New Delhi, November 29, 2025 – The Central Drugs Standard Control Organization's (CDSCO) Subject Expert Committee (SEC) has directed Mankind Pharma to conduct a Phase I clinical trial in India for Sintilimab Injection 100 mg/10 ml before proceeding to Phase III studies.
The decision came after Mankind Pharma submitted a proposal to conduct a Phase III study using data generated primarily from non-Indian populations.
The pharmaceutical company had sought approval for a "Randomized, open-label, multi-center Phase III trial comparing Sintilimab plus chemotherapy against chemotherapy alone as first-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)," vide protocol no. MPL-SIN-001 version 1.1 dated 14.08.2025.
Sintilimab functions as a fully human immunoglobulin G4 (IgG4) monoclonal antibody designed to target the programmed cell death receptor-1 (PD-1). By binding to this receptor, the drug prevents PD-1 from interacting with its ligands, PD-L1 and PD-L2, which allows the body's natural anti-cancer immune response to be reactivated.
The therapy has received approval in China for treating classical Hodgkin's lymphoma in patients whose disease has relapsed or proven resistant following at least two lines of systemic chemotherapy. 1
The SEC raised concerns about insufficient safety evidence specific to the Indian population, noting that available data does not adequately establish tolerability for Indian patients.
The committee's review revealed that the PK/PD and Phase III data presented by Mankind Pharma were predominantly generated from studies conducted on Chinese patients, where the drug currently holds approval.
Beyond population-specific safety concerns, the SEC highlighted problems with the proposed trial design, specifically that the comparator arm used standard chemotherapy, which the panel considered inferior given that indicated immunotherapies are already available in India.
The committee's evaluation, documented in file BIO/CT04/FF/2025/50397, concluded that advancing directly to Phase III without prior assessment in Indian participants would pose unacceptable risk and fail to meet regulatory standards for local safety validation.
Mankind Pharma must submit a detailed Phase I protocol to CDSCO for review and approval before any late-stage clinical development can proceed. The Phase I study must be conducted specifically in the Indian population.
1. Hoy, S.M. Sintilimab: First Global Approval. Drugs 79, 341–346 (2019). https://doi.org/10.1007/s40265-019-1066-z
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