【Good News】Haibu Pharmaceutical's Riluzole Tablets (40mg) have obtained clinical trial approval.
Classification:
Company News
Release time:
2024-10-24
Introduction: The indications are to improve the following symptoms of uterine fibroids (heavy menstrual bleeding, lower abdominal pain, back pain, anemia); to alleviate the pain of endometriosis.
Recently, Relugolix tablets (40mg), independently developed by Beijing Haibu Pharmaceutical Technology Co., Ltd. (referred to as 'Haibu Pharmaceutical'), received clinical trial implied approval from the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE), with indications for improving the following symptoms of uterine fibroids (heavy menstrual bleeding, lower abdominal pain, back pain, anemia); alleviating the pain of endometriosis.
Source: National Medical Products Administration Drug Evaluation Center official website
01.Basic Information
Product Name: Relugolix tablets
English Name: Relugolix tablets
Dosage Form/Specification: Tablets, 40mg
Indications: Improvement of symptoms related to uterine fibroids (heavy menstrual bleeding, lower abdominal pain, back pain, anemia); alleviation of pain from endometriosis.
Registration Classification: Class 3
Original Research: Takeda Pharmaceutical Company Limited in Japan
Patent Overview: Compound patent until January 2024; process patent until September 2033.
02. Mechanism of Action
Estrogen-dependent imbalance is the main cause of uterine fibroids and endometriosis in women of childbearing age. Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist that can block endogenous GnRH from binding to its receptors, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), inhibiting ovarian secretion of sex hormones such as estradiol and progesterone, thereby improving various symptoms caused by uterine fibroids.
03. Market Status at Home and Abroad
(Approved for marketing in Japan on January 8, 2019, with a specification of 40mg for improving the following symptoms related to uterine fibroids: heavy menstrual bleeding, lower abdominal pain, back pain, anemia; and pain caused by endometriosis.)
(Approved in the United States (FDA) on December 18,2020 with a specification of120mg for treating adult patients with advanced prostate cancer.)
(Currently not yet marketed domestically.)
04.项目优势
04. Project Advantages1. Good safety profile and flexible administration
Relugolix is a new type of GnRH antagonist that can be taken orally once daily with good patient compliance and fewer adverse reactions compared to multiple peptide GnRH agonists or inducers that require intramuscular or subcutaneous injection.2. High prevalence and clear clinical demand
Uterine fibroids are the most common benign tumors in premenopausal women accounting for about80%of female reproductive organ tumors; according to relevant expert consensus in China,the estimated prevalence among women of childbearing age may reach25%,indicating high prevalence and significant medication demand.3. Stable upward trend in global market
The40mg specification Relugolix tablets are currently only sold in Japan.The global market has shown an upward trend since2019,reaching58.14million USD in2022and61.63million USD in2023,and continues to grow.If more countries approve it for sale,the global market will further increase.4. Considerable domestic market
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