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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 ...
登上Cell子刊:迈威生物ADC新药,有望克服多重耐药胃肠道癌症
生物世界· 2025-07-03 07:51
撰文丨王聪 编辑丨王多鱼 排版丨水成文 胃肠道 (GI) 癌症,包括肝癌、胃癌、胰腺癌、神经内分泌肿瘤以及最为常见的结直肠癌,是全球癌症相关死亡的主要原因。根据国际癌症研究机构 (IARC) 的最新统计数据,这些癌症约占所有癌症诊断病例的 24.6%,占癌症死亡病例的 34.2%。 在这项最新研究中,研究团队证明了 CDH17 在胃肠道癌症中高度表达,在结直肠癌的临床样本中几乎 100% 表达, 在其他胃肠道癌症中表达率也高达 23%-88%, 高表达与肿瘤进展、转移及临床预后不良密切相关,且 在正常组织中低表达, 因此成为胃肠道癌症治疗干预的理想靶点。 研究团队开发了一种抗 CDH17 的 抗体药物偶联物 (ADC) ,命名为—— 7MW4911 ,其采用了迈威生物专有的拓扑异构酶抑制剂 MF-6 (Topi MF-6) 有 效载荷,通过可裂解 Linker 的连接, 7MW4911 实现了 4 个 MF-6 与一个抗体偶联的均一偶联比,旨在解决胃肠道癌症中的多药耐药性 。 在全球范围内,结直肠癌 (CRC) 在所有癌症的发病率中排名第三,在癌症相关死亡率中排名第二,而胰腺癌尽管发病率较低,但死亡率却是最高 ...
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
根据披露,CS2013通过差异化分子设计同步阻断B细胞和浆细胞发育及存活所需的两个关键配体-BAFF 与APRIL,临床前研究显示其可触发高效协同效应;同时较融合蛋白类药物具备更优的药代动力学特 性,例如较长的半衰期,潜在更长的给药间隔,支持皮下给药等。拟开发适应症包括系统性红斑狼疮 (SLE)、类风湿性关节炎(RA)、IgA肾病(IgAN)等多种B细胞相关自身免疫性疾病。 格隆汇7月3日丨基石药业-B(02616.HK)发布公告,公司首次披露两款自主研发、针对自身免疫/炎症性 疾病的双特异性抗体药物靶点:CS2013(B细胞激活因子[BAFF]/ 增殖诱导配体[APRIL]);和 CS2015(OX40配体[OX40L]/ 胸腺基质淋巴细胞生成素[TSLP])。这两款药物具备同类最佳/同类首创潜 力,目前均处于临床前候选化合物(PCC)确认阶段,临床前研究数据将在相关国际学术会议上公布。此 外,基石药业计划于2025年下半年启动新药临床试验申请(IND)准备工作。 CS2015作为一款潜在同类首创、同时靶向OX40L(免疫应答细胞上的关键配体)和TSLP(上皮细胞分泌的 重要预警分子)的双抗,通过双重抑制T ...
中国两大医药“隐形冠军”专利战曝光 千亿市场谁出局谁独享
经济观察报· 2025-07-01 11:54
Core Viewpoint - The article discusses a patent dispute between two leading Chinese biopharmaceutical companies, Heptares Therapeutics and Baiaosaitu, focusing on their antibody technology platforms, which are crucial for their revenue and cash flow [2][5]. Company Overview - Heptares Therapeutics, known as "China's BD King," provides drug development and antibody technology to global pharmaceutical companies [4]. - Baiaosaitu, referred to as "China's Mouse King," initially focused on providing transgenic mice for drug testing and has developed its own antibody technology platform [4][13]. Patent Dispute Details - The core of the patent dispute involves a technology for producing antibody drugs, which is essential for both companies' operations [5]. - Heptares' technology was acquired from a Dutch company in 2016 and received patent authorization in China in 2022 after a lengthy legal battle [6][18]. - Baiaosaitu's technology was developed internally over ten years, with claims that it could reach Heptares' level in just three months [7]. - Heptares filed a lawsuit against Baiaosaitu in September 2024, alleging patent infringement, while Baiaosaitu countered by challenging the jurisdiction and claiming Heptares' patent is invalid [7][8]. Financial Performance - Heptares has secured significant contracts, including a deal worth up to $620 million, and has generated $185 million in revenue from licensing its technology from 2020 to 2024 [11]. - Baiaosaitu's antibody business revenue reached 318 million yuan in 2024, with a year-on-year growth of over 80% [14]. Technology Comparison - The article highlights the differences in technology between the two companies, with Baiaosaitu's platform utilizing a more comprehensive gene replacement method compared to Heptares' approach [22][25]. - The dispute centers on whether the methods of producing heavy-chain antibodies are equivalent, with differing opinions on the implications of gene usage [25]. Market Impact - The ongoing patent dispute has affected the market valuations of both companies, with Heptares' stock experiencing significant fluctuations in response to developments in the case [23].
Innovent Biologics (01801) Update / Briefing Transcript
2025-06-28 01:00
Summary of Innovent Biologics Update / Briefing Company Overview - **Company**: Innovent Biologics (01801) - **Event**: Healthy China 2030 Oncology Innovation Summit and R&D Day - **Date**: June 27, 2025 Key Points Industry Context - The oncology sector is a major health threat globally, affecting individuals regardless of socioeconomic status [10][14] - The biomedicine industry in China has evolved significantly over the past decade, transitioning from generics to innovative biologics [15][20] Company Achievements - Innovent was established in 2011 and has launched 16 products, with over 20 in R&D [21][22] - The company has invested over ¥8 billion (approximately $1.2 billion) and holds 20% of China's total biologics production capacity [21][22] - In 2024, Innovent's total revenue exceeded ¥9.4 billion (approximately $1.4 billion) [24] Market Position - Innovent is a leader in several oncology segments, including PD-1, VEGF, and CD20, with three of the top ten oncology drugs in China coming from Innovent [24] - The company has made significant strides in drug accessibility and affordability, with prices for monoclonal antibodies now a fraction of those in the U.S. [17][18] Future Outlook - By 2027, Innovent aims to achieve product revenue of ¥20 billion (approximately $3 billion) and to be among the top five in sales revenue in China's biopharma sector [26][40] - The company plans to have five assets in global MRCT Phase III trials by 2030 [30][41] R&D Innovations - Innovent is focusing on next-generation technologies, including new generation immuno-oncology (IO) and antibody-drug conjugates (ADC) [32][37] - The company is developing IBI-363, a PD-1 IL-2 fusion protein, which shows promise in enhancing anti-tumor immunity [36] - Collaborations with multinational firms like Roche, Eli Lilly, and Sanofi are ongoing to enhance R&D capabilities [21][22] Challenges and Opportunities - Despite progress, there are still unmet clinical needs in oncology, and Innovent aims to address these through innovative therapies [47][49] - The company is optimistic about the potential of ADCs combined with IO therapies to improve treatment outcomes for lung cancer and other malignancies [93][94] Conclusion - Innovent Biologics is positioned as a key player in the Chinese biopharma landscape, with a strong focus on innovation and collaboration to drive future growth in oncology treatments [49][50]
Kiniksa Pharmaceuticals International (KNSA) FY Conference Transcript
2025-06-10 13:00
Kiniksa Pharmaceuticals International (KNSA) FY Conference June 10, 2025 08:00 AM ET Speaker0 Thank you. Good morning, everyone. I'm Paul Choi. I'm a biotech analyst here at Goldman Sachs. It's my pleasure to welcome Conixa for our session this morning on the day of the conference. I'm required to read off certain disclosures, which primarily relate to investment banking relationships that Goldman Sachs may have with firm, companies presenting here at the conference. These relationships include, investment ...
DUALITYBIO(9606.HK):EMERGING AS A GLOBAL LEADER IN ADC INNOVATION WITH NEXT-GEN PLATFORMS AND STRATEGIC COLLABORATIONS
Ge Long Hui· 2025-06-07 09:53
Core Insights - DualityBio has a strong pipeline of antibody-drug conjugate (ADC) candidates, showcasing its innovation capabilities in the ADC space [1][2] - The company has established multiple strategic partnerships with global biopharmaceutical firms, enhancing its development efforts and validating its platform [3] - Revenue projections indicate significant growth, with expectations of reaching RMB2.0 billion by FY25E, primarily from licensing and collaborations [4] Group 1: ADC Product Pipeline - DB-1303/BNT323 (HER2 ADC) is expected to file for FDA accelerated approval by 2025 for HER2-expressing endometrial cancer [1] - DB-1311/BNT324 (B7-H3 ADC) shows promising early results with a 70.4% response rate in 3L+ SCLC patients [1][2] - DB-1310 (HER3 ADC) has demonstrated a median progression-free survival (mPFS) of 8.3 months in heavily pre-treated 4L+ EGFR-TKI resistant NSCLC [2] Group 2: Strategic Partnerships - DualityBio has formed partnerships with major companies like BioNTech, BeiGene, and GSK, resulting in a total deal value exceeding US$6.0 billion [3] - The partnerships focus on various ADC programs, including B7-H3, HER2, and TROP2 ADCs, which enhances the company's market position [3] - The replicable partnership model is seen as a sustainable path for future innovation and growth in the ADC sector [3] Group 3: Financial Projections - Total revenue is projected to reach RMB2.0 billion in FY25E, with expectations of product sales revenue starting in 2027E [4] - The target price for DualityBio is set at HK$270.34 based on a discounted cash flow (DCF) valuation [4]
四川首富,身家激增至900亿元!只因一笔交易
21世纪经济报道· 2025-06-05 12:26
以下文章来源于21新健康 ,作者季媛媛,韩利明 21新健康 . 21世纪传媒 · 公众号矩阵成员。 作 者丨季媛媛 韩利明 昨天,百利天恒(688506.SH)股价创阶段新高,而在5月30日该股收盘市值首次突破1200亿 元。2024年和2025年至今,百利天恒的股票涨幅分别达37%和56%。 持有百利天恒股票达 74.35%的董事长朱义,个人身家也涨至近900亿元,稳坐四川富豪头把交椅。 朱义财富快速飙升,源于一年半前的一笔大买卖。 2023年12月12日,一项足以撼动全球医药界的交易在中国低调完成。百利天恒与全球制药巨 头百时美施贵宝(BMS)签订了关于BL-B01D1的授权协议, 潜在总交易额高达84亿美元。 在那个被业界称为"资本寒冬"的严酷时期,这场交易犹如一声惊雷,唤醒了沉寂的医药市 场。 消息一出,上海张江药谷的众多办公室彻夜灯火通明。有创业者不断刷新手机屏幕以确认消 息的真实性,有投资人连夜召开紧急会议,重新评估行业赛道的价值。84亿美元——这一数 字不仅刷新了中国创新药BD交易的首付款及总金额纪录,更标志着一个新时代的到来:中国 本土研发的双特异性抗体药物(ADC)首次成功走向国际市场。 " ...
2025年ASCO中国之声:映恩生物公布两项ADC药物最新试验结果 首次评估时肿瘤缩小
Mei Ri Jing Ji Xin Wen· 2025-06-05 11:32
目前,映恩生物已披露了27条ADC研发管线,本次在ASCO大会上公布数据的DB-1310和DB- 1311/BNT324,目前均处于临床Ⅰ/Ⅱa期。 近日,2025年美国临床肿瘤学会(ASCO)年会在美国芝加哥拉开帷幕。中国ADC(抗体药物偶联物) 企业映恩生物(HK09606)以口头报告的形式,首次公布了DB-1310用于治疗晚期实体瘤患者的Ⅰ/Ⅱa 期试验的初步结果,以及DB-1311用于经多线治疗的去势抵抗性前列腺癌患者的数据。 《每日经济新闻》记者注意到,5月底,全球头部ADC药企"第一三共"撤回了类似药物的适应证在美国 寻求加速批准的BLA(生物制品许可申请)。 6月3日,映恩生物首席科学官邱杨在公司召开的2025年ASCO数据说明会上表示,团队对HER3(一种 表皮生长因子受体)靶点和DB-1310充满信心,未来,公司可能公布DB-1310在EGFR(也是一种表皮生 长因子受体,此处意在标明癌症基因分型)野生型肺癌和乳腺癌领域的更多数据。 研究结果:近三分之一患者首次评估时肿瘤缩小 DB-1310是一款HER3 ADC药物,对应的临床试验是一项多中心、开放性、非随机的首次人体研究,旨 在评估晚期/ ...
84亿美元交易撬动近900亿元财富:四川首富朱义的创新药生意经
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-05 10:30
21世纪经济报道记者 季媛媛 韩利明 上海报道 5月30日,百利天恒(688506.SH)股价再度大涨5.31%,收盘市值首次突破1200亿元。2024年和2025年 至今,百利天恒的股票涨幅分别达37%和56%。持有百利天恒股票达74.35%的董事长朱义,个人身家也 涨至近900亿元,稳坐四川富豪头把交椅。 朱义财富快速飙升,源于一年半前的一笔大买卖。 2023年12月12日,一项足以撼动全球医药界的交易在中国低调完成。百利天恒与全球制药巨头百时美施 贵宝(BMS)签订了关于BL-B01D1的授权协议,潜在总交易额高达84亿美元。 在那个被业界称为"资本寒冬"的严酷时期,这场交易犹如一声惊雷,唤醒了沉寂的医药市场。 消息一出,上海张江药谷的众多办公室彻夜灯火通明。有创业者不断刷新手机屏幕以确认消息的真实 性,有投资人连夜召开紧急会议,重新评估行业赛道的价值。84亿美元——这一数字不仅刷新了中国创 新药BD交易的首付款及总金额纪录,更标志着一个新时代的到来:中国本土研发的双特异性抗体药物 (ADC)首次成功走向国际市场。 "这证明了中国在创新药研发领域,特别是在顶尖技术领域,开始拥有全球话语权。"一位不愿具名 ...