Salvat Laboratories enters in the chinese market with Cetraxal® Plus Clinical Trial

  • Salvat has an agreement with Lee’s Pharmaceuticals to distribute Cetraxal® Plus in China
  • Cetraxal® Plus is the only pharmaceutical product in the world that is available in single-dose vials for external otitis and otitis media. It was launched in 2002 in Spain and is already exported to more than 50 countries
  • The Phase III clinical trial will include 600 patients from 44 hospitals. This process is a necessary step in order to obtain approval for a medicine in China
  • With this project, Salvat reinforces its commitment to the Chinese market, where it has already initiated agreements to commercialize other drugs

Salvat Laboratories (“Salvat”) and Lee’s Pharmaceutical Holding Limited (“Lee’s Pharm”) (SEHK Stock Code:0950) in January 2021, started a the Phase III clinical trial of Salvat’s Cetraxal® Plus otic treatment in China. The study will include 600 patients from 44 centers across the country and will be led by researchers from Fudan University. The trial will be conducted throughout this year, with the expectation of the regulatory approval in 2022.

This clinical trial is the prerequisite for obtaining authorization from the Chinese National Medical Products Administration to market the drug, in their country. Lee’s Pharmaceutical was successful in acquiring the rights from Salvat to sell Cetraxal® Plus in China, in the single-dose vial format.

Strategic commitment to the Chinese market

Once approved, this will be the first drug that Salvat markets in China, a market that has become key for the company. “The Chinese market is a market with great growth potential and with a very high demand for health and self-care products. For us, it has already become a strategic market after the US and Europe”, explains Alberto Bueno, CEO of Salvat.
In this regard, the laboratory has already begun negotiations with other companies to present products from its portfolio in China. In the near future, Salvat plans to launch more than five products in this market.


The world´s first otic treatment in single-dose vials

Cetraxal® Plus is a treatment for external otitis and otitis media with tympanostomy tubes, which combines an antibiotic and a corticosteroid. This medication was developed by Salvat and approved in Spain in 2002. Authorizations were subsequently obtained in other European countries, followed by the United States and Canada. Cetraxal® Plus is currently exported to more than 50 countries around the world.

The presentation in single-dose vials of Cetraxal® Plus is a very important advantage compared to other treatments available in multidose. This presents several benefits over competitors as it facilitates correct administration with the exact amount of product and maintains sterility of treatment. “At Salvat, our commitment to technology and innovation in drug development allows us to offer increasingly advanced solutions. One of these improvements is the single-dose format, which we manufacture thanks to the BFS (Blow-Fill-Seal) technology that we have in the 3 manufacturing plants owned by the Salvat Group: Salvat (Barcelona), Pharmaloop (Alcalá de Henares, Madrid) and Tamarac (Florida)” explains the CEO of Salvat, Alberto Bueno.

With almost twenty years on the market, Cetraxal® Plus has become one of Salvat’s star products. Every year more than 1,500,000 units are sold in Spain and more than 3,000,000 are exported to other countries.