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交易总金额最高超47亿元,迈威生物官宣两项许可协议,均聚焦肿瘤领域药物
Mei Ri Jing Ji Xin Wen· 2025-06-27 15:06
Core Viewpoint - Recently, Maiwei Biotech announced two significant licensing agreements, potentially exceeding a total value of 4.7 billion RMB, which could enhance the company's operational strength and support its long-term development strategy [2][3][5]. Group 1: Licensing Agreements - Maiwei Biotech signed an exclusive licensing agreement with CALICO, a subsidiary of Alphabet, for the IL-11 targeted therapy, which includes the product 9MW3811. The agreement allows CALICO to develop, produce, and commercialize the product outside of China [3][4]. - The agreement with CALICO includes an upfront payment of 25 million USD (approximately 250 million RMB) and potential milestone payments totaling up to 571 million USD (approximately 4.095 billion RMB), along with royalties based on net sales [3][4]. - The second agreement with Qilu Pharmaceutical involves the product 8MW0511, which is an injectable drug for treating febrile neutropenia in cancer patients. This agreement includes an upfront payment of 3.8 billion RMB and potential sales milestone payments, as well as royalties based on net sales [4][6]. Group 2: Company Background and Financials - Founded in 2017, Maiwei Biotech focuses on the research, production, and sales of innovative drugs and biosimilars, primarily in oncology and other therapeutic areas [3][6]. - As of the end of 2024, the company has three products on the market but has not yet achieved profitability, with accumulated losses [3][6]. - In Q1 2025, the company reported revenue of 44.79 million RMB, a year-on-year decline of 33.7%, and a net loss of 292 million RMB, indicating an increase in losses due to high R&D expenditures [7]. - The company is preparing for an IPO on the Hong Kong Stock Exchange to alleviate financial pressures and enhance its international presence [7].
君实生物H股年涨超100%却高折价“输血”,创新药企 “融资—研发—再融资”的繁华与困局|创新药观察
Hua Xia Shi Bao· 2025-06-20 12:15
值得一提的是,此次高折价配售(较前一日收盘价折让11.52%)不仅创下年内港股生物医药板块最大折价融资纪 录,更暴露出公司现金流的严峻形势,折射出市场对创新药企"融资—研发—再融资"循环模式的担忧。 对此,中国企业资本联盟副理事长柏文喜对《华夏时报》记者表示,"君实生物此次折价配售,主要是因为公司面 临较大的资金压力,公司需要通过配售来快速筹集资金以维持研发和运营。此次以11.52%的年内最大折价配售, 可以看作是公司在资金压力下的无奈之举。" 资本困局:十载亏百亿元,四年融七十亿元 这已经是君实生物最近四年间的第三次大规模融资。 华夏时报(www.chinatimes.net.cn)记者 于娜 见习记者 赵文娟 北京报道 近日,君实生物(688180.SH,01877.HK)以每股25.35港元配售4100万股H股,预计募资净额约10.26亿港元。今 年以来,得益于多项BD交易达成,以及基本面的改善,创新药整体表现突出。截至6月18日收盘,君实生物的H 股年涨幅超100%;其A股亦同步冲高,年涨幅超25%。 从资金消耗与偿债能力指标看,君实生物的财务压力呈持续攀升态势。2021—2024年间,公司资产负债率 ...
君实生物(688180.SH):近30项在研药物处于临床试验阶段
Ge Long Hui· 2025-06-18 09:18
格隆汇6月18日丨君实生物(688180.SH)在互动平台表示,公司的创新研发领域已经从单抗药物类型扩展 至包括小分子药物、多肽类药物、抗体药物偶联物(ADCs)、双特异性或多特异性抗体药物、双特异 性抗体偶联药物、融合蛋白、核酸类药物等更多类型的药物研发以及癌症、自身免疫性疾病的下一代创 新疗法探索。公司在研产品管线覆盖五大治疗领域,包括恶性肿瘤、自身免疫系统疾病、慢性代谢类疾 病、神经系统类疾病以及感染类疾病。截至目前,公司已有4款商业化药品(拓益®、君迈康®、民得 维®以及君适达®),近30项在研药物处于临床试验阶段,超过20项在研药物处在临床前开发阶段。公 司核心产品特瑞普利单抗(拓益®)的12项适应症已于中国内地获批,其中10项适应症已纳入国家医保 目录。目前公司正在加快推进抗BTLA单抗tifcemalimab(代号:TAB004/JS004)、抗IL-17A单抗(代 号:JS005)、PD-1单抗皮下注射制剂(代号:JS001sc)、PD-1/VEGF双特异性抗体(代号:JS207) 等后期阶段管线的研发和上市申请等工作,并持续探索包括抗Claudin18.2 ADC(代号:JS107)、 PI ...
君实生物再募10亿加码最热创新药
Xin Lang Cai Jing· 2025-06-13 08:44
在预期的资金用途一项上,6月13日,君实生物在接受智通财经记者采访时表示,公司拟将配售款的七成用于创新药研 发,包括PD-1/VEGF双特异性抗体(代号JS207)、EGFR/HER3双特异性抗体偶联药物(代号JS212)、PD-1/IL-2双功 能性抗体融合蛋白(代号JS213),剩余款项将用于补充营运资金等。 智通财经记者 | 黄华 智通财经编辑 | 谢欣 6月13日,君实生物公告称,拟在H股配售募资,企业将按每股25.35港元价格配售4100万股新H股,配售价较公司6月12 日的港股收市价折让约11.52%,此次配售将获得约10.39亿港元。 除了特瑞普利单抗,君实生物的其他三款主力商业化产品为:阿达木单抗注射液(君迈康)、氢溴酸氘瑞米德韦片(民 得维)和昂戈瑞西单抗注射液(君适达)。这三款产品针对的领域分别系生物类似药治疗免疫系统疾病、新冠口服药、 新型降脂药。受市场竞争等因素影响,前述产品的商业预期均较为有限,这也使得君实生物现阶段的发展陷入瓶颈。 截至目前,君实生物仍未实现扭亏。但在2024年,该公司的亏损额较前两年已大幅收窄。今年一季度,该公司营收和归 母净利润分别为5亿元、-2.35亿元,进一 ...
君实生物: 君实生物2024年年度股东大会会议资料
Zheng Quan Zhi Xing· 2025-05-29 12:12
上海君实生物医药科技股份有限公司 上海君实生物医药科技股份有限公司 为了维护全体股东的合法权益,保证股东在上海君实生物医药科技股份有限 公司(以下简称"公司")依法行使股东权利,确保 2024 年年度股东大会的正常 秩序和议事效率,根据《中华人民共和国公司法》 (以下简称" $$\langle\langle\lambda\overline{{{\Xi}}}|\langle\vec{\lambda}\rangle\;\;"\rangle\;\;\;\;\;\;$$ 《中 华人民共和国证券法》(以下简称"《证券法》")、中国证券监督管理委员会(以 下简称"中国证监会") 《上市公司股东会规则》以及《上海君实生物医药科技股 份有限公司章程》 (以下简称"《公司章程》")、 《上海君实生物医药科技股份有限 公司股东大会议事规则》 (以下简称"《股东大会议事规则》")等有关规定,特制 定本须知,请全体出席股东大会的人员自觉遵守。 一、为确认出席大会的股东或其代理人或其他出席者的出席资格,会议工作 人员将对出席会议者的身份进行必要的核对工作,请被核对者给予配合。 二、经公司审核后符合参加本次股东大会条件的股东(含股东代理 ...
迈威生物困局:26%产能闲置下的10亿债务悬崖,董事长被查或掐断H股“输血”通道
Xin Lang Zheng Quan· 2025-05-28 10:32
Core Insights - The company is facing a dangerous expansion paradox with significant fixed asset investments of 1.894 billion yuan and ambitious capacity expansion plans, while experiencing a low capacity utilization rate of only 26.15% and actual drug sales revenue of 145 million yuan [1][2] Group 1: Sales Performance - The company's main products are underperforming, with a drastic decline in sales revenue. The projected sales for three key drugs were expected to reach between 1.435 billion to 1.762 billion yuan by 2025, but actual revenue for 2024 is only 145 million yuan, less than one-tenth of the optimistic forecast [2] - The drug Junmaikang (similar to Adalimumab) saw a 70% drop in shipment volume from approximately 166,900 units in 2023 to 48,800 units in 2024, facing intense competition and high costs [2] - The drug Mailishu (similar to Dexamethasone) also fell short of expectations, with actual sales of only 84,400 units and revenue of 42.09 million yuan in 2023, compared to a forecast of at least 300,000 units and 180 million yuan [2] - The drug Maiweijian (similar to Dexamethasone) was only approved by the end of March 2024, with shipments of just 12,530 units, limited by fewer approved indications and a lengthy market access process [2] Group 2: Capacity Expansion and Financial Strain - Despite poor sales performance, the company has aggressively expanded its production capacity, with fixed assets increasing by 165.49% to 1.653 billion yuan by the end of 2024, and total fixed assets and construction in progress reaching 1.894 billion yuan, accounting for 44.31% of total assets [3] - The actual capacity utilization rate is only 26.15%, with a production and sales rate of 81.08%. The company anticipates annual fixed asset depreciation costs of approximately 130 million yuan, nearly equal to its total drug sales revenue for 2024 [3] Group 3: Debt and Cash Flow Challenges - The company is under significant financial pressure, with short-term borrowings and long-term borrowings due within one year totaling 1.035 billion yuan by the end of 2024, leading to a debt-to-asset ratio of 63.61% and a negative operating cash flow of -956 million yuan [4] - The company is relying on two strategies to address its financial challenges: completing an H-share IPO for capital infusion and hoping for future revenue from unlisted pipelines to cover debts [4] Group 4: Leadership and IPO Uncertainty - The chairman and general manager of the company is under investigation for suspected insider trading, which has caused a significant drop in stock price and raised concerns about the impact on the H-share IPO process [5] - Although the company claims the investigation does not affect daily operations or the IPO plan, the Hong Kong Stock Exchange has strict scrutiny over management stability and integrity, which could delay the IPO process significantly [6] - The company submitted its prospectus for the Hong Kong IPO on January 6, and must complete the hearing or listing within six months, or the prospectus will become invalid, adding pressure to resolve the investigation quickly [6]
迈威生物: 国泰海通证券股份有限公司关于迈威(上海)生物科技股份有限公司2024年报告的信息披露监管问询函的专项核查意见
Zheng Quan Zhi Xing· 2025-05-20 10:31
国泰海通证券股份有限公司 关于迈威(上海)生物科技股份有限公司 上海证券交易所: 根据贵所《关于迈威(上海)生物科技股份有限公司2024年报告的信息披 露监管问询函》(上证科创公函【2025】0064号)(以下简称"《问询函》") 的要求,国泰海通证券股份有限公司(以下简称"国泰海通"或"保荐机构") 作为迈威(上海)生物科技股份有限公司(以下简称"公司")首次公开发行 股票并在科创板上市的保荐机构及持续督导机构,对问询函相关问题进行了审 慎核查,并出具核查意见如下: 本核查意见中若出现总计数尾数与所列数值总和尾数不符的情况,均为四 舍五入所致。本核查意见中所列示的包括但不限于收入、利润及产能规划等数 据的相关测算和预计均不构成业绩承诺或盈利预测。如无特别说明,本核查意 见中使用的简称或名词释义与《迈威(上海)生物科技股份有限公司2024年年 度报告》(以下简称"2024年报")一致。 问题一 关于经营业绩 关于经营业绩。年报显示,2024 年公司实现营业收入 2.00 亿元,同比增长 面,公司已有君迈康、迈利舒、迈卫健等 3 款产品获批上市,其中君迈康全年 发货 48,821 支,同比下降 66.61%,迈 ...
迈威生物: 迈威生物关于2024年报告的信息披露监管问询函的回复公告
Zheng Quan Zhi Xing· 2025-05-20 10:20
Core Viewpoint - The company received an inquiry letter from the Shanghai Stock Exchange regarding its 2024 annual report, prompting a detailed response about its operational performance and product sales [1][2]. Group 1: Operational Performance - In 2024, the company achieved operating revenue of 200 million yuan, a year-on-year increase of 243.53% [2][19]. - The company has three commercialized products: Junmaikang, Mailishu, and Maiweijian, with varying sales performance and challenges [2][3]. - Junmaikang's sales volume significantly decreased by 66.61%, with 48,821 units shipped in 2024 [2][10]. - Mailishu's sales revenue increased by 195.50%, with a total revenue of 12.44 million yuan in 2024 [3][5]. - Maiweijian achieved a total revenue of 14.46 million yuan in 2024, with a gross margin of 78.47% [4][11]. Group 2: Product Analysis - Junmaikang's sales were impacted by its late market entry and intense competition, leading to a strategic shift in sales approach [6][9]. - Mailishu's cost increased by 1,122.70% compared to the previous year, resulting in a decrease in gross margin by 9.96 percentage points [5][6]. - Maiweijian's market entry was slow, with only 75 hospitals approved by the end of 2024, attributed to its limited indications compared to the original drug [12][14]. Group 3: Market Trends and Strategies - The TNF-α drug market in China grew from 3.5 billion yuan in 2019 to 42.9 billion yuan in 2023, with a compound annual growth rate of 17.5% [6][7]. - The company plans to expand Maiweijian's indications to include SREs, which could enhance its market presence [23][24]. - The company is actively pursuing international collaborations and expanding its product pipeline to enhance revenue streams [25][26]. Group 4: Financial Outlook - The company anticipates gradual revenue growth and a reduction in net losses over the next three years, with a low risk of expanding losses [20][19]. - The company is focusing on improving operational efficiency and expanding its commercialized product offerings to achieve profitability [20][21].
迈威生物: 安永华明会计师事务所(特殊普通合伙)就上海证券交易所《关于对迈威(上海)生物科技股份有限公司2024 年报告的信息披露监管问询函》中部分涉及财务报表项目问询意见的专项说明
Zheng Quan Zhi Xing· 2025-05-20 10:20
Core Viewpoint - The company, Maiwei (Shanghai) Biotechnology Co., Ltd., reported a significant increase in revenue for 2024, driven by its commercialized products and technical services, while facing challenges in market penetration and competition in the biopharmaceutical sector [3][21]. Financial Performance - In 2024, the company achieved a revenue of 200 million RMB, representing a year-on-year growth of 56.28% [3]. - The revenue breakdown includes 145 million RMB from antibody drugs and 55 million RMB from technical services [3]. - The sales volume of the product Junmaikang decreased by 66.61% year-on-year, with a total shipment of 48,821 units [3][10]. Product Analysis - The company has three commercialized products: Junmaikang, Mailishu, and Maiweijian, with detailed sales revenue, costs, and gross margins provided [3][5]. - Junmaikang's sales revenue for 2024 was 124.37 million RMB, with a gross margin of 6.25% [5]. - Mailishu's sales revenue was 145.94 million RMB, with a gross margin of 86.87% [5]. - Maiweijian's sales revenue reached 145.92 million RMB, with a gross margin of 78.47% [5]. Market Dynamics - The TNF-α drug market in China grew from 3.5 billion RMB in 2019 to 10.1 billion RMB in 2023, with a projected growth to 42.9 billion RMB by 2032 [7]. - The competitive landscape for Junmaikang is challenging, with multiple similar products already in the market, leading to a decline in its sales volume [9][10]. Strategic Adjustments - The company is optimizing its regional operating model to improve efficiency and resource utilization, transitioning from self-operated sales to cooperative sales in underperforming areas [10][21]. - The company plans to expand the indications for Maiweijian to enhance its market competitiveness and sales revenue [25][21]. Research and Development - The company has several products in the pipeline, with multiple candidates entering Phase III clinical trials, expected to launch between 2028 and 2031 [20][21]. - The company is actively pursuing international collaborations and market expansions, particularly in emerging markets [26][27]. Technical Services - The technical service revenue composition includes significant contracts with major clients, contributing to the overall revenue [15][19]. - The company has received substantial payments for milestone achievements in its technical service agreements [15].
迈威生物董事长被立案 赶上港股IPO估值前景几何
Sou Hu Cai Jing· 2025-05-15 10:37
《投资者网》蔡俊 迈威生物(688062.SH,下称"公司")在关键时刻,迎来一场风波。 5月,公司披露董事长兼总经理刘大涛收到证监会出具的《立案告知书》,其因涉嫌短线交易被立案调查,该事项针对个人不会对公司日常经营活动产生重 大影响。 目前,公司正处于港股IPO的过程中。现金流的捉襟见肘和负债率的高企,已让公司到了一个关键时刻。追溯上市以来的路程,公司自上而下变化正将趋势 推至一个十字路口。 极度渴求资金 2017年,刘大涛与唐春山联合创立迈威生物。早前,刘大涛履历过上海莱士、上海医药等企业,担任过研发总监的职位。不同于专业背景出身,主修材料专 业的唐春山一直在商海摸爬滚打,先在海南创业,再收购江西省的多家药企打造青峰医药集团。 彼时,创新药正值黄金期,大量资本涌入风口,公司及创始人趁势快速崛起。刘大涛与唐春山以收购方式向公司注入多家企业,通过不断整合资源将业务覆 盖到产业链的研发、生产、销售等环节。 风口期的创新药,研发赛道是估值的黄金标准。公司主营单抗、双抗、ADC等热门领域,IPO前最后一轮投后估值60亿元,股东包括东方富海、正心谷、海 通资本等机构。2022年,公司沿用第五套标准,即未盈利、无上市产 ...