December 24, 2025
Source: drugdu
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Recently, according to information published on the official website of the National Medical Products Administration (NMPA), Shandong Huabo Kaisheng Biotechnology, a wholly-owned subsidiary of Guangdong Taienkang, has received approval for the marketing of finasteride tadalafil capsules (trade name: Aitinglie® ) , successfully becoming the first generic version of this drug in China. The original drug was developed by VERU in the United States and approved there in 2021. This domestic production fills a market gap for compound treatment drugs for benign prostatic hyperplasia in China . The unique feature of finasteride tadalafil capsules lies in the synergistic effect of its dual mechanisms of action .
• Finasteride, as a type II 5α-reductase inhibitor, can inhibit benign prostatic hyperplasia at its source by reducing the gland size by lowering dihydrotestosterone levels;
• Tadalafil, as a PDE5 inhibitor, quickly relieves urinary difficulties by relaxing smooth muscles.
This combination achieves both symptomatic and root-cause treatment: finasteride targets the underlying cause of hyperplasia, while tadalafil improves symptoms. Clinical studies show that this combination is superior to finasteride monotherapy in improving the International Prostate Symptom Score (IPSS), significantly relieving symptoms within 4 weeks of treatment. The once-daily dosing is convenient and helps improve patient adherence. Benign prostatic hyperplasia (BPH) is a common urinary disease in middle-aged and elderly men, mainly manifested as urinary frequency, urgency, and increased nocturia, seriously affecting quality of life. According to data from Yaozhi, the market size of BPH drugs in China approached 10 billion yuan in 2024, with an annual growth rate exceeding 10%, indicating strong market demand.
This approval is not Taincon's first breakthrough in the field of andrology treatment. The company has long focused on this area, with its wholly-owned subsidiary, Shandong Huabokaisheng Biotechnology, specializing in the research and development and commercialization of andrology drugs. Through years of accumulation, Taincon has gradually built a complete product portfolio:
• In April 2020, Taincon's first blockbuster andrology product— dapoxetine hydrochloride tablets (trade name: Aitingjiu® ) —was approved, becoming the first generic drug for the treatment of premature ejaculation in China;
• tadalafil tablets (trade name: Aitingwei® ) for the treatment of erectile dysfunction were approved, further enriching the andrology product line;
• Now, with the approval of finasteride tadalafil capsules (trade name : Aitinglie® ) as the first generic, Taencon has established a complete pipeline of andrology products covering "premature ejaculation + erectile dysfunction + benign prostatic hyperplasia", achieving a comprehensive layout in this treatment field.
of Aitinli® not only signifies a revolution in treatment concepts but also demonstrates the significant progress in domestic pharmaceutical research and development capabilities. With the emergence of more treatment options, the health of middle-aged and elderly men will receive further attention, thus injecting tangible momentum into the construction of a "Healthy China."
https://news.yaozh.com/archive/46726.html
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