Lukang Enters the Booming $700M+ Urological Drug Market with Dapoxetine Hydrochloride, Driving 180% Sales Surge

Recently, the CDE official website showed that the Dapoxetine Hydrochloride Tablets submitted by Suzhou Vigonvita Life Sciences Co., Ltd. | Shandong Lukang Group Saite Co., Ltd. for marketing application as a Category 4 generic drug have been accepted. Data from Menet shows that the market for urological system chemical drugs in China's urban physical pharmacies has steadily grown in recent years, with sales expected to reach nearly 5 billion yuan in 2021, and Dapoxetine Hydrochloride Tablets are among the top five products. Entering 2022, Lukang Pharmaceutical has had frequent good news. The company successively announced that Amoxicillin Sodium Clavulanate Potassium for Injection, Penicillin Sodium for Injection, Tinidazole Tablets have been approved, and Ticagrelor Tablets have obtained a drug registration certificate.

Data shows that dapoxetine hydrochloride tablets, a selective serotonin reuptake inhibitor (SSRIs) developed by Johnson & Johnson, were approved for import in China in 2010 and are used to treat premature ejaculation in males aged 18-64.

Data from Menet shows that in recent years, the market for urological system chemicals in China's urban physical pharmacies has been growing steadily. Sales are expected to reach nearly 5 billion yuan in 2021. Dapoxetine Hydrochloride Tablets rank among the top five products. In 2020, sales of this product in China's urban physical pharmacies exceeded 70 million yuan, with a year-on-year increase of over 180%. It is projected to hit new highs again in 2021, with a year-on-year growth rate of 106.43%. Among these, Berlin-Chemie AG holds the largest market share, followed by Sichuan Kelun Pharmaceutical Co., Ltd. and Shandong Huabai Kaisheng Biotechnology in second and third place, respectively.

Source: MiNeiNet One-Click Search

Currently, eight companies hold the production approval for Dapoxetine Hydrochloride Tablets. Among them, seven domestic pharmaceutical companies, including Shandong Langnuo Pharmaceutical, Sichuan Kelun Pharmaceutical, and Shenzhen Salubris Pharmaceutical, have been approved as Category 4 generics, which are deemed to have passed the quality and efficacy evaluation. Additionally, five companies, including Jiangxi Pharmaceutical and Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Group, have submitted their applications for Category 4 generic approval and are currently under review. Once approved, they will also be considered as having passed the evaluation.

Entering 2022, Lukang Pharmaceutical has been reporting good news frequently. The company successively announced that the injections of Amoxicillin Sodium Clavulanate Potassium and Penicillin Sodium, as well as Tinidazole Tablets, have been approved for evaluation, and Ticagrelor Tablets have obtained a drug registration certificate.