The R & D expenditure has increased steadily, and the research projects and commercialization have progressed smoothly: the company's operating income in 2020 was 22.49 million yuan, down 50% from the same period last year, mainly due to the sales volume of Smuri 1, an agent product, affected by the state's volume procurement, and the need for CDMO business to cooperate with customers'R & D plans under the epidemic. The net loss in 2020 was 288 million yuan, which narrowed by 4%.
The R & D expenditure in 2020 was 235 million yuan, an increase of 23% over the same period last year, mainly due to the increase in related expenditure on CRO and APIs after TAA013 (HER2 ADC) entered large-scale phase 3 clinical trials directly after completing phase 1 clinical trials. In 2020, the company's research and development of a number of core antineoplastic drugs are progressing smoothly. TAB008 (bevasu bioanalogue) has submitted an application for listing and is expected to be approved for listing this year. TAA013 successfully entered the phase 3 clinical trial. TOZ309 (temozolomide) has submitted its listing application and is expected to be approved for listing this year. The application for TAB014 (VEGF) Phase 3 clinical IND has been submitted to FDA in the United States and was approved in January 2021.
Actively lay out the commercial production of ADC drugs and forge the platform of the whole industry chain of ADC: the company first began to lay out the research of ADC drugs in 2013. In terms of specific technology, the company has the core coupling technology, the complete ADC analysis technology platform and the independent analysis ability of ADC key quality attributes, as well as breaking through the technical problems of regulating sugar type, which can accurately control the component content of sugar type. At the same time, the company is actively building a commercial production platform for ADC drugs, has completed the commercial ADC raw liquid workshop within the year, and has successfully produced multiple batches of TAA013 clinical drugs.
In terms of team, the company has ADC coupling technology research and development experts and complex ADC molecular structure analysis team.
On the whole, the company has layout in ADC research and development, commercial production, technical team and so on, and the embryonic form of ADC whole industry chain platform has appeared.
CDMO/CMO has multiple advantages such as production capacity and technology, and its business continues to expand: the company has built a large-scale production workshop of McAbs with international standards in 2018, with a design capacity of 16000 liters. The PB-Hybrid Technology independently developed by the company can be directly enlarged from a 25-liter WAVE reactor to a 2000-liter reactor, eliminating a large number of amplification steps, shortening the production cycle and increasing the annual output. With the surge of international and domestic CDMO/CMO market demand, the company is expected to rely on competitive commercial production platform and technology platform to expand business volume and create new revenue growth points for the company. In particular, the company has reached commercial cooperation with a number of innovative pharmaceutical companies in 2020, including the supply of clinical trial samples of COVID-19 's indications for the development of the pharmaceutical industry.
Our point of view: the company is about to enter the harvest period, and the core products TAB008 and TOZ309 are expected to be approved and put on the market in 2021. The company has three major technology platforms: monoclonal antibody and ADC drug technology platform, genetic engineering-based treatment technology platform and innovative drug delivery technology platform, which can continuously promote the expansion of innovation pipelines; especially in the field of ADC, the company has obvious advantages in technology, commercial production and talents, and the embryonic form of the whole industry chain platform has emerged, with domestic scarce ADC drug research and development and large-scale production capacity. On the other hand, the company's business in the field of CDMO/CMO continues to expand, which not only provides a guarantee for innovation and research, but also drives the growth of the company's performance.
Risk hints: the progress of research and development is lower than expected, market competition intensifies, policy risks, and the impact of the epidemic exceeds expectations.