Lunan Pharmaceutical Secures First Domestic Approval for Bilastine Orally Disintegrating Tablets with 3-Year CAGR Exceeding 100%
Lunan Pharmaceutical
Comprehensive Pharmaceutical Group
On September 19, according to the latest announcement on the NMPA official website,Lunan PharmaceuticalGroup SubsidiaryShandong New Era PharmaceuticalDeclared under Chemical Drug Registration Category 3Bilastine Oral Tablets(Specification: 20mg)Approved for marketing, this formulation is the first domestic generic in China.
Screenshot source: NMPA
BilastineThe original product is from SpainFAES PharmaceuticalDeveloped as a second-generation non-sedating long-acting antihistamine, it was first approved for marketing in the EU in August 2010. In June 2023, Menarini applied for...Bilastine TabletsApproved for marketing in China. 2023BilastineSales rank among global antihistaminesThe 6th, of which the orally disintegrating tablet market is approximately$61.31 million, Sales volume approximately200 million tablets, Sales have grown rapidly since its listing in 2017, with a 3-year CAGR exceeding100%。
2024 Year,Jiangsu Huayang PharmaceuticalTake DownBilastine TabletsFirst domestic generic. In the Chinese market, Mosentropy Medical Database shows that, in 2024Bilastine TabletsExceeding 1.3 million yuan in sales across all terminals in China.
Source of screenshot: Mosentropy Medicine All-Terminal Hospital Sales Database
This timeLunan Pharmaceutical Group Corporation's subsidiary, Shandong New Era Pharmaceutical, has applied forBilastine Orally Disintegrating Tablets Approved for Marketing in China, as the First Domestic Generic of This Dosage Form+First to Pass。
In terms of drug layout, currently, forBilastine Orally Disintegrating TabletsFour pharmaceutical companies, including Sichuan Kelun Pharmaceutical and Shandong Langnuo Pharmaceutical, have submitted Class 3 new generic drug registration applications, all of which are currently under review.
Screenshot source: Mosentropy China Drug Evaluation Database
Lunan Pharmaceutical(Including subsidiaries)Continuously making efforts in the pharmaceutical field, to date, the number of approved and positively evaluated drug varieties exceeds 100! Among them, there are 16 varieties that were the first to pass the evaluation. Additionally, regarding the declaration of bioequivalence (BE) trials,Lunan Pharmaceuticalis also proceeding steadily.Tolterodine Tartrate Tablets, Acipimox Capsules, Sapropterin Hydrochloride TabletsThe BE trials for 8 varieties have been successfully completed.
This time, Lunan Pharmaceutical has takenBilastine Orally Disintegrating TabletsFirst Domestic Generic: The Approval of This Product Provides a New Option for Clinical Use. The Market Potential of This Dosage Form in China is Emerging, with Multiple Pharmaceutical Companies Competing in the Layout. This Approval Highlights Lunan Pharmaceutical's Innovation Strength, Assisting in Expanding the Allergy Treatment Market.
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