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Anti-tumor New Drug CM082

Malignant tumor has been the major disease threatening human life severely. Despite of certain curative effect of existing treatments, most of tumor patients are facing with limited time to live and lack of effectively curative drugs. It is necessary to develop new drugs to satisfy their demands. At present, a great majority of anti-tumor drugs in clinical treatment are featured by severe toxic and side effect, MDR and other problems. 

2-indolone targeted specific anti-tumor drug of CM082 series have the similar skeletal structures to Icotinib Hydrochloride, as the multi-target RTK (receptor tyrosine kinase) inhibitor, mainly targeting at VEGFR and PDGFR. This project is the new-generation product based on the sufficient study on Icotinib Hydrochloride’s action mechanism and toxic and side effect, featured by the sound safety and treatment effect in clinical application. 

This project has launched the clinical research in America for over 6 years, in which over 60 cases have completed at least one treatment course. The same clinical research has been simultaneously conducted in clinical bases in China, including Tumor Hospital of Chinese Academy of Medical Sciences, Peking University First Hospital and Tianjin Municipal Cancer Hospital. These trials results have shown the common characteristic as sound tolerance, without DLT or MDR within the clinical research dosage scale as 50-800mg. 

The early-stage clinical trial results have shown that single drug of CM082 has a sound curative effect for kidney cancer. 

Clinical research on single drug of CM082 and combination of anti-tumor drugs, including CM082 and docetaxel and everolimus, for several tumor treatment have been conducted in China and America at present. 

New Drug for eye-ground Maculopathy CM082

AMD is the most common reason leading to blindness of patients aged 50 years old or above. 10% cases of of AMD belong to the type of new vessel leakage (namely wet type), which can cause 90% cases of blindness. Direct VEGF/PDGF inhibitors have a curative effect on wet AMD. 

So far, four anti-VEGF new drugs have been widely applied in clinical treatment with sound curative effects, in which the most well-known and successful representative shall be Lucentis launched by Roche. However, one of the common grounds of these drugs is that they are biological drugs for eye-ground injection, featuring inconvenient transportation, storage and application. At the same time, intravitreal injection on a monthly or bimonthly basis will be expensive for patients, leading to an annual expenditure of RMB 100,000 approximately. These two features have severely restricted their application scopes, because most of Chinese patients can’t have access to or afford them. 

CM082 is dual targeted inhibitors for VEGF and PDGF, which has been applied in clinical research of wet AMD in America for over two years; its application in clinical trial in China has been initiated since Feb. 2015. American clinical trial has completed over 50 subjects, who have showed great tolerance to CM082, without the occurrence of major toxicity or DLT. During the trial period for 163 months in total, all of subjects have received 8 times of eye-ground injection of Lucentis to prevent deterioration. Namely, each subject has received 0.59 time of eye-ground injection each year, which is far lower than the required at least 7 times of eye-ground Lucentis injection per capita annually. It has been unnecessary for 89% of subjects to receive any eye-ground injection to maintain no vision deterioration or even improvement. 

So far, Anew has received the clinical application approval for 4 ophthalmic indications including AMD, diabetic macular oedema, macular oedema secondary to etinal vein obstruction and pathologic myopic CNV. 

If the research and development of CM082 is successful, it will turn into the first effective oral medicine for wet AMD in the world, of great social and academic values.