JAKARTA - PT Etana Biotechnologies Indonesia (Etana) has reiterated its commitment to supporting national pharmaceutical independence by obtaining Approval for the Implementation of Clinical Trials (PPUK) and Circular Permit Number (NIE) from the Indonesian Food and Drug Supervisory Agency (BPOM) for two strategic products. This achievement is proof of Etana's concrete steps in presenting locally safe, quality, and appropriate biotechnology products that meet global standards.
One of the important achievements is the acquisition of PPUK for tuberculosis vaccines. Etana President Director Nathan Tirtana said that almost 100 percent of this vaccine was developed in Indonesia.
This is our first product where now we buy full licenses and technology in all of us. We will carry out phase 1 clinical trials and will continue to phase 2, 3 independently in Indonesia. And this factory will be built in Indonesia from the initial production stage of raw materials," said Nathan during the "Integrated Drug Regulatory Asistency" event in Jakarta on Monday, May 19.
More than just innovation, continued Nathan, this product is the first inhalation tuberculosis vaccine. Nathan said that this vaccine was developed using three antigens.
"We hope that the efficacy will be higher. So we will conduct phase 1, phase 2 and 3 clinical trials in Indonesia," added Nathan.
In addition, Etana has also obtained NIE from BPOM for the latest mRNA vaccine with a serotype. Even though the COVID-19 pandemic has ended, Etana continues to develop the mRNA vaccine platform and is the only company in ASEAN to obtain distribution permit for mRNA vaccine production.
"So even though there is no covid now, we continue to develop. It's not that we hope that there will be a pandemic, but if there is, we are ready. We also continue to maintain GMP standards and develop this mRNA vaccine product," explained Nathan.
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In the future, Etana hopes to continue the stages of clinical trials of the inhalation tuberculosis vaccine, build local production facilities, and strengthen the national biotechnology ecosystem. Nathan also expressed his hope for government support and cross-sector collaboration so that the development and production process can run smoothly and efficiently.
"We hope that health agencies such as the community, BPOM and the Ministry of Health can support this project," concluded Nathan.
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