Biotech (688177) New Shares Research Report: Biopharmaceutical Innovative Enterprise Approved for the First Domestic Adalimumab

Biotech (688177) New Shares Research Report: Biopharmaceutical Innovative Enterprise Approved for the First Domestic Adalimumab
Biopharmaceutical innovation companies have no profit during the R & D promotion period.Biotech was established in 2003. It is an innovative biopharmaceutical company focusing on drug research and development in the fields of tumors, autoimmune diseases, cardiovascular diseases and other diseases.The actual controllers of the company are Mr. Yi Xianzhong, Ms. Guan Yuzheng and Mr. Yi Liangyu, and the three are immediate family members, who together control the company through indirect shareholding.3111% equity. One of the company’s existing adalimumab biosimilars, BAT1406, was approved for marketing. Of the remaining major products in the pipeline for clinical research, three are biosimilars and six are innovative drugs.Biosimilars in the middle and late clinical stages: (1) Adalimumab BAT1406: the first domestically approved product with the brand name Glebli and is expected to be officially commercialized in early 2020.(2) Bevacizumab BAT1706: NSCLC indication, clinical phase III, is expected to be declared for marketing in 2020.(3) Tocilizumab BAT1806: Wind-like indications, clinical stage III, is expected to be declared for listing in 2021.Innovative drugs in the middle and late clinical stages: (1) Batifaban BAT2094: PCI perioperative antithrombotic, has been declared for production, and is expected to be approved for marketing in 2020.(2) BAT8001: ADC of HER2 target, advanced breast cancer indication, clinical stage III, single drug is expected to be listed in 2021.(3) BAT1306: PD-1 monoclonal antibody, combined with XELOX first-line treatment of EBV-related gastric cancer indications, clinical phase II, single-agent clinical phase II trial is expected to be completed in 2022. Deeply cultivated the autoimmune disease market and won the first domestic adalimumab biosimilar.The three major diseases of rheumatoid arthritis, ankylosing spondylitis and psoriasis have approximately 15 million patients and have not been effectively treated.For the first time in RA, the Chinese Medical Association Rheumatology Branch published research results on effective relieving alternatives for Chinese RA patients8.6%, a long way from the expected remission rate of more than 50%.In the past, due to low domestic awareness of rheumatoid disease, unsupported payment systems, and alternative pricing of competitors, the sales of TNFα biopharmaceuticals including adalimumab in China were not satisfactory. The overall market size in 2018Only about 2-30 billion.In the future, the quality of life will gradually increase, and the ability to pay will increase. With reference to the penetration rate of half of the United States (10%) and considering price reduction factors, we expect that the market is expected to achieve more than 10 times growth in the future, reaching 25 billion.The company’s BAT1406 (Geleb), the first domestically produced adalimumab biosimilar drug, was priced at 1,160 yuan / 40mg / branch, reducing the original research by about 10%, extrapolating all domestic indications for adalimumabAnkylosing spondylitis, rheumatoid arthritis, and psoriasis), trying to share a broad market for internal autoimmune diseases.In addition, the company’s BT1806, which is a similar biotoxin of tocilizumab, has entered clinical phase III and is expected to report production in 2021, forming a product echelon in the field of autoimmune diseases. Except for the field of self-immunity, the other three major late-clinical products are located in tumors and cardiovascular and cerebrovascular fields.(1) Bevacizumab biosimilar BAT1706: clinical phase III, trying to report production in 2020.(2) BAT8001: The first domestically-produced HER2-ADC in clinical phase III is expected to be reported in 2021.(3) Batifaban BAT2094: For PCI perioperative antithrombotic, it has been declared for production, and it is expected to be approved for listing in 2020. Fundraising 天津夜网 projects: The company intends to publicly issue no more than 60 million shares (without considering the over-allotment portion). The raised funds will be used for drug research and development, marketing network construction, and supplementary working capital after paying the issuance expenses. Profit forecast: We expect the company’s operating income for 2019-2021 to be 0.7, 50 and 200 million yuan, the growth rate was NA, 7042.86% and 300.00%; net profit attributable to mothers is -10.5, -9.05 and -11.2.6 billion, not yet profitable. Risk Warning: Adalimumab biosimilar drug Glelyx sells less than expected, risks of products under development failing to meet expectations, risks of failure to develop new drugs, interactions, risk of loss of core technical staff, failure to issue or delisting after listing(Long-term unprofitable) risks.