SHANGHAI, CHINA, Oktoba 10, 2022 - JW Therapeutics (HKEX: 2126), wani kamfani mai zaman kansa kuma ƙwararren ƙwararren masanin ilimin halittu wanda ke mai da hankali kan haɓakawa, masana'antu, da kasuwancin samfuran rigakafin ƙwayoyin cuta, ya sanar da cewa Hukumar Kula da Kayayyakin Kiwon Lafiyar Jama'a (NMPA) ta kasar Sin ta amince da ƙarin Sabuwar Drug Application (sNDA) don anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy samfurin relmacabtagene autoleucel allura (daga baya an rage shi da relma-cel, sunan kasuwanci: Carteyva®) don kula da tsofaffi marasa lafiya tare da lymphoma follicular wanda ke da wuyar gaske ko kuma ya sake dawowa a cikin watanni 24 na layi na biyu ko sama da tsarin tsarin (r / r FL). Wannan ita ce alama ta biyu da aka amince da ita ga relma-cel biyo bayan amincewarta ta farko da ƙaddamar da ita a watan Satumbar bara, kuma ta sa ta zama samfurin rigakafi na farko da aka amince da shi a China don kula da marasa lafiya na r/r FL.
Kuna so karanta: CAR T Cell far in China
Wannan amincewa ya dogara ne akan sakamakon asibiti na watanni 6 daga ƙungiyar B na hannu guda ɗaya, tsakiya mai yawa, nazarin mahimmanci (nazarin RELIANCE) akan Carteyva.® a cikin manya marasa lafiya tare da relapsed ko refractory B cell non-Hodgkin lymphoma a kasar Sin. An gabatar da bayanan watanni 3 a cikin 63rd Ƙungiyar Ƙwararrun Ƙwararrun Ƙwararrun Amirka (ASH) Taron Shekara-shekara a cikin Disamba 2021. Sakamakon ƙungiyar B ya nuna cewa Carteyva® ya nuna babban ƙimar amsawar cuta mai ɗorewa (ƙimar amsa gabaɗaya (ORR) = 100%, ƙimar amsa cikakke (CRR) = 85.19% a wata 3; ORR = 92.58%, CRR = 77.78% a watan 6) da CAR-T mai sarrafawa. Abubuwan da ke tattare da guba a cikin marasa lafiya tare da r/r FL. Ganin yadda ake samun jiyya a China, Carteyva® na iya zama zaɓin jiyya tare da ƙimar fa'ida mafi girma ga marasa lafiya tare da r/r FL, kuma yana da yuwuwar zama samfurin CAR-T mafi kyau-a-aji.
Farfesa Yuqin Song, babban mai bincike na binciken RELIANCE, Mataimakin Darakta na Sashen Lymphoma, kuma Mataimakin Shugaban Asibitin Cancer na Jami'ar Peking, yayi sharhi, "Ƙididdigar amsa gabaɗaya (ORR) na ƙarshen tasiri ya wuce 90%, kuma ana iya sarrafa bayanan martaba gabaɗaya. Remal-cel ya zama na farko CAR-T cell rigakafin rigakafi samfurin don kula da r / r FL a China."
Kuna so karanta: CAR T Cell far don Multi myeloma a China
James Li, co-kafa, shugaban, da kuma Shugaba na JW Therapeutics, ya ce, "Na gode wa marasa lafiya da masu binciken da suka ba da gudummawa ga nazarin asibiti na Carteyva.®, kuma godiya ga masu gudanarwa don amincewa da Carteyva®. Mun gamsu da nuni na biyu da aka amince da shi, wanda ke ba da sabon zaɓi na jiyya ga marasa lafiya na r / r FL. JW Therapeutics ya himmatu don haɓaka ƙimar Carteyva®, ci gaba da haɓaka sabbin fasahohin fasaha da haɓaka bututun mai, da haɓaka samun damar tantanin halitta. immunotherapy kayayyakin. ”
As the first product of JW Therapeutics and the first CAR-T product approved as a Category 1 biologics product in China, relma-cel has been approved for two indications in China, including the treatment of adult patients with relapsed or refractory large B-cell linzoma (r/r LBCL) after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL). JW Therapeutics is currently doing or plans to do more clinical studies on hematologic malignancies and autoimmune diseases to fully explore the clinical potential of Carteyva®. These include third-line maganin sutturar ƙwayar sel (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
Game da allurar Relmacabtagene Autoleucel (sunan kasuwanci: Carteyva®)
Relmacabtagene autoleucel allura, wanda kuma ana sayar da shi a ƙarƙashin sunan alamar Carteyva®. Yana da autologous anti-CD19 CAR-T cell immunotherapy samfurin da aka gina akan tsarin tsarin salula na CAR-T daga Juno Therapeutics, wani kamfanin Bristol Myers Squibb. Kasancewa samfurin farko na JW Therapeutics, relma-cel ta sami amincewar Hukumar Kula da Kayayyakin Kiwon Lafiya ta kasar Sin (NMPA) don alamu guda biyu, gami da kula da manya marasa lafiya tare da babban ƙwayar lymphoma B-cell da suka koma baya ko kuma suna jujjuyawa bayan layi biyu ko fiye na tsarin tsarin. jiyya, da kuma kula da manya marasa lafiya tare da lymphoma follicular wanda ke da ƙarfi ko kuma ya sake dawowa a cikin watanni 24 na layi na biyu ko sama da tsarin tsarin (r/r FL), yana mai da shi samfurin CAR-T na farko da aka amince da shi azaman samfurin Halittu na 1. a kasar Sin. A halin yanzu, shi ne kawai CAR-T samfurin a China wanda aka haɗa a lokaci guda a cikin Sabon Muhimmancin Sabon Shirin Ci gaban Magunguna na Ƙasa, bita na fifiko, da kuma naɗin jiyya.
Kuna so karanta: Farashin CAR T Cell a China
Game da JW Therapeutics
JW Therapeutics (HKEX: 2126) kamfani ne mai zaman kansa kuma ƙwararren ƙwararren masanin ilimin halittu wanda ke mai da hankali kan haɓakawa, masana'antu, da kasuwancin samfuran rigakafin ƙwayoyin cuta, kuma ya himmatu wajen zama jagorar ƙididdigewa a cikin rigakafin ƙwayoyin cuta. An kafa shi a cikin 2016, JW Therapeutics ya gina dandamali na duniya don haɓaka samfura a cikin ƙwayoyin rigakafi, da bututun samfurin da ke rufe duka cututtukan jini da ciwace-ciwace. JW Therapeutics ya himmatu wajen kawo ci gaba da ingantattun samfuran rigakafin rigakafin ƙwayoyin cuta da kuma fatan samun waraka ga marasa lafiya a cikin Sin da ma duniya baki ɗaya, da kuma jagorantar ingantaccen ci gaban masana'antar rigakafin ƙwayoyin cuta ta Sinawa.
