Baiaotai seeks for scientific and technological innovation board, biological similar drug enterprises will meet three kills

Wen Liang Jian After Zejing pharmaceutical, baiaotai biopharmaceutical Co., Ltd (hereinafter referred to as "baiaotai") has become the second enterprise to choose the fifth set of listing standards for science and technology innovation board This time, baiaotai chose the listing standard of "estimated market value is not less than 4 billion yuan", which is also the fifth listing standard of science and technology innovation board This is another enterprise that has chosen this listing standard after Zejing pharmaceutical to apply for landing in science and technology innovation board This standard has been considered as the standard for unprofitable biomedical companies On the eve of its listing, the product gelleli of baiaotai was officially approved by the State Food and Drug Administration on November 7 last year Gelleli is the first adalimumab injection product developed in China with the original adalimumab as the reference drug and in accordance with the guiding principles of biological similar drugs However, at present, 15 pharmaceutical companies in China have carried out clinical trials of adalimumab biological similar drugs Whether the first mover advantage of baiaotai can guarantee the company's strong profitability in the future still needs careful observation by investors In fact, similar to Zejing biology, at present, no product of baiaotai has entered the stage of commercialization, and it has not yet realized sales revenue and will continue to lose money Even after listing, baiaotai cannot guarantee to realize profit within a few years In this regard, the company made multiple risk prompts in the prospectus According to its prospectus, the total revenue of baiaotai in 2016 and 2017 is about 5 million yuan, which are a few occasional technology transfer income From 2016 to 2018 and from January to June 2019, the net profit attributable to the parent of the company was - 140 million yuan, - 240 million yuan, - 550 million yuan and - 720 million yuan respectively, with a cumulative loss of 1.64 billion yuan, and there was a trend of continuous expansion of the loss Of course, baiaotai is one of the few domestic enterprises that mainly focus on the research and development of bio similar drugs, which is also an important reason why it has attracted the attention of investors The prospectus shows that one product has been approved for marketing, and 20 products are mainly under research, among which one product has submitted NDA application, three products are in phase III clinical research stage, one product is in phase II clinical research stage, four products are in phase I clinical research stage, and a number of research projects in pre clinical research stage are stored at the same time The main products of the company that have submitted listing application and are in clinical trial stage are as follows: Photo source: prospectus It is worth mentioning that on November 7 last year, the approval of the State Food and drug administration was officially passed by gelleli, a product of baiaotai, on the eve of listing, which is used to treat autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis and psoriasis Gelleli is the first adalimumab injection product developed in China with the original adalimumab as the reference drug and in accordance with the guidelines of similar biological drugs Of course, as the first biologically similar drug of adamumumab in China, baiaotai has the first advantage But whether we can make good use of the above advantages will test the sales ability of the company In the inquiry, the municipal Party committee of science and technology innovation board also questioned the market competition, prospect and space of adamumumab In response, baiaotai replied that adalimumab was superior to other products such as fusion protein in terms of tolerance and patient compliance, and the therapeutic effect of adalimumab on autoimmune diseases has been widely verified, with great market potential in the future More importantly, baiaotai does not have no competitors in this field According to incomplete statistics, at present, 15 domestic pharmaceutical companies have carried out clinical trials of adalimumab biological similar drugs, 4 of which have submitted listing applications and 3 have carried out phase III clinical trials It can be said that if baiaotai still puts its performance on top of adamumumab biological similar drugs after its listing, it may face the risk of strangulation by its peers in all directions In fact, in recent years, the market of bioequivalent drugs is in full swing According to the forecast of evaluate, the global market of bioequivalent drugs will reach 9 billion US dollars in 2022, with an annual compound growth rate of 33%, far exceeding the market of bioequivalent drugs Compared with chemical drugs, the development cycle of biological drugs is longer and the cost is higher According to some data, it will take 8-10 years to develop bio similar drugs successfully, and the investment may be as high as US $250 million Although the investment is high, the income brought by biological similar drugs also makes every enterprise dare to take risks In recent years, the share of biological drugs in the world's best-selling drugs is more and more heavy, and the annual sales of a single drug can reach 10 billion dollars In 2018, xiumeile (generic name: adamumumab) achieved $19.936 billion and won the title of "medicine king" However, with the successive listing of biological similar drugs after the expiration of the patent, I wonder whether xiumeile's sales volume will still be the first one this year In addition to the baiaotai to be listed this time, there are also Fuhong Hanlin and Shenzhou cell, among which, as the first one to be listed in China, hanlikang (generic name: Rituximab) of Fuhong Hanlin was approved to be listed in China in February last year, and began commercial sales in May At present, there are more than 20 biological analogues, biological innovative drugs and tumor immunotherapy in Fuhong Hanlin R & D pipeline Among the 23 drug R & D product pipelines currently owned by Shenzhou cell, 2 are bio similar drugs, namely bevacizumab and adamumumab, which also forms a competitive pattern with baiaotai In addition, Qilu pharmaceutical's bevacizumab injection (trade name: andak) was approved in December last year It is the first biologically similar bevacizumab approved in China It is mainly used for the treatment of patients with advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer.