July 8, 2025 – 昂伟达® (Product Name: Simenafil Hydrochloride Tablets; R&D Code: TPN171), a Class 1 new drug collaboratively developed by Vigonvita Life Sciences Co., Ltd., Shanghai Institute of Materia Medica Chinese Academy of Sciences, Xinjiang Technical Institute of Physics and Chemistry Chinese Academy of Sciences, and other institutions, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of Erectile Dysfunction (ED).
昂伟达® is a highly active and highly selective phosphodiesterase 5 (PDE5) inhibitor with a novel chemical structure. It demonstrates significant clinical efficacy, high safety, broad applicability across patient populations, and diverse usage scenarios. It possesses the potential to become a Best-in-Class drug, offering ED patients a superior treatment option.
Non-clinical study results show that昂伟达® exhibits potent inhibition of PDE5 (IC₅₀ = 0.62 nM)[1] and significantly enhances penile erectile function in SD rats, Beagle dogs, and rabbits[2]. Phase III clinical trials demonstrated the significant clinical efficacy of 昂伟达®. Its recommended starting dose is lower than that of currently marketed drugs targeting with the same target. When taken on-demand at doses of 2.5 mg, 5 mg, and 10 mg, 昂伟达® achieved vaginal insertion success rates of 88.67%, 90.33%, and 92.02% respectively (40.58%, 42.43%, and 43.98% increase), and intercourse success rates of 70.52%, 72.09%, and 74.65% respectively (61.91%, 63.70%, and 65.19% increase). The International Index of Erectile Function – Erectile Function (IIEF-EF) domain scores reached 25.7, 25.6, and 26.1 points respectively (12.3, 12.3, and 12.7 points increase), approaching normal levels (≥26 points is considered normal)[3, 4].
昂伟达® exhibits outstanding safety advantages, with a lower incidence of clinical adverse reactions compared to currently marketed drugs with the same target. Phase III clinical trials showed that the incidence rates of common adverse reactions such as headache (2.6%, 3.2%, 3.7%) and dyspepsia (0%, 0.5%, 0.5%) in the 2.5 mg, 5 mg, and 10 mg 昂伟达® dose groups were lower[3, 4]. 昂伟达® has weak inhibitory effects on other PDE subtypes (associated with side effects)[1], consequently, related adverse reactions were either not observed or occurred rarely. For instance, no visual disturbances (PDE6 related), back pain or myalgia (PDE11related) were reported[3-5], and the incidence of flushing (PDE1related) was much lower than that of sildenafil[3-6].
Common Adverse Reactions: 昂伟达® vs. Sildenafil vs. Tadalafil
Note: 1) 昂伟达® data sourced from the prescribing information and Phase III clinical trial data[3, 4]; Sildenafil and Tadalafil data sourced from their respective prescribing information[6, 7].
2) 昂伟达® had no adverse reactions of visual disturbance, back pain, or myalgia.
昂伟达® has a rapid onset of action, taking effect within 30 minutes after oral administration, allowing for use as needed. It also has a prolonged duration of efficacy, with a half-life of 8 to 11 hours, aligning well with typical daily routines. The efficacy of 昂伟达® is not affected when taken with moderate amounts of alcoholic beverages. 昂伟达® is suitable for a wide range of patient populations, including special populations such as the elderly, patients with mild to moderate hepatic impairment, and patients with mild, moderate, or severe renal impairment.
References
[1] Wang Z, Jiang X, Zhang X, et al. Pharmacokinetics-Driven Optimization of 4(3H)-Pyrimidinones as Phosphodiesterase Type 5 Inhibitors Leading to TPN171, a Clinical Candidate for the Treatment of Pulmonary Arterial Hypertension. J Med Chem. 2019;62(10):4979-4990.
[2] Xu Zijie. Study on the Effect of New Compound TPN171H on Penile Erectile Function in Experimental Animal Models [D]. Zhejiang University, 2019.DOI:10.27461/d.cnki.gzjdx.2019.001866.
[3] Phase III Clinical Trial Clinical Study Report: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial on the Efficacy and Safety of TPN171H Tablets in the Treatment of Male Erectile Dysfunction.
[4] Semenafil Hydrochloride Tablets Prescribing Information.
[5] Bischoff E. Potency, selectivity, and consequences of nonselectivity of PDE inhibition. Int J Impot Res. 2004;16 Suppl 1:S11-S14.
[6] Sildenafil Citrate Tablets Prescribing Information.
[7] Tadalafil Tablets Prescribing Information.
Special Notes
1.This press release aims to disseminate information regarding the company’s R&D and regulatory progress, facilitate communication and exchange of medical information, and is intended for healthcare professionals only. It is not for advertising purposes.
2.The company does not recommend any specific drugs and/or indications.
3.The information contained in this press release is for reference only and cannot in any way replace professional medical guidance, nor should it be construed as diagnostic or treatment advice. For specific information on disease diagnosis and treatment, please follow the advice or guidance of a physician or other qualified healthcare professional.