艾加莫德是治疗gMG的最佳疗法 根据多项研究，艾加莫德的多项指标具备优势：1)MSE(最小症状表达，MG-ADL≤1分)累计达标率为 40%-73%，该指标对患者回归生活有明确指导意义，明显优于竞品;2)起效迅速：用药第1周ADL就有明 显改善，ADL改善≥3分第4周就达到73.0%;3)长期疗效持久：3年随访研究(ADAPT+)证明艾加莫德长期 反复使用疗效可以长期维持;4)靶向FcRn，选择性降低IgG(不影响IgA/IgM)，对免疫系统干预更为精 准，感染风险可控，SAE发生率4.8%。总结来看，艾加莫德具备起效更快，疗效更深，达标率高/实现 临床双达标，安全性更好，两年独家医保的先发优势。 公司全年催化剂丰富，多款重磅产品即将读出关键数据 智通财经APP获悉，中金发布研报称，维持再鼎医药(09688)2025年和2026年盈利预测不变。该行维持跑 赢行业评级，基于DCF模型，该行维持H/US股目标价34.41港元/44.24美元不变。4月11日，公司合作伙 伴argenx宣布艾加莫德预充针皮下注射剂型获美国FDA批准上市。此外，4月10日，公司也于美国神经 病学会公布了艾加莫德ADAPT NXT(B阶 ...

近日闭幕的神经领域年度盛会美国神经病学会(AAN)年会上，众多神经领域前沿进展惊艳亮相，其中重症肌无力(MG)的研究进展更是硕果 累累。多款新型靶向生物制剂公布了最新临床研究结果，不仅推动MG治疗进入分子免疫时代，也预示着MG治疗药物竞争格局的改变。 智通财经APP获悉，4月14日，国际投行高盛发布了一份深度研究报告，重点聚焦了这一疾病领域的最新进展。报告中高盛详细分析了再鼎 医药(09688)的FcRn拮抗剂艾加莫德与荣昌生物双靶点抑制剂泰它西普(RC18)之间的对比，并探讨了未来市场趋势和关键的可能影响因素。 gMG治疗领域的竞争格局 在2025年的AAN大会上，荣昌生物的APRIL/BAFF双靶点生物制剂RC18在三期临床试验中取得了积极的治疗数据。RC18展现了深度的患者 响应能力，也引发了市场对APRIL/BAFF双靶点生物制剂与FcRn拮抗剂(包括艾加莫德、巴托利单抗和罗泽利昔珠单抗等)效果对比的广泛讨 论。 高盛认为，由于作用机制(MOA)的差异，FcRn 类药物在gMG治疗上会有起效速度的优势，从而在市场中带来竞争优势。高盛通过对RC18 和艾加莫德的临床数据对比，强调了快速起效在gMG治疗中 ...

[Table_Main] 证券研究报告 | 公司点评 再鼎医药(09688.HK) 2025 年 04 月 14 日 买入（维持） 所属行业：医疗保健业/药品及生物科技 当前价格(港币)：22.20 元 证券分析师 1.《---创新药管线更新系列报告-再鼎 医药(09688.HK)：艾加莫德上调销售 指引，爆款潜力初现》，2024.8.12 2.《再鼎医药(09688.HK)：新品放量超 预 期 ， 公 司 迈 入 发 展 新 阶 段 》， 2024.5.10 再鼎医药(09688.HK)：艾加莫德 新剂型获 FDA 批准，不惧竞 争，大单品销售可期 周新明 资格编号：S0120524060001 邮箱：zhouxm＠tebon.com.cn 李霁阳 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 市场表现 -31% 0% 31% 63% 94% 126% 157% 188% 2024-04 2024-08 2024-12 再鼎医药 恒生指数 | 恒 生 指 数 对 | 1M | 2M | 3M | | --- | --- | --- | --- | | 比 | | | | ...

[Table_Main] 证券研究报告 | 公司点评 再鼎医药(09688.HK) 2025 年 04 月 14 日 买入（维持） 所属行业：医疗保健业/药品及生物科技 当前价格(港币)：22.20 元 证券分析师 周新明 资格编号：S0120524060001 邮箱：zhouxm＠tebon.com.cn 李霁阳 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 市场表现 -31% 0% 31% 63% 94% 126% 157% 188% 2024-04 2024-08 2024-12 再鼎医药 恒生指数 | 恒 生 指 数 对 | 1M | 2M | 3M | | --- | --- | --- | --- | | 比 | | | | | 绝对涨幅(%) | -18.83 | 5.21 | 17.34 | | 相对涨幅(%) | -7.45 | 9.53 | 7.63 | | 资料来源：德邦研究所，聚源数据 | | | | 重症肌无力领域近期新药进展众多，我们认为艾加莫德作为 BIC，在 MG 治疗领 域地位难以被撼动。 1）快速起效，快速达标：越来越多的临床试验使用基 ...

相关ETF方面，截至发稿，港股创新药ETF（159567）高开高走，现涨5%。成分股中，再鼎医药涨超 14%，药明合联、科伦博泰生物-B、东阳光长江药业、荣昌生物等涨幅居前。 4月14日，港股集体高开，创新药板块涨幅居前。 消息面上，Wind金融终端数据显示，截至4月13日，已有超过230家生物医药行业上市公司披露了2024 年度经营数据（含年报、业绩快报）。其中，25家公司营收突破百亿元大关，上海医药以2752.51亿元 的营收一骑绝尘；有近半数企业盈利能力持续上升，26家公司归母净利润超过10亿元，药明康德以94.5 亿元的归母净利润领跑行业；超过半数的企业研发投入持续增长，其中百济神州全年研发费用高达 19.53亿美元（约合人民币142.79亿元），同比增长9.8%，占营收比例约为52%。 广发证券表示，建议重视港股创新药的配置价值，原因在于：首先，中国创新药出海的全球竞争优势正 在凸显。近年来，中国药企在海外市场的License-out交易实现了跨越式发展，展现出中国创新药研发的 全球竞争力。NewCo模式的兴起，进一步为原药企解决了融资难、变现难、研发风险大等问题。其 次，当前关税政策对创新药影响远 ...

截至2025年4月14日 09:43，恒生医疗保健指数(HSHCI)强势上涨2.95%，成分股再鼎医药(09688)上涨12.39%，东阳光长江药业(01558)上涨9.04%，科伦博泰 生物-B(06990)上涨6.69%，百济神州(06160)，云顶新耀-B(01952)等个股跟涨。恒生医疗ETF(513060)上涨3.15%， 冲击4连涨。最新价报0.46元。拉长时间 看，截至2025年4月11日，恒生医疗ETF近3月累计上涨21.98%。 流动性方面，恒生医疗ETF盘中换手3.65%，成交4.42亿元。拉长时间看，截至4月11日，恒生医疗ETF近1周日均成交24.90亿元，排名可比基金第一。 规模方面，恒生医疗ETF近1周规模增长12.54亿元，实现显著增长，新增规模位居可比基金1/3。 数据显示，杠杆资金持续布局中。恒生医疗ETF最新融资买入额达3.26亿元，最新融资余额达5.03亿元。 截至4月11日，恒生医疗ETF近1年净值上涨26.66%。从收益能力看，截至2025年4月11日，恒生医疗ETF自成立以来，最高单月回报为28.34%，最长连涨月 数为4个月，最长连涨涨幅为38.75%，上涨月份平 ...

智通财经4月14日电，截至发稿，再鼎医药(09688.HK)涨13.51%、来凯医药-B(02105.HK)涨10.34%、基 石药业-B(02616.HK)涨6.28%、腾盛博药-B(02137.HK)涨6.17%、药明合联(02268.HK)涨5.94%。 港股医药股多数走强 再鼎医药涨超13% ...

Group 1 - The company reported total revenue of $399 million for the year ending December 31, 2024, representing a year-on-year increase of 49.59% [1] - Revenue growth was primarily driven by the strong commercialization of Weiwei Jia since its launch in September 2023 and its inclusion in the national medical insurance catalog in January 2024 [1] - The company continues to maintain its leading position in the ovarian cancer PARP inhibitor market and has seen steady sales growth from its products included in the national medical insurance catalog [1] Group 2 - The company achieved positive results in the global Phase I study of ZL-1310, a targeted DLL3 ADC for the treatment of extensive small cell lung cancer [2] - Encouraging preclinical data was obtained for ZL-1503, a dual-specific antibody targeting IL-13/IL-31R for the treatment of atopic dermatitis [2] - The company expanded its product pipeline through strategic collaborations, including a partnership with Yilian Bio to develop ZL-6201, a novel targeted LRRC15 ADC for specific solid tumors [2]

Revenue Growth - Product revenue increased by $130.9 million (or 49%) to $397.6 million, driven by the sales growth of Weiwei Jia® since its launch in September 2023 and its inclusion in the national medical insurance catalog in January 2024 [4] - Total revenue for the year ended December 31, 2024, was $398.988 million, a significant increase of 49.5% compared to $266.719 million in 2023 [20] - Product revenue, net, reached $397.614 million, up from $266.719 million in the previous year, indicating strong growth in product sales [20] - Total product revenue for 2024 reached $423.855 million, a 42% increase from $298.911 million in 2023 [81] - The net revenue from the product "卫偉迦╱衛力迦" surged by 835% to $93.6 million in 2024 from $10.0 million in 2023 [180] Expenses and Losses - R&D expenses decreased by $31.4 million (or 12%) to $234.5 million, primarily due to the progress of existing research projects, partially offset by increased licensing fees [4] - Selling, general and administrative expenses increased by $17.1 million (or 6%) to $298.7 million, mainly due to increased general sales expenses from the launch of Weiwei Jia® and the sales growth of Nuo Zai Le® [4] - Net loss decreased by $77.5 million (or 23%) to $257.1 million, primarily due to product revenue growth outpacing net operating expenses, offset by decreased interest income and increased foreign exchange losses [4] - The net loss for 2024 was $257,103,000, a decrease from the net loss of $334,620,000 in 2023, representing a 23.2% improvement [21] - The comprehensive loss for 2024 was $244,214,000, compared to $322,679,000 in 2023, indicating a 24.4% reduction [21] Cash and Liquidity - Cash and cash equivalents as of December 31, 2024, were $449.667 million, down from $790.151 million in 2023, indicating a reduction in liquidity [19] - The company reported a total cash and cash equivalents of $550,781,000 at the end of 2024, down from $791,264,000 at the end of 2023 [23] - Cash flow from operating activities showed a net cash outflow of $214,869,000 in 2024, compared to $198,178,000 in 2023, reflecting a 8.4% increase in cash outflow [23] - Cash, cash equivalents, and restricted cash amounted to $550.8 million as of December 31, 2024, including $531.0 million in USD [194] Assets and Liabilities - Total assets increased to $1.185753 billion in 2024 from $1.036295 billion in 2023, showing overall growth in the company's asset base [19] - Total liabilities rose to $344.855 million in 2024, compared to $240.177 million in 2023, indicating increased financial obligations [19] - Shareholders' equity increased to $840.898 million in 2024 from $796.118 million in 2023, reflecting a positive trend in equity position [19] - The company reported a decrease in accumulated deficit to $2,453,083,000 in 2024 from $2,195,980,000 in 2023, reflecting ongoing financial challenges [22] Research and Development - Research and development expenses totaled $234.504 million, a decrease from $265.868 million in the prior year, suggesting a focus on efficiency [20] - Clinical project expenses were $86,126, down from $112,158, indicating a reduction of approximately 23.2% year-over-year [138] - The investment in R&D and operational expenses continues to drive significant losses, with a focus on long-term development of quality candidates [165] - The company has multiple candidates in late-stage clinical development, with the ability to generate revenue dependent on obtaining regulatory approvals [174] Stock and Equity - Basic and diluted loss per share was $0.26, a decrease of 25% from $0.35 [4] - The weighted average number of shares outstanding increased to 989,477,730 in 2024 from 966,394,130 in 2023, reflecting potential dilution effects [20] - The company granted 20,947,480 stock options in 2024, with an average exercise price of $1.69 [108] - The total intrinsic value of stock options exercised in 2024 was approximately $9.4 million, compared to $20.3 million in 2023 [108] Collaborations and Agreements - The company has entered into a licensing agreement with Seagen for the development and commercialization of Tisotumab Vedotin (TIVDAK) in Greater China, with potential milestone payments up to $258 million [122] - A collaboration and licensing agreement with Yilian Biopharmaceuticals was established for the global exclusive rights to develop and commercialize DLL3-targeted ADC compounds, with potential milestone payments up to $592 million [124] - The company recorded a milestone expense of $12.0 million related to sales for the collaboration agreement with GSK for Niraparib in 2023 [113] Financial Instruments and Accounting - The company operates under US GAAP for its consolidated financial statements, ensuring compliance with important accounting policies [27] - The company applies ASC 606 for revenue recognition, confirming revenue when control of goods or services is transferred to customers [49] - The company recognizes lease liabilities and right-of-use assets at the commencement date of the lease, measuring lease liabilities at the present value of future fixed lease payments [39] Market and Future Outlook - The company expects revenue growth from existing and recently launched commercialized products to continue into 2025 [167] - The company plans to continue its market expansion efforts and explore new product development opportunities [139] - Strategic collaborations have been established with Yilian Bio and Vertex to enhance the product pipeline and leverage new therapeutic developments [168]

Investment Rating - The report maintains an "Outperform" rating for Zai Lab with a target price of HKD 56.73, indicating an expected upside from the current price of HKD 27.90 [2][9][20]. Core Insights - Zai Lab's Efgartigimod sales exceeded expectations, generating USD 93.6 million in FY24, significantly higher than the previous year's USD 10 million, driven by its inclusion in the National Reimbursement Drug List for generalized myasthenia gravis [3][17]. - The management projects FY25 revenue between USD 560 million and USD 590 million, with a potential for non-GAAP operating profitability by Q4 2025 [4][16][20]. - The company anticipates a compound annual growth rate (CAGR) of approximately 40% in revenue from FY24 to FY28, supported by multiple potential blockbuster products nearing commercialization [5][18]. Financial Performance - For FY24, Zai Lab reported a net revenue of USD 400 million, a year-on-year increase of 49%, with a gross profit margin of 63.1% [3][16]. - R&D expenses were USD 235 million, down 11.8% year-on-year, while SG&A expenses increased by 6.1% to USD 299 million [3][16]. - The net loss for FY24 was USD 257 million, an improvement from the previous year's loss of USD 335 million [3][16]. Product Pipeline and Growth Drivers - Efgartigimod is expected to continue its growth trajectory, potentially exceeding USD 150 million in revenue in FY25 due to its exclusivity advantage and expanding patient base [4][17]. - Zai Lab has several products in the pipeline, including KarXT for schizophrenia, which is projected to have peak sales of USD 1 billion, and Bemarituzumab for gastric cancer, with Phase III data expected in 1H25 [5][18]. - ZL-1310 has received orphan drug designation from the FDA for small cell lung cancer and is expected to accelerate overseas licensing opportunities [6][19]. Valuation Adjustments - Revenue forecasts for FY25 and FY26 have been adjusted to USD 561 million and USD 775 million, respectively, reflecting a growth of 41% and 38% year-on-year [9][20]. - The net profit forecast for FY25 and FY26 has been fine-tuned to USD -140 million and USD 10 million, respectively, indicating a path towards profitability by FY26 [9][20].