LIVZON PHARMA(01513): Recombinant Human Follicle-Stimulating Hormone Injection receives "Drug Registration Certificate"

LIVZON PHARMA (01513) announced that recently, the recombinant human follicle-stimulating hormone injection (the product) of its holding subsidiary Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd. (Lizhu Monoclonal Antibody) has received the "Drug Registration Certificate" issued by the National Medical Products Administration (NMPA). The recombinant human follicle-stimulating hormone injection was independently developed by Lizhu Monoclonal Antibody. The indications for this registration application are: (1) Women with anovulation (including polycystic ovary syndrome [PCOS]) who do not respond to clomiphene citrate treatment. (2) Women undergoing assisted reproductive technology (ART) (such as in vitro fertilization-embryo transfer (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT)) who undergo controlled ovarian hyperstimulation, can use this product to stimulate the development of multiple follicles. (3) Patients with severe deficiency of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), i.e., patients with serum LH levels <1.2 IU/L. LH is recommended to be used in conjunction with FSH to stimulate follicular development. The product is produced using recombinant gene technology, with stable and controllable processes, and is administered using an injection pen, which can improve the patient's user experience and enhance compliance. The product has completed clinical Phase I to III evaluations of biosimilar drugs, and the data show that it is equivalent to the reference drug in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK). The product uses advanced production processes and strict analytical techniques to ensure product safety and purity, ensuring patient safety in medication use. As of the date of this announcement, the cumulative direct R&D investment in the recombinant human follicle-stimulating hormone injection is approximately RMB 121.7 million. According to the NMPA and the Drug Evaluation Center website database, as of the date of this announcement, there are 4 imported products and 4 domestically produced products of recombinant human follicle-stimulating hormone injection on the market in China. Currently, the incidence of infertility and reproductive diseases in China is increasing year by year, and patients are becoming younger. This product, as a commonly used drug in assisted reproduction, will continue to see increasing market demand. According to IQVIA's estimated data, the domestic terminal sales of follicle-stimulating hormone (FSH) drugs in 2025 will be RMB 25.41 billion, while the domestic terminal sales of FSH drugs in January-March 2026 will be RMB 5.38 billion, with recombinant human follicle-stimulating hormone drugs accounting for over 56%.