SIM0270

DALLAS--(BUSINESS WIRE)--Susan G. Komen®, the world’s leading breast cancer organization, today issued its 2026 Breast Cancer Progress Outlook. New data shows the U.S. breast cancer death rate has declined 44% between its peak in 1989 and 2023 — averting an estimated 546,000 deaths due largely to advances in treatment and earlier detection through screening. Yet breast cancer remains an urgent public health challenge. Incidence of invasive breast cancer has been rising since the mid-2000s, increasing by an average of 1% per year from 2013 to 2022, with faster growth among women under 50 (1.4% per year). An estimated 43,000 people in the U.S. are expected to die from the disease this year. While decades of progress demonstrate what is possible when science, early detection and access to high quality care come together, these gains have not been experienced equally. Persistent socioeconomic and racial disparities continue to drive barriers to lifesaving care; breast cancer mortality has not decreased among American Indian and Alaska Native women over the past 30 years and remains 37% higher in Black women compared with white women, despite lower incidence, and resistance to existing therapies is still driving breast cancer to spread and become deadly for tens of thousands of people in the U.S. annually. Closing these gaps and accelerating research progress is essential to save lives and improve for everyone affected by the disease. These efforts must be complemented by state and federal policies that drive new discoveries and provide greater access to affordable, high-quality care. What’s Next: The Innovations Shaping the Future of Breast Cancer Care Over the past 30 years, Komen’s investment in research contributed to the development of 30 lifesaving, FDA-approved breast cancer drugs. More promising research advances for patients are on the way in 2026 thanks to the collective work of the scientific community. Three areas in particular are making significant progress for patients: new oral treatments for metastatic hormone receptor-positive breast cancer, simple blood tests that may be able to detect tiny traces of cancer DNA in the bloodstream and next-generation therapies that use lab-made antibodies to deliver chemotherapy directly to cancer cells. Oral pills called Selective Estrogen Receptor Degrader, or SERDs, which can be taken at home, offer an easier alternative to long-standing injected treatments for people with hormone receptor–positive breast cancer. These new options could make care more convenient and help people stay on treatment longer. Another major area to watch is antibody-drug conjugates (or ADCs), which act like targeted missiles by attaching chemotherapy to an antibody that seeks cancer cells. Early results show these therapies can be highly effective and more targeted to cancer cells. Researchers are also making progress with “liquid biopsies” (also known as ctDNA and MRD testing) which allow doctors to look for cancer DNA in the blood. This could one day help detect recurrence earlier and guide more personalized treatment decisions. To educate our community on the rapid advances in breast cancer care, Komen reports on the latest advances in breast cancer research and treatment through its Breast Cancer Breakthroughs YouTube series. “All these developments point toward a future of more precise, personalized care — matching the right treatment to each person at the right time,” said Victoria Smart, senior vice president of mission, Susan G. Komen. “Most importantly, this lifesaving progress would never be possible without our researchers, the investment made to support them at all stages of their careers and most importantly the countless patients who have helped inform these advancements along the way and participated in clinical trials. There is so much to be proud of and look forward to in the breast cancer research space — every day a step closer to a world where no one dies from breast cancer.” Harnessing the Power of AI Without Creating More Inequities While we look to the lab and clinic for advances in research and treatment, the rise of artificial intelligence (AI) also presents new opportunities and challenges for patients and doctors alike. For example, patients can utilize AI to research their treatment plan, learn more about their disease and discover possible clinical trial options to discuss with their care team. While not yet part of today’s standard care, AI is being used by some to help alleviate provider burden and improve accuracy of screening mammograms and, therefore, detecting the disease earlier — leading to better survival rates. What’s more, recent studies suggest that AI could help build risk-prediction models to better identify higher-risk patients, offering a chance for more personalized cancer screening plans. At the same time, careful and responsible implementation is essential. The use of AI in breast cancer screening is still under study, and overall, providers and health care systems must ensure that the utilization of AI doesn’t inadvertently deepen disparities or create additional barriers to high-quality care: increased costs, limited availability or create new barriers for patients seeking timely, high-quality care. For example, since AI tools often use information from unclear or no evidenced based resources, guidance from a patient’s care team is always necessary to prevent the spread of mis- and disinformation. Additionally, AI is trained on existing datasets, and if those datasets do not represent the population of people impacted by breast cancer, the information can be skewed or even harmful to certain people. In fact, only about 5% of adults with cancer participate in clinical trials, and fewer than 10% of those participants represent people who are historically marginalized. This inclusivity is essential not only to developing treatments that work for every demographic but also to building the robust data needed to avoid deepening health inequities. While mis-information has long been a concern in health care, Komen continues to serve as a trusted resource of breast health information. With its long-standing partnership with Harvard University and the Dana-Farber Cancer Institute, Komen and our team of scientific and public health experts ensure our educational content reflects the latest research and best practices in breast cancer care. “As science continues to accelerate, Komen remains focused on ensuring progress reaches every person affected by breast cancer and that every person has the information they need to make informed health care decisions,” Smart continued. “We’re living in the future we dreamt about only 20 years ago — emerging therapies, smarter screening tools and countless lessons learned. But with this power comes the great responsibility to both challenge and embrace new technology as it becomes a permanent tool in the patient experience.” About Susan G. Komen® Susan G. Komen® is the world’s leading nonprofit breast cancer organization, working to save lives and end breast cancer forever. Komen has an unmatched, comprehensive 360-degree approach to fighting this disease across all fronts and supporting millions of people in the U.S. and in countries worldwide. We advocate for patients, drive research breakthroughs, improve access to high-quality care, offer direct patient support and empower people with trustworthy information. Founded by Nancy G. Brinker, who promised her sister, Susan G. Komen, that she would end the disease that claimed Suzy’s life, Komen remains committed to supporting those affected by breast cancer today, while tirelessly searching for tomorrow’s cures. Visit komen.org or call 1-877 GO KOMEN. Connect with us on social at www.komen.org/contact-us/follow-us/.

出品 | 创业最前线作者 | 张珏编辑 | 蛋总美编 | 邢静审核 | 颂文随着国内传统药企创新转型步入深水区，药企分拆业务板块独立上市正成为普遍趋势。继去年四环医药拆分轩竹生物、三生制药拆分蔓迪国际等，又一家老牌药企宣布拆分。2026年1月，先声药业旗下的肿瘤创新药平台先声再明正式向港交所递交招股说明书，拟在主板独立挂牌上市。这不仅是先声药业自2020年重回港股后的又一重大资本动作，也标志着这家老牌药企试图进一步理顺内部最具增长潜力的业务板块之一。肿瘤板块是先声药业“仿转创”的重要阵地，作为其肿瘤业务子公司，近年来先声再明每年都为先声药业贡献超10亿营收，去年更是达成三项肿瘤资产海外授权交易。因此，拆分消息一出，市场担忧先声药业肿瘤核心资产独立融资对其利润与发展的影响，先声药业股价在消息宣布当日下跌超5%。实际上，先声药业早已有拆分先声再明的计划，希望赋予其独立估值。这背后，是先声再明面临业绩与对赌的压力，还有在高杠杆运营下的市场挑战。1、先声药业分拆旗下增长引擎作为一家老牌制药公司，先声药业从2000左右就开始探索仿制药向创新药转型，但在很长一段时间内，先声药业在肿瘤领域仅有恩度这一款创新药。于2020年前后，先声药业逐渐加大在创新药领域的资源投入，先声再明也在2020年成立为有限责任公司，此后先声药业肿瘤创新药进度明显加快，自2022年起至今，先声再明相继推动四款肿瘤创新药与生物类似药步入商业化。在先声药业近年来逐步形成的肿瘤、神经系统、自身免疫及抗感染四大领域中，肿瘤板块贡献愈发明显。2025年上半年，先声药业抗肿瘤领域实现收入8.74亿元，同比增长达到41.1%，成为公司增速最快的板块，而先声再明几乎等同于先声药业的肿瘤板块。根据招股书数据，2025年前三季度，先声再明的营业收入已达到12.38亿元，相较于2024年全年12.96亿元的营收规模，先声再明在2025年的增长势头显著回升。（图 / 先声再明招股书）先声再明的增长主要依赖于其已经商业化的创新药产品：恩度、科赛拉、恩立妥、恩泽舒及恩维达。2023年至2025年前三季度，这五款创新药产品所产生收入分别为14.2亿、11.8亿和10.4亿元，占同期医药产品销售及商业化收入的93.7%、91.5%及83.7%。其中，恩度为重组人血管内皮抑制素注射液，科赛拉为CDK4/6抑制剂相关肿瘤支持用药，恩立妥为抗EGFR肿瘤改良型新药，恩泽舒及恩维达分别覆盖铂耐药卵巢癌及PD-1肿瘤免疫用药相关治疗场景，整体以实体瘤为核心适应症。医保准入是这些产品推动其放量的关键。2024年，科赛拉与恩立妥通过谈判进入国家医保目录，在2025年迅速实现了进院规模的扩张。就在递交招股书的前夕，其另一款重磅产品恩泽舒也于2025年12月成功入选医保，并在2026年初正式生效，这被市场视为其2026年营收持续增长的重要支撑。除了国内市场的销售，先声再明在过去一年里还扮演了先声药业海外“BD主力”的角色。2025年，先声再明连续达成了三项重大对外授权交易，按肿瘤资产交易数量计算，位居中国生物制药企业首位。这三笔交易涉及三特异性TCE分子SIM0500、CDH6靶向ADC（抗体偶联药物）药物SIM0505以及LRRC15靶向ADC药物SIM0613，合作伙伴包括跨国巨头艾伯维（AbbVie）、益普生（Ipsen）以及美国生物科技公司NextCure。三项交易的累计潜在交易价值超过28亿美元，不仅为先声再明带来了国际药企的背书，更直接贡献了现金流。2025年前三个季度，其许可收入（首付款等）达1.22亿元，占总收入9.9%。但在高增长与强BD表现的背后，先声再明尚未走出“烧钱”阶段。招股书显示，先声再明目前仍处于持续亏损状态。根据招股书，2023年公司亏损为3.36亿元，2024年亏损扩大至5.06亿元，2025年前三季度虽然亏损收窄至3.03亿元，但和稳定盈利的先声药业形成鲜明对比。这种亏损，也成为母公司业绩的拖累。2、早有计划上市，赎回负债在身在创新药研发的高投入与商业化销售的高成本压力之下，先声药业对于先声再明的独立运行与上市融资或许早有筹谋。招股书显示，先声再明的研发费用始终处于高位，2023年、2024年及2025年前三季度分别达到8.31亿元、7.08亿元和5.1亿元，占先声药业研发开支一半。从管线结构看，先声再明后续研发投入可能大幅增长，公司已布局TCE、ADC等高技术壁垒平台，相关药物研发本身具有周期长、临床试验成本高的特征。招股书显示，先声再明目前共拥有20条创新药管线，其中16条仍处于临床前至1期阶段，早期资产占比超过70%，而耗资巨大的7条ADC管线全部处于非常早期阶段。此外，随着商业化产品线不断扩容，先声再明为了在竞争激烈的肿瘤药市场抢占份额，不得不付出庞大的市场开拓成本。2025年前三季度，随着科赛拉在医保政策下的全面放量以及新药恩泽舒的上市推广，先声再明的销售及分销开支达到5.32亿元，这一数字已经超过了同期的研发投入，销售费率达42.9%。2024年，其销售费用率更是一度攀升至48.5%。（图 / 先声再明招股书）先声再明构建了一支超过1200人的专业销售团队，拥有逾120家分销商，覆盖全中国超过2000家医院，其中包括1500所三级医院，从而“确保商业化产品能覆盖全国关键的高价值市场”。2025年前三季度，先声再明销售员工成本增加2830万元，根据招股书，这主要由于其销售及营销团队的薪酬水平提升。先声药业在2024年加速了子公司的拆分进程，将先声再明改制为股份有限公司，并完成了一笔关键的A轮融资。这笔融资共计10.7亿元，由先进制造基金二期、中深新创、太平医疗健康、苏州杏泽及泉州鼎信等地方产业基金和医疗基金共同参与。此轮融资完成后，先声再明的投后估值达到了85.7亿元。根据招股书，先声药业目前通过数家实体合计持股约83.1%，先进制造基金二期占股9.33%，是最大的其他股东。这笔融资协议中附带了严苛的上市对赌与回购权安排：若先声再明未能在2027年年中前向证券交易所递交上市申请，或者未能在2028年底前完成上市，外部投资者有权要求公司回购股份，回购价格为本金加年化7%的利息。截至2025年9月30日，先声再明的赎回负债已达11.6亿元，其中仅赎回负债产生的利息就已接近1亿元。（图 / 先声再明招股书）2025年三季度，先声再明的总负债合计为21.41亿元，其中流动负债7.73亿元，非流动负债高达13.69亿元。其负债率从2023年底约21%的健康水平，在短短两年的时间里迅速飙升至接近61%。由于先声再明是先声药业的核心控股子公司，其全部负债均需纳入母公司的合并资产负债表。先声再明的对赌压力与高杠杆运营，正在直接推高先声药业的资产负债率。若上市进程受阻，先声药业或将面临数亿元的利息支出及回购压力。3、分拆之后，市场会重估先声吗？长期以来，作为一家从仿制药向创新药转型的老牌药企，先声药业在资本市场的表现难言亮眼。2022年至2024年间，受仿制药集采剥蚀利润及研发投入加大的双重挤压，先声药业的营收始终在60亿元规模上下徘徊，净利润增速放缓，呈现出明显的增长瓶颈。尽管2025年上半年业绩有所回暖，创新药收入占比首次超过77%，甚至在比例上超过了行业标杆恒瑞医药，但二级市场的反应依然平淡。到2026年1月，先声药业市值约270亿元。但先声药业本身仍具备稳定的盈利能力和较为充裕的现金储备。2025年上半年，公司实现营业收入35.85亿元，归母净利润6.04亿元，同比增长32.2%，现金及现金等价物约26.7亿元，在港股创新药企业中处于较高水平。（图片已获授权，基于VRF协议）市场对先声药业的保守评价，核心在于对其“管线拼盘化”的质疑。过去几年，先声药业的创新药产出高度依赖外部引进创新药，自研管线的成色一直未能得到资本市场的充分认可。在资本市场眼中，这类业务更接近于传统的商业化代理而非具备爆发力的生物创新药公司。因此，将增长最快、毛利较高的肿瘤资产先声再明独立分拆，是先声药业释放肿瘤板块价值的关键一步。根据计划，在分拆及上市完成后，先声药业仍将保持50%以上的控股权。这类似于科伦药业拆分科伦博泰的操作。2022年1月，科伦药业启动对旗下肿瘤创新药公司科伦博泰的股权结构优化，以增强其独立融资能力，并在2023年完成港股上市。截至2025年6月，科伦药业仍直接持有科伦博泰51.45%的股份，科伦博泰控股子公司地位未改变，然而科伦博泰市值最高点时已在千亿规模，近两倍于母公司。但是，科伦博泰的成功路径是以ADC技术平台为绝对核心，通过与全球制药巨头默沙东达成的累计超过118亿美元的巨额授权交易达成的。科伦博泰在尚未有商业化收入时，便凭借顶级药企背书和可见的全球化预期完成了市场定价。（图片已获授权，基于VRF协议）当前，科伦博泰的管线推进迅速，除15项全球3期临床研究正在与默沙东推进，已有三款自研创新药进入商业化。核心产品芦康沙妥珠单抗（TROP2 ADC）已在乳腺癌和非小细胞肺癌多个适应症获批，并被纳入国家医保目录。对比之下，尽管先声再明在2025年完成了三笔累计28亿美元的对外授权，但无论是单笔交易金额还是合作方的层级，与科伦博泰当年的默沙东大单相比仍有不小差异。且几款合作产品均在早期，合作方将来是否重视推进还是未知。此外，先声再明当前的创新药收入均非来自其自研产品：恩度由先声药业收购后优化改进，恩泽舒为联合开发，科赛拉与恩维达则是引进授权。自研项目中进度最领先的是定位治疗晚期乳腺癌的SIM0270，该项目已进入临床3期阶段。此次分拆对先声药业的实际意义，更多体现在财务结构的优化与融资渠道的拓展上。通过让先声再明独立面对资本市场，先声药业可以有效对冲研发和销售端的高额投入。但若想要真正实现肿瘤板块价值的重估，先声再明必须在上市后努力证明——其不仅是一个高效的商业化公司，更是一个具备技术壁垒和自研能力的创新药公司。*注：文中题图及未署名图片来自先声药业官方微博。