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Dinorecept | A popular product with a compound growth rate of 263%

来源:本站发布时间:2024-05-17 10:09:00[关闭][打印]

1. Introduction to product indications
Endometriosis (EMs):
Endometriosis (EMs) refers to a common gynecological disease in women where endometrial cells are implanted in an abnormal position. Endometrial cells should have grown inside the uterine cavity, but due to the connection between the uterine cavity and the ovaries and pelvic cavity through the fallopian tubes, endometrial cells can enter the ovaries, pelvic cavity, and adjacent areas of the uterus through the fallopian tubes for ectopic growth.
EMs are a common clinical benign disease among women of childbearing age, with an incidence rate of 10.0% and a significant upward trend. The symptoms of this disease include severe menstrual cramps, painful sexual intercourse, painful urination or defecation, lower back or abdominal pain, causing serious damage to the emotions and overall quality of life of female patients.
Approximately 10% of women of reproductive age worldwide suffer from endometriosis, which means approximately 176 million women worldwide are affected by endometriosis: 20% to 50% of infertile women have endometriosis, and 71% to 87% of women with chronic pelvic pain suffer from endometriosis. The incidence rate in China is as high as 10%~15%, and has a rising trend year by year.
In clinical practice, management is mainly achieved through oral contraceptives, nonsteroidal anti-inflammatory drugs, opioid drugs, and gonadotropin-releasing hormone (GnRH) antagonists. When these drug treatments fail, surgical interventions (such as cesarean section or laparoscopic surgery) are often used, but these measures still cannot cure EMs.
Therefore, the long-term management of EMs should maximize the effectiveness of drug therapy, which should be effective and safe, and continuously used until menopause or planned pregnancy; Patients planning to conceive should resume long-term medication management as soon as possible after completing childbirth. The goal of drug therapy is long-term persistence, selecting drugs with good efficacy and tolerance.
The new progesterone denogestrin (2 mg/d) has a dual mechanism of action, both central and peripheral, which can alleviate endometriosis and dysmenorrhea while reducing ovarian endometriotic cysts. With the prolongation of medication time, the effect of reducing endometriotic cysts is more significant. There is sufficient evidence of efficacy and safety for long-term use for more than 1 year, making it the preferred drug for long-term management of endometriosis.
 
2. Product Introduction&Market Scenario Analysis
Product Introduction
Preparation:
Tablets: 2MG
Indications: Endometriosis
Usage and Dosage: Take one tablet orally daily without interruption, preferably at the same time every day, and take with water if needed.
characteristic
Uniqueness of Deinorgestrel: It is an artificially synthesized progesterone with characteristics of both 19-demethyltestosterone derivative and progesterone derivative
Unlike other synthetic progesterones, 17 α The acetylene group on the site is replaced with cyanomethyl, which gives it a high affinity for PR. There is no activity of androgens, glucocorticoids, and mineralocorticoids, therefore, denogestrin has little effect on glucose, salt, and lipid metabolism.
Unlike other 19 nortestosterone classes, denogestrin does not have androgenic effects, and its anti androgenic effect is 40% of that of cyproterone. The unique molecular formula makes its plasma half-life relatively short (10 hours), with high oral bioavailability and strong inhibitory effect on endometrial proliferation. It moderately inhibits the HPO axis and has anti androgenic activity. Deinorgestrel is mainly excreted by the kidneys and can be mostly excreted within 24 hours without drug accumulation. Overall, it has good tolerance and ovarian function can be restored after discontinuation.
Dinorectin 2mg daily can effectively treat endometriosis with minimal side effects and is suitable for long-term use.
 
3. Competitiveness and advantages
Product competitiveness
According to the analysis of IQVIA and ATC-G03D progesterone competitors, there are a total of 6 domestic ATC competitors. Based on market competition (total number of listed/declared/BE companies) and market growth rate (2022 growth rate), compared and analyzed, denogestrin is currently a product with rapid growth and relatively stable competition. However, it will also face fierce market competition in the future, so the cost of denogestrin preparations is particularly critical.
Product advantages:
The new type of progesterone is a selective progesterone receptor agonist that can inhibit ovarian function and the proliferation of endometrial cells, thereby reducing the pain of endometriosis and reducing the size of the lesion;
Compared with the current standard drug GnRH-a for treating endometriosis, there is no difference in efficacy and fewer side effects;
Significant clinical advantages as the preferred drug for long-term management;
The FDA has approved the use of this product in combination with estradiol valerate tablets for oral contraceptives, while other indications can be tailored to different needs due to the formulation;
Class B medical insurance, with rapid market growth;
Advantages of Pharmacare's raw materials:
Professional manufacturer of gynecological raw materials in India, with raw materials supporting the declaration of formulations in China, the United States, and Europe
High quality standards, good impurity control, and large batch size
Competitive prices, long shelf life of active pharmaceutical ingredients, large production capacity, and exports to multiple countries and regions around the world
Flexible and convenient delivery, and regular inventory after product approval
CDE filing for raw materials
 
If you need cooperation and negotiation, please feel free to contact:
Manager Chen: 18888123663 (same as WeChat)
Manager Chen: 13356653012 (same as WeChat)
 
Reference materials:
1. Diagnosis and Treatment Guidelines for Endometriosis, Third Edition, 2021
2. Dinorestrel intrauterine data
3. IQVIA ATC G034D
4. Insight data