Sunshine Mandi Files for Female-Specific 5% Minoxidil Foam in China Following Phase 3 Trial

Zhejiang Sunshine Mandi Pharmaceutical Co., Ltd. has filed a new drug application for its 5% minoxidil foam formulated for female patients, the Center for Drug Evaluation (CDE) confirmed on October 14, 2026. The application, bearing registration number CYHS2602536, was accepted under Category 3 of China's generic drug classification system, marking a pivotal moment for a company that has spent more than two years navigating the regulatory complexities of expanding its hair-loss treatment to women.

The filing represents the culmination of a circuitous regulatory journey. In January 2024, Sunshine Mandi secured approval for its 5% minoxidil foam as a treatment for male androgenetic alopecia and alopecia areata, becoming the first domestic company to bring a minoxidil foam product to the Chinese market. Just three months later, in April 2024, the company submitted a supplementary application seeking to extend the approved indication to female patients. The bid was swiftly rejected, forcing Sunshine Mandi to abandon the shortcut and instead conduct a full Phase 3 clinical trial.

The clinical program enrolled 296 female patients aged 18 and older diagnosed with androgenetic alopecia, with hair-loss severity classified as Savin grades D3 through D6. The primary endpoint measured changes in target area hair count (TAHC) from baseline at 24 weeks, assessed via microscopic hair image analysis. Participants applied 1 gram of foam once daily, either in the morning or evening, over the 24-week treatment period.

The distinction between male and female formulations traces back to the original product developed by Johnson & Johnson, now held by its consumer-health spinoff Kenvue. According to the reference drug listings published by China's National Medical Products Administration in August 2020 as part of the 30th batch of its Chemical Generic Drug Reference Preparation Catalog, the minoxidil foam was categorized separately for men and women. Yet the two versions are nearly identical: both contain 5% minoxidil at a single dose of 1 gram. The sole meaningful difference lies in dosing frequency. Men are instructed to apply the foam twice daily, while women need only one application per day, making the male regimen effectively double the female dosage.

Sunshine Mandi is not alone in grappling with the regulatory hurdle of gender-specific indications for minoxidil foam in China. In July 2023, Shanxi Zhendong Anxin Biopharmaceutical submitted applications for both male and female versions simultaneously. Both were rejected. The company subsequently initiated its own clinical trials and re-filed for the male indication in April 2026, under application number CYHS2600956.

More recently, two other companies have taken a different approach. Shandong Jingwei Pharmaceutical filed its application on August 20, 2026 (CYHS2602075), followed by Chenguang (Tianjin) Pharmaceutical on August 14, 2026 (CYHS2602020). Both submissions listed the product simply as "minoxidil foam" without specifying a gender indication, and neither company appears to have conducted clinical trials. Whether regulators will accept these applications without gender-specific clinical evidence remains an open question.

The commercial stakes are substantial. Sunshine Mandi's minoxidil foam has emerged as one of the most successful commercialization stories in China's hair-loss drug market. In its first year on the market, the product sold more than 2.5 million bottles and generated revenue exceeding CNY 300 million (approximately USD 42 million). The company currently holds an exclusive position in the domestic minoxidil foam segment, with no direct competitors yet approved.

The foam formulation offers several advantages over traditional minoxidil tinctures. By eliminating propylene glycol, a common irritant, the product reduces the risk of allergic reactions and scalp itching. Its lower foam density and stronger adhesion enable more precise application. In vitro studies have demonstrated that the foam achieves significantly higher drug accumulation in hair follicles, with 24-hour cumulative penetration approximately 18.9 times that of conventional tincture formulations.

Whether the CDE will ultimately require additional clinical data or mandate a gender-specific label for Sunshine Mandi's female formulation remains to be seen. The outcome of this review will likely set a precedent for how regulators handle gender-differentiated indications for topical hair-loss treatments in China, shaping the competitive landscape for all players in the space.