Mabwell's Adalimumab Biosimilar Receives Marketing Approval in Indonesia

Release time:Dec 31, 2025

Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its Adalimumab Injection 9MW0113 (Marketed as JUNMAIKANG in China) has been granted marketing authorization by the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM). This marks the third overseas marketing approval obtained by Mabwell so far this year.

Co-developed by Mabwell and Junshi Biosciences, 9MW0113 has become the first Adalimumab biosimilar independently developed in China to receive marketing approval from BPOM. To date, Mabwell has signed formal cooperation agreements for 9MW0113 in more than ten countries and has submitted registration applications in multiple countries, including Jordan and Peru.

Mr. Hu Huiguo, Board Director, Senior Vice President, and Board Secretary at Mabwell, stated, “Indonesia is the most populous country in Southeast Asia with an ever-growing demand for healthcare. As a member of PIC/S (Pharmaceutical Inspection Co-operation Scheme), Indonesia maintains a rigorous drug quality review system. This validation further reinforces our global commercialization strategy and reflects our commitment to expanding access to high‑quality biologics that address unmet medical needs for patients around the world.”