Lukang subsidiary secures Finasteride tablet drug registration certificates

Shandong Lukang Pharmaceutical Co., Ltd. announced its controlled subsidiary, Shandong Lukang Pharmaceutical Group Saite Co., Ltd., has received drug registration certificates for Finasteride Tablets from the National Medical Products Administration. The drug, approved under new registration classification 4, is considered to have passed quality and efficacy consistency evaluations for generic drugs. The certificates cover both 5mg and 1mg specifications.

Finasteride Tablets are a synthetic steroid compound that inhibits type II 5α-reductase. The 1mg specification treats male pattern baldness, while the 5mg specification treats and controls benign prostatic hyperplasia (BPH) and prevents urological events. The drug aims to shrink enlarged prostate glands, improve urine flow, and alleviate BPH-related symptoms.

As of the announcement date, 24 enterprises have 29 Finasteride Tablet approvals that have passed or are deemed to have passed consistency evaluation for generic drugs. According to YaoZhi data, national hospital sales for Finasteride Tablets were approximately CNY 469 million in 2022, CNY 483 million in 2023, CNY 490 million in 2024, and CNY 343 million in the first half of 2025. The total R&D investment for this product by Saite Co., Ltd. amounts to approximately CNY 3.5 million.