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Jiudian Pharmaceutical’s Dapoxetine Hydrochloride Tablets Approved for PE Indication
Release time:
2025-06-08 00:00
Source:
Abstract
Recently, Jiudian Pharmaceutical’s Dapoxetine Hydrochloride Tablets were approved for marketing by CDE of NMPA and passed the consistency evaluation of generic drugs in quality and efficacy. As the only domestically approved drug for the treatment of premature ejaculation (PE), this product is recommended as a first-line treatment in authoritative domestic and international PE diagnosis and treatment guidelines. Manufactured using Jiudian’s self-produced active pharmaceutical ingredients (APIs), the drug aims to provide effective, convenient, and safe treatment options for PE patients.
With the accelerating aging population and risingwork-life stress, male health issues are becoming more prominent. Public data shows that male urological diseases are growing at an annual rate of 3%, with premature ejaculation (PE), erectile dysfunction (ED), and chronic prostatitis (CP) emerging as the "three major burdens" crushing modern men, severely threatening their health and quality of life.
Dapoxetine Hydrochloride Tablets are consistently recommended as a first-line treatment in authoritative "PE Diagnosis and Treatment Guidelines" worldwide. Its mechanism of action is well-defined: as a potent selective serotonin reuptake inhibitor (SSRI), dapoxetine increases the concentration of 5-HT neurotransmitters in the central nervous system, effectively regulating the neural pathways associated with ejaculatory control. This significantly prolongs intravaginal ejaculatory latency time (IELT). Extensive clinical studies have confirmed that for men with a shorter baseline IELT (e.g., 40-50 seconds), dapoxetine can help extend it to nearly 2 minutes (effects vary by individual), significantly improving sexual satisfaction and alleviating personal distress and interpersonal difficulties caused by PE.
A core advantage of Dapoxetine Hydrochloride Tablets is its "on-demand dosing" feature. The drug is rapidly absorbed, typically reaching peak plasma concentration within 1-3 hours after administration. Patients only need to take it 1-3 hours before sexual activity. Additionally, its short half-life, low systemic accumulation, and rapid metabolism minimize the potential risks of long-term use, ensuring good overall safety, tolerability, and high patient compliance.
With its proven efficacy, convenient dosing, and excellent safety profile, Dapoxetine Hydrochloride Tablets have become a benchmark in PE treatment. According to the latest data from Menet, the drug’s total sales in China’s three major healthcare terminals and six key markets exceeded 1.3 billion yuan in 2023, demonstrating significant market potential. Notably, online pharmacies accounted for over 70% of its sales, making it the primary distribution channel.
As society pays increasing attention to male health issues and the standardization of PE diagnosis and treatment improves, Dapoxetine Hydrochloride Tablets hold broad market prospects. Jiudian Pharmaceutical will continue to deepen its focus on male health, leveraging its self-produced APIs and quality assurance from consistency evaluations to benefit more patients and advance the development of male health initiatives.