Iphuhliswe yi-Ascentage Pharma ngenkxaso evela kwiNkqubo yeSizwe yokuFumana kweZiyobisi eziNtsha kunye neNkqubo yokuVelisa, i-olverembatinib lichiza elinokuba ligqwesileyo kwiklasi eliya kuthengiswa ngokubambisana kwimakethi yaseTshayina yi-Innovent kunye ne-Ascentage Pharma, ukuze kuxhamle izigulana ezininzi kunye nezabo. iintsapho. Njengoko isizukulwana sokuqala sesithathu saseTshayina i-BCL-ABL TKI iphuhliselwe unyango lwe-TKI-resistant CML, olu lwamkelo luzalisa isithuba sonyango esibalulekileyo kwi-T315I-mutant CML, kwaye iphawula isiganeko esibalulekileyo esibonisa ukuba i-Ascentage Pharma ingene ngempumelelo kwinqanaba lorhwebo.
Le mvume ye-olverembatinib isekelwe kwiziphumo ezivela kwizifundo ezimbini ezibalulekileyo zeSigaba sesi-II - uphononongo lwe-HQP1351CC201 kunye nophononongo lwe-HQP1351CC202. Ezi ziphumo zibonise ukuba i-olverembatinib iyasebenza kwaye inyamezeleke kakuhle kwizigulane ezine-CML-CP kunye ne-CML-AP, kwaye amathuba kunye nobunzulu bempendulo yeklinikhi kulindeleke ukuba kwandiswe kunye nexesha elide lonyango.
I-CML yi-hematological malignancy yeeseli ezimhlophe zegazi. Ukuqaliswa kwe-BCR-ABL TKIs iphucule kakhulu ulawulo lweklinikhi ye-CML. Nangona kunjalo, ukuxhathisa okufunyenweyo kwii-TKIs kuhlala kungumngeni omkhulu kunyango lwe-CML. Ukuguqulwa kwe-BCR-ABL tyrosine kinase kubonisa indlela ephambili yokuxhathisa iziyobisi; I-T315I, lolona tshintsho luxhaphakileyo lokunganyangeki ngamachiza, lwenzeka malunga ne-25% yezigulane ezine-CML enganyangekiyo ngamachiza. Izigulana ezine-T315I-mutant CML ziyaxhathisa kwisizukulwana sokuqala kunye nesesibini kwisizukulwana se-BCR-ABL inhibitors, kungoko zibonakalisa imfuno yonyango engxamisekileyo yonyango olusebenzayo.
INTO ONOKUYITHATHA KWELI NQAKU:
- As China’s first third-generation BCL-ABL TKI developed for the treatment of TKI-resistant CML, this approval fills an important treatment gap in T315I-mutant CML, and marks a major milestone signifying that Ascentage Pharma has successfully entered the commercial-stage.
- These results showed that olverembatinib is efficacious and well-tolerated in patients with CML-CP and CML-AP, and the probability and depth of clinical response is expected to increase with prolonged treatment period.
- Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing program, olverembatinib is a potentially best-in-class drug that will be co-commercialized in China market by Innovent and Ascentage Pharma, for the benefit of more patients and their families.
