AstraZeneca China and Junshi Biosciences Announce Strategic Collaboration for Anti-PD-1 Monoclonal Antibody Toripalimab

Shanghai, 2021March 1/PRNewswire/ -- AstraZeneca China and Junshi Biosciences (1877.HK, 688180.SH) onYesterdayJointly Announce a Major Strategic Partnership: Leveraging Their Respective Strengths in Drug R&D, Market Coverage, and Channel Expansion, the Two Parties Will Actively Explore New In-Depth Collaboration in the Field of Oncology. Effective February 28, 2021, AstraZeneca Will Officially Obtain the Rights to Toripalimab Injection (Brand Name: Tuoyi), an Anti-PD-1 Monoclonal Antibody Drug Independently Developed by Junshi Biosciences^®the promotional rights for non-core markets in mainland China, as well as the exclusive nationwide promotional rights for the subsequently approved urothelial carcinoma indication. Junshi Biosciences will continue to be responsible for the core market promotion of toripalimab for approved indications in mainland China, excluding urothelial carcinoma. This strong partnership between the two companies will help bring high-quality local innovative drugs to more patients in China. It is also another important step by AstraZeneca in fulfilling its commitment to China, deepening localized cooperation and development with a global perspective. The two parties will continue to explore commercial collaborations overseas, including in emerging markets. Building on their existing cooperation, they will actively seek to expand the depth and breadth of future collaboration, jointly creating a model for multi-pipeline cooperation between multinational and local pharmaceutical companies, and promoting Chinese innovative drugs to go global and benefit patients worldwide.

Oncology is one of AstraZeneca’s key therapeutic areas. AstraZeneca China has cultivated deep expertise and maintained leadership for many years in the treatment of lung, breast, ovarian, and prostate cancers, while establishing a comprehensive presence across four major scientific platforms: tumor immunotherapy, tumor driver genes and resistance mechanisms, DNA damage repair, and antibody-drug conjugates (ADCs). Committed to advancing tumor immunotherapy, AstraZeneca has built on the significant success of durvalumab, a PD-L1 inhibitor, in Phase III trials for non-small cell lung cancer (NSCLC), and continues to actively explore its potential in other tumor types, including esophageal cancer, lung cancer, and liver cancer. This strategic partnership fully complements the existing indications of immuno-oncology products and will help more Chinese cancer patients benefit from immunotherapy. Leveraging AstraZeneca’s extensive innovative resources in oncology and its outstanding local commercialization capabilities, both parties are dedicated to expanding access and accelerating the availability of locally developed innovative medicines for patients, thereby upholding the value of being “patient-centric.”

Regarding this collaboration, Wang Lei, Executive Vice President of AstraZeneca and President of International Business and China, stated, “As a localized multinational pharmaceutical company, AstraZeneca is committed to benefiting patients and promoting the long-term development of China’s healthcare industry by continuously deepening cooperation with local Chinese enterprises. Junshi Biosciences is an outstanding domestic biopharmaceutical company with exceptional R&D capabilities and growth potential. We are also confident in the clinical efficacy demonstrated by toripalimab and its future commercial expansion opportunities. We believe that this strategic partnership with Junshi Biosciences marks a beginning. Through close collaboration between multinational and domestic pharmaceutical companies, high-quality innovative drugs developed in China will deliver greater value to patients.”

Li Ning, CEO of Junshi Biosciences, stated, “We are delighted to partner with AstraZeneca to jointly advance the commercialization of toripalimab in China. We firmly believe that, leveraging AstraZeneca’s extensive channel network cultivated over many years in China, particularly its strong promotional capabilities in county-level markets, this innovative drug, which has demonstrated excellent efficacy and safety profiles, will achieve greater success in the Chinese market, enabling more patients to receive timely and effective treatment. Furthermore, guided by our strategy of ‘being rooted in China while expanding globally,’ we look forward to deepening our collaboration with AstraZeneca across broader areas in the future, so as to provide patients in China and around the world with therapeutic options that offer superior efficacy and better affordability.”

Toripalimab, independently developed by Junshi Biosciences, was approved for marketing by the National Medical Products Administration (NMPA) on December 17, 2018, as the first domestically produced anti-PD-1 monoclonal antibody. Its first approved indication was for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. In February this year, toripalimab officially received NMPA approval for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who had failed second-line or further systemic therapies, becoming the first anti-PD-1 monoclonal antibody approved worldwide for NPC treatment. Previously, the NMPA accepted the new drug application for toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had failed or were intolerant to prior systemic therapy, and included it in the priority review program in July 2020.

Disclaimer: The indication of toripalimab injection for urothelial carcinoma has not yet been approved in China. AstraZeneca does not recommend the use of any unapproved drug indications.