New Delhi: The Subject Expert Committee functioning under the Central Drugs Standard Control Organisation (CDSCO) has opined Mankind Pharma should first conduct a Phase I clinical trial in India for Sintilimab Injection 100 mg/10 ml, instead of proceeding directly with a Phase III study as proposed.
This came after the firm presented a proposal to conduct a clinical trial titled, “A Phase III, Randomized, Open label, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of Sintilimab plus Chemotherapy compared to Chemotherapy alone as First-Line Treatment for Patients with 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.
The firm has presented the PK/PD and Phase III data, primarily generated on the Chinese population.
Sintilimab is a fully human IgG4 anti-programmed cell death 1 (PD-1) monoclonal antibody used as an immuno-oncology therapeutic
The committee noted that Sintilimab Injection is approved in China only. Safety in the Indian Population has not been adequately addressed either by available data or provision in the present study design. It was also observed that the comparator arm (chemotherapy) is inferior when the indicated therapy is available in India.
After detailed deliberation, the committee recommended that the firm should first conduct a Phase I study in the Indian population. Furthermore, the expert panel suggested that the firm is required to submit the Phase-I protocol to the CDSCO.
