Lunan Pharmaceutical Secures China's First Generic Approval for Bilastine Orally Disintegrating Tablets Amid Surge in Consistency Evaluation Approvals

　　【Pharmaceutical Network Industry DynamicsAccording to data statistics, from September 15th to September 21st, a total of 68 varieties passed/were considered to have passed the consistency evaluation. Among them, the bilastine orally disintegrating tablet applied for by Lunan Pharmaceutical was approved for marketing, becoming the first domestically produced generic + the first to pass the evaluation in China for this dosage form.
 

On September 19, according to the NMPA website, Bilastine Orodispersible Tablets (specification: 20mg), a Category 3 chemical drug application submitted by Shandong New Time Pharmaceutical, a subsidiary of Lunan Pharmaceutical Group, was approved for marketing and is considered to have passed the generic drug quality and efficacy consistency evaluation.
 

This product is the first in China to be approved for marketing, used for symptomatic treatment of urticaria in adults and adolescents (12 years and above). Data shows that bilastine is a second-generation non-sedating long-acting histamine antagonist, with selective peripheral H1 receptor antagonist affinity, no affinity for muscarinic receptors, no sedative effects, no cardiac toxicity, and does not interact with cytochrome P450 enzyme substrates. It has the characteristics of rapid onset, long duration, and high efficacy. The orally disintegrating tablets can rapidly disintegrate or dissolve in the mouth, have a pleasant taste, are easy to swallow, and are non-irritating to the oral mucosa. They are commonly used for patients with swallowing difficulties or those who are uncooperative with taking medication.
 

The original product was developed by Spanish FAES Pharma and was approved for marketing in the EU as early as August 2010. In June 2023, Bilastine Tablets applied by Menarini were approved for marketing in China. In 2023, the sales of Bilastine Orally Disintegrating Tablets were approximately 61.31 million US dollars, with a sales volume of about 200 million tablets.
 

In terms of drug development, multiple pharmaceutical companies, including Sichuan Kelun Pharmaceutical and Shandong Langnuo Pharmaceutical, have submitted Class 3 new generic registration applications for bilastine orally disintegrating tablets. These applications are currently under review and approval. This indicates that the domestic market potential of this formulation has drawn industry attention, and a competitive landscape is taking shape.
 

It is reported that Lunan Pharmaceutical (including its subsidiaries) continues to make efforts in the pharmaceutical field. Up to now, the number of approved and evaluated drug varieties has exceeded 100! Among them, the company was the first to evaluate 16 varieties. In addition, Lunan Pharmaceutical is also steadily advancing in the declaration of bioequivalence (BE) trials. The BE trial declarations for eight varieties, including Tolterodine Tartrate Tablets, Acipimox Capsules, and Sapropterin Hydrochloride Tablets, have been successfully completed. The approval and market launch of the company's Bilastine Orally Disintegrating Tablets will provide a new option for clinical medication.
 

According to data statistics, from September 15th to September 21st, a total of 68 varieties passed/were considered to have passed the consistency evaluation. Among them, 12 products passed the consistency evaluation, including Zhi'en Biotech's Mesaselt Granules, Qinghai Pharmaceutical's Naloxone Hydrochloride Injection, Zhengfang Pharmaceutical's Pioglitazone Hydrochloride Tablets, Zhengda Qingjiang's Cefixime Tablets, and Xinyi Pharmaceutical's Nicorandil Tablets, etc.;
 

There are 56 varieties deemed to have passed the consistency evaluation, including Tadalafil Tablets from Runbang Pharmaceutical, Tapentadol Hydrochloride Tablets from Enhua Pharmaceutical, Ipratropium Bromide Nebulizer Solution from Licheng Pharmaceutical, and Sildenafil Citrate Tablets from Kaiman Pharmaceutical, among others. Sildenafil Citrate Tablets are used for ED and were developed by Pfizer in the United States. To date, more than 20 companies in China have obtained drug registration certificates for Sildenafil Citrate Tablets.
 

From the results of this week's 68 varieties passing the evaluation, the consistency evaluation of generic drugs in China has entered a stage of routine advancement. This is not only an important measure by the national drug regulatory authorities to promote the upgrading of drug quality, but also provides a stage for domestic pharmaceutical companies to showcase their R&D and production capabilities. Drugs that pass the consistency evaluation are considered equivalent to originator drugs in terms of quality, safety, and efficacy, achieving the goal of "generic drug substitution for originator drugs." This can not only reduce patients' medication costs and ease the medical burden but also enhance the international competitiveness of domestically produced drugs, driving China's transformation from a "major pharmaceutical manufacturing country" to a "strong pharmaceutical manufacturing country."
 

For pharmaceutical companies, the consistency evaluation has become an important indicator to measure the core competitiveness of enterprises. Being able to take the lead in achieving drug approval in fierce competition, especially with "first generics + first-to-market approval," not only secures a first-mover advantage in the market but also establishes a brand edge in specific fields. As seen in the case of Lunan Pharmaceutical, through continuous focus on generic drug development and accumulating first-to-market approved products, the company has formed differentiated competitive advantages in areas such as anti-allergy, cardiovascular, and metabolic treatments.
 

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