Established in December 2012, in less than a decade, Chinese biotech Junshi Biosciences has already transformed itself into a publicly-listed commercial company with a successful USD 450 million IPO on the Hong Kong Stock Exchange and their first product, toripalimab, being the first anti-PD-1 monoclonal antibody self-developed by a Chinese company to be marketed in China. Their vision is stated as becoming “a pioneer in the area of translational medicine by developing first-in-class and best-in-class drugs through original innovation.” Initially focusing on immuno-oncology, Junshi has since expanded its innovation repertoire to include small molecule drugs and antibody drug conjugates (ADCs) as well as broadening their focus to cancer and autoimmune diseases.
Entering into this agreement with Lilly empowers us to accelerate the clinical development of Junshi SARS-CoV-2 antibodies globally
Headquartered in Suzhou and Shanghai in China, Junshi also has a presence in the US, specifically San Francisco and Maryland, to support their global clinical and commercial development. They have two manufacturing facilities in Shanghai and Suzhou. CEO Dr Li Ning held positions with the US FDA Office of Biostatistics and Sanofi before joining Junshi Biosciences in 2018.
Toripalimab, their first marketed compound, received its first approval for second-line treatment of metastatic melanoma in December 2018 and was commercially launched in February 2019. 2019 sales revenues for toripalimab reached RMB 774 million (USD 109.2 million) with a reported gross profit margin of 88.3 percent. Junshi has since filed for a number of supplemental NDAs including as a second-line treatment for patients with locally advanced or metastatic urothelial carcinoma who have received systemic therapy and as a treatment for patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) who failed at least two lines of systemic therapy. The latter sNDA is the world’s first NDA of an anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In addition, Junshi is also working on a number of additional indications as well as combination studies with partners including Pfizer, Hutchison MediPharma and Betta Pharma.
Junshi is continuing their push on the R&D side, with a 21-asset strong portfolio, spearheaded by their three core assets: JS002, an anti-PCSK9 mAb for the treatment of cardiovascular diseases; UBP1211, an adalimumab biosimilar; and JS005, an anti-IL-17A mAb for the treatment of autoimmune diseases like psoriasis. Another noteworthy asset to highlight is TAB004/JS004, whose IND was approved by the US FDA in April 2019 as the world’s first anti-BTLA mAb for injection to be approved for clinical trials. The IND application in China was approved in January 2020.
Most recently, with the COVID-19 outbreak, Junshi formed a collaboration with Eli Lilly to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi was one of the first companies to investigate potential therapies against COVID-19 and they have since engineered a number of neutralizing antibodies, with the lead asset expected to enter clinical trials in the US and China soon. In the press release, CEO Dr Li said, “since the outbreak of COVID-19, we have been working diligently to join the fight against the pandemic. Entering into this agreement with Lilly empowers us to accelerate the clinical development of Junshi SARS-CoV-2 antibodies globally.” The compound in question is JS016, a recombinant fully human monoclonal neutralizing antibody specific to the SARS-CoV-2 surface spike protein receptor-binding domain, which Junshi jointly developed with the Institute of Microbiology, Chinese Academy of Science. Lilly will receive an exclusive license to conduct clinical development, manufacturing and distribution of products outside of Greater China. Junshi Biosciences will maintain all rights in Greater China.
2020 will certainly be an exciting year for the company, which more than doubled their organization size in 2019, increasing from 600 employees to over 1,400. They are also preparing for an IPO on the Shanghai STAR Market, which would make them the first biotech company to be dual-listed in Hong Kong and Shanghai.