The British-Swedish pharma company will be given the right to market Junshi’s anti-PD-1 cancer drug, toripalimab, for urothelial carcinoma across China, and for other cancer types in some areas.
The two companies will also evaluate further commercial cooperation in emerging markets.
Dr Ning Li, CEO, Junshi Biosciences, commented on the deal: "We are confident that by leveraging the extensive networks AstraZeneca has established over the years, 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.”
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. Such treatments leverage a patient’s own immune system to fight cancer.
More than 30 company-sponsored clinical studies covering more than 15 indications have been conducted globally on that PD-1 inhibitor, including in China and the US. In December 2018, toripalimab obtained a conditional approval from Chinese regulatory body, the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. The supplemental new drug application (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 that agency in July 2020.
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 Chinese regulator 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.
The drug has also been granted breakthrough, fast frack, and orphan drug designations by the US Food and Drug Administration (FDA) for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.
AstraZeneca is not the only global pharma group teaming up with Chinese innovators in this domain.
In September 2020, Pfizer stepped into the PD-1 ring in China, paying out US$200m to take a 9.9% stake in Hong Kong-listed cancer biotech, CStone.
The US pharma giant gained exclusive marketing rights to that biotech's PD-L1 checkpoint inhibitor, sugemalimab, in mainland China. That immunotherapy is being developed for common cancers including lung, gastric, and esophageal cancers.
Meanwhile, in earlier collaborations in this arena, Eli Lilly and China headquartered, Innovent, co-developed Tyvyt - an anti-PD-1 monoclonal antibody immuno-oncology medicine. In 2019, the partners began commercializing Tyvyt in China after being granted marketing approval for relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy.
February 2021 saw that PD-1 inhibitor also get Chinese regulatory approval in combination with pemetrexed and platinum chemotherapy as a first-line therapy for people with nonsquamous non-small cell lung cancer (nsqNSCLC).
In August 2020, Lilly and Innovent announced a global expansion of that immunotherapy focused strategic alliance.
More recently, Novartis, last week, announced the closing of the multibillion-dollar collaboration and licensing deal with Chinese biotech, BeiGene, first revealed in January, with a focus outside of China. Novartis will develop, manufacture and commercialize BeiGene’s anti-PD-1 antibody, tislelizumab, in North America, Mexico, Japan, and in the EU as well as in six other European countries.
While the cancer therapy is approved and marketed by BeiGene in China for classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression, it is not approved for use outside of China.