Astra Zeneca and Junshi Biosceinces partner to commercialize Toripalimab

March 5, 20210

Junshi Biosciences, a Chinese biotech company has entered into an exclusive commercialization agreement with Astra Zeneca, granting the latter exclusive commercialization rights for its anti-PD1 monoclonal antibody Toripalimab in China. As part of the agreement, Astra Zeneca will market the Toripalimab monoclonal antibody for urothelial carcinoma indication in core regions (mainland China) and for all approved indications in non-core (county-level) markets.  

Astra Zeneca has been able to make significant in-roads into the Chinese market and gain substantial commercial presence when compared to its other Big Pharma competitors in China. Having established a robust large scale marketing outreach extending well into the hinterlands of China, the alliance gives Junshi a strategic commercial partner for its monoclonal antibody. By the inclusion of its other innovative drugs on the national reimbursement drug list (NDRL), Astra Zeneca has been able to get the advantage of volume demand, albeit at significant price reductions. The volume demand made accessible through the NDRL listing has allowed Astra Zeneca to tap into the remote county-level hospitals and have a broad nationwide coverage.  

Junshi’s Toripalimab was the first approved domestic anti-PD1 monoclonal antibody in China in 2018 for the second-line treatment of unresectable or metastatic melanoma and consecutively Junshi has pursued more than fifteen different indications for the drug. China NMPA granted priority review designation for urothelial carcinoma indication for the supplemental NDA application in July 2020 and in September 2020, US FDA granted Breakthrough Therapy Designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma. It is also interesting to note that Astra Zeneca’s own anti-PD1 monoclonal antibody Imfinzi failed to yield clinical results in front-line metastatic bladder cancer post an Accelerated Approval Pathway by the US FDA and subsequently lead to an indication withdrawal.  

Junshi has previously licensed the Canadian and US rights for Toripalimab to Coherus Biosciences for a USD 150 million upfront payment, 20% royalty on sales and additional $380 million in milestone payments and have recently announced rolling submission of BLA for nasopharyngeal carcinoma to the US FDA. It has joined the league of two other China-based biotech companies having tapped a strategic US partner to bring their therapies to the highly sought-for US market. BeiGene has partnered with Novartis for tislelizumab and Eli Lilly has partnered with Innovent Biologics for sintilimab. With six anti-PD1 monoclonal antibodies already in the US market, the upcoming therapies could face stiff competition for several highly pursued indications such as NSCLC. However, the range of indications that can be targeted with anti-PD1 therapies keeps the market interesting for potential contenders. 

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