Intas Gets SEC Nod to Import, Market Anti-Cancer Drug Serplulimab, Phase IV Trial Mandated
New Delhi: Intas Pharmaceutical has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the anti-cancer drug Serplulimab.
In addition, the committee recommended the firm to Phase IV Clinical Trial protocol of the anti-cancer drug Serplulimab.
This came after the firm presented the additional data for seeking approval to import and market Serplulimab Concentrate for Solution for Infusion 100 mg/10 ml Vial based on the safety and efficacy data generated from global clinical studies along with a request of local clinical trial waiver.
The committee noted that drug is now approved in EMA and the drug falls under the category of Orphan Drug.
Serplulimab is a fully humanized IgG4 monoclonal antibody that targets the PD-1 receptor, an immune checkpoint protein. It's designed to block PD-1, preventing cancer cells from shutting down the immune system's ability to attack them. Serplulimab has demonstrated promising anti-tumor activity and a manageable safety profile in various clinical trials, particularly in lung cancer.
At the recent SEC meeting for Oncology held on 13th May 2025, the expert panel reviewed the additional data for seeking approval to import and market Serplulimab Concentrate for Solution for Infusion 100 mg/10 ml Vial based on the safety and efficacy data generated from global clinical studies along with a request of local clinical trial waiver.
After detailed deliberation, the committee recommended for the grant of permission to import and market the drug with the condition to conduct Phase-IV clinical trial in India. "Accordingly, firm shall submit Phase IV Clinical Trial protocol to CDSCO within 03 months of grant of marketing authorization,m" the expert panel noted.
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