• 4/25/2005
  • Cuba
  • Cubasi
  • Cuba Travel Explorer

TheraCIM h-R3, a humanized monoclonal antibody, received the certificate of first-category drug granted by the State Food and Drug Administration of China, for its production and commercialization in that Asian nation.

According to Prensa Latina news agency, the drug is prescribed for the combined treatment of advanced head and neck epithelial cancer, of bad prognosis and resistant to the chemotherapy, explained PhD. Patricia Sierra, responsible on the Cuban side of this project.

The h-R3 is a new type of drug obtained through biotechnology, with high effectiveness in the marking and specificity, and little side effect, that has been patented in other countries, including the United States.

This drug will be produced and commercialized by Biotech Pharmaceutical, Chinese-Cuban Company constituted in 2000 by the CIMAB (representative of the Molecular Immunology Center) and three Chinese companies.

Sierra, also general submanager of Biotech Pharmaceutical, pointed out that the industrial-scale cultivation of the recombinant antibody would kick off next September.

To obtain that certificate, it was necessary to carry out clinical trials for more than one year with 120 patients affected by head and neck cancer in six hospitals of Beijing, capital of China, following strict protocols set for that aim.

The studies wound up with very good results, with full response in 70% of the cases, without evidences of severe clinic toxicity, Prensa Latina assures in its note.

That was the first time in which a humanized monoclonal antibody was subject to clinical test in China, country that does not have this production technology at large scale.

It was released that in addition to the h-R3, three other drugs conceived by CIM scientists are completing different phases of development, among them the CD6, a monoclonal antibody destined for the treatment of different types of lymphomas, that is currently in its phase of clinical trial; the c5, for ovarian tumors, under humanization process and works are underway for the development of the EGF anti-cancer vaccine.