SHANDONG XINHUA (00719.HK): Dapoxetine Hydrochloride Tablets Obtain Drug Registration Certificate, Enriching Formulation Portfolio
NewTimeSpace News: On 28 August 2026, Shandong Xinhua Pharmaceutical Company Limited (stock code: 00719) announced that it had recently received the Drug Registration Certificate for Dapoxetine Hydrochloride Tablets, approved by the National Medical Products Administration, with approval number Guoyao Zhunzi H20265706, certificate number 2026S03108 and acceptance number CYHS2501422.
According to the announcement, the product is in tablet form with a specification of 30 mg (calculated as C21H23NO), classified as a prescription drug under Chemical Drug Category 4, with the application for domestic drug registration. Shandong Xinhua submitted the registration application for domestic manufacturing and marketing approval to the Center for Drug Evaluation of the National Medical Products Administration in April 2025, and obtained the Drug Registration Certificate in August 2026.
The product is indicated for the treatment of male patients aged 18 to 64 with premature ejaculation (PE) who meet all specified conditions, including an intravaginal ejaculation latency time of less than two minutes and significant personal distress or interpersonal difficulty resulting from PE. According to relevant statistics, sales of dapoxetine in Chinese public medical institutions in 2025 amounted to approximately RMB 1.03 billion.
The Company stated that the Drug Registration Certificate will further enrich its formulation product portfolio and enhance market competitiveness, while cautioning that drug sales are subject to uncertainties arising from policy changes, tendering and procurement, and market conditions in the domestic pharmaceutical industry.
NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.
