Isihloko sokuqala sifumana unyango olutsha lwechiza lweHemophilia B

I-BBM-H901 lichiza elitsha lophando lokuqala (IND) elivunyiweyo e-China kunyango lwemfuza ngomzila we-IV wonikezelo lwezifo zemfuza, kwaye ngokuthe ngqo, kwi-hemophilia B. Okwangoku, akukho mveliso yonyango lwemfuza ye-AAV evunyiweyo ukuba ithengiswe i-hemophilia. eTshayina nakwihlabathi jikelele.

Olu phononongo lweklinikhi olubhalisiweyo (CTR20212816) luziko oluninzi, ingalo enye, i-open-label kunye nesifundo sonyango olulodwa. Injongo yayo kukuvavanya ukhuseleko, ukunyamezela, i-pharmacokinetics, kunye nokusebenza kwexesha elide kunye nokhuseleko lokufakwa kwi-intravenous enye ye-BBM-H901 kwizigulane ze-hemophilia B ≥iminyaka eyi-18 ubudala kunye ne-endogenous blood coagulation factor IX (FIX) umsebenzi ≤ I-2 IU/dL (≤2%).

“Njengemveliso yokuqala yenkampani eyenziwe kwiziko lethu le-cGMP elikumgangatho ophezulu, siyavuya kuba i-Belief BioMed ifikelele kwinqanaba elibalulekileyo kuphando lwezonyango emva kokudosa isifundo sokuqala kuphononongo lwezonyango olubalulekileyo. I-BBM-H901 ngaphambili ibonise ukhuseleko oluhle kunye nokusebenza kwexesha elide kumphandi oqaliswe ulingo lwezonyango (IIT). Kweso sifundo isantya sokuphuma kwegazi ngonyaka (ABR) sancitshiswa kakhulu, kwaye inqanaba lemiba ye-coagulation FIX yanda kakhulu kwaye yaqhubeka kuzo zonke izigulane emva kwesitofu se-IV se-BBM-901. Akukho siganeko esibi esibi (SAE) sibikiwe, "utshilo uDkt. Xiao Xiao, umququzeleli, uSihlalo kunye neGosa eliyiNtloko leNzululwazi (CSO) ye-Belief BioMed.

"Siyabulela kubalingane bethu bezonyango, uluntu lwethu lwesigulane kunye neqela lethu lonke elenze oku kwenzeke," uGqr Xiao wongezelela. I-Belief BioMed, njengeyona nkampani iphambili yonyango lwemfuza e-China, iya kuqhubeka nokuthatha amanyathelo kuzo zombini izifundo zeklinikhi kunye nekliniki ukuzisa amayeza amatsha ngakumbi kwizigulana ezisweleyo. Ukongeza, esi siganeko sibalulekileyo sibeke isiseko esiluqilima sokusetyenziswa kwezonyango kumachiza ethu onyango lwemfuza kwaye kwavula indlela yophuhliso lwezonyango lwala machiza kwiimfuno ezahlukeneyo zeklinikhi ezinkulu nezingafezekiswanga kwixesha elizayo. Injongo yethu kukwenza ukuba amayeza onyango lwemfuza afumaneke kwaye afikeleleke kwizigulana, kwaye kwangaxeshanye, ukuququzelela ukukhula kweshishini lonyango lwemfuza.