"Science and Technology Innovation Board**" on December 11 (Reporter Zheng Bingxun).Recently, Bio-Thera (688177SH) has released a revised draft of the 2023 A-share Private Placement Plan after completing the progress update on its R&D pipeline and expansion projects, further promoting the pace of the private placement.
According to the private placement plan, Bio-Thera will issue up to 70 million shares** to no more than 35 investors, and the total amount of funds raised will not exceed 164 billion yuan, all of which will be used for:There are 3 projects, including the new drug research and development project, the second phase expansion project of Bio-Taiyong and the replenishment of working capital.
Focus on "betting" on new drug research and development
In this fixed increase, Bio-Thera will focus on the research and development of new drugs, and the raised funds to be invested in the new drug research and development project are 128.9 billion yuan, accounting for 78 percent of the total funds raised62%, much higher than the remaining other projects. The focus of R&D is to advance the domestic and overseas research of multiple clinical projects, including BAT2606, BAT6026, BAT8006, BAT8008 and BAT8007.
As an innovative biopharmaceutical company, Bio-Thera has always focused on major diseases such as tumors, autoimmune diseases, and cardiovascular diseases. Many of the products of this new drug research and development project are also carried out around these fields.
Specifically, BAT2606, a biosimilar of mepolizumab injection, is currently in phase I clinical trials for **autoimmune diseases and **cancer, and is in phase I and II clinical trials for **atopic dermatitis. Indications for this product include patients with eosinophilic granulomatosis with polyangiitis (EGPA)**, severe eosinophilic asthma, etc.
Also worth paying attention to is BAT8006, an ADC (antibody-drug conjugate) drug developed by Bio-Thera that targets the folate receptor (FR) and will be used in solid tumors.
Bio-Thera regards BAT8006 and BAT2606 as key products for international development, and will increase its international capabilities by promoting the international clinical trials of these two products.
In contrast, the R&D of BAT6026, BAT8007 and BAT8008 is currently in Phase I clinical stage, and the main indications include atopic dermatitis and solid tumors.
In fact, Bio-Thera has recently tasted the "sweetness" in its international layout, and its "Bevacizumab Injection" (BAT1706) has recently been officially approved by the US FDA for 7 indications, including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma.
Prior to this, bevacizumab had been approved by the National Medical Products Administration (NMPA) for marketing in China, and the marketing authorization application submitted to the European EMA was also in progress.
Prior to bevacizumab, Bio-Thera's other product, Tocilizumab Injection (BAT1806), was also approved by the FDA in September this year, becoming the first product of Bio-Thera to receive FDA marketing approval. Similarly, tocilizumab has been approved by the NMPA for marketing in China, and the application for marketing authorization submitted to the European EMA has also been accepted.
It has not turned a profit for many years
In addition to the above two commercial products, Bio-Thera's other product, "Adalimumab Injection" (BAT1406), has also been launched and included in the National Medical Insurance Catalogue along with two other products.
However, since Bio-Thera has more than 20 projects under research and its revenue cannot cover R&D investment, since its listing, Bio-Thera has achieved a net profit of 81.94 million yuan in 2021 due to an increase in licensing revenue, and has been in a state of loss in the rest of the years.
Taking the first three quarters of 2023 as an example, Bio-Thera achieved revenue of 46.1 billion yuan, with a net loss of 38.2 billion yuan, R&D investment of 61 billion yuan, accounting for 132 percent of revenue29%, an increase of 21 year-on-year73 percentage points. During the same period, Bio-Thera had a cash and cash equivalents balance of only 3$2.5 billion, net cash from financing activities of 39.7 billion yuan.
It can be seen that in the fundraising and use plan, Bio-Thera will use 200 million yuan to replenish the flow to alleviate the pressure on the demand for working capital.
In addition to this, Bio-Thera will also 1RMB 5.1 billion will be raised for the "Yonghe Phase 2 Expansion Project" to further expand the production scale of monoclonal antibody stock solution and drug preparation, and enhance its ability in commercialization.
Bio-Thera pointed out that after the completion of the expansion project, it will be able to afford the production needs of drug substance to sterile preparation of monoclonal antibody drugs at different stages such as large-scale clinical drugs and commercial production, and solve the bottleneck of future production capacity.
However, at present, Bio-Thera has a number of production lines, including but not limited to 4 sets of 4000L stainless steel bioreactors and their supporting downstream purification production lines, 2 sets of 3500L stainless steel bioreactor systems and their supporting downstream purification production lines, 1 set of 200L antibody drug conjugate reactor tanks and their supporting isolator systems and purification production lines, etc.
The reporter of the Science and Technology Innovation Board called the secretary of the board of directors of Biotai on whether there was excessive expansion of production capacity, and the other party said that it was mainly for the follow-up product planning"Because it is included in foreign countries, we will have drugs to be marketed soon, and the production capacity will definitely be insufficient at that time, which is to make a layout for the future production capacity demand in advance. ”The other party said.
Xingkuang data shows that from 2020 to 2022, the inventory turnover days of Bio-Thera have increased from 80889 days dropped sharply to 23795 days, during the same period, the inventory turnover rate also increased from 045 to 151。