ETANA SECURES PPUK AND NIE FOR TWO STRATEGIC PRODUCTS TO SUPPORT INDUSTRY SELF-RELIENCE

Jakarta, May 19, 2025 – PT Etana Biotechnologies Indonesia (Etana) confirmed its dedication to helping Indonesia become self-sufficient in pharmaceuticals by getting approval for Clinical Trials (PPUK) and a Marketing Authorization Number (NIE) from the Indonesian Food and Drug Authority (BPOM RI) for two important products. This achievement serves as concrete proof of Etana’s efforts to deliver safe, high-quality, locally produced biotechnology products that meet global standards. The official handover of the PPUK and NIE took place during the "Integrated Drug Regulatory Assistance" event in Jakarta on Monday, May 19, 2025.

 “This is a significant milestone marked by the issuance of the PPUK for our tuberculosis vaccine, which is our first product for which we now fully own the license and have complete control over all the technology—indicating that it is almost 100 percent developed in Indonesia. We will carry out phase 1 clinical trials, followed by phases 2 and 3 independently in Indonesia. The manufacturing facility will also be built in Indonesia, starting from the raw material production phase,” said Nathan Tirtana, President Director of Etana.

More than just an innovation, this product is the first inhaled tuberculosis vaccine, developed using three antigens in the hope of achieving higher efficacy. Indonesia will conduct clinical trials for phases 1, 2, and 3.

In addition, Etana has also received a Marketing Authorization Number (NIE) from BPOM for an mRNA vaccine with the latest serotype. Although the COVID-19 pandemic has ended, Etana continues to develop its mRNA vaccine platform. It is the only company in ASEAN to obtain marketing approval for the production of mRNA vaccines.

“So even though COVID is no longer around, we continue developing our platform—not because we expect another pandemic, but so we are prepared if it happens again. We also maintain GMP standards and continue developing our mRNA vaccine products,” Nathan explained.

Looking ahead, Etana aims to continue the clinical trial phases of the inhaled tuberculosis vaccine, build local manufacturing facilities, and strengthen the national biotechnology ecosystem. With support from the government, including the community, BPOM, and the Ministry of Health, as well as cross-sector collaboration, the development and production processes are expected to run smoothly and efficiently.

About Etana

Established in 2014, Etana is an Indonesian biopharmaceutical company that researches, manufactures and markets biological therapies for the Southeast Asian market. With a mission to serve patients by providing high quality, affordable, and innovative therapies, the company has built state-of-the-art local production facility that meet international and Indonesian FDA standards. The facility is able to produce biological therapy with halal certification from the Indonesian Ulema Council (MUI). Etana aspires to become a leading biopharmaceutical company in the ASEAN region through aggressive expansion in production capacity and product development, with a primary focus on oncology and vaccine products.

Etana is led by a local management team who come from various international and domestic educational backgrounds and have strong experience in the biopharmaceutical industry and are supported by a team of international investors and leading biopharmaceutical companies. Etana aims to provide innovative yet affordable therapies through local production, to support Indonesian government programs and larger market demands. Etana is currently a leading biotech company in Indonesia committed to the research and manufacture of monoclonal antibodies, mRNAs and other biological platforms. For more information on Etana, visit: www.id.etanabiotech.com.