Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Advanced Nasopharyngeal Carcinoma

SHANGHAI, China, April 30, 2020 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental New Drug Application (sNDA) for toripalimab as a treatment for patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) who failed at least two lines of systemic therapy. The sNDA is the world’s first new drug application of anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma.

“We believe toripalimab has the potential to meet the urgent need for safe and effective treatments in more advanced recurrent and metastasized NPC patients. The incidence and mortality rates for NPC in China are among the highest in the world. This is the second indication in China for toripalimab after metastatic melanoma. We have now completed POLARIS-02, the Phase II clinical study in NPC patients who have failed first line systemic therapy. Enrollment of JUPITER-02, the international multicenter Phase III study for first line treatment of NPC has also been completed,” commented Dr. Ning Li, Chief Executive Officer of Junshi Biosciences. “We hope to increase the treatment efficacy of NPC utilizing immunotherapy as a monotherapy or in combination with other treatment modalities. We are working closely with NMPA and hope to bring this therapy to patients.”

NPC is the most common cancer originating in the nasopharynx, and the most common type of the head-and-neck cancer in China. According to World Health Organization (WHO), almost half of the NPC patients in the world live in China. Incidence rates in some regions of Guangdong Province, for example, is 40 times the world average. Incidence rate is also high in Southeast Asian countries. NPC tends to metastasize during early stages of the disease, and early stage patient tend to relapse after radiation or chemotherapy treatment. Platinum-based therapy is currently standard of care for first-line treatment of recurrent or metastatic NPC patients; however, there is no standard treatment after failure of the firs-line systemic treatment.

The sNDA is based on results from the POLARIS-02 study (NCT02915432), which is a multicenter, open-label, Phase II pivotal registrational clinical study, led by Professor Ruihua Xu of Sun Yat-Sun University Cancer Center, with an aim to evaluate the safety and efficacy of toripalimab for patients with metastatic nasopharyngeal carcinoma after failure of systemic treatment. The study is the world’s first large clinical trial of anti-PD-1 monoclonal antibody for the treatment of advanced nasopharyngeal carcinoma enrolling 190 patients. Independent Review Committee has determined that overall response rate (ORR) has recently met its primary endpoint, based on solid tumor evaluation criteria (RECIST 1.1). The safety profile is consistent with what has been reported for toripalimab.

In addition, JUPITER-02 study (NCT03581786), a Phase III clinical study of toripalimab in combination with chemotherapy versus chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal carcinoma has completed enrollment.

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences. Toripalimab received its first approval for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019.

About Junshi Biosciences

Established in 2012, Junshi Biosciences is committed to developing first-in-class and best-in-class drugs through original innovation and becoming a pioneer in the area of translational medicine to provide patients with effective and affordable treatment options. On December 24, 2018, Junshi Biosciences was listed on the Main Board of the Stock Exchange of Hong Kong with the stock code: 1877.HK. The Company has established a diversified R&D pipeline comprising 21 drug candidates with therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, neurologic diseases, and Infectious disease. Product types include monoclonal antibodies, fusion proteins, antibody-drug conjugates, and small molecule drugs. With a combined 33,000L fermentation capacity in two GMP-facilities at Shanghai and Suzhou, Junshi has established the manufacturing infrastructure to support commercialization and provide our partners and patients with high-quality products through a global supply chain network. For more information, please visit: http://junshipharma.com/en/Index.html

Contact Information

IR Team:
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Michael Levitan
mlevitan@soleburytrout.com
+1 646.378.2920

 

Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Advanced Nasopharyngeal Carcinoma

SHANGHAI, China, April 30, 2020 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental New Drug Application (sNDA) for toripalimab as a treatment for patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) who failed at least two lines of systemic therapy. The sNDA is the world’s first new drug application of anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma.

“We believe toripalimab has the potential to meet the urgent need for safe and effective treatments in more advanced recurrent and metastasized NPC patients. The incidence and mortality rates for NPC in China are among the highest in the world. This is the second indication in China for toripalimab after metastatic melanoma. We have now completed POLARIS-02, the Phase II clinical study in NPC patients who have failed first line systemic therapy. Enrollment of JUPITER-02, the international multicenter Phase III study for first line treatment of NPC has also been completed,” commented Dr. Ning Li, Chief Executive Officer of Junshi Biosciences. “We hope to increase the treatment efficacy of NPC utilizing immunotherapy as a monotherapy or in combination with other treatment modalities. We are working closely with NMPA and hope to bring this therapy to patients.”

NPC is the most common cancer originating in the nasopharynx, and the most common type of the head-and-neck cancer in China. According to World Health Organization (WHO), almost half of the NPC patients in the world live in China. Incidence rates in some regions of Guangdong Province, for example, is 40 times the world average. Incidence rate is also high in Southeast Asian countries. NPC tends to metastasize during early stages of the disease, and early stage patient tend to relapse after radiation or chemotherapy treatment. Platinum-based therapy is currently standard of care for first-line treatment of recurrent or metastatic NPC patients; however, there is no standard treatment after failure of the firs-line systemic treatment.

The sNDA is based on results from the POLARIS-02 study (NCT02915432), which is a multicenter, open-label, Phase II pivotal registrational clinical study, led by Professor Ruihua Xu of Sun Yat-Sun University Cancer Center, with an aim to evaluate the safety and efficacy of toripalimab for patients with metastatic nasopharyngeal carcinoma after failure of systemic treatment. The study is the world’s first large clinical trial of anti-PD-1 monoclonal antibody for the treatment of advanced nasopharyngeal carcinoma enrolling 190 patients. Independent Review Committee has determined that overall response rate (ORR) has recently met its primary endpoint, based on solid tumor evaluation criteria (RECIST 1.1). The safety profile is consistent with what has been reported for toripalimab.

In addition, JUPITER-02 study (NCT03581786), a Phase III clinical study of toripalimab in combination with chemotherapy versus chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal carcinoma has completed enrollment.

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences. Toripalimab received its first approval for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019.

About Junshi Biosciences

Established in 2012, Junshi Biosciences is committed to developing first-in-class and best-in-class drugs through original innovation and becoming a pioneer in the area of translational medicine to provide patients with effective and affordable treatment options. On December 24, 2018, Junshi Biosciences was listed on the Main Board of the Stock Exchange of Hong Kong with the stock code: 1877.HK. The Company has established a diversified R&D pipeline comprising 21 drug candidates with therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, neurologic diseases, and Infectious disease. Product types include monoclonal antibodies, fusion proteins, antibody-drug conjugates, and small molecule drugs. With a combined 33,000L fermentation capacity in two GMP-facilities at Shanghai and Suzhou, Junshi has established the manufacturing infrastructure to support commercialization and provide our partners and patients with high-quality products through a global supply chain network. For more information, please visit: http://junshipharma.com/en/Index.html

Contact Information

IR Team:
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Michael Levitan
mlevitan@soleburytrout.com
+1 646.378.2920