CDSCO Panel Directs Mankind Pharma to Conduct Phase I Trial of Sintilimab Before Phase III Launch
Written By : Susmita Roy
Published On 2025-11-27 17:18 GMT | Update On 2025-11-27 17:18 GMT
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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.
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