BioNTech SE

▎Armstrong2025年3月31日，和铂医药公布2024年度业绩，全年总收入2.74亿元人民币，盈利约1941万元，这也是和铂医药连续两年实现盈利。截至2024年12月31日，和铂医药现金及现金等价物约12亿元人民币，财务状况保持稳健，为后续发展奠定了坚实的财务基础。值得注意的是，和铂医药2024年净现金流入高达2.21亿元，创历史新高。研发管线：差异化显著，临床开发快速推进和铂医药聚焦于免疫和炎症性疾病、肿瘤等治疗领域，拥有多款处于临床阶段及IND或IND申报准备阶段的、高度差异化的创新候选药物。FcRn抗体巴托利单抗于2024年6月递交治疗全身型重症肌无力（gMG）的上市申请并于7月获得受理。长效TSLP抗体治疗COPD的IND申请于2025年2月获批。新一代CTLA-4抗体普鲁苏拜单抗在针对晚期实体瘤的单药治疗以及联合PD-1抑制剂治疗黑色素瘤、结直肠癌、神经内分泌癌及肝细胞癌的临床试验中，均观察到了积极的疗效及安全性数据。全球首创B7H7抗体HBM1020，去年ESMO会议上披露初步临床数据，在接受治疗后肿瘤评估的15例患者中，7例患者（46.7%）达到疾病稳定（SD），其中2例患者观察到肿瘤缩小，缩小比例分别为11%和25%。后续还有多个管线处于IND或者准备IND阶段，包括转向自免领域的BCMA/CD3双抗，PD-L1/CD40双抗，B7H4/CD3双抗，全球首创LIFR抗体等。创新管线及技术：推动国际化全新模式和铂医药子公司诺纳生物已通过多元创新合作模式达成多项国际战略合作，并基于HCAb构建形成四大前沿核心技术，包括蛋白质工程、抗体偶联技术、药物递送技术和细胞治疗，应用场景也从肿瘤免疫向验证和免疫等更广泛的领域扩展，全面赋能新一代疗法开发。2024年5月，诺纳生物与阿斯利康就一款临床前抗肿瘤抗体达成授权合作。2024年12月，诺纳生物与Candid Therapeutics合作开发新一代TCE。2025年1月，超长效TSLP抗体通过NewCo模式出海。长效TSLP抗体的成功也标志着和铂医药的实力在向炎症领域扩展过程中得到验证。2025年3月21日，和铂医药宣布与阿斯利康达成全球战略合作，双方将共同研发针对免疫性疾病、肿瘤及其他多种疾病的新一代多特异性抗体疗法。根据协议，和铂医药将获得总计1.75亿美元的首付款、近期里程碑付款和额外新增项目的选择权行使费，以及最高达44亿美元的研发及商业里程碑付款，外加一定比例的销售分成。此外，阿斯利康还将对和铂医药进行1.05亿美元的股权投资。此次合作进一步优化了和铂医药的财务状况，可以最大化和铂医药创新能力的商业价值，加速创新管线的产出和全球临床开发进度，并为全球生物医药行业发展注入越来越多的创新源动力。总结药物形式层面，和铂医药的TCE在自免领域开始攻城略地，实体瘤TCE也蕴藏巨大机会，完成迭代升级的ADC平台可以助力进一步打造差异化优势的产品组合。在中国biotech公司中，和铂医药走出了一条独特的创新和商业化路径，连续两年实现盈利且2024年经常性收入增幅接近200%，不断证明这种模式的可行性和强大的增长潜力。2025年，和铂医药有望进一步扩大合作网络，建立更为广泛的全球合作伙伴关系。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

Shares of several prominent vaccine makers fell Monday morning after the resignation late Friday evening of the Food and Drug Administrations top vaccine official, Peter Marks.In his resignation letter, Marks cited differences with new Health and Human Services Secretary Robert F. Kennedy Jr., who he said sought subservient confirmation of his misinformation and lies.As head of the FDAs Center for Biologics Evaluation and Research since 2016, Marks has overseen the agencys review of new vaccines, blood products and gene therapies. He helped drive forward Operation Warp Speed under the first Trump administration, which led to the U.S. quickly obtaining safe and effective vaccines for COVID-19.Marks apparent ouster has raised new alarms over how Kennedy, who has for years sowed vaccine misinformation, might change the regulation and review of shots for infectious diseases.Shares in major vaccine makers such as Pfizer and GSK fell around 1% Monday morning, while smaller biotechnology companies like Moderna, BioNTech, Vaxcyte and Novavax declined more steeply. (Vaxcyte also released new trial data Monday that disappointed some analysts on Wall Street.)Kennedys vaccines views were a point of contention during his Senate confirmation hearings. Hes long been known as a vaccine skeptic and, as founder and the former chair of Childrens Health Defense, has helped spread disproven theories about the safety of some available shots.Since taking office, Kennedy has faced criticism for his handling of the measles outbreak that has infected nearly 500 people across the U.S. through last week. (Confirmed totals may undercount the true spread.)Marks addressed the outbreak directly in his letter: The ongoing multistate measles outbreak that is particularly severe in Texas reminds us of what happens when confidence in well-established science underlying public health and well-being is undermined.Two doses of the available vaccine for measles are 97% effective against the disease. While Kennedy has encouraged parents discuss vaccination of their child with their physician, hes also said the decision to vaccinate is a personal one, and touted treatments considered ineffective such as vitamin A.Vaccine advisory meetings have also been disrupted under Kennedy, although one involving Centers for Disease Control and Prevention advisers was rescheduled to next month. It will include discussion of vaccines for COVID, respiratory syncytial virus, human papillomavirus infection and measles.David Risinger, an analyst at Leerink Partners, wrote in a Sunday note to clients that the CDC meeting will be an important catalyst for vaccine developers.Analysts at Jefferies see Marks departure as causing greater uncertainty for vaccine makers, but wrote that the rescheduled meeting agenda signals a commitment to established vaccine evaluation processes.Analysts also viewed President Donald Trumps nomination of Susan Monarez to be CDC director, replacing the withdrawn nomination of vaccine critic David Weldon, as a positive. Monarez has been with the Advanced Research Projects Agency for Health since 2023.The choice of Marks successor may also be another litmus test. Senator Bill Cassidy, R.-La., who provided the key vote for confirming Kennedy, said on X Saturday that Marks should be replaced with someone of similar stature and credibility amongst the scientific community, who will lead without bias.Martin Makary, confirmed as FDA Commissioner last week, would typically control who is named to fill Marks position.Moderna, BioNTech, Novavax and HHS did not respond to requests for comment from BioPharma Dive. '

▎Armstrong2025年美国癌症研究协会年会（AACR）即将于4月25-30日在美国芝加哥举行，最近会议摘要已经公开，中国创新密集亮相。以ADC领域为例，绝大部分的报告来自中国药企，创新ADC接近100款，覆盖各种技术路线和靶点上的创新，真正开始引领ADC的创新前沿。双靶点ADC为ADC领域当前最热门的方向之一，百力司康、百奥赛图、博锐生物、橙帆医药、多禧生物、恒瑞医药、基石药业、金赛药业、康宁杰瑞、康源博创、联进生物、启德医药、石药集团、拓济生物、先声药业、信达生物、映恩生物、亲和力生物等多家企业布局。双毒素ADC也开始走到台前，康弘药业、亲和力生物系统布局双毒素ADC，康弘药业的KH815为全球首款进入临床阶段的双毒素ADC新药。两种payload分别为TOP1i和RAN POL2i，同时抑制RNA合成并诱导DNA双链断裂。康宁杰瑞进一步开发了双靶点双毒素ADC，即EGFR/HER3双毒素ADC新药JSKN021。传统ADC的理念是毒素经抗体结合受体介导内吞后释放，DXd-ADC则证明了旁观者效应的重要作用，宜联生物则进一步开发了非内吞ADC，靶向游离靶标VEGF，通过肿瘤微环境特异性酶来释放毒素，进一步打开了ADC药物的应用空间。维立志博开发了首款TCE的ADC，即DLL3/CD3 ADC新药LBL-058，由DLL3/CD3双抗偶联TOP1i而成，T细胞杀伤与payload细胞毒杀伤效应协同。虽然TCE在少数靶点已经开始突破实体瘤，但TCE-ADC的设计无疑为突破实体瘤提供了一种全新强化设计的思路。总结从此次AACR会议来看，中国ADC无论在数量上，还是在差异化设计上，毫无疑问都在真正引领ADC的创新前沿，新靶点ADC、新靶点组合双靶点ADC、双毒素ADC、PDC、TCE-ADC、非内吞ADC等等，以及AACR会议不涉及的自免ADC（映恩生物已经进入临床阶段）等。未来几年，国产ADC的临床突破和出海交易仍然是值得期待的行业焦点所在。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。