医药行业|公司深度研究报告 证券研究报告 2025/06/04 德琪医药深度报告—— 聚焦肿瘤领域的创新先锋，TCE 2.0蓄势待发 | 证券分析师： | 周豫 | | --- | --- | | 分析师登记编号： | S1190523060002 | | 证券分析师： | 霍亮 | | 分析师登记编号： | S1190523070002 | | 研究助理： | 戎晓婕 | | 一般证券业务登记编号： | S1190123070050 | P2 报告摘要 德琪医药核心推荐逻辑：1） 塞利尼索已实现商业化，随着适应症扩增和上市地区增加，为公司提供稳定的现金流支撑。 2）临床管线： ATG-022是具备差异化竞争优势的CLDN18.2 ADC，CD73小分子抑制剂ATG-037在免疫检查点抑制剂耐药肿瘤中展现出积极疗效；3）早 研管线中，第二代TCE平台具备更高安全性和更强疗效，首款产品25H2递交IND。 估值和投资建议：基于NPV和DCF法，我们测算目标市值为58亿港元（汇率0.92），对应目标价为8.57港元，首次覆盖给予"买入"评级。 请务必阅读正文之后的免责条款部分 守正 出奇 宁静 致远 ◼ ATG- ...

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]

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） 截至2024年12月31日止年度年度業績公告 德琪醫藥有限公司（「本公司」或「德琪」）董事（「董事」）會（「董事會」）欣然公佈本 公司及其附屬公司（統稱「本集團」或「我們」）截至2024年12月31日止年度（「報告 期」）的綜合業績，連同截至2023年12月31日止年度的比較數字。本集團於報告期 內的綜合財務報表已由本公司審核委員會（「審核委員會」）及本公司核數師審閱。 財務摘要 截至12月31日止年度 | | 2024年 | 2023年 | | --- | --- | --- | | | 人民幣千元 | 人民幣千元 | | 收入 | 91,950 | 67,305 | | 其他收入及收益 | 48,870 | 115,786 | | 研發成本 | (258,912) ...

德琪醫藥有限公司 Antengene Corporation Limited (於開曼群島註冊成立的有限公司) 股票代號 : 6996 中期報告 2024 目錄 公司資料2 財務摘要4 業務摘要6 管理層討論及分析8 董事及高級管理層 21 其他資料 25 獨立審閱報告 38 中期簡明綜合損益表 39 中期簡明綜合全面收益表 40 中期簡明綜合財務狀況表 41 中期簡明綜合權益變動表 42 中期簡明綜合現金流量表 43 中期簡明綜合財務資料附註 45 公司資料 錢晶女士 董事會 執行董事 梅建明博士（董事長兼首席執行官） John F. Chin先生（辭任自2024年8月1日起生效） 龍振國先生（首席財務官） 非執行董事 陳侃博士（於2024年6月14日辭任） 獨立非執行董事 錢晶女士 唐晟先生 Rafael Fonseca博士 梅建明博士 陳侃博士（於2024年6月14日辭任） 科學委員會 Rafael Fonseca博士（主席） 授權代表 梅建明博士 龍振國先生 聯席公司秘書 曹洋先生 黃偉超先生 註冊辦事處 Maples Corporate Services Limited辦事處 PO Box 309, ...

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倚賴 該等內容而引致的任何損失承擔任何責任。 1 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） 截至2024年6月30日止六個月 中期業績公告 德琪醫藥有限公司（「本公司」或「德琪」）董事（「董事」）會（「董事會」）欣然公佈本 公司及其附屬公司（統稱「本集團」或「我們」）截至2024年6月30日止六個月（「報 告期」）的未經審核簡明綜合業績，連同截至2023年6月30日止六個月的比較數 字。本集團於報告期內的綜合財務報表已由本公司審核委員會（「審核委員會」）及 本公司核數師審閱。 | --- | --- | --- | |------------------------------------------------------------------------------------------------------------|------------- ...

聯席公司秘書 曹洋先生 黃偉超先生 | --- | |------------------------------------------| | | | | | 註冊辦事處 | | Maples Corporate Services Limited 辦事處 | | PO Box 309, Ugland House | | Grand Cayman, KY1-1104 | | Cayman Islands | （於2023年4月14日獲委任） | --- | --- | |--------------------------------------------------|----------------------------| | | | | | | | Mark J. Alles 先生 （於 2023 年 4 月 14 日辭任） | 中國 | | | 上海市 | | 審核委員會 | 長寧區 | | 唐晟先生 （主席） | 中山西路 1065 號 | | Rafael Fonseca 博士 | SOHO 中山廣場 | | 錢晶女士 | B 座 1206-1209 室 | | 薪酬委員會 | 中國 | | | ...

截至2023年12月31日止年度年度業績公告 及 建議修訂現有組織章程大綱及章程細則 並採納新組織章程大綱及章程細則 及 更改所得款項用途 * 《國際財務報告準則》並無界定經調整年內虧損，它是指年內虧損，不包括以權益結算並以 股份為基礎的付款開支帶來的影響。 我們的其他收入及收益從截至2022年12月31日止年度的人民幣293.9百萬元減少 人民幣178.1百萬元至截至2023年12月31日止年度的人民幣115.8百萬元，主要歸 因於外匯收益淨額減少。 由於上述原因，年內虧損從截至2022年12月31日止年度的人民幣601.5百萬元減 少人民幣20.3百萬元至截至2023年12月31日止年度的人民幣581.2百萬元。 2 • 塞利尼索（ATG-010，XPOVIO®，大中華區商品名：希維奧®，同類首款 XPO1抑制劑） • 澳大利亞：於2023年6月，希維奧®（塞利尼索）聯合硼替佐米及地塞米松 (XVd)已獲藥品福利計劃(PBS)收錄，用於治療既往接受過至少一次治療 的復發╱難治性多發性骨髓瘤成人患者。 後期資產： • Eltanexor（ATG-016，第二代XPO1抑制劑） • ATG-101（PD-L1 ...

德琪醫藥有限公司 Antengene Corporation Limited 中期報告 公司資料2 業務摘要6 其他資料 30 中期簡明綜合全面收益表 45 中期簡明綜合現金流量表 48 公司資料 唐晟先生 執行董事 梅建明博士 龍振國先生 (於開曼群島註冊成立的有限公司) 股票代號 : 6996 2023 財務摘要4 董事及高級管理層 24 中期簡明綜合損益表 44 中期簡明綜合權益變動表 47 目錄 錢晶女士 董事會 | --- | |-----------------------------------------| | | | | | 非執行董事 | | 陳侃博士 | | 劉逸倫先生（於 2023 年 4 月 14 日辭任） | 聯席公司秘書 黃偉超先生 | --- | --- | |-------------------------------------------------|----------------------------| | | | | Mark J. Alles 先生（於 2023 年 4 月 14 日辭任） | 總部及中國主要營業地點 | | | 中國 | | 審核委員會 | ...

截至2023年6月30日止六個月 中期業績公告 1 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） | --- | --- | --- | |---------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------| | | | | | 財務摘要 | | | | | 截至 6 月 30 2023 年 人民幣千元 未經審核 | 日止六個月 2022 年 人民幣千元 未經審核 | | | | | | 收入 | 72,016 | 53,956 | | 其他收入及收益 | 121,073 | 167,820 | | 研發成本 | (226,093) | (179,407) | | 銷售及分銷開支 | (88,246) | ...

德琪醫藥有限公司 Antengene Corporation Limited 2022 年度報告 (於開曼群島註冊成立的有限公司) 股票代號 : 6996 | --- | --- | |----------------------|-------| | | | | | | | 目錄 | | | | | | 公司資料 | 2 | | 財務摘要 | 4 | | 業務摘要 | 6 | | 董事長致辭 | 10 | | 管理層討論及分析 | 13 | | 董事及高級管理層 | 27 | | 董事會報告 | 33 | | 企業管治報告 | 59 | | 環境、社會及管治報告 | 77 | | 獨立核數師報告 | 117 | | 綜合損益表 | 122 | | 綜合全面收益表 | 123 | | 綜合財務狀況表 | 124 | | 綜合權益變動表 | 125 | | 綜合現金流量表 | 126 | | 財務報表附註 | 128 | 公司資料 審核委員會 | --- | |-----------------------------------------| | | | 執行董事 | | 梅建明博士 （董事長兼首席執行官） ...