(2) 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 survi
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 survival a
AstraZeneca delivered strong results in the year, in line with guidance that was reconfirmed during the year. With over half of Total Revenue coming from the fast-growing new medicines
1, the Company leveraged its revenue growth to make further progress in profitability, while the strategy of sustainable growth through innovation brought numerous further benefits for patients. AstraZeneca s patient-centric strategy, focus on innovation and capital-allocation priorities remain unchanged, with sustainable long-term growth in revenue, profit and cash generation set to continue.
Pascal Soriot, Chief Executive Officer, commented: The performance last year marked a significant step forward for AstraZeneca. Despite the significant impact from the pandemic, we delivered double-digit revenue growth to leverage improved profitability and cash generation. The consistent achievements in the pipeline, the accelerating performance of our business and the progress of the COVID-19
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SAN FRANCISCO and SUZHOU, China, Feb. 8, 2021 /PRNewswire/ Innovent Biologics, Inc. ( Innovent ) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the first patient has been successfully enrolled and dosed in the randomized, open-label, phase III, multicenter clinical study (NCT04720716) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the first-line treatment of patient with advanced hepatocellular carcinoma (HCC).
In recent years, immune checkpoint inhibitors have brought new hope to HCC patient population with acceptable safety and encouraging efficacy. NCT04720716 is a randomized, open-label, controlled, multicenter phase III study evaluating the efficacy and safety of IBI310 in combination with TYVYT® (sin
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SAN FRANCISCO, CA, USA and SUZHOU, China I February 08, 2021 I Innovent Biologics, Inc. ( Innovent ) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the first patient has been successfully enrolled and dosed in the randomized, open-label, phase III, multicenter clinical study (NCT04720716) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the first-line treatment of patient with advanced hepatocellular carcinoma (HCC).
In recent years, immune checkpoint inhibitors have brought new hope to HCC patient population with acceptable safety and encouraging efficacy. NCT04720716 is a randomized, open-label, controlled, multicenter phase III study evaluating the efficacy and safety of IBI310 in combination with TYVYT® (sintilimab injection) for