Approval and registration of IPO of bio tech Innovation Board

On the 14th, according to the CSRC, the IPO of bio tech Innovation Board was approved for registration Baiaotai passed the science and technology innovation board meeting on November 20, and its first product adamumumab analog was approved in November last year, and the company is expected to achieve listing sales by the end of 2019 or early 2020 In addition, there are four products in clinical phase III, including bat1706 (bevacizumab bioequivalent), bat8001, bat1806 (tobacizumab bioequivalent) and bat2094 (batifiban) According to the prospectus, no more than 60 million A-share common shares are to be publicly issued, totaling 2 billion yuan, mainly for drug research and development According to the prospectus, Biostar meets the fifth set of standards and conditions for listing on the science and technology innovation board The science and technology innovation board has set up five listing conditions According to the development situation and recent situation under different market values, different thresholds can be selected Even if it has not yet made profits, it can apply for listing 1 The accumulated net profit for two years is more than 50 million yuan, or the net profit for the past year is more than 100 million yuan, and the estimated market value of the enterprise is more than 1 billion yuan 2 The annual revenue is more than 200 million yuan, and more than 15% of the total revenue is used for R & D investment The estimated market value of the enterprise is more than 1.5 billion yuan 3 One year's revenue is more than 300 million yuan, and the net amount generated by three years' business activities is more than 100 million yuan, and the market value is not less than 2 billion yuan 4 The total annual revenue is over 300 million yuan, and the estimated market value of the enterprise is over 3 billion yuan 5 It is estimated that the market value will not be less than 4 billion yuan The main business or products need to be approved by the relevant departments of the state There is a large market space At present, phased results have been achieved Pharmaceutical enterprises need to have at least one core product approved to carry out phase II clinical trials, and other enterprises that meet the positioning of scientific and technological innovation board need to have obvious technical advantages and meet the corresponding conditions Up to now, one product of BioTek has been approved for marketing The corresponding indications of bat1406 are ankylosing spondylitis, rheumatoid arthritis and psoriasis There are 20 main products under research, 4 of which are in phase III clinical research, 1 in phase II clinical research and 4 in phase I clinical research In addition, there are several innovative antibodies in the pre clinical research stage In the next three years, Biostar will focus on the development strategic planning, accelerate the process of product industrialization and marketization, including realizing the listing and sales of bat1406 and bat2094 in China, completing the phase III clinical research of bat1706 meeting the requirements of Chinese and European and American regulations, applying for marketing in major global markets, completing the phase III clinical research of bat8001, and completing the phase II of bat1806 meeting the requirements of Chinese and European and American regulations Phase I clinical trial; promote global or Chinese clinical trials of multiple innovative drugs and bio similar drugs It is worth mentioning that bat8001 is an ADC (antibody drug conjugate) drug, which is covalently linked by an anti HER2 monoclonal antibody and a toxin linker batansine (a medetonin derivative) via a stable thioether bond Up to now, three clinical trials of antibody coupling drugs have been carried out to phase II and later in China Among them, ADO trastuzumab emtansine of Roche has submitted NDA application, bat8001 of baiaotai has entered phase III, and rc48 of Rongchang biology has entered phase II In addition, there are six drugs in clinical phase I In addition, bat8003 is an ADC drug targeting trop2 It is covalently linked by glycosylated recombinant human anti trop2 monoclonal antibody and batansine by site-specific coupling technology Its clinical indication is trop2 positive advanced epithelial cancer.