Shanghai Securities News – Recently, BoRui Pharmaceuticals received approval from the National Medical Products Administration (NMPA) for its Dienogest tablets, which are considered to have passed consistency evaluation, with the approval number being H20249468. The product is marketed under the brand name BoLü® and is indicated for patients with endometriosis.

Endometriosis is a common disease among women of childbearing age, and commonly used treatment options include non-steroidal anti-inflammatory drugs, combined oral contraceptives, GnRH agonists, and high-efficiency progestins (such as the levonorgestrel intrauterine system (LNG-IUS) and dienogest).

The novel progestin Dienogest has a dual mechanism of action, working centrally and peripherally. It alleviates dysmenorrhea associated with endometriosis while also reducing the size of ovarian endometriotic cysts. Furthermore, the effect on reducing cysts becomes more pronounced with prolonged use. Dienogest also has effects against endometrial hyperplasia, inflammatory responses, and angiogenesis. Due to its low daily dosage, minimal impact on liver and kidney function and metabolism, good tolerance, and ample evidence of long-term efficacy and safety, Dienogest is unanimously recommended as a first-line treatment for endometriosis in both domestic and international guidelines.

Statistics show that the domestic sales of Dienogest tablets were 198 million yuan in 2022 and 364 million yuan in 2023, with 432 million yuan in the first three quarters of 2024, indicating a rapid growth trend. Dienogest was approved for the treatment of endometriosis in Japan in 2007 and has been used internationally for 17 years. With ongoing domestic penetration and increasing usage experience, Dienogest is expected to become a higher-quality treatment option for endometriosis patients.

The launch of BoRui Pharmaceuticals’ Dienogest tablets (BoLü®) marks a further enhancement of the company's market competitiveness in the field of obstetrics and gynecology, providing a new first-line treatment option for long-term management of endometriosis and bringing hope of recovery to more patients, helping more women return to a healthy life.

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