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迈威生物(688062):2025Q1业绩承压 大力推进研发 多款管线取得进展
Xin Lang Cai Jing· 2025-05-07 02:38
盈利预测: 我们预计公司2025-2027 年营收分别为8.51、15.14、20.8 亿元,同比增速分别为325.97%、77.91%、 37.38%,归母净利润分别为-5.91、-2.8、1.04 亿元,同比增速分别为43.4%、52.65%、137.14%。维 持"推荐"评级。 风险提示:临床失败风险、竞争加剧风险、产品销售不及预期风险、政策风险。 2) 2025Q1,公司在研管线取得了多项进展,AACR 大会披露了6 项创新产品以及平台研究成果。 NECTIN-4 ADC 于 2025 年 1 月再度被国家药品监督管理局药品审评中心纳入突破性治疗品种名单;公 司研发的重组人源化抗 ST2 单克隆抗体创新药 9MW1911 于 2025 年 1 月完成了针对慢性阻塞性肺疾病 (COPD)患者的 Ib/IIa 期临床试验方案规定的全部 80 例入组,处于受试者随访阶段,并预期于 2025 年下半年完成受试者随访;公司研发的重组抗 TMPRSS6 单克隆抗体创新药9MW3011 于 2025 年 1 月完 成了首例受试者入组。此外,公司与英矽智能于2025 年3 月27 日建立合作,通过AI 算法优化药物设 ...
迈威生物(688062):由仿及创渐入佳境 ADC深度布局引领潮流
Xin Lang Cai Jing· 2025-05-02 10:39
研发管线丰富。公司聚焦于肿瘤和慢病领域,拥有16 个处于上市或临床阶段的品种。目前3 个生物类似 药已上市,正处于销售快速放量的阶段;三代长效升白针已申请NDA,3 个品种处于Ⅲ期关键注册临床 阶段。 盈利预测和估值建议:公司已有三个产品上市,研产销一体化布局初步完成,目前核心ADC 管线已进 入注册临床阶段,未来可期。预计2025/2026/2027 年总收入分别为6.13、10.30、17.95 亿元。根据峰 值销售额预测市值,公司合理股权价值为134.47 亿元,对应股价为33.65 元。首次覆盖,给予公司"买 入"评级。 Nectin-4 ADC 具备BIC 潜质。Nectin-4 ADC 单药后线以及联合用药一线已进入三期临床,围手术期用 药即将开展,有望在尿路上皮癌治疗领域构筑竞争壁垒;另有宫颈癌后线单药治疗进入三期,单药治疗 对以拓扑异构酶抑制剂为载药的ADC 耐药的TNBC 临床进入二期,海外即将开展桥接1b 期临床。 风险提示:候选药物研发不及预期的风险;相关技术迭代的风险;第三方合作的风险;核心人才流失的 风险;经营风险。 此外,另有两个潜力ADC 品种在临床阶段,其中一个即将开展临床,产 ...
阿斯利康一季报:中国区收入18亿美元,ADC药物驱动新增长
根据财报,今年一季度阿斯利康在美国收入 56.46 亿美元,同比增长10%,占总营收的 42%;中国区收 入 18.05 亿美元,同比增长5%,占总营收的 13%。目前,中国是阿斯利康继美国、欧洲后的第三大市 场。 观察中国生物医药生态体系的演变,不难发现,过去几十年间,它经历了显著的变革。回溯早期,众多 中国企业主要扮演快速追随者角色,其药物研发活动多集中于模仿,诸如仿制欧美药品,或仅对药品中 的某个细微成分进行微调。紧接着,这些企业步入了挑战重重的时期,资金与研发投入的巨大需求成为 了它们难以克服的难关,从而阻碍了创新的步伐。 21世纪经济报道记者季媛媛 上海报道 4 月 29 日,阿斯利康发布 2025 年一季度财报,营收 135.88 亿美元,同比增长 10%,其中产品销售 额 达128.75 亿美元,同比增长9%;研发投入 31.59 亿美元,同比增长 15%。 德曲妥珠单抗于2023年2月在中国首次获批上市,不到2年时间,已接连获批了单药治疗既往接受过抗 HER2药物治疗的HER2阳性晚期乳腺癌患者;或既往在转移性阶段接受过至少一种系统治疗的,或在辅 助化疗期间或完成辅助化疗之后6个月内复发的HE ...
复宏汉霖:再启航,创新+国际化步入收获期-20250427
Tianfeng Securities· 2025-04-27 14:23
Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 61.59 per share, compared to the current price of HKD 37.85 [6]. Core Insights - The company is entering a harvest period for its innovation and internationalization efforts, following significant progress in its pipeline and global expansion after privatization [1]. - The company has achieved historical profitability in the first half of 2023, with a revenue of HKD 25.01 billion, marking a year-on-year increase of 93.9% [6][25]. - The innovative drug segment, particularly the differentiated PD-1 drug, is expected to drive significant revenue growth in the medium term [4][6]. Summary by Sections 1. Commercialization and Innovation - The company has established itself as a pioneer in biosimilars, with its first product, Rituximab, approved in 2019, and is now focusing on expanding its innovative drug portfolio [14][15]. - The revenue from biosimilars reached HKD 36.3 billion in 2024, while the innovative drug segment generated HKD 13.1 billion, accounting for 22.86% of total sales [29]. 2. HLX43: Potential in PD-L1 ADC - HLX43 is the second PD-L1 ADC drug to enter clinical trials globally, showing significant potential as a future pillar in the company's pipeline [2]. - The drug is currently in clinical phase II and has demonstrated promising data, indicating a strong confidence from the company in its development [2]. 3. HLX22: Potential to Change HER2 Positive Gastric Cancer Treatment - HLX22 has shown superior clinical benefits compared to standard treatments in HER2 positive gastric cancer, with ongoing international phase III trials [3]. - The drug has received orphan drug designation in the US, highlighting its potential in the gastric cancer treatment landscape [3]. 4. Differentiated PD-1 Drug: Surulitinib - Surulitinib is positioned to address unmet clinical needs in small cell lung cancer, with expected rapid market uptake upon approval [4]. - The drug has shown optimal data in clinical trials, indicating a strong commercial potential in various indications [4]. 5. Internationalization and Market Expansion - The company has a strong track record in internationalization, with significant licensing agreements and expected revenue growth from overseas markets starting in 2025 [5]. - The company aims to leverage its first-mover advantage in biosimilars and innovative drugs to maximize market value domestically and internationally [5]. 6. Profit Forecast - Revenue projections for 2025-2027 are estimated at HKD 58.73 billion, HKD 59.70 billion, and HKD 71.25 billion, with corresponding net profits of HKD 8.27 billion, HKD 7.97 billion, and HKD 11.22 billion [6]. - The company is expected to continue its upward trajectory in profitability, driven by its innovative pipeline and effective cost management strategies [6][32].
复宏汉霖(02696):再启航,创新+国际化步入收获期
Tianfeng Securities· 2025-04-27 08:06
Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 61.59 per share, maintaining the rating from previous assessments [6]. Core Views - The report emphasizes that the company is entering a harvest period for its innovation and internationalization efforts, following significant progress in its pipeline and global expansion after privatization [1]. - The company has achieved historical profitability in the first half of 2023, with a notable increase in revenue and net profit, indicating strong growth potential [6][25]. Summary by Sections 1. Commercialization and Innovation - The company has established itself as a pioneer in biosimilars, with its first product, Rituximab, being the first biosimilar approved in China [14]. - The company is focusing on innovative drugs and has seen significant sales growth, with projected revenues of HKD 57.24 billion in 2024, reflecting a year-on-year increase of 6.06% [25][29]. 2. HLX43: PD-L1 ADC Development - HLX43 is the second PD-L1 ADC to enter clinical trials globally, showing promising potential for treating patients who do not respond to PD-1/PD-L1 therapies [2]. - The report highlights the urgent clinical need for effective treatments in EGFR wild-type NSCLC, where current therapies primarily rely on chemotherapy [37]. 3. HLX22: HER2 Positive Gastric Cancer - HLX22 has demonstrated significant clinical benefits in treating HER2 positive gastric cancer, with ongoing international trials expected to enhance its market position [3]. - The drug has received orphan drug designation in the US, indicating its potential as a key revenue driver for the company [3]. 4. Differentiated PD-1 SruLi monoclonal antibody - The company is advancing its differentiated PD-1 monoclonal antibody, SruLi, targeting unmet clinical needs in small cell lung cancer, with expected revenue of HKD 13.13 billion in 2024 [4]. - The report notes that SruLi has shown superior efficacy in clinical trials compared to existing treatments, positioning it for rapid market uptake [4]. 5. Internationalization and Market Expansion - The company has a strong track record in internationalization, with successful licensing agreements and product approvals in various global markets [5]. - The anticipated approval of SruLi in Europe and the US is expected to drive overseas revenue growth starting in 2025 [5]. 6. Financial Forecast - The company is projected to achieve revenues of HKD 58.73 billion, HKD 59.70 billion, and HKD 71.25 billion for the years 2025 to 2027, with corresponding net profits of HKD 8.27 billion, HKD 7.97 billion, and HKD 11.22 billion [6]. - The report indicates a significant improvement in the company's financial health, with a historical achievement of breakeven in 2023 [6][25].
ADC Therapeutics (ADCT) Conference Transcript
2025-02-06 20:00
ADC Therapeutics (ADCT) Conference February 06, 2025 02:00 PM ET Company Participants Ameet Mallik - CEO Conference Call Participants Michael Schmidt - Senior Managing Director & Equity Research Analyst - Biotechnology Michael Schmidt All right. So welcome to this next fireside chat with ADC Therapeutics. My name is Michael Schmidt, biotech analyst with Guggenheim. And with me today, I have Amit Malik, CEO of ADC And so, Amit, welcome. Thanks for joining us. Ameet Mallik Thank you. Michael Schmidt So just a ...