ETANA LAUNCHES INNOVATIVE CANCER THERAPIES IN INDONESIA THROUGH COLLABORATION WITH BEIGENE

Jakarta, December 10, 2024 – PT Etana Biotechnologies Indonesia (Etana), an Indonesian biopharmaceutical company, has obtained marketing authorization for two innovative cancer therapies, Tislelizumab (ETAPIDI®) and Zanubrutinib (BRUKINSA®). Developed by BeiGene, which plans to change its name to BeOne Medicines, a global oncology leader committed to making cutting-edge and accessible treatments available worldwide, these therapies are set to transform cancer care in Indonesia by combining global advancements with local accessibility.

The marketing authorizations were formally handed over by Dr. Taruna Ikrar, Head of the Indonesian Food and Drug Authority (BPOM), in the presence of key government officials, including Dita Novianti Sugandi Argadiredja, S.Si.,apt.,MM, Director of Pharmaceuticals Production and Distribution at the Indonesian Ministry of Health.

Dr. Taruna Ikrar stated, "These two targeted therapies meet the drug safety and efficacy requirements set by BPOM, ensuring product quality and compliance with production standards. We hope this achievement inspires the Indonesian pharmaceutical industry to develop more innovative medicines needed by patients in Indonesia."

A Commitment to Affordable, Innovative Therapies

Nathan Tirtana, President Director of Etana, expressed gratitude for the regulatory and government support that made this milestone possible. ”The availability of ETAPIDI (and BRUKINSA will make it easier for cancer patients in Indonesia to access the most up-to-date treatments in compliance with international guidelines, at lower costs, " he said.

Highlighting the collaboration with BeiGene, Mr Tirtana added, “Our partnership with BeiGene exemplifies Etana’s commitment to providing high-quality, innovative products at affordable prices. Looking ahead, we will carry out technology transfer and local production of ETAPIDI in Indonesia through our partnership with BeiGene, supporting the government’s vision for independence in the pharmaceutical sector."

Synergizing Local Expertise with Global Innovation

Etana’s collaboration with BeiGene demonstrates the power of partnerships in addressing critical healthcare challenges. By combining Etana’s established presence and understanding of Indonesia’s healthcare landscape with BeiGene’s global expertise in oncology innovation, this partnership is designed to tackle the country’s growing cancer burden

Michelle Tan, General Manager, BeiGene Southeast Asia and leading the sub-region from Singapore, stated, “Our collaboration with Etana underscores BeiGene’s mission to advance health equity by ensuring that innovative cancer treatments reach more patients in need. Together, we are addressing the growing cancer burden in Indonesia and reaffirming our commitment to making life-changing therapies accessible and affordable worldwide.”

Dita Novianti Sugandi Argadiredja, "We appreciate Etana and BeiGene's collaboration in bringing these innovative therapies to Indonesia. The anticipated technology transfer will strengthen Indonesia's pharmaceutical sector and support our shared mission of improving patient outcomes."

ETAPIDI is an anti-PD-1 monoclonal antibody product that has also been approved by regulatory agencies in over 40 countries, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The therapy has been approved in Indonesia for the treatment of Non-Small Cell Lung Cancer (NSCLC) and Esophageal Squamous Cell Carcinoma (ESCC ).

BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) (Zanubrutinib) that is marketed in more than 70 countries and more than 100,000 patients have been treated globally. BRUKINSA has the broadest label globally of any BTK inhibitor and is indicated in Indonesia for the treatment of Waldenstrom's Macroglobulinemia (WM), and Mantle Cell Lymphoma (MCL). BRUKINSA is recommended in the National Comprehensive Cancer Network® (NCCN) Guidelines as a treatment option for various lymphomas, including WM, Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), and MCL, reinforcing its role as an effective and evidence-based therapy for patients worldwide .

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.