The National Agency of Drug and Food Control (NA-DFC) of Indonesia (BPOM) is the government insitution which is responsible for 3 main functions: supervision of drugs and foods, including development of policies, standards, procedures, and criteria; supervision of drugs and foods before release as preventive action to ensure drugs and foods meet the standards and safety requirements, benefits, and product quality; and supervision during the drugs and foods are released on market and including the law enforcement.

On 19 Oct 2022, Indonesia’s FDA (BPOM) has approved new indication “Locally advanced non-nasopharyngeal Squamous Cell Carcinoma of Head and Neck (SCCHN) (Stage III or IV A/B) in combination with concurrent chemoradiotherapy for Theracim (Nimotuzumab). Nimotuzumab is a humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody with intermediate affinity and high specificity. Nimotuzumab inhibits EGF binding to its receptor and inhibits tumor cell growth in vivo and in vitro. Nimotuzumab has potent anti-angiogenic, anti-proliferative and pro-apoptotic effects in EGFR overexpressing tumors.

KGbio at a Glance

KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biologics medical innovation to markets outside the US/Canada, Western Europe and China. The business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out-license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals.

Platforms of interest include Fc-fusion proteins, antibodies, bispecifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharma companies Kalbe, Genexine and US private equity giant General Atlantic.