Shanghai Pharma unit wins approval for minoxidil topical solution

Shanghai Pharmaceuticals Holding Co. (Shanghai Pharma) announced its subsidiary, Shanghai Pharma Sinopharm East-China Pharmaceutical Co., received a drug registration certificate from the National Medical Products Administration for its minoxidil topical solution. The approved specifications are 2% (60ml: 1.2g) and 5% (60ml: 3.0g), categorized as a Class 3 chemical drug. This approval allows the product to be managed as a Class A over-the-counter medicine.

The minoxidil topical solution was initially developed by Johnson & Johnson, with the 2% strength launched in the US in 1988 and the 5% strength in 1997. The 2% strength is indicated for male pattern hair loss and alopecia areata, while the 5% strength is exclusively for male pattern hair loss and alopecia areata. Shanghai Pharma Sinopharm East-China submitted its registration application in January 2024, incurring approximately 6.56 million yuan in research and development costs to date.

According to the Minet.com database, the procurement amount for minoxidil topical preparations in the Chinese pharmaceutical market in 2024 was 236.067 million yuan. This approval is expected to help Shanghai Pharma expand its market share and enhance competitiveness. However, the company also noted that sales could fall short of expectations due to uncertainties in national policies and market conditions.