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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

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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

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