\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )
Event: on March 2, 2022, the company announced the submission of adalimumab injection (ubp1211, junmaikang) ®） The application for marketing license of drugs for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis has been in the stage of “approval completed – Certificate pending”, indicating that the State Food and drug administration has completed the approval, and its corresponding administrative departments are preparing the approval documents for drug registration. Jun Maikang ® It has become the sixth listed adalimumab biological analogue in China.
Viewpoint: keep up with the “king of medicine”, TNF- α The anti-inflammatory market is unprecedented. Adamu single antigen research product xiumeixin was approved by FDA in 2002, and at least 17 indications have been approved worldwide. According to Alberto’s financial report, its total sales exceeded US $20 billion for the first time in 2021, and it has been the “king of medicine” of single products except vaccines for nine years. In China, xiumeile has covered 8 major indications and has been included in medical insurance. The accessibility of drugs has been greatly improved, and the product market scale has grown rapidly. In 2020, the sales volume of terminal adalimumab in public medical institutions in China was nearly 1 billion yuan, with a year-on-year increase of nearly 1000%. According to the estimate of frost Sullivan research, the market of adalimumab biological analogues in China will increase to 4.7 billion yuan in 2023 and expand to 11.5 billion yuan in 2030.
McAb has a deep accumulation in the field and is expected to seize the dominant position in the market. Jun Maikang ® It is a domestic adalimumab biological analogue approved for listing in paragraph 6. Previously, in addition to the original research products, products from Bio-Thera Solutions Ltd(688177) , Haizheng biology, Xinda biology, Fuhong Hanlin and Zhengda Tianqing have been approved. Jun Maikang ® Rheumatoid arthritis, which accounts for the largest proportion of sales of the original research Meile, is taken as the phase III clinical indication. Through deep cultivation in the field of rheumatoid arthritis, the company has accumulated a large number of clinical data and application experience of the indication, which is conducive to the commercial promotion of the product. At the same time, compared with other approved manufacturers, the company has realized the successful commercialization of monoclonal antibody drugs earlier, the relevant R & D and production system is more mature, the cost control ability is strong, the production technology is leading, and the production capacity has realized large-scale. Therefore, we believe that the company has great advantages in the market competition of adalimumab biological analogues.
For the first time, the products in the field of self exemption were successfully listed, and the commercialization process met another milestone. Jun Maikang ® It is a cooperative research and development between the company and Maiwei biology. After listing, the two sides will jointly invest in the joint venture as the holder of drug marketing license (MAH). The profits of the joint venture will be distributed by the company and Maiwei biology according to 50:50. Before the approval of adalimumab this time, the company has successfully commercialized two products, including the first domestic PD-1 inhibitor treprizumab and the first domestic macromolecular covid-19 neutralizing antibody etesville monoclonal antibody (js016) approved for sale in the United States. The approval of adalimumab laid a foundation for subsequent performance growth, and the company’s commercial territory has achieved a historic leap from the field of tumor and anti infection to autoimmune diseases; It has greatly expanded the coverage of the company’s listed products, helped to improve the construction of the company’s sales system while expanding the income and cash flow, further improved the commercialization influence, and helped to realize the comprehensive and sustainable development in the field of covering a variety of diseases.
Profit forecast and investment rating. Based on the change of covid-19 epidemic situation, the neutralization effect of js016 on Omicron mutant was limited, and the distribution was stopped in the United States; In addition, the company accelerated the clinical R & D process of multiple products and increased relevant investment. We lowered the profit forecast. It is estimated that the revenue of the company from 2021 to 2023 will be 4.014 billion yuan, 2.328 billion yuan and 4.238 billion yuan respectively, with a year-on-year increase of 151.7%, – 42.0% and 82.0% respectively; The net profit attributable to the parent company was -739 million yuan, – 1037 million yuan and -811 million yuan respectively, and the corresponding EPS was -0.81, -1.14 and -0.89 yuan respectively, maintaining the “buy” rating.
Risk warning: the risk of decline in product demand; The risk that the promotion of commercialization is less than expected.
