INI Bio, a subsidiary of GC Wellbeing, is stepping up efforts to enter the global botulinum toxin (BTX) market, with regulatory milestones achieved in both China and Brazil.
INI Bio, a GC Wellbeing subsidiary, is accelerating its global botulinum toxin expansion with a China NDA submission and Brazil GMP certification for its INI101 product.
INI Bio, a GC Wellbeing subsidiary, is accelerating its global botulinum toxin expansion with a China NDA submission and Brazil GMP certification for its INI101 product.
The company announced that it submitted a New Drug Application (NDA) for its BTX product, INIbo 100 Units (INI101), to China’s National Medical Products Administration (NMPA) on March 31. If approved, INI101 would become the seventh botulinum toxin product officially launched in the Chinese market.
The NDA submission includes data from clinical trials conducted in China involving adult patients with moderate to severe glabellar lines, comparing the safety and efficacy of INI101. The application also contains documentation on the company's manufacturing processes and regulatory compliance.
To support its entry into China, INI Bio has been actively engaging local partners since the product development stage. In 2022, the company signed a distribution agreement worth $370 million with an unnamed Chinese company specializing in medical aesthetics. T
In another key development, INI Bio secured good manufacturing practice (GMP) certification from Brazil's National Health Surveillance Agency (ANVISA) on March 28. The certification follows an on-site inspection conducted in February for INI101. The company aims to obtain final product approval within the year and officially enter the Brazilian market, the largest BTX market in Latin America.
“The GMP certification marks our first official step into the Brazilian market,” a company official said. “With our NDA filed in China and GMP certification in Brazil, we are laying the groundwork to become a leading player in the South American market through tailored expansion strategies.”
Founded in 2017, INI Bio operates Korea’s largest single-site GMP-certified facility for biopharmaceutical production in Bucheon, Gyeonggi Province. Following its acquisition by GC Wellbeing in February, the company has been pursuing joint development of new pipelines and leveraging GC Wellbeing’s global network to accelerate regulatory approvals and market entry in additional countries.
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