On January 6, Tasly issued an announcement stating that recently its wholly-owned subsidiary Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. variety of minodronic acid tablets received the "Drug Registration Approval Document" approved and issued by the State Food and Drug Administration, which is suitable for treating postmenopausal patients. Osteoporosis in women.
Minodronic acid tablets received clinical approval in May 2014, completed the human pharmacokinetic test in December 2015, completed the confirmatory clinical trial in January 2018, and completed the human bioequivalence (BE) test in January 2018 , Applied for CDE in June 2018 (accepting CYHS1800139), after CDE technical review, and then clinical on-site inspection by the National Audit and Inspection Center, it was recently approved and issued by the State Food and Drug Administration as the "Drug Registration Approval Document".
Minodronic acid is a new type of nitrogen-containing aromatic heterocyclic bisphosphonic acid compound. The main raw material is Ethyl Trans-4-oxobutenoate. It can be used as a first-line drug for the treatment of osteoporosis. The drug inhibits the farnesyl group in osteoclasts. The synthesis of the synthase (FPP) of the mevalonate pyrophosphate metabolic pathway shows the effect of inhibiting bone resorption, which in turn reduces the circulation of bone metabolism, and thus has the effect of treating osteoporosis. In terms of the effect of inhibiting bone resorption, minodronic acid is equivalent to zoledronic acid, 10 times that of alendronic acid, 3,000 times that of clodronic acid, and 10,000 times that of itidronic acid. Compared with the oral alendronic acid, the dosage of minodronic acid is significantly reduced (alendronic acid is 10mg/day, minodronic acid is 1mg/day) under the similar curative effect. Patient compliance and reduced gastrointestinal adverse reactions common to bisphosphonates. (Data source: Tohoku J Exp Med 230: 141-149)
Minodronic acid tablets were jointly developed by Japan's Ono Pharmaceutical Co., Ltd. and Japan Astellas Pharmaceutical Co., Ltd. In January 2009, it was the first in Japan under the trade names "Recalbon®" (Ono Pharmaceuticals) and "Bonoteo®" (Astellas Pharmaceuticals). Approved for listing, so far it has not been listed in China. The quality and efficacy of the company's generic drugs are consistent with the original drugs.
Up to now, the company has invested a total of RMB 22,689,800 in research and development for this project.