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NMPA Approves Toripalimab in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Published: Apr 12, 2021
SHANGHAI, China, April 12, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. This is the third approved indication for toripalimab in China. In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) afte ....

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Investegate |Junshi Biosciences Announcements | Junshi Biosciences: Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma

Investegate |Junshi Biosciences Announcements | Junshi Biosciences: Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma
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Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma

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- BLA submitted with FDA s breakthrough therapy designation -
SHANGHAI, China and REDWOOD CITY, Calif., March 03, 2021 (GLOBE NEWSWIRE) Shanghai Junshi Biosciences Co., Ltd. ( Junshi Biosciences , HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. ( Coherus , Nasdaq: CHRS) announced today the initiation of the rolling submission of the Biologics License Application ( BLA ) for toripalimab to the U.S. Food and Drug Administration ( FDA ) for the treatment of recurrent or metastatic nasopharyngeal carcinoma ( NPC ). A rolling submission allows Junshi Biosciences to submit sections of the BLA to the FDA as they are completed.
Toripalimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies. The designation is intended to expedite the development and review o ....

United States , Patricia Keegan , Denny Lanfear , Junshi Bioscience , Eli Lilly , Mcdavid Stilwell , Denise Powell , Junshi Biosciences , Coherus Biosciences , Exchange Commission On , Coherus Biosciences Inc , Shanghai Junshi Biosciences Co Ltd , Committee On Foreign Investment , Pr Team , Abbvie Inc , Institute Of Microbiology Chinese Academy Science , Guidelines Of Chinese Society Clinical Oncology , Ir Team , Drug Administration , Genentech Inc , Exchange Commission , National Reimbursement Drug List , National Medical Products Administration , Biologics License Application , Breakthrough Therapy Designation , Hart Scott Rodino Antitrust Improvements Act ,

Investegate |Junshi Biosciences Announcements | Junshi Biosciences: Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China

Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China
Junshi grants AstraZeneca exclusive promotion rights of toripalimab in mainland China for the urothelial carcinoma indications and for all indications in non-core areas
Junshi will continue to be responsible for the promotion of other indications in core areas
The companies will continue to explore business collaborations in overseas markets including emerging markets
SHANGHAI, China, March 01, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the Company has entered into an exclusive promotion agreement with AstraZeneca Pharmaceutical Co., Ltd. (“AstraZeneca Pharmaceutical” or the “Promoter”), pursuant to which Junshi Biosciences will grant AstraZeneca Pharmaceutical the ....

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Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China

Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China
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