JW Therapeutics, perusahaan bioteknologi independen sing fokus ing ngembangake, nggawe lan komersialisasi produk imunoterapi sel, ngumumake yen Administrasi Produk Medis Nasional (NMPA) China nampa Aplikasi Obat Anyar (sNDA) tambahan kanggo reseptor antigen chimeric autologous anti-CD19 T ( Produk imunoterapi sel CAR-T Carteyva® (injeksi autoleucel relmacabtagene) kanggo perawatan pasien diwasa kanthi limfoma folikel sing kambuh utawa refraktori (r / r FL). Iki minangka aplikasi marketing kapindho ing Carteyva® sing diajukake dening JW Therapeutics, lan samesthine minangka produk terapi sel pisanan sing disetujoni ing China kanggo perawatan pasien r / r FL. Carteyva® diwenehi Penetapan Terapi Terobosan dening NMPA ing September 2020.
sNDA didhukung dening asil klinis saka kohort B saka siji-lengen, multi-pusat, sinau pivotal (RELIANCE sinau) ing Carteyva® ing patients diwasa karo limfoma non-hodgkin sel B kambuh utawa refraktori ing China. Asil panaliten kasebut ditampilake ing Rapat Tahunan American Society of Hematology (ASH) kaping 63 ing Desember 2021. Asil kohort B nuduhake yen Carteyva® nuduhake tingkat respon penyakit tahan lama sing dhuwur banget (Tingkat Tanggepan Lengkap Paling apik lan Tingkat Tanggepan Umum ing 3 wulan yaiku 92.6% lan 100%, masing-masing) lan CAR-T sing bisa dikontrol kanthi keracunan ing pasien kanthi r / r FL (42.9% lan 17.9% saka pasien duwe Sindrom Pelepasan Sitokin (CRS) lan Neurotoxicity (NT), dene 0% lan 3.6% saka pasien ngalami CRS lan NT saka Grade 3 utawa ndhuwur).
Profesor Yuqin Song, Kepala Dokter Departemen Lymphoma ing Rumah Sakit Kanker Universitas Peking, Direktur China Society of Clinical Oncology (CSCO), nyathet ing Rapat Tahunan American Society of Hematology (ASH) kaping 63: "Asil sinau RELIANCE nuduhake yen Carteyva® nuduhake khasiat lan profil safety sing apik banget ing pasien karo r / r FL lan kita ngarepake persetujuan sNDA ing China.
APA sing kudu dijupuk saka ARTIKEL INI:
- 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.
