CHRS - Junshi's toripalimab gets Chinese regulator review for expanded use in breast cancer

2023-05-23 06:21:26 ET

Shanghai Junshi Biosciences ( OTCPK:SHJBF ) said China's National Medical Products Administration (NMPA) accepted an application seeking expanded approval of toripalimab, in combination with albumin-bound paclitaxel, to treat PD-L1 positive (CPS ? 1) untreated metastatic or recurrent metastatic triple-negative breast cancer (TNBC).

Toripalimab is already approved in China under the name Tuoyi to treat certain types of melanoma, nasopharyngeal, urothelial, esophageal and lung cancers. Currently, there are six approved indications in China for toripalimab, which was the first domestic anti-PD-1 monoclonal antibody approved in the Asian nation, according to the company.

The supplemental new drug application (sNDA) was backed by data from a phase 3 trial called TORCHLIGHT.

Junshi added that TORCHLIGHT is the first domestic phase 3 registered study to achieve positive results in advanced TNBC immunotherapy.

"We at Junshi Biosciences have remained steadfast in our patient-centric approach and successfully collaborated with researchers on the TORCHLIGHT study, which has demonstrated significant improvements in PFS and OS," said Jianjun ZOU, Global Research and Development President of Junshi.

Toripalimab is currently under review in the U.S. to treat for nasopharyngeal carcinoma. The FDA was expected to make decision on the Coherus BioSciences' ( CHRS ) application by Dec. 23, 2022. However the agency was not able to conduct a site inspection of Junshi's manufacturing facility in China.

Junshi announced in March that it was collaborating with Rxilient Biotech to develop and sell toripalimab through a joint venture, Excellmab. Junshi also has a licensing agreement with London-based Hikma Pharmaceuticals ( OTCPK:HKMPF ) ( OTCPK:HKMPY ) for the cancer drug in the Middle East and North Africa.

More on Junshi and Coherus

Missing The Covid Boat, Junshi Stumbles Back To Old Business

Coherus: Biosimilar And Immuno-Oncology Pipeline Setup Could Pay Off

Coherus Still Looks Good, Multiple Catalysts This Year (Rating Downgrade)

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