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Junshi Biosciences Announces Acceptance by the NMPA of Supplemental New Drug Application for Toripalimab Combined with Chemotherapy for The First-Line Treatment of Nasopharyngeal Carcinoma

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the 3rd sNDA for Toripalimab in China
SHANGHAI, China, Feb. 19, 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 accepted its supplemental New Drug Application (sNDA) for Toripalimab combined with chemotherapy for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.
The supplemental NDA is based on the JUPITER-02 study (NCT03581786), which is a randomized, double-blind, placebo-controlled Phase III study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. The results of the study showed that Toripalimab combined with gemcitabine/cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma significantly prolonged the progressio ....

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Junshi Biosciences Announces Acceptance by the NMPA of Supplemental New Drug Application for Toripalimab Combined with Chemotherapy for The First-Line Treatment of Nasopharyngeal Carcinoma | Comunicados | Edición USA

the 3rd sNDA for Toripalimab in China
SHANGHAI, China, Feb. 19, 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 accepted its supplemental New Drug Application (sNDA) for Toripalimab combined with chemotherapy for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.
The supplemental NDA is based on the JUPITER-02 study (NCT03581786), which is a randomized, double-blind, placebo-controlled Phase III study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. The results of the study showed that Toripalimab combined with gemcitabine/cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma significantly prolonged the progression-free s ....

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Coherus BioSciences to expand late-stage pipeline to immuno-oncology with in-license of Junshi ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Coherus BioSciences to expand late-stage pipeline to immuno-oncology with in-license of Junshi .
Coherus BioSciences, Inc.February 1, 2021 GMT
- Coherus to pay $150 million upfront for U.S. and Canada rights to toripalimab, an extensively studied, late-stage anti-PD-1 antibody
- First U.S. BLA filing expected this year for nasopharyngeal carcinoma with breakthrough therapy designation
- Options to PD-1 combination agents, TIGIT and IL-2, add long-term growth potential
- Conference call at 8:00 am Eastern Time today
REDWOOD CITY, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced a collaboration with Shanghai Junshi Biosciences, Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) for the development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody, in the Uni ....

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Junshi Biosciences and Coherus BioSciences Announce Collaboration to Co-Develop Anti-PD-1 ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Junshi Biosciences and Coherus BioSciences Announce Collaboration to Co-Develop Anti-PD-1 .
Junshi BiosciencesFebruary 1, 2021 GMT
Junshi Biosciences to receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in US and Canada
The first toripalimab BLA to be filed with the US FDA for nasopharyngeal carcinoma later this year
SHANGHAI, China, Feb. 01, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced a collaboration with Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) for the development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 a ....

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Investegate |Junshi Biosciences Announcements | Junshi Biosciences: Junshi Biosciences and Coherus BioSciences Announce Collaboration to Co-Develop Anti-PD-1 Antibody, Toripalimab, in U.S. and Canada

Junshi Biosciences
Junshi Biosciences and Coherus BioSciences Announce Collaboration to Co-Develop Anti-PD-1 Antibody, Toripalimab, in U.S. and Canada
Junshi Biosciences and Coherus BioSciences Announce Collaboration to Co-Develop Anti-PD-1 Antibody, Toripalimab, in U.S. and Canada
Junshi Biosciences to receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in US and Canada
The first toripalimab BLA to be filed with the US FDA for nasopharyngeal carcinoma later this year
SHANGHAI, China, Feb. 01, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced a collaboration with Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) for the development and commerci ....

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