Ua hoʻolaha ʻo JW Therapeutics, kahi hui biotechnology kūʻokoʻa i ka hoʻomohala ʻana, ka hana ʻana a me ke kūʻai ʻana i nā huahana immunotherapy cell, ua hoʻolaha ka National Medical Products Administration (NMPA) o Kina i ka hoʻohui ʻana i ka New Drug Application (sNDA) no kāna anti-CD19 autologous chimeric antigen receptor T ( CAR-T) huahana immunotherapy cell Carteyva® (relmacabtagene autoleucel injection) no ka mālama ʻana i nā poʻe maʻi makua me ka lymphoma follicular relapsed a refractory (r/r FL). ʻO kēia ka lua o ka noi kūʻai aku ma Carteyva® i waiho ʻia e JW Therapeutics, a ua manaʻo ʻia ʻo ia ka huahana cell therapy mua i ʻae ʻia ma Kina no ka mālama ʻana i nā maʻi r/r FL. Ua hāʻawi ʻia ʻo Carteyva® i ka Breakthrough Therapy Designation e NMPA i Kepakemapa 2020.
Ua kākoʻo ʻia ka sNDA e nā hopena lapaʻau mai ka cohort B o kahi hoʻopaʻa lima hoʻokahi, multi-center, pivotal study (RELIANCE study) ma Carteyva® i nā poʻe maʻi makua me ka relapsed a refractory B cell non-hodgkin lymphoma ma Kina. Ua hōʻike ʻia nā hopena noiʻi ma ka 63rd American Society of Hematology (ASH) Annual Meeting in December 2021. Ua hōʻike nā hopena cohort B ua hōʻike ʻo Carteyva® i nā helu kiʻekiʻe loa o ka pane ʻana i ka maʻi lōʻihi (Best Complete Response Rate and Overall Response Rate ma 3 mahina. ʻO 92.6% a me 100%, kēlā me kēia) a me ka controllable CAR-T pili i nā meaʻawaʻawa i nā maʻi me ka r / r FL (42.9% a me 17.9% o nā maʻi i loaʻa i kekahi papa Cytokine Release Syndrome (CRS) a me Neurotoxicity (NT), aʻo 0% a ʻO 3.6% o nā maʻi i loaʻa iā CRS a me NT o ka Papa 3 a i luna paha).
Ua hōʻike ʻo Professor Yuqin Song, Kauka Nui o Lymphoma Department ma Peking University Cancer Hospital, Luna Hoʻokele o China Society of Clinical Oncology (CSCO), i ka 63rd American Society of Hematology (ASH) Annual Meeting: "Ua hōʻike nā hopena noiʻi RELIANCE ua hōʻike ʻo Carteyva®. ʻO ka maikaʻi maikaʻi loa a me ka ʻike palekana i nā maʻi me ka r / r FL a ke kakali nei mākou i ka ʻae sNDA ma Kina.
He aha e lawe ʻia mai kēia ʻatikala:
- 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.
