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Drugs in development · updated 30 October 2026

Serplulimab: clinical trials and development status

Other names and codes: HLX10, Hetronifly

FDA substance registryNot approved in the USAuthorised in the EU (EMA) since 3 February 2025Estimated launch Dec 2027 – Oct 2028 (Phuturdex estimate)

As of 30 October 2026 Serplulimab is in 96 active clinical trials (recruiting or ongoing, phases I–III) for 24 diseases. The most advanced phase is III.

96Active trials
IIIMost advanced phase
24Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Serplulimab and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
Colorectal neoplasmII–III8NCT06280495
Lung small cell carcinomaIII7NCT05353257
Rectal neoplasmIII6NCT07113275
Triple-negative breast neoplasmIII4NCT04301739
Colonic neoplasmIII3NCT07877597
Stomach neoplasmII9NCT07902648
Non-small-cell lung carcinomaII8NCT07647094
Breast neoplasmII4NCT07283692
Esophageal squamous cell carcinomaII3NCT06601309
Uterine cervix neoplasmII3NCT07340489
AdenocarcinomaII2NCT07699939
Biliary tract neoplasmII2NCT07506057
Esophageal neoplasmII2NCT06601309
Lung neoplasmII2NCT07398937
MeningiomaII2NCT07713745
Neurofibromatosis 2II2NCT07713745
Neuroma, AcousticII2NCT07713745
Pancreatic neoplasmII2NCT06531291
EpendymomaII1NCT07713745
Hepatocellular carcinomaII1NCT06349980
Intermittent fastingII1NCT07779694
Neuroendocrine carcinomaI–II1NCT05747729
Transitional cell carcinomaII1NCT07506057
Adverse drug reactionI2NCT06716619

Everything on Serplulimab

In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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