2026年2月24日，复星医药子公司复宏汉霖（2696.HK）宣布，已与Abbott达成一项独家许可协议，授权其在亚太、非洲、中亚、东欧及其他新兴市场的部分国家和地区，就其创新抗PD-1单抗H药汉斯状?（斯鲁利单抗，欧洲商品名：Hetronifly?）开展包括广泛期小细胞肺癌（ES-SCLC）在内的多项适应症的商业化合作。本次合作是在双方于2022年及2024年达成的两项合作基础上的进一步深化，将充分依托Abbott在新兴市场广阔的商业化网络与在新兴市场和拉丁美洲分别成功上市和商业化落地肿瘤生物类似药以及H药的专业能力。
复宏汉霖首席商务发展官兼高级副总裁
曹平女士表示
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此次与Abbott的合作进一步深化，是公司全球化进程中的又一重要里程碑。依托Abbott广泛的市场覆盖和成熟的商业化经验，我们相信本次合作将有助于推动H药进入更多国家和地区，惠及更广泛的患者群体。未来，复宏汉霖将继续坚持以患者为中心的使命，携手全球合作伙伴，不断提升创新疗法的可及性与可负担性，让中国生物医药创新的成果惠及全球患者。
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作为全球首个获批用于ES-SCLC一线治疗的抗PD-1单抗，截至2025年12月，H药已在全球40多个国家和地区获得当地监管批准，包括中国、欧盟、英国、瑞士、秘鲁、印度及多个东南亚国家和地区。复宏汉霖正通过一系列战略合作，加速推进H药的全球商业化进程。2022年，复宏汉霖与复星医药已就H药在美国市场的商业化达成独家许可合作协议。
2023年，复宏汉霖授予Intas 就H药在欧洲及印度市场的独家开发及商业化权益。2025年，复宏汉霖授予Lotus就H药在韩国市场的独家商业化和半独家开发权益。此外，根据2019年及2023年签署的相关协议，复宏汉霖授予PT Kalbe Genexine Biologics（KGbio） H药在东盟10个成员国及中东和北非（MENA）地区12个国家的独家开发和商业化权益。
在复宏汉霖与KGBio协商一致终止此前就H药的合作后，KGBio除继续保留H药在印度尼西亚市场的独家权益之外，复宏汉霖已将H药在上述地区的商业化权益重新分配并转授予Abbott。本次战略调整有助于复宏汉霖进一步优化区域合作布局，并充分发挥Abbott在相关市场的综合能力，加速推动H药的全球覆盖与可及性。
H药已在多种实体瘤中展现出良好的抗肿瘤活性和良好的安全性。基于其在肺癌及消化道肿瘤领域已验证的疗效基础，该产品目前已获批用于多项适应症，包括鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）以及非鳞状非小细胞肺癌（nsNSCLC）1。
复宏汉霖正全面推进H药的全球临床开发计划，目前已在全球开展超过10项肿瘤免疫联合治疗研究，累计入组患者超过5,100例。其中，III期ASTRUM-006研究评估了H药联合化疗作为新辅助治疗，以及H药单药作为辅助治疗用于胃癌围手术期的治疗方案。该研究是全球首个以术后免疫单药替代术后辅助化疗的胃癌围手术期治疗方案，是该领域的重要临床突破2。该方案近期亦获得中国国家药品监督管理局（NMPA）授予的突破性疗法认定（BTD）。
在结直肠癌领域，III期国际多中心ASTRUM-015研究已完成患者入组。该研究评估了H药联合贝伐珠单抗及化疗用于转移性结直肠癌（mCRC）一线治疗的疗效与安全性。同时，其II期临床的最新数据进一步凸显了H药在带来高疾病负担的恶性消化道肿瘤领域持续拓展临床价值的潜力3。
展望未来，复宏汉霖将继续与国际合作伙伴保持紧密协作，充分发挥各方资源与专业优势，加速推进H药的全球开发与商业化进程。通过这一共同努力，H药有望在更多国家和地区实现可及性提升，为患者提供更加丰富的治疗选择。
【参考文献】
Serplulimab Prescribing Information. Henlius. Accessed December,23 2025.
https://www.henlius.com/upload/202501/14/%E6%96%AF%E9%B2%81%E5%88%A9%E5%8D%95%E6%8A%97%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf
China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer. Henlius. December 12, 2025. Accessed December,232025. https://www.henlius.com/en/NewsDetails-5670-26.html
Wang ZX, Peng J, Liang X, et al. First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. Med. 2024;5(9):1150-1163.e3. doi:10.1016/j.medj.2024.05.009
Henlius’ Novel anti-PD-1 mAb Serplulimab Will be Available in More Markets
Shanghai, China, February 24, 2026 - Shanghai Henlius Biotech, Inc.(2696.HK) has entered into an exclusive license agreement with Abbott for the commercialisation of serplulimab (trade name in Europe: Hetronifly?), Henlius’ novel anti-PD-1 mAb for several indications including extensive stage small cell lung cancer (ES-SCLC) in selected markets across Asia Pacific, Africa, Central Asia, Eastern Europe, and other emerging regions. This agreement builds on the companies’ two prior collaborations, signed in 2022 and 2024, building on Abbott’s broad emerging markets commercial footprint and expertise for the commercialisation and launch of oncology biosimilars in emerging markets and serplulimab in Latin America.
Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said:“This expanded collaboration with Abbott marks another significant milestone in our globalization journey. Leveraging Abbott’s extensive market presence and commercialisation expertise, we believe that this collaboration will help expand the reach of serplulimab in more countries and regions, benefiting a broader patient population. Moving forward, Henlius will continue to uphold its patient-centric mission and work hand in hand with global partners to enhance the accessibility and affordability of innovative therapies, bringing the value of China’s biopharmaceutical innovation to patients worldwide.”
As of December 2025, serplulimab has obtained regulatory approvals across over 40 countries and regions, including China, the EU, the UK, Switzerland, Peru, India, and multiple Southeast Asian markets, and stands as the world’s first anti-PD-1 mAb approved for the first-line treatment of ES-SCLC. Henlius continues to accelerate the global commercialisation of serplulimab through a series of strategic partnerships. In 2022, Henlius and Fosun Pharma entered into an exclusive license agreement for serplulimab in the U.S.
In 2023, Henlius granted Intas exclusive rights to develop and commercialise serplulimab in Europe and India. Henlius also granted Lotus an exclusive license for commercialisation and a co-exclusive for development in South Korea in 2025. In addition, Henlius granted PT Kalbe Genexine Biologics (KGbio) exclusive rights to develop and commercialise serplulimab across 10 ASEAN member countries and 12 MENA countries under agreements signed in 2019 and 2023.
Following a mutual agreement to conclude the previous collaboration with KGBio, Henlius has reassigned and transferred the commercialisation rights for serplulimab in the aforementioned regions to Abbott, while KGBio retains exclusive rights in Indonesia. This strategic realignment enables Henlius to further consolidate its regional partnerships and leverage Abbott''s extensive capabilities to accelerate serplulimab’s global reach.
Serplulimab has demonstrated robust anti-tumour activity and a favourable safety profile across multiple solid tumours. Built on its proven efficacy in lung cancer and gastrointestinal cancers, the product has been approved for indications including squamous non-small cell lung cancer (sqNSCLC), extensive stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). 1
Henlius is advancing a comprehensive global clinical development programme for serplulimab, with over 10 immune-oncology combination studies underway and 5,100 patients enrolled worldwide. Its phase 3 ASTRUM-006 trial—evaluating serplulimab plus chemotherapy as neoadjuvant therapy and serplulimab monotherapy as adjuvant therapy for gastric cancer—represents the world’s first perioperative gastric cancer regimen in which immune monotherapy replaces postoperative adjuvant chemotherapy, marking a major clinical breakthrough in the field.2 It was also recently granted Breakthrough Therapy Designation (BTD) by China''s National Medical Products Administration (NMPA) for the perioperative treatment of gastric cancer.
In colorectal cancer, the international multicentre phase 3 stage of ASTRUM-015 study—evaluating serplulimab in combination with bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC)—has completed patient enrolment, while emerging data from its phase 2 stage further underscore serplulimab’s potential to expand its clinical value across high-burden gastrointestinal malignancies.3
In the future, Henlius will continue to collaborate closely with its international partners, leveraging their respective resources and expertise to accelerate the global development and commercialisation of serplulimab. This joint effort aims to expand access across more countries and regions, offering patients a broader range of therapeutic options.