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创国产新药出海预付款纪录,百利天恒双抗ADC临床试验结果登上Nature Medicine
生物世界· 2025-07-11 03:41
撰文丨王聪 编辑丨王多鱼 排版丨水成文 食管癌 是癌症相关死亡的第七大常见原因,其中, 食管鳞状细胞癌 (ESCC) 是全球最常见的食管癌类型。免疫检查点抑制剂 (例如抗 PD-1、PD-L1 和 CTLA-4 单抗) 与基于铂类药物的化疗相结合,已成为晚期食管鳞状细胞癌的标准治疗方法,并带来了显著的生存获益。然而,仅有 10%-20% 的食管鳞状细 胞癌患者能长期存活,因为大多数患者会对这些药物产生耐药性。 晚期食管鳞状细胞癌的二线治疗采用 伊立替康 (Irinotecan) ,但其疗效也有限,客观缓解率 (ORR) 不超过 10%。 因此,迫切需要开发新的有效治疗策略,以克服当前疗法的局限性,提高食管鳞状细胞癌患者的生存率。 2025 年 7 月 10 日, 北京大学肿瘤医院 鲁智豪 、 沈琳 、 龚继芳 等人在国际顶尖医学期刊 Nature Medicine 上发 表了题为: A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a ph ...
新股前瞻|搭上TCE热门赛道“风口”,岸迈生物IPO能否可期?
智通财经网· 2025-07-04 02:47
Group 1: Company Overview - Company, Anmai Biotech, is preparing for an IPO in Hong Kong, having completed multiple rounds of financing with notable investors, achieving a post-money valuation of $492 million in its last funding round in 2022 [1] - The company specializes in developing T-cell engagers for cancer and autoimmune diseases, currently in the clinical stage with no commercialized products yet [3][6] - Anmai Biotech reported projected revenue of approximately 459 million RMB for 2024, with a profit of 47.7 million RMB, marking a turnaround from previous losses [3][4] Group 2: Financial Performance - The company experienced a significant drop in R&D spending from 185 million RMB in 2023 to 123 million RMB in 2024, with R&D expenses constituting 78.8% and 74.1% of total expenses respectively [5] - As of April 30, 2025, the company has cash and cash equivalents of 327 million RMB, sufficient to maintain financial stability for the next 12 months [5] - The total accumulated loss of the company reached 2.355 billion RMB by the end of 2024 [3] Group 3: Product Pipeline and Market Potential - Anmai Biotech's lead product, EMB-01, is the first dual-specific antibody targeting EGFR/cMET for colorectal cancer, currently in Phase II clinical trials [6][12] - The global market for colorectal cancer drugs is projected to grow from $3.1 billion to $7.4 billion by 2034, with over 2 million new cases expected globally in 2024 [8][9] - The company has established a strong international collaboration network, with total transaction values exceeding $2.1 billion in licensing agreements [14] Group 4: Industry Trends and Competitive Landscape - The innovative drug sector, particularly in T-cell engagers, has seen significant growth, with the Hong Kong innovation drug index rising by 65.5% year-to-date [2] - Anmai Biotech ranks second globally in international collaboration transaction volume within the T-cell engager field, indicating strong market positioning [14] - The TCE market is competitive, with 10 TCE therapies approved globally, and Anmai Biotech's unique technology platforms may provide a competitive edge [15]
岸迈生物冲刺港股IPO 公司与三生制药存在渊源
Mei Ri Jing Ji Xin Wen· 2025-07-03 12:23
Core Viewpoint - The rise of domestic innovative drugs in China since 2025 is significantly driven by Business Development (BD) strategies, allowing companies to monetize their research through partnerships with multinational pharmaceutical firms [1][2]. Company Overview - A notable player in this space is Anmai Biotech, which is preparing for an IPO in Hong Kong and has gained attention for its BD transactions, accumulating over $2.1 billion in deal value since the end of 2023, ranking second globally in the TCE bispecific antibody sector [1][3]. - The founder, Wu Chenbing, previously served as the Chief Scientific Officer at 3SBio, indicating a strong lineage of expertise and a shift in Chinese biotech from "following" to "leading" in innovation [1][3]. Financial Performance - As of the end of 2024, Anmai Biotech's cash and equivalents are sufficient for only 12 months of operations, highlighting the importance of clinical progress and commercialization capabilities for its transition from a "transaction star" to a "profit benchmark" [2][8]. - The company reported a revenue of 459 million yuan in 2024, with a net profit of 47.7 million yuan, following a loss of 595 million yuan in 2023 primarily due to R&D expenses [7]. Product Pipeline - Anmai Biotech's lead product, EMB-01, is a bispecific antibody targeting EGFR/cMET, which is among the first to enter Phase II trials for colorectal cancer, with a market potential driven by the increasing incidence of the disease [6][7]. - The global bispecific antibody market is projected to grow from $13.4 billion in 2024 to over $220 billion by 2034, with a compound annual growth rate of 32.4% [6]. Strategic Partnerships - The company has engaged in multiple licensing agreements, including a significant deal with Vignette Bio valued at $635 million for EMB-06, and a recent global licensing agreement with Juri for KLK2/CD3 TCE with a potential value of $210 million [7]. Leadership and Expertise - The leadership team includes Dr. Zhu Yonghong, who brings extensive international clinical development experience, complementing Wu Chenbing's background in drug development [4]. - Anmai Biotech's FIT-Ig technology platform, patented in the U.S. in 2018, is a key competitive advantage, addressing stability issues in traditional bispecific antibodies [4][5].
基石药业-B(02616.HK)首次披露两款自身免疫/炎症性疾病全新双抗分子靶点
Ge Long Hui· 2025-07-03 00:08
Core Insights - Company disclosed two proprietary bispecific antibody drug candidates targeting autoimmune/inflammatory diseases: CS2013 and CS2015, both showing potential as best-in-class or first-in-class therapies [1][2] - CS2013 targets BAFF and APRIL to block B cell and plasma cell development, with preclinical data indicating a synergistic effect and superior pharmacokinetic properties compared to fusion protein drugs [1] - CS2015 targets OX40L and TSLP, providing a new treatment strategy for type 2 inflammatory diseases such as atopic dermatitis and asthma, also showing long half-life and potential for subcutaneous administration [2] Company Strategy - The CEO emphasized the significant unmet needs in the autoimmune/inflammatory disease market, which is becoming the second-largest disease market after oncology, due to the variety of diseases and large patient base requiring lifelong treatment [2] - The development of CS2013 and CS2015 reflects the company's strategic expansion beyond oncology and its commitment to innovation aimed at improving global patient health [2] - The company plans to initiate IND preparation for new drug clinical trials in the second half of 2025 [1]
手握大额交易单,岸迈生物冲刺港交所丨医健IPO解码
Core Viewpoint - The company Anmai Biotech has submitted its IPO application to the Hong Kong Stock Exchange, aiming to raise funds primarily for clinical development, pipeline expansion, and operational funding, thereby solidifying its leading position in the dual antibody innovation field [1] Financial Performance - In 2023, the company reported a loss of 594.82 million RMB, mainly due to research and management expenses, as well as losses related to redeemable preferred shares [3][4] - For 2024, the company expects to generate revenue of 458.87 million RMB, all from external licensing and collaboration agreements, and anticipates a profit of 47.69 million RMB [3][4] - As of the end of 2024, the company's net debt is projected to be 2.34 billion RMB, with cash and cash equivalents at 386 million RMB [4] Research and Development - Research and development expenses are a core component of the company's cost structure, with expenditures of 184.63 million RMB in 2023 and 122.63 million RMB in 2024 [3][4] - The company has a research team of 30 members and plans to monitor cash flow closely, with potential for further financing if necessary [4] Business Development and Partnerships - The company has secured multiple external licensing agreements since the end of 2023, with a total transaction value exceeding 2.1 billion USD, ranking second globally in the TCE dual antibody field [1][5] - A notable partnership with VignetteBio involves a total transaction amount of 635 million USD for the overseas rights to the EMB-06 TCE drug, highlighting market recognition of Anmai Biotech's TCE pipeline [5] Product Pipeline and Market Potential - Anmai Biotech's core product, EMB-01, is designed for treating colorectal cancer and is the first EGFR/cMET dual-specific antibody to enter Phase II clinical trials globally [8][10] - The colorectal cancer market in China is projected to be valued at approximately 3.1 billion USD in 2024, with significant growth expected, indicating a substantial market opportunity for the company's products [9][10] - The competitive landscape is intensifying, with seven other candidates targeting the same EGFR/cMET pathway in development, posing challenges for the company's market position [10]
国产抗癌神药,转手卖了800亿
36氪· 2025-06-27 10:15
以下文章来源于投中网 ,作者蒲凡 投中网 . 投中网是领先的创新经济信息服务平台,拥有立体化传播矩阵,为创新经济人群提供深入、独到的智识和洞见,在私募股权投资行业和创新商业领域拥有权 威影响力。官网:www.chinaventure.com.cn 一笔交易直接赚麻了。 文 | 蒲凡 来源| 投中网(ID:China-Venture) 封面来源| P exels 假如有这样一款神药:它可以有效治疗癌症,走出了一条与化疗的"杀敌一千、自损八百"截然不同的路线,一方面能够阻止恢复患者的T细胞功能,增强身 体对肿瘤的免疫反应,另一方面还能抑制肿瘤部位的血管生成,从而切断肿瘤的营养供应,双管齐下的抑制肿瘤的发展。与此同时,又因为这款神药可 以"双管齐下",患者还能减少药物种类,降低药物相互作用的风险。 而你是一家制药公司的老板,你的技术顾问告诉你这款神药将成为下一代癌症治疗方案的"主角",现在你有一个机会买下这款神药的研发权,你愿意出多少 钱? 美国制药巨头百时美施贵宝的答案是,800亿。 日前,百时美施贵宝与德国生物技术公司BioNTech达成合作协议,获得联合开发和销售抗癌神药PD-L1/VEGF-A双特异性抗体B ...
“BD”之王和铂医药又有新生意了
Guo Ji Jin Rong Bao· 2025-06-23 10:43
Core Viewpoint - Heptagon Pharmaceuticals has entered into a global strategic collaboration with Otsuka Pharmaceutical to jointly develop and commercialize the BCMAxCD3 bispecific T cell engager HBM7020, with a total collaboration value of up to $670 million [1][2]. Group 1: Collaboration Details - The collaboration includes an upfront payment of $47 million and potential milestone payments, with Heptagon eligible for up to $623 million in additional payments upon achieving specific research and commercial milestones [1]. - This marks Heptagon's second major business development (BD) deal with a multinational corporation (MNC) in 2023, following a $4.6 billion deal with AstraZeneca in March [1]. Group 2: Product Information - HBM7020 is a BCMAxCD3 bispecific antibody developed using Heptagon's fully human HBICE bispecific technology and Harbour Mice platform, designed to effectively activate T cells and target specific cells [2]. - The antibody features two binding sites for BCMA, allowing for precise targeting and reduced risk of cytokine release syndrome (CRS), showcasing strong cytotoxic capabilities with broad applications in immunology and oncology [2]. Group 3: Market Position and Achievements - Heptagon has successfully licensed out its bispecific antibody pipeline to international pharmaceutical companies, with total transaction amounts exceeding $1.6 billion, highlighting its global competitiveness [3]. - In Q1 2023, the number of pharmaceutical transactions in China increased by 34% year-on-year, with Heptagon ranking among the top 10 in both global and Chinese pharmaceutical transactions due to its significant deal amounts [3]. - The company has diversified its collaborations across various mechanisms, including ADCs, single/double/multi-antibodies, cell therapies, mRNA, and AI, indicating a successful transition since 2022 [3].
手握21亿美金BD!岸迈生物冲击IPO,尚无产品上市
Ge Long Hui· 2025-06-23 10:31
Group 1: Industry Overview - Domestic innovative drugs have recently secured significant overseas deals, particularly in the bispecific antibody sector, leading to a substantial rise in the domestic innovative drug market, with the Hong Kong innovative drug ETF (513120) achieving a maximum increase of 73% from the beginning of the year to June 13 [1] - On June 23, Heptares Therapeutics announced a collaboration with Japan's Otsuka Pharmaceutical, granting global development rights (excluding Greater China) for its self-developed BCMA/CD3 bispecific T cell engager HBM7020, with a total transaction value of up to $670 million, resulting in a stock price increase of over 12% for Heptares [1] Group 2: Company Profile - Anmai Biotech, founded in 2015 under the leadership of Dr. Wu Chenbing, focuses on the bispecific antibody field and is headquartered in Shanghai [4] - The company has undergone multiple rounds of financing, with major institutional investors including State Investment Innovation, Decheng Capital, Yuanhe Origin, and others, achieving a valuation of approximately $492 million in April 2022 [5] Group 3: Product Pipeline - Anmai Biotech is advancing a series of innovative T cell engagers, with core products EMB-06 and EMB-07 currently in Phase I clinical trials [20] - EMB-01, a bispecific antibody targeting EGFR/cMET, is among the first to enter Phase II trials for colorectal cancer, with IND approval received in May 2025 and expected to start trials in the second half of 2025 [15][16] - The company has eight self-developed pipelines under research as of June 10, 2025, with six in oncology and two in immunology [11][12][13] Group 4: Financial Performance - In 2023, Anmai Biotech reported a loss of 595 million yuan, primarily due to R&D and management expenses, with no product sales revenue [22] - The company generated revenue of 459 million yuan in 2024, all from external licensing and collaboration agreements, achieving a profit of 47.7 million yuan [22][25] - As of the end of 2024, the company had net liabilities of 2.344 billion yuan, largely due to redeemable preferred shares amounting to 2.747 billion yuan [24]
岸迈生物递表港交所
Jing Ji Guan Cha Bao· 2025-06-18 10:05
Group 1 - The core viewpoint of the news is that Anmai Biotech has submitted its listing application, with CITIC Securities and China Merchants International Capital serving as joint sponsors [1] - Anmai Biotech, established in 2015, is a clinical-stage biotechnology company focused on developing T-cell engagers for treating various cancers and autoimmune diseases [1] - The oncology pipeline includes three clinical-stage candidates: EMB-01 targeting EGFR/cMET for colorectal cancer, EMB-06 targeting BCMA/CD3 for multiple myeloma, and EMB-07 targeting ROR1/CD3 for lymphoma and solid tumors [1] Group 2 - Anmai Biotech's core business model leverages nearly a decade of experience in the field, utilizing proprietary bispecific antibody platforms and CD3 binding domain libraries for the discovery, development, and commercialization of bispecific antibodies and T-cell engagers [2] - As of the end of 2023, Anmai Biotech has established multiple global licensing collaborations with a total transaction value exceeding $2.1 billion, ranking second globally in the T-cell engager field [2] - Financially, Anmai Biotech is projected to generate approximately 459 million RMB in revenue for the fiscal year 2024, with a loss of 595 million RMB in 2023 and a profit of 48 million RMB anticipated for 2024 [2]
国产抗癌神药,转手卖了800亿
投中网· 2025-06-18 02:21
将投中网设为"星标⭐",第一时间收获最新推送 一笔交易直接赚麻了。 作者丨 蒲凡 来源丨 投中网 假如有这样一款神药:它可以有效治疗癌症,走出了一条与化疗的 " 杀敌一千、自损八百 " 截然不同的路线,一方面能够阻止恢复患者的 T 细胞功 能,增强身体对肿瘤的免疫反应,另一方面还能抑制肿瘤部位的血管生成,从而切断肿瘤的营养供应,双管齐下的抑制肿瘤的发展。与此同时,又因为 这款神药可以 " 双管齐下 " ,患者还能减少药物种类,降低药物相互作用的风险。 而你是一家制药公司的老板,你的技术顾问告诉你这款神药将成为下一代癌症治疗方案的 " 主角 " ,现在你有一个机会买下这款神药的研发权,你愿 意出多少钱? 美国制药巨头百时美施贵宝的答案是, 800 亿。 什么叫赚麻了?这就叫赚麻了。 抗癌神药,中国造 这款神药名字里的 "PD-1/VEGF" ,指代的是 PD-1 和 VEGF 两个治疗靶点。 PD-1 是一种关键的免疫检查点蛋白,与 T 细胞、 B 细胞和 NK 细 胞等免疫细胞的表达程度息息相关。科学家们研究发现,当 PD-1 与其配体 PD-L1 和 PD-L2 结合时,会抑制 T 细胞的活性,帮助肿瘤细胞 ...