Self-developed targeted anti-cancer drug in China has been confirmed

According to a report from the business community on September 18, targeting cancer drugs is almost equivalent to "expensive foreign patent drugs." However, the news released by the academician of the Chinese Academy of Engineering and Professor Sun Yan of the Cancer Hospital of the Chinese Academy of Medical Sciences on the 17th is expected to change the reality: China's icotinib hydrochloride, a small molecular targeted anti-cancer innovative drug with complete independent intellectual property rights, has completed phase III clinical trials. The curative effect was confirmed.

Electinib hydrochloride is a new generation of targeted anticancer drugs targeting epidermal growth factor receptor kinase. It was completely independently developed by our country's scientists and tumor clinical experts. It has been developed for 8 years and its first adaptation The disease is advanced non-small cell lung cancer.

As the moderator of the phase III clinical trial of icotinib hydrochloride, Academician Sun Yan announced the research results and introduced the research process at the 13th National Conference on Clinical Oncology and 2010 CSCO Academic Annual Meeting.

He said that the phase III clinical trial involved 27 well-known cancer hospitals across the country. Randomized, double-blind, double-dummy, and positive-drug parallel study designs were used, and the imported drug gefitinib was directly used as a control drug. "The study examined the efficacy and safety of advanced lung cancer patients who failed chemotherapy.

Studies have shown that icotinib hydrochloride is no worse than the comparator in terms of efficacy. The median progression-free period in the icotinib group is 137 days, which is 34.3% longer than 102 days in the gefitinib group; disease progression time In the median comparison, the 154 days of the icotinib group was significantly longer than the 109 days of the gefitinib group.

In terms of safety, the incidence of adverse reactions to icotinib was 60.5%, which was significantly lower than that of gefitinib 70.4%. The incidence of rash in the two groups was 40.0% and 49.2%, and the incidence of diarrhea was 18.5% and 27.6, respectively. %, it can be seen that ictenini is safer than gefitinib.

“The double-blind clinical trial of head-to-head with imported brand-name drugs is on the one hand to meet the requirements for national new drug approvals, and on the other hand, it shows our confidence in ethatinib.” Zhejiang Beida Pharmaceuticals is in charge of this research. Dr. Tan Fen-lai said, "The company has spent more than 20 million yuan to purchase gefitinib."

Targeted anticancer drugs have been highly respected by doctors and patients because they have overcome the problems of poor specificity and toxic side effects of traditional chemotherapy drugs. At present, the targeted anticancer drugs used for the treatment of oncological patients in the country mainly rely on imports, and are expensive, and the average patient is unbearable.

Academician Sun Yan said that if ictinib hydrochloride goes on the market, its price will likely be more than 50% lower than that of imported similar products.

According to reports, the ecritinib hydrochloride project has received support from the Innovation Fund of the Ministry of Science and Technology, the "863 Program", the special major new drug creation project, and the Zhejiang Province "Eleventh Five-Year" major special project.