 Home > Medical News > Latest Medical News > WuXi Giant Noreki Oronza injection is about to be approved or become the second CAR-T product in China

WuXi Giant Noreki Oronza injection is about to be approved or become the second CAR-T product in China

 Last Update: 2021-09-05
 Source: Internet
 Author: User

Tags

metformin time release

cell differentiation examples

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

FinishingRhee

Today, China's National Food and Drug Administration (NMPA) announced that the listing application of WuXi's Noreji Orencil injection (relma-cel) has entered the "pending approval" status and is expected to be approved in China in the near future
.

Public information shows that the indications to be approved this time are: for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) in adult patients after second-line or above systemic treatment

Image source: NMPA official website

Ruiji Orense Injection is a CAR-T product targeting CD19
.

In June 2020, the marketing application for the third-line treatment of Diffuse Large B-cell Lymphoma for Regiorunza injection was accepted by the NMPA and was included in the priority review

At the 2020 ASH annual meeting of WuXi Bio-Tech, WuXi Bio-Tech announced the key clinical trial data of the drug for the treatment of diffuse large B-cell lymphoma (DLBCL)
.

The results showed that compared with the approved Kymriah and Yescarta, WuXi Noreji Orenxil injection has better efficacy (ORR: 75.

On June 27, 2018, WuXi Giant Biotech and its affiliated company Mingju Biotech announced that the State Food and Drug Administration approved the IND application for Mingju Bio's CAR-T product JWCAR029
.

This is the first CAR-T product that has been approved for IND and targets CD19 since the release of the "Technical Guidelines for Research and Evaluation of Cell Therapy Products" in December 2017.

In addition, the clinical trial application of a CAR-T therapy JWCAR129 targeting BCMA by WuXi Giant Nuo was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration on July 6

Reference source: WuXi AppTec, Instant Medicine News, Gelonghui, R&D customer

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

Related Products

L-Ascorbate-2-Monophosphate Feed Grade

CAS No.: 109620-90-8

Feed Grade

Potassium Sorbate from reliable manufacturer

CAS No.: 590-00-1

Food Grade

Doxycycline Hydrochloride

CAS No.: 10592-13-9

Pharmaceutical Grade

Hot Tags

united states jobs(223)

jobs united states(236)

1 year treasury(277)

1 year subscription(296)

single use technology(195)

announcements today(81)

ups united states(221)

united states logo(227)

80 20 company(94)

healthy food name(42)

Hot Articles

The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.