China-based Bloomage Biotech (SHA: 688363) announced that its wholly owned subsidiary, Gentix Limited, has issued a lawyer’s letter to South Korea-headquartered Medytox Inc. on July 29, 2022, seeking to terminate the agreement between the two companies related to Botox and other medical aesthetics products. The move comes after no products were provided for sale since the signing of the joint venture (JV) agreement.
Background of the JV
Bloomage, which has been delisted, entered into a joint venture agreement with Medytox on May 7, 2015, to establish Medybloom Limited. The JV was tasked with developing, promoting, and marketing certain injectable botulinum toxin type A and other medical aesthetic products manufactured by Medytox in mainland China. In September 2019, Gentix acquired a 50% stake in Medybloom from Bloomage, obtaining Bloomage’s rights under the JV agreement. Gentix and Medytox agreed to invest HKD17 million (USD2.16 million) each into Medybloom in March 2020.
Regulatory Issues
In 2020, the Korean Ministry of Food and Drug Safety issued a series of executive orders for recalling, destroying, cancelling product approval procedures, and suspending manufacturing, sales, and use of a range of Medytox products, including botulinum toxin products. The botulinum toxin products registered by Medytox in China have been under review by the Center for Drug Evaluation (CDE) since November 11, 2019, with product registration procedures still pending. Gentix believes that the purpose of cooperation between the two parties cannot be realized in the foreseeable future. Bloomage stated that following the termination of the agreement with Medytox, it will not rule out seeking cooperation in other botulinum toxin products.
Market Context
Statistics show that the domestic regular channel botulinum toxin market is valued at approximately RMB3.92 billion (USD580 million), a figure expected to reach RMB14 billion (USD2 billion) by 2025. South Korea’s Daewoong Pharmaceutical Co., Ltd initiated a Phase III clinical study for its Botox Nabota in China in December 2019, with expectations to enter the market this year. Huadong Medicine secured exclusive agency rights to South Korea-based Jetema’s A type Botox in August 2020, while Fosun Pharma in-licensed Revance’s Botox RT002 in December.
Regulatory Environment
Due to its neurotoxin properties, botulinum toxin is strictly regulated. Currently, only four botulinum toxin products are approved in China: Allergan’s Botox (onabotulinumtoxinA), Ipsen’s Dysport, South Korea firm Hugel’s Letybo, and Lanzhou Institute of Biological Products’ Hengli (Botulinum Toxin Type A for Injection).-Fineline Info & Tech
