JW Therapeutics, wani kamfani mai zaman kansa na fasahar kere kere da ke mai da hankali kan haɓakawa, masana'antu da kasuwancin samfuran rigakafin rigakafi, ya sanar da cewa, Hukumar Kula da Kayayyakin Kiwon Lafiyar Jama'a (NMPA) ta kasar Sin ta amince da ƙarin Sabbin Drug Application (sNDA) don anti-CD19 autologous chimeric antigen receptor T. CAR-T) samfurin immunotherapy cell Carteyva® (relmacabtagene autoleucel allura) don kula da manya marasa lafiya tare da relapsed ko refractory follicular lymphoma (r/r FL). Wannan shine aikace-aikacen tallace-tallace na biyu akan Carteyva® wanda JW Therapeutics ya gabatar, kuma ana tsammanin zai zama samfurin farko na maganin tantanin halitta da aka amince da shi a kasar Sin don kula da marasa lafiya na r/r FL. An bai wa Carteyva® Ƙwararren Ƙwararrun Ƙwararrun Ƙwararru ta NMPA a cikin Satumba 2020.
sNDA ta sami goyan bayan sakamakon asibiti daga ƙungiyar B na hannu guda ɗaya, cibiyar da yawa, bincike mai mahimmanci (nazarin RELIANCE) akan Carteyva® a cikin manya marasa lafiya tare da sake dawowa ko refractory B cell non-hodgkin lymphoma a China. An gabatar da sakamakon binciken a taron shekara-shekara na 63rd American Society of Hematology (ASH) a watan Disamba 2021. Sakamakon ƙungiyar B ya nuna cewa Carteyva® ya nuna yawan ƙimar amsawar cuta mai ɗorewa (Mafi kyawun Cikakkar Amsa Rate da Yawan Amsa Gabaɗaya a cikin watanni 3 ya kasance. 92.6% da 100%, bi da bi) da kuma CAR-T da ke da alaƙa masu guba a cikin marasa lafiya tare da r / r FL (42.9% da 17.9% na marasa lafiya suna da kowane nau'in Cytokine Release Syndrome (CRS) da Neurotoxicity (NT), yayin da 0% da 3.6% na marasa lafiya sun sami CRS da NT na Grade 3 ko sama).
Farfesa Yuqin Song, Babban Likitan Sashen Lymphoma na Asibitin Ciwon daji na Jami'ar Peking, Daraktan Cibiyar Kula da Cututtukan Kanjamau ta kasar Sin (CSCO), ya bayyana a taron shekara-shekara karo na 63 na American Society of Hematology (ASH) cewa: "Sakamakon binciken RELIANCE ya nuna cewa Carteyva® ya nuna. ingantacciyar inganci da bayanin martaba a cikin marasa lafiya tare da r / r FL kuma muna sa ido ga amincewar sNDA a China.
ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:
- The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva® in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China.
- JW Therapeutics, an independent biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL).
- This is the second marketing application on Carteyva® submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients.
