ETANA AND CELLTRION SIGN STRATEGIC AGREEMENT FOR HERZUMA® AND TRUXIMA®

Jakarta, 14 November 2024 – PT Etana Biotechnologies Indonesia (Etana), a local Indonesian biopharmaceutical company and Celltrion, a leading global biopharmaceutical company specialized in researching, developing and manufacturing innovative therapeutics medicine, today announced that the companies have entered a strategic distribution and marketing agreement for Herzuma® (trastuzumab) and Truxima® (rituximab). These two treatments are first-line targeted therapies for breast cancer and non-Hodgkin's lymphoma, and listed in the National Formulary (Fornas) and e-catalogue.

"We are grateful to collaborate with Celltrion one of the largest pharmaceutical companies in South Korea, on the development of innovative cancer therapeutic products. We hope this collaboration can provide easy access for cancer patients who need targeted therapy treatment. As a biopharmaceutical company in Indonesia Etana committed to serving patients by providing high quality, affordable and innovative products to support the government for better health in Indonesia," said Nathan Tirtana, President Director of Etana.

“As a global leading biopharmaceutical company, we are delighted to partner with Etana to bring trastuzumab and rituximab biosimilars to Indonesian market,” said JiTae Kim, Regional General Manager of Southeast Asia at Celltrion. “This strategic partnership leverages our combined strengths and expertise, and we look forward to making a positive impact on the lives of patients in need.”

Trastuzumab is a targeted therapy for breast and stomach cancers. This drug is effective in cancers that overexpress a specific protein known as human epidermal growth factor 2 (HER2).

Rituximab is an anti-CD20 targeted therapy treatment used for chronic lymphocytic leukemia, follicular lymphoma, and non-Hodgkin's lymphoma. Furthermore, this treatment is acceptable to treat joint inflammation (rheumatoid arthritis) when other therapies are ineffective.

In 2017 and 2018 the United State Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) approved Herzuma and Truxima, which are currently marketed in over 110 countries worldwide.

About Truxima® (rituximab)

Truxima® is a monoclonal antibody that targets CD20, a transmembrane protein found on the surface of most B cells. Truxima is approved in the EU for the treatment of patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), pemphigus vulgaris (PV). In the U.S., Truxima is approved to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

About Herzuma® (trastuzumab)

Herzuma® is a monoclonal antibody designed to bind selectively to the extracellular domain of an antigen called human epidermal growth factor receptor 2 (HER2). Herzuma is approved in the EU for the treatment of early breast cancer (EBC), metastatic breast cancer (MBC), metastatic gastric cancer (MGC). In the U.S., Herzuma is indicated for HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

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 are able to produce biological therapy with halal certification from the Indonesian Ulama Council (MUI). Etana aspires to become the 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

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima® and Herzuma®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma® and Yuflyma®, FDA approval for Zymfentra®, and EC approval for Remsima® SC, Omlyclo®, SteQeyma®. To learn more, please visit www.celltrion.com/en-us.