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.
References
1. 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
2. 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
3. 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