AriBio and AriBio Lab have received approval from Indonesia’s drug regulator, BPOM, for four products under their next-generation hyaluronic acid (HA) filler brand Bidan. This approval clears the way for their expansion into the Indonesian medical aesthetics market.
The four Bidan products were developed by AriBio Group for the anti-aging and medical aesthetics market after seven years of research in collaboration with a university hospital. Indonesia, with a population of around 300 million, is the world’s fourth-most populous country and has seen rapid growth in its skin care and medical aesthetics market alongside economic expansion.
AriBio said Indonesia is also considered a relatively difficult market for overseas medical devices and aesthetic products to enter due to its regulatory procedures and verification requirements. The company said the BPOM approval reflects the quality, safety, and technological competitiveness of its filler products.
Bidan incorporates AriBio Group’s proprietary Precise Control Refinement Technique (PCRT), which is designed to produce smooth and uniform hyaluronic acid particles while optimizing their viscoelastic properties. The products also use the company’s HCCL (Homogeneous HA Composition Cross-linked) technology, a manufacturing process designed to minimize residual cross-linking agents.
Following the Indonesian approval, AriBio Group has begun discussions with a major local aesthetics company over the supply and launch of Bidan fillers. They plan to establish a distribution network through partnerships with major Indonesian companies and accelerate market penetration and sales growth.
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The Indonesian approval also forms part of AriBio Group’s broader strategy to expand its business beyond drug development into anti-aging and medical aesthetics.
AriBio is currently analyzing data from the global phase 3 trial of AR1001, its oral Alzheimer’s disease treatment candidate, in line with its planned procedures ahead of the release of the study results. Alongside its Alzheimer’s drug development program, the group is stepping up overseas exports of functional anti-aging products, including fillers, as it seeks to strengthen its position as a biotechnology company spanning innovative drug development and medical aesthetics.
The fillers were evaluated in a human application study led by Professor Huh Chang-hun of the Department of Dermatology at Seoul National University Bundang Hospital (SNUBH). The study confirmed the products’ biocompatibility, efficacy, and safety, according to AriBio, and the results supported their subsequent marketing approval in Korea.
The company’s commitment to quality and safety has been recognized by regulatory authorities. It has obtained approval for its products in several countries, including Korea and Indonesia.
