June 15,Chengdu Yuandong Bio-PharmaceuticalMirogabalin Besylate Tablets Approved for Market Launch: All Three Strengths Approved, Making It the Third Holder in China (Including the Originator)Three months ago, Chia Tai Tianqing had just secured the first generic approval for this product. It held the position of first generic entrant for only a short period before the second competitor entered the market. Moreover, Chia Tai Tianqing offers only one strength, whereas Chengdu Yuandong provides three strengths, two of which are not even marketed domestically by the originator company.Image source: Mornsun PharmaMirogabalin Mesylate Tablets,A DPNP analgesic with annual sales exceeding $380 million,This drug, independently developed by Daiichi Sankyo, is a third-generation calcium channel modulator. Its mechanism of action involves regulating calcium channel function to reduce calcium influx, thereby inhibiting neuronal hyperexcitability and excessive neurotransmitter release, ultimately achieving analgesic effects.Compared with traditional calcium channel modulators, mirogabalin mesylate tablets offer the advantages of sustained analgesic efficacy, significantly reduced incidence and duration of central nervous system adverse reactions, a more favorable safety profile, and suitability for long-term clinical use.At the global market level, since meloxicam besylate tablets were first approved and launched in Japan in January 2019, sales have shown a rapid growth trend. According to the Minseng Pharmaceutical Database, the cumulative sales of this drug from 2019 to 2023 reached 142.9 billion yen (approximately 1 billion US dollars based on the current exchange rate).Global sales exceeded $380 million in 2024, representing a year-on-year increase of 21.59%.In June 2024, mirogabalin besylate tablets were officially approved for entry into the Chinese market, with an indication for diabetic peripheral neuropathic pain (DPNP) in adults, thereby filling a therapeutic gap in DPNP treatment in China. In November of the same year, the drug was included in the National Reimbursement Drug List through national medical insurance negotiations, significantly improving its clinical accessibility.CHIATAI TIANQING and Qilu Pharmaceutical were the earliest to make their moves. In August 2024, CHIATAI TIANQING took the lead by submitting the marketing application for the generic drug Mirogabalin Mesylate Tablets, followed closely by Qilu Pharmaceutical, and then Yuandong Bio-Pharmaceutical.
To date, more than 20 companies have submitted listing applications. The patent for the core compound of this drug (CN101878193B) is protected in China until September 2028. Upon patent expiration, this product is expected to be directly included in the centralized volume-based procurement program.
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