LIVZON PHARMA (ASX: 01513) has announced that its recombinant human follitropin injection has been granted a Drug Registration Certificate by the National Medical Products Administration.

The injection, developed by the company's subsidiary Zhuhai Livzon Mabpharm Inc., is approved for several indications. These include treating anovulation in women who do not respond to clomiphene citrate therapy, controlled ovarian stimulation for assisted reproductive technologies, and use in patients with severe deficiency of luteinizing hormone and follicle-stimulating hormone.

Produced using recombinant gene technology, the product offers a stable manufacturing process and is administered via an injection pen designed to improve patient experience and compliance. Clinical evaluations from Phase I to III have demonstrated its bioequivalence to the reference product in terms of efficacy, safety, immunogenicity, and pharmacokinetics.

As of the announcement date, the cumulative direct research and development expenditure for this injection was approximately RMB 121.7 million. Market data indicates there are currently four imported and four domestic recombinant follitropin products available in China.

The domestic market for follicle-stimulating hormone drugs is growing, driven by rising infertility rates and a trend of younger patients. According to IQVIA estimates, the total domestic sales value for FSH drugs reached RMB 2.541 billion in 2025, with recombinant products accounting for over 56% of the market.