20 06:15
Core Viewpoint - The stock of Deqi Pharmaceutical-B (06996) rose over 6% following the announcement of positive clinical trial results for its ADC ATG-022 at the ESMO 2025 conference, indicating strong safety and anti-tumor activity across various patient groups [1] Group 1: Clinical Research Results - Deqi Pharmaceutical presented the latest findings from the I/II phase clinical study of ATG-022, an antibody-drug conjugate targeting CLDN18.2, at the ESMO 2025 conference in Berlin [1] - ATG-022 demonstrated good safety and significant anti-tumor activity in patients with gastric cancer (GC) and gastroesophageal junction cancer (GEJC) across different levels of CLDN18.2 expression [1] - Preliminary efficacy was also observed in other non-gastrointestinal tumors, with further data expected to be presented at upcoming academic meetings [1] Group 2: Dosage and Safety Data - The safety data for the 2.4 mg/kg dosage group was reported to be good, while the 1.8 mg/kg dosage group showed even better safety and tolerability [1] - These findings support the potential for ATG-022 to be combined with immune checkpoint inhibitors and chemotherapy in frontline treatment, significantly expanding its clinical applicability and commercialization potential [1] Group 3: Ongoing Development - The I phase dose expansion study of ATG-022 is progressing smoothly in mainland China and Australia [1] - The company is actively preparing for clinical research on combination therapies involving ATG-022 to further advance its clinical development process [1]
港股异动 | 德琪医药-B(06996)涨超6% 公布ATG-022的I/II期临床研究最新研究成果
智通财经网· 2025-10-20 06:13
Core Viewpoint - The announcement of the latest research results for the CLDN18.2 antibody-drug conjugate ATG-022 at the ESMO 2025 conference has positively impacted the stock price of DQ Pharma-B, reflecting investor confidence in the drug's potential [1][2]. Group 1: Clinical Research Results - ATG-022 demonstrated good safety and significant anti-tumor activity in patients with varying levels of CLDN18.2 expression in gastric cancer (GC) and gastroesophageal junction cancer (GEJC) [1]. - Preliminary efficacy was also observed in other non-gastrointestinal tumors, with further data expected to be presented at upcoming academic conferences [1]. Group 2: Dosage and Safety Data - The safety data for the 2.4 mg/kg dosage group was favorable, while the 1.8 mg/kg dosage group showed even better safety and tolerability [2]. - This data supports the potential for ATG-022 to be combined with immune checkpoint inhibitors and chemotherapy in frontline treatment, which could significantly expand its clinical applications and commercialization potential [2]. Group 3: Ongoing Development - The I phase dose expansion study of ATG-022 is progressing smoothly in mainland China and Australia [2]. - The company is actively preparing for clinical research on combination therapies involving ATG-022 to further advance its clinical development [2].
德琪医药(06996) - 截至2025年9月30日止月份之股份发行人的证券变动月报表
2025-10-08 10:26
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 德琪醫藥有限公司(於開曼群島註冊成立的有限公司) 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06996 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 2,000,000,000 | USD | | 0.0001 | USD | | 200,000 | | 增加 / 減少 (-) | | | | 0 | | | USD | | 0 | | 本月底結存 | | | 2,000,000,000 | USD | | 0.0001 | USD | ...
交银国际:四季度医药行业催化剂丰富 布局优质创新标的
智通财经网· 2025-10-03 06:29
Core Insights - The report from CMB International highlights the release of the first batch of innovative pharmaceutical technology medical insurance payment incentive catalog by Zhejiang Province, which is expected to alleviate the challenges of innovative drugs entering hospitals [1] - Despite the Trump administration's announcement of a 100% tariff on imported innovative drugs, the overall impact on China's pharmaceutical industry chain is considered manageable, with a recommendation to monitor subsequent developments [1] - The upcoming ESMO conference in mid to late October is noted as a key event, with a focus on companies such as CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (688331.SH) that are expected to release significant data [1] Industry Summary - The Hong Kong pharmaceutical sector has shown relatively flat performance in September, but with increasing industry catalysts such as academic conferences and favorable policy implementations in October, a market rebound is anticipated [1] - The report recommends focusing on specific segments: 1) Innovative drugs: Companies like 3SBio (01530) and Eucure Biopharma-B (06996) have rich short-term catalysts and their valuations do not yet reflect the core value of major products; companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered significantly undervalued with clear long-term growth logic [1] 2) CXO: Leaders in this segment, such as WuXi AppTec (02268), are expected to benefit from high downstream demand and marginal recovery in financing [1]
德琪医药(06996) - 2025 - 中期财报
2025-09-29 08:36
Financial Performance - Revenue for the six months ended June 30, 2025, was RMB 53.2 million, a decrease of 12.5% from RMB 60.8 million for the same period in 2024[8]. - Loss for the period decreased significantly by 54.5% to RMB 76.4 million from RMB 167.0 million in the previous year[10]. - Adjusted loss for the period was RMB 72.9 million, a reduction of 52.2% from RMB 152.6 million in the same period last year[11]. - Total comprehensive loss for the period was RMB 87,994,000, compared to RMB 168,242,000 in 2024, marking a 47.8% decrease[123]. - The company reported a loss attributable to ordinary shareholders of RMB 76,378,000 for the six months ended June 30, 2025, a significant improvement from a loss of RMB 167,033,000 in the same period of 2024[157]. Income and Expenses - Other income and gains increased to RMB 38.1 million, up 39.5% from RMB 27.3 million in the prior year[9]. - R&D expenses decreased by 38.9% to RMB 79.9 million from RMB 130.8 million in the previous year[10]. - Sales and distribution expenses reduced by 33.9% to RMB 37.0 million compared to RMB 56.0 million in the same period last year[10]. - Administrative expenses fell by 32.8% to RMB 39.3 million from RMB 58.5 million in the prior year[10]. - The cost of goods sold for the six months ended June 30, 2025, was RMB 10,274 thousand, an increase from RMB 8,856 thousand in 2024, reflecting a rise of approximately 16%[143]. Product Development and Pipeline - The company’s product pipeline and business operations achieved significant progress during the reporting period[12]. - The commercialized asset includes ATG-022, a Claudin 18.2 antibody-drug conjugate, which is in clinical development[13]. - ATG-031 is currently undergoing a Phase I trial in the U.S. for advanced solid tumors[16]. - The company is developing multiple bispecific antibodies targeting various cancers, including ATG-201 for B-cell related autoimmune diseases and ATG-106 for ovarian and kidney cancers[27]. - The company has ongoing global clinical trials in collaboration with partners for its pipeline products[27]. Regulatory Approvals and Market Expansion - XPOVIO® (Selinexor) has been approved for inclusion in Taiwan's National Health Insurance as of March 1, 2025, for adult patients with relapsed/refractory multiple myeloma (rrMM) who have received at least two prior lines of therapy[14]. - The company has received NDA approvals for XPOVIO® in multiple regions including mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, Malaysia, Thailand, Indonesia, and Australia[25]. - The company is focused on expanding its market presence in the Asia-Pacific region with its pipeline products[27]. - The company entered a commercialization agreement with Hansoh Pharmaceutical for the drug Xivivo® (Selinexor) in mainland China, with a potential upfront payment of up to RMB 200 million[33]. Corporate Governance and Leadership - The board of directors has committed to maintaining high standards of corporate governance to protect shareholder interests[89]. - The roles of the chairman and CEO are currently held by the same individual, Dr. Mei Jianming, which the board believes facilitates effective execution of strategic initiatives[89]. - The company has a strong leadership team, including CFO Long Zhen Guo, who has over 20 years of experience in investment banking and asset management[77]. - The management team is committed to strategic planning and market expansion to drive future growth[85]. - The company aims to leverage its experienced board and management team to navigate market challenges and capitalize on growth opportunities[85]. Shareholder Information and Equity Incentives - As of June 30, 2025, Dr. Jay Mei holds a total of 184,267,994 shares, representing approximately 27.12% of the company's equity[98]. - The total number of shares held by major shareholders includes 175,927,994 shares owned by JAY MEI 2025 GRAT, accounting for 25.89% of the equity[101]. - The company has various stock options and restricted share units granted to executives, which may influence future shareholdings[98]. - The company has granted a total of 42,814,766 stock options, with 2,048,000 options being canceled or expired during the reporting period[107]. - The company aims to retain and attract talent through the Restricted Share Unit Plan, which vests over a four-year period[170].
交银国际:特朗普加征药品关税对中国医药影响有限 建议重点关注康方生物(09926)等
智通财经网· 2025-09-29 03:53
Core Viewpoint - The announcement of a 100% tariff on all branded/patented drugs by Trump starting in October is expected to have limited impact on China's innovative drug industry chain, with no excessive concerns warranted [1] Group 1: Impact on Innovative Drugs - Most Chinese innovative drugs that are currently being exported have either established production capacity in the U.S. or have outsourced production to local CMO companies [1] - The majority of domestic innovative drugs are exported using a business development (BD) model, which mitigates the impact of the tariff [1] Group 2: Impact on CXO Sector - The export products in the CXO sector primarily consist of raw materials and biological raw liquids, which are not affected by the new tariff; the proportion of finished dosage forms exported is low [1] - The investment timeline for multinational corporations (MNCs) to build factories in China will take time, leading to limited direct impact on CXO orders in the short term [1] - Long-term policy changes may influence the pace of factory construction by MNCs [1] Group 3: Upcoming Catalysts - The ESMO conference will take place in mid to late October, with a focus on companies like CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (09995) that are expected to release significant data [1] - The results of medical insurance negotiations and the first version of the commercial insurance innovative drug directory are expected to be announced in October-November [1] Group 4: Mid to Long-term Recommendations - Recommended stocks in the innovative drug sector include 3SBio (01530) and Eucure Biopharma-B (06996), which have rich short-term catalysts and their valuations do not yet reflect the core value of major products [2] - Companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered undervalued with clear long-term growth logic [2] - In the CXO sector, WuXi AppTec (02268) is highlighted as a leading player benefiting from high downstream demand and improving financing conditions [2]