Huons’ Chinese partner Aimeikang announced on Monday that it postponed the launch of Hutox, Huon’s botulinum toxin (BTX), by one year to December 2025. 

According to Aimeikang's announcement on Monday, the Chinese market release of Hutox, originally planned for Dec. 31, 2024, was put off by a year with the company rescheduling the launch to Dec.31, 2025.

The delay comes as Aimeikang awaits regulatory approval for its BTX product. The company received the National Medical Products Administration’s (NMPA) Acceptance Notice for the registration form of its BTX in July 2024.

However, the company explained that the ongoing review process requires additional time, prompting the extension.

A Huons official confirmed that Aimeikang postponed the approval timeline, but told Korea Biomedical Review that they are certain that the drug will receive approval by next year.

However, the official did not further comment on when the company expects to roll out Hutox in China.

While Aimeikang aimed to become the sixth company to receive approval for a BTX product in China, industry insiders believe the launch delay may negatively impact its prospects in an oversaturated market.

Without any distinctive advantages, late market entry could make the product less appealing.

Although only five products are currently available in China -- Allergan's Botox, Lanzhou Bio's Hengli, Ipsen's Dysport, Hugel's Letybo, and Merz's Xeomin – over ten companies are in clinical stages, signaling increasing competition in the Chinese market.

“At this stage of market maturity, new entrants need to offer something truly innovative to stand out," a local BTX company official said, asking to remain anonymous due to his company’s policies. "Whether it's enhanced duration, faster onset, or competitive pricing, simply being another BTX option isn't enough anymore.”

The window of opportunity is narrowing as market leaders strengthen their positions, he added.

Meanwhile, Aimeikang secured exclusive rights to import, register, and distribute Hutox in China through a partnership with Huons Global in 2018.

The company further strengthened this collaboration by investing approximately 155.4 billion won ($107.2 million) in Huons BioPharma, a subsidiary of Huons Global, acquiring a 25.42 percent stake.