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港股异动丨药品股再度强势 凯莱英涨超14% 三生制药涨7.6%
Ge Long Hui· 2025-05-21 02:43
Group 1 - The pharmaceutical sector in Hong Kong is experiencing a strong rally, with notable gains in stocks such as Kailaiying, which rose over 14%, and Sangfor Pharmaceuticals, which increased by 7.6% [1][2] - Sangfor Pharmaceuticals announced a licensing agreement with Pfizer, receiving an upfront payment of $1.25 billion, which significantly boosted investor confidence [1] - The China National Medical Products Administration has accepted a new drug application for cyclosporine eye gel from Zhaoke Ophthalmology, indicating positive regulatory developments in the industry [1] Group 2 - Longcheng Securities expressed optimism about the pharmaceutical sector, citing frequent favorable policies that are expected to lead to a steady recovery in industry sentiment [1] - Morgan Stanley's research report maintains a positive outlook on the Chinese pharmaceutical industry, highlighting supportive policies for innovation and low dependency on U.S. exports, which mitigates risks from geopolitical tensions and uncertainties in U.S. drug pricing [1]
德琪医药(06996) - 股东週年大会通告
2025-04-27 10:19
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通告的內容概不負責,對其準確性或完整性亦 不發表任何聲明,並明確表示,概不對因本通告全部或任何部分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 (於開曼群島註冊成立的有限公司) (股份代號:6996) 股東週年大會通告 茲通告德琪醫藥有限公司(「本公司」)謹訂於2025年6月13日(星期五)上午十時 三十分在線並假座中華人民共和國上海市長寧區中山西路1065號SOHO中山廣場B座 1206-1209室實體舉行股東週年大會(「股東週年大會」)以考慮及酌情處理以下事項: 普通決議案 – 1 – 1. 審批本公司截至2024年12月31日止年度之經審核綜合財務報表及本公司董 事(「董事」)會報告與本公司核數師報告。 2. (i) 重選龍振國先生為執行董事。 (ii) 重選Rafael Fonseca博士為獨立非執行董事。 (iii) 授權董事會(「董事會」)釐定董事薪酬。 3. 續聘安永會計師事務所為本公司核數師並授權董事會釐定其酬金。 4. 考慮及酌情通過以下決議案為普通 ...
德琪医药(06996) - (1)有关发行及转售股份以及购回股份的一般授权建议;(2)重选董事;及(...
2025-04-27 10:15
此乃要件 請即處理 閣下如對本通函的任何方面或應採取的行動有任何疑問,應諮詢 閣下的股票經紀或其他註冊證券交易 商、銀行經理、律師、專業會計師或其他專業顧問。 閣下如已售出或轉讓名下所有德琪醫藥有限公司的股份,應立即將本通函及隨附的代表委任表格送交買主 或承讓人或經手買賣或轉讓的銀行、股票經紀或其他代理商,以便轉交買主或承讓人。 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通函的內容概不負責,對其準確性或完整性亦 不發表聲明,並明確表示概不就因本通函全部或任何部分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。 股東將能夠從2025年6月13日(星期五)上午十時三十分起至股東週年大會結束 時,在電腦、平板電腦或任何支持瀏覽器的設備上,通過網絡直播觀看及收聽股東 週年大會。請注意,在線出席股東週年大會的股東將不被計入股東週年大會的法定人 數,且該等參與股東無法在線投票。 Antengene Corporation Limited 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) (1)有關發行及轉售股份以及 購回股份的一般授權建議; (2)重選董事; 及 (3)股東週 ...
德琪医药(06996) - 2024 - 年度财报
2025-04-27 10:10
Financial Performance - Revenue increased from RMB 673.05 million in 2023 to RMB 919.50 million in 2024, representing a significant growth of 36.7%[10] - Other income and gains decreased from RMB 1,157.86 million in 2023 to RMB 488.70 million in 2024, primarily due to a reduction in foreign exchange gains[10] - Net loss for the year decreased from RMB 5,812.83 million in 2023 to RMB 3,192.50 million in 2024[11] - Adjusted net loss decreased from RMB 5,339.04 million in 2023 to RMB 3,046.72 million in 2024, a notable decline of 42.9%[12] - The overall gross profit for the year ended December 31, 2024, was RMB 75.26 million, up from RMB 55.01 million in 2023[62] - The pre-tax loss for the year ended December 31, 2024, was RMB 319.25 million, compared to a loss of RMB 581.18 million in 2023[62] Cost Management - R&D costs decreased from RMB 4,056.69 million in 2023 to RMB 2,589.12 million in 2024, attributed to improved R&D efficiency[10] - Sales and distribution expenses reduced from RMB 1,927.39 million in 2023 to RMB 737.30 million in 2024, with no milestone payments related to the commercialization of a specific product in the Asia-Pacific region[11] - Administrative expenses decreased from RMB 1,480.56 million in 2023 to RMB 1,062.63 million in 2024, mainly due to reduced employee costs[11] - Employee costs decreased from RMB 151.7 million in 2023 to RMB 93.6 million in 2024, a reduction of approximately 38.3%[64] - Total sales and distribution expenses fell from RMB 192.7 million in 2023 to RMB 73.7 million in 2024, a decrease of about 61.7%[65] - Administrative expenses decreased from RMB 148.1 million in 2023 to RMB 106.3 million in 2024, representing a reduction of approximately 28.2%[66] Clinical Development and Pipeline - Selinexor (XPOVIO®) received reimbursement approval in South Korea for treating relapsed or refractory multiple myeloma (rrMM) adult patients, effective July 1, 2024[13] - In China, Selinexor was approved for a new indication to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two lines of systemic therapy[13] - The ORR for Onatasertib (ATG-008) combined with toripalimab in cervical cancer patients was reported at 53.3%, with a disease control rate (DCR) of 86.7%[14] - The clinical pipeline includes ATG-022, a Claudin 18.2 antibody-drug conjugate, which is expected to demonstrate strong anti-tumor efficacy across various Claudin 18.2 expression levels[25] - ATG-022 is anticipated to complete additional dose escalation cohorts by 2025 to support its transition to critical development stages[25] - The company is conducting late-stage clinical studies for several candidates, including ATG-008 (onatasertib) in combination with other therapies[44] Strategic Initiatives - The company plans to continue focusing on cost reduction and efficiency improvements in R&D and administrative operations[12] - The company plans to establish a dedicated AI department to accelerate the development of a next-generation proprietary T cell engager platform[21] - The company aims to commercialize first-in-class therapies to meet significant unmet medical needs and improve patient quality of life globally[22] - The company is actively pursuing regulatory approvals in multiple regions, including the US, EU, and Asia, to expand its market presence[40] - The company has established global innovation drug development and commercialization teams in China and the Asia-Pacific region to enhance its market presence[119] Market Expansion - The commercial business achieved significant milestones in 2024, including the approval of a second indication for Hivio® and its inclusion in the national insurance directory, enhancing patient accessibility[28] - The company has received NDA approvals for Hivio® in multiple regions, including mainland China, Australia, and several Southeast Asian countries, indicating strong market expansion efforts[33] - The drug Xivio® (Selinexor) has been included in the Pharmaceutical Benefits Scheme (PBS) in June 2023 for treating adult patients with relapsed/refractory multiple myeloma who have received at least one prior therapy[41] - Xivio® was included in the national medical insurance catalog in December 2023, effective January 1, 2024, for treating adult patients with relapsed/refractory multiple myeloma[42] - As of December 31, 2024, Xivio® has received NDA approvals in multiple regions including mainland China, South Korea, Singapore, Australia, Malaysia, Thailand, Taiwan, Hong Kong, Macau, and Indonesia[43] Leadership and Governance - Dr. Mei has extensive experience in oncology research and drug development, having held senior positions at Johnson & Johnson, Novartis, and Celgene, contributing to the development of several blockbuster drugs[81] - The company has a strong leadership team with members holding advanced degrees in medicine and business, enhancing its strategic direction and financial management[83][86] - The board includes members with diverse backgrounds in consulting, investment, and pharmaceutical industries, providing a well-rounded perspective on strategic decisions[84][86] - The company has established a strong governance structure with independent directors to ensure accountability and strategic oversight[88] Financial Position and Liquidity - The company has a cash reserve of RMB 900 million, sufficient to fund pipeline product development for the next three years without additional financing[30] - The company reported a total available reserve of approximately RMB 3,755.0 million as of December 31, 2024, compared to RMB 3,710.5 million in 2023, reflecting an increase of 1.2%[101] - The company maintains a healthy liquidity position, closely monitoring its cash flow to meet funding needs[108] - Cash and bank balances decreased from RMB 1,187.7 million in 2023 to RMB 900.1 million in 2024, a decline of approximately 24.2%[71] - The company has no specific plans for significant investments or capital assets as of December 31, 2024[76] Risks and Challenges - The company has incurred significant net losses since its inception and expects to continue doing so in the foreseeable future, posing a risk of substantial investment loss for potential investors[123] - The future business and financial outlook heavily depend on the successful clinical development and regulatory approval of its clinical and preclinical candidates[127] - The company may face difficulties in identifying and developing new candidate drugs, potentially limiting its resource allocation to more profitable opportunities[127] - The company faces intense industry competition, with rivals potentially achieving commercialization of competitive drugs ahead of it[123] Shareholder Information - The largest customer accounted for 78.6% of the group's revenue, while the top five customers contributed 99.8%[194] - The largest supplier represented 16.7% of the group's procurement, with the top five suppliers making up 51.4%[195] - The total number of shares held by the top five shareholders exceeds 50% of the company's total shares[144] - The independent non-executive directors receive an annual director's fee ranging from $25,000 to $50,000[140] - The company has established service contracts for executive directors with a term of three years, with a two-month notice period for termination[138]
德琪医药(06996) - 自愿公告拟进行市场内股份购回
2025-04-07 22:08
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分內容而產生或因依 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 (於開曼群島註冊成立的有限公司) (股份代號:6996) 自願公告 擬進行市場內股份購回 本公告乃由德琪醫藥有限公司(「本公司」)自願作出,以向本公司股東及潛在投資 者提供有關本公司之最新發展資料。 本公司董事會(「董事會」)謹此宣佈,其有意行使根據本公司股東(「股東」)於 2024年6月14日舉行的本公司股東週年大會(「股東週年大會」)上通過的決議案授 予董事會的一般授權(「股份購回授權」)項下的權力,以購回至多67,488,874股本 公司股份(「股份」),即於股東週年大會日期已發行股份總數的10%(「建議股份購 回」)。 於2025年4月7日,董事會已決議動用股份購回授權,並根據市況不時於公開市場 按最高總價40百萬港元購回股份。本公司將根據本公司組織章程細則、《香港聯 合交易所有限公司證券上市規則》(「《上市規則》」) ...
德琪医药(06996) - 2024 - 年度业绩
2025-03-21 08:30
Financial Performance - Revenue increased by 36.7% from RMB 673.05 million in 2023 to RMB 919.50 million in 2024, driven by a 27.4% growth in mainland China[6] - Other income and gains decreased from RMB 1,157.86 million in 2023 to RMB 488.70 million in 2024, primarily due to a reduction in foreign exchange gains[6] - Net loss decreased by 45.1% from RMB 5,811.83 million in 2023 to RMB 3,192.50 million in 2024[7] - Adjusted net loss decreased by 42.9% from RMB 5,339.04 million in 2023 to RMB 3,045.72 million in 2024, reflecting effective cost reduction strategies[8] - The company achieved a net loss of RMB 319,250,000 in 2024, which is a 45.0% improvement compared to a net loss of RMB 581,183,000 in 2023[46] - The pre-tax loss for 2024 was RMB 144,408,000, significantly reduced from RMB 282,437,000 in 2023[63] - The adjusted loss for the year improved from RMB 533.9 million in 2023 to RMB 304.6 million in 2024, reflecting a reduction of about 43.1%[99] Research and Development - R&D costs reduced by 36.2% from RMB 4,056.69 million in 2023 to RMB 2,589.12 million in 2024, attributed to improved R&D efficiency[6] - The company has made steady progress with its preclinical candidates, including ATG-042, ATG-201, ATG-102, ATG-106, ATG-107, and ATG-110[14] - The new "2+1" T cell engager platform, AnTenGagerTM, has shown steady progress, enhancing efficacy and reducing the risk of cytokine release syndrome (CRS)[15] - The Phase I trials for ATG-101 in treating advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL) are ongoing in mainland China, Australia, and the United States[17] - The company is conducting key clinical trials in the US for its bispecific antibody products[22] - The company has initiated multiple Phase II and III clinical trials for its drug candidates[22] - The company reported an overall response rate (ORR) of 42.9% in a trial for ATN-022 in advanced or metastatic gastric cancer patients[41] Product Development and Approvals - Selinexor received approval for reimbursement in South Korea for treating relapsed or refractory multiple myeloma starting July 1, 2024[9] - New indications for Selinexor were approved in China for treating relapsed/refractory diffuse large B-cell lymphoma in July 2024[9] - The company has received NDA approvals for its product, Cevinostat, in multiple regions including mainland China, Australia, and several Southeast Asian countries[20] - The first commercial product, XPOVIO® (Selinexor), is a selective nuclear export inhibitor approved for multiple myeloma and solid tumors, with exclusive rights in Greater China and several other regions[24] - XPOVIO® received accelerated approval from the FDA for treating adult patients with relapsed/refractory multiple myeloma after at least four lines of therapy[25] - The company has received conditional approval from NMPA for XPOVIO® to treat adult patients with relapsed/refractory DLBCL after at least two lines of therapy[29] - The company has received multiple NDA approvals for its product, Xivio® (Selinexor), in various regions, including approvals in 2021, 2022, and upcoming approvals in 2024 and 2025[44] Cost Management - Sales and distribution expenses decreased by 61.5% from RMB 1,927.39 million in 2023 to RMB 737.30 million in 2024, with no milestone payments related to the commercialization of Selinexor in the Asia-Pacific region[7] - Administrative expenses fell by 28.2% from RMB 1,480.56 million in 2023 to RMB 1,062.63 million in 2024, mainly due to reduced employee costs[7] - Research and development costs decreased to RMB 258,912,000 in 2024 from RMB 405,669,000 in 2023, reflecting a 36.3% reduction[45] - Selling and distribution expenses dropped from RMB 192.7 million in 2023 to RMB 73.7 million in 2024, mainly due to the absence of milestone payments and reduced employee costs[94] - Employee costs decreased from RMB 77.5 million in 2023 to RMB 20.5 million in 2024, representing a decline of about 73.5%[96] Market Expansion and Strategy - The company is focusing on expanding its market presence in Greater China, South Korea, Singapore, Malaysia, Indonesia, Vietnam, Laos, Cambodia, the Philippines, Thailand, and Mongolia[22] - The company is exploring new strategies for commercialization and market expansion[22] - The company plans to establish a dedicated AI department to accelerate the development of a next-generation proprietary T cell engager platform[15] - The company is preparing its commercial team for the launch of Xivio® in the Asia-Pacific region to address unmet medical needs[44] Financial Position - The total assets less current liabilities amounted to RMB 1,198,407,000 in 2024, down from RMB 1,427,699,000 in 2023[48] - Cash and bank balances decreased to RMB 900,138,000 in 2024 from RMB 1,187,703,000 in 2023, indicating a liquidity reduction[48] - The company’s total equity decreased to RMB 850,801,000 in 2024 from RMB 1,147,384,000 in 2023, reflecting a decline in shareholder value[48] - The debt-to-asset ratio increased to 36.7% in 2024 from 29.1% in 2023, indicating a rise in leverage[105] Corporate Governance - The audit committee, consisting of three independent non-executive directors, has reviewed the financial performance and confirmed compliance with relevant accounting standards and regulations[120] - The company has maintained a public float of at least 25% of its total issued share capital in accordance with listing rules[124] - The company has adopted the "Standard Code" for securities trading by directors and confirmed compliance throughout the reporting period[114] - The company will continue to review and monitor its corporate governance practices to ensure compliance with the Corporate Governance Code[113]
德琪医药(06996) - 董事会会议日期通告
2025-03-10 22:06
德琪醫藥有限公司 (於開曼群島註冊成立之有限公司) (股份代號:6996) 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,概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 董事會會議日期通告 德琪醫藥有限公司(「本公司」)董事會(「董事會」)謹此宣佈,本公司將於2025年 3月21日(星期五)舉行董事會會議,藉以(其中包括)考慮並批准本公司及其附屬 公司截至2024年12月31日止年度業績及其發佈。 承董事會命 德琪醫藥有限公司 董事長 梅建明博士 香港,2025年3月11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Rafael Fonseca博士。 ...
德琪医药(06996) - 自愿公告希维奥的新药上市申请获印度尼西亚食品药品监督管理局批准
2025-03-05 04:00
香港交易及結算所有限公司及香港聯合交易所有限公司(「香港聯交所」)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 (於開曼群島註冊成立的有限公司) (股份代號:6996) 自願公告 希維奧®的新藥上市申請獲印度尼西亞食品藥品監督管理局批准 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,印度尼西亞食品藥品監督管理局(BPOM)已批准希 維奧® (塞利尼索片)用於三項適應症的新藥上市申請(NDA):(1)與硼替佐米和地 塞米松聯用,用於治療既往接受過至少一種先前治療的多發性骨髓瘤(MM)的成年 患者;(2)聯合地塞米松用於治療既往接受過至少四次既往治療且對至少兩種蛋白 酶體抑制劑(PI)、至少兩種免疫調節劑(IMiD)、一種抗CD38單克隆抗體難治的復 發或難治性多發性骨髓瘤(rrMM)的成年 ...
德琪医药(06996) - 自愿公告 业务进展及更新
2025-02-19 08:52
(股份代號:6996) 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 (於開曼群島註冊成立的有限公司) 香港,2025年2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Rafael Fonseca博士。 自願公告 業務進展及更新 本公告乃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,本公司計劃加大投入,整合資源成立專門的AI部 門。這一舉措包括本地部署DeepSeek以加速具有空間位元阻遮蔽效應的T細胞銜 接器(TCE)平台後續管線研發。 本公司早在2021年便以天使投資人身份投資杭州德睿智藥AI藥物發現平台,並借 此戰略性的切入了AI藥物發現賽道。這一戰略舉措使本公司能夠在內部利用AI能 ...
德琪医药(06996) - 自愿公告希维奥获批纳入台湾全民健康保险
2025-02-13 09:10
(於開曼群島註冊成立的有限公司) (股份代號:6996) 自願公告 希維奧®獲批納入台灣全民健康保險 本公告乃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,希維奧® (塞利尼索)(與硼替佐米和地塞米 松(XVd)聯用,用於治療既往接受過至少兩種治療的復發╱難治性多發性骨髓瘤 (rrMM)成年患者)已在台灣獲批納入全民健康保險。自2025年3月1日起,希維 奧®將獲正式納入台灣《全民健康保險用藥品項表》。 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 1 關於希維奧® (塞利尼索) 希維奧®是世界首款獲批准的核輸出蛋白口服選擇性XPO1抑制劑。其具有新穎的 作用機制,在聯合治療中具有協同作用,快速起效,且反應持久。 此為本公司刊發的自願公告。本公司 ...