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Press Conference on Rituxikal Distribution Permit Approval by BPOM

Press Conference on Rituxikal Distribution Permit Approval by BPOM

On 28 December 2022, BPOM has issued a distribution permit for Rituxikal as the first monoclonal antibody product produced by the domestic pharmaceutical industry. To find out more and answer questions about Rituxikal products, a press conference was held today, 30 January 2023, at PT Kalbio Global Medika (KGM), Cikarang, Indonesia.

The press conference was attended by the Chairperson of the Indonesian Food and Drug Authority (BPOM RI), Dr. Ir. Penny K. Lukito, MCP, Deputy for Drug Control, Narcotics, Psychotropics, Precursors and Addictive Substances Supervision of BPOM, Dra. Togi Junice Hutadjulu, along with other members of BPOM RI. Board of Directors from Kalbe Group and Kalbio Global Medika also attended, Bernadette Ruth Irawati Setiady as President Commissioner of PT Kalbe Farma Tbk, Vidjongtius as President Director of PT Kalbe Farma Tbk, and Sie Djohan as President Director of PT Kalbio Global Medika.

Rituxikal is used for blood cancer therapy or the treatment of Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia, in the form of a concentrated solution given intravenously.

Quoted from Alodokter, Non-Hodgkin Lymphoma is a blood cancer that develops in the lymph nodes, when the white blood cells (lymphocytes), which help fight infections, begin to grow out of control, impacting the lymphocytes accumulate in the lymph nodes and lymphatic vessels.

Meanwhile, Chronic Lymphocytic Leukemia is a blood cancer that occurs when the bone marrow produces too many immature and abnormal lymphocytes, making the patient susceptible to infection.

The active ingredient in Rituxikal, namely Rituximab, is a monoclonal antibody product whose job is to bind to the CD20 transmembrane antigen on B-cell lymphocytes produced by cancer cells, causing an immunological reaction that triggers cancer cells to lysis.

Rituxikal is a Biosimilar product, which is a biological product with the same active substance, where the efficacy, safety and quality profiles are similar to those of FDA-approved biologic products. Rituxikal contains rituximab whose characteristics are similar to the innovator rituximab with the trade name Mabthera which is produced by Roche Diagnostics Gmbh, Germany. Kalbio Global Medika itself has received a technology transfer from Sinergium Biotech S.A., Argentina and mAbxience S.A.U, Argentina, to be able to manufacture Rituxikal locally in Indonesia.

Mr. Vidjongtius revealed that Rituxikal was not the only product that had been produced locally facilitated by KGM. However, it completes the list of other products that have obtained distribution permits from BPOM: Insulin (Ezelin), Epoetin Alfa (Hemapo), and Filgrastim (Leucogen).

"In the future, we will also have a new molecule that we produce from raw materials to finished products, namely Efepoetin Alfa (Efesa). This product is the pride of Indonesia, because it will be a product with a new molecule whose entire development will be carried out in Indonesia, starting from the development of facilities and production methods, non-clinical trials and clinical trials in seven countries involving developed countries, one of which is Australia, with Indonesia as the lead-dev. Currently, the product is in the evaluation process at BPOM and it is hoped that around the end of Q1 or early Q2 it will be able to obtain a distribution permit from BPOM," said Pak Vidjongtius.


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.

KGM at a Glance

Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is part of the Kalbe Group, a subsidiary of PT Kalbe Genexine Biologics (KGbio), which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. KGM is an Innovative CDMO, equipped with CMC and scale-up capabilities plugged into Boston biotech ecosystem and state-of-the-art facility to enhance efficiency and productivity. With API manufacturing, formulation, fill and finish capabilities of biosimilar and novel biologics, averaging 10 million units of syringes, cartridges, and vials, KGM supplies local and international markets.



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