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Biopharmaceutical company Junshi Biosciences has entered into an exclusive promotion agreement with AstraZeneca Pharmaceutical.

Pursuant to which Junshi Biosciences will grant AstraZeneca Pharmaceutical the exclusive promotion right of toripalimab in mainland China for the urothelial carcinoma indications to be approved subsequently for marketing and the exclusive promotion right for all indications approved and to be approved in non-core areas.

Junshi Biosciences will continue to be responsible for the promotion of other indications approved and to be approved excluding urothelial carcinoma indications in core areas, a release said.

This strong alliance between the two companies will help promote local high-quality innovative drugs to benefit more Chinese patients. Junshi Biosciences and AstraZeneca will continue to explore overseas business collaboration including the emerging markets and actively explore the possibility of expanding the depth and breadth of future collaborations.

“We are delighted to work with AstraZeneca in the commercialisation of Toripalimab in China,” said Junshi Biosciences CEO Dr. Ning Li.

“We are confident that by leveraging the extensive networks AstraZeneca has established over the years, and especially by utilizing its ability to promote in the county-level markets, this innovative drug with excellent performance in efficacy and safety will achieve greater success in the Chinese market and will enable more patients to receive timely and effective treatment,” he added.

Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States.

On 17 December 2018, Toripalimab obtained a conditional approval from the the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma.

Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for the second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in May 2020 and received priority review designations from the NMPA in July 2020.

In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA application of Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA.

In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma, the company release added.

 

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