Toripalimab is an anti-PD-1 monoclonal antibody independently developed by Junshi Biosciences. Junshi Biosciences has conducted over 30 clinical trials globally (in China, the USA, Southeast Asia, and Europe) covering more than 15 indications, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. Six of these indications have been approved in China, and multiple marketing applications are currently under review by regulatory agencies in the US, EU, and UK.
“Cancer patients need toripalimab. We are confident that the highly professional and experienced Rxilient team will drive quick access to this valuable drug, toripalimab to patients in Southeast Asia,” said Mr. HONG Tan, MD of Legend Capital.
“This collaboration is a good case example of Chinese pharmaceutical companies venturing overseas to help improve access to important novel drugs in emerging markets. Southeast Asia has a thriving innovative pharmaceuticals market, harmonized drug registration system, and diversified healthcare systems. Hence, it has great potential for innovative drugs. Legend Capital will continue to pay attention to investment opportunities in the healthcare industry of Southeast Asia, actively promote and assist Chinese pharmaceutical companies to enter the international markets, thus facilitating innovative drugs from China to benefit patients around the world,” said Mr. HONG Tan.
Through this collaboration, Rxilient will introduce Toripalimab, a novel anti-PD-1 monoclonal antibody, into Southeast Asia. This joint venture leverages the strengths of Rxilient and Junshi Biosciences in drug registration and commercialization, and the R&D capabilities respectively. Rxilient plans to continue collaboration with Junshi Biosciences to introduce more high-quality innovative drugs into Southeast Asia.
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.
Rxilient Biotech, established in November 2021, is a subsidiary controlled by China Medical System Holdings Limited (“CMS”, (00867.HK)). Rxilient Biotech and other companies related to CMS that are involved in Southeast Asian businesses (together with Rxilient Biotech, “Rxilient”, promoted and cofounded by CMS and Legend Capital) have formed an open platform integrating innovative R&D, formulation contract development, and manufacturing organization (CDMO), manufacturing, marketing, and promotion. Leveraging CMS’s capability in acquiring high-quality products and strong financial position, Rxilient aims to bring innovative solutions from leading pharmaceutical companies in the USA, Europe, Japan, and China, to meet medical needs in Southeast Asia. Rxilient is operated independently by professional and experienced local teams in Southeast Asia.
 Junshi Biosciences’s related license to the joint venture is subject to the fulfillment of the conditions precedent as agreed under the Shareholders Agreement.
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