Junshi Biosciences's toripalimab and Innovent's sintilimab were successively approved in Dec. 2018, to become the first Chinese-produced anti-PD-1 monoclonal antibodies marketed. Innovent and Junshi Biosciences have recently released their 2019 semiannual reports in succession, according to which, sales of toripalimab and sintilimab both exceeded RMB300 million, which are noteworthy.
Source: Semiannual reports of the companies, and public data
Sales of Innovent’s sintilimab reached RMB331 million in the first half year
According to the report of Innovent on Aug. 28, the company achieved operating income of RMB440 million in the first half of 2019. Innovent’s first commercialized drug product: Sintilimab Injection was commenced sales on Mar. 9, 2019 with the trade name of Tyvyt; its sales income reached RMB331 million in the first half year, accounting for about 79% of the total income of the company. The sales team of Innovent has 400 people, and the selling and marketing expenses of Tyvyt reached about RMB280 million in the first half year.
R&D expenses of Innovent reached RMB671 million in the first half of 2019. Its R&D pipeline reserves 21 innovative drugs in the fields of oncology, metabolic diseases and other therapeutic areas, wherein, the marketing applications for the 3 biosimilars (IBI-301/IBI-303/IBI-305) have been successively accepted by the NMPA and included in the priority review, and its 16 drugs in development have entered the clinical development stages.
Sales of Junshi Biosciences’ toripalimab reached RMB308 million in the first half year
According to the report released by Junshi Biosciences on Aug. 29, the company achieved operating income of RMB309 million in the first half of 2019. Toripalimab has been for sale in China since the end of Feb. 2019 and been established with a sales network that covers major large and medium-sized cities in China; its total income reached RMB308 million in the first half year, making it the main source of income of Junshi Biosciences at present. The sales team of Junshi Biosciences has 250 people, and the selling and marketing expenses of Tuoyi reached about RMB111 million in the first half year.
R&D expenses of Junshi Biosciences reached RMB369 million in the first half of 2019. Its R&D pipeline reserves 19 pharmaceutical products in development, including 17 innovative drugs and 2 biosimilar varieties, covering fields of pharmaceutical products for oncology, metabolic diseases, inflammatory or autoimmune diseases, and neurogenic diseases.
Production capacity situations
Innovent’s Phase I sintilimab production line includes three 1,000L bioreactors, and in Phase II production line, Innovent’s new six 3,000L stainless steel bioreactors have completed GMP commissioning and validation, and the total production capacity will increase to 21,000L in the future.
Junshi Biosciences has the capacity to produce 1,500L monoclonal antibodies at present. In the first half of 2019, Junshi Suzhou Zhonghe production base completed the technical transformation and upgrading to increase three 500L fermenters to expand the production capacity to 3,000L. The increased production capacity has been filed with the government medical product regulator and will be put into commercial production.
Clinical layout of indications in development in China
From the perspective of the clinical layout, Innovent’s sintilimab has been registered 17 clinical trials in China, including 7 Phase III clinical trials. Those clinical trials focus on indications of sintilimab for lung cancer treatment: the clinical trials using it to treat non-small cell lung cancer (NSCLC) as first-line and second-line therapies are in Phase III and the clinical trial using it in combination with bevacizumab/chemotherapy regimen to treat EGFR-positive NSCLC as a second-line therapy is also in Phase III. Drug combination therapeutic regimens of sintilimab are based on chemotherapeutics and use fewer targeted drugs.
(All Rights Reserved)