Text: Linan
On August 29, BIOSETU publicly submitted a prospectus to be listed on the main board of the Hong Kong Stock Exchange, and the joint sponsors are Goldman Sachs and CICC. Due to the similar business model, BIOSAItu is also known as "China's regeneration yuan", mainly with the help of the underlying technology to drive drug research and development, through foreign cooperation or the sale of product rights to drive product commercialization.
Previously, according to a number of media reports, BIOSET had signed a listing counseling agreement with CICC in February this year, and originally planned to complete the listing counseling work and sprint to the science and technology innovation board in May, and the counseling agreement was terminated on August 9. The reason for the termination is said to be BASED ON MARKET REASONS AND ITS OWN STRATEGIC CONSIDERATIONS. Industry analysts believe that BIOSETU's IPO strategy is good, first to declare Hong Kong stocks, and then return to the science and technology innovation board after the later stage may be suitable.
Beausset lost more than 900 million yuan in more than two years, sitting on the "thousands of rats and ten thousand resistances"
Founded in 2009 by Dr. Yuelei Shen, BIOSAItu is a revenue-generating company for clinical biotechnology and preclinical research services, relying on proprietary gene editing technology, transgenic mouse platform, comprehensive animal patient model and high-throughput in vivo antibody discovery platform.
In the prospectus, BIOSAITU said that the company combined proprietary gene editing technology, perfect animal platform and high-throughput in vivo discovery strength to launch the world's first large-scale in vivo antibody discovery screening program - "Thousand Rats and Ten Thousand Resistances". The industry commented that the plan, as an important part of THE ANTIBODY DRUG DEVELOPMENT PLATFORM, is the core embodiment of its intrinsic value, and is also the key point for investors to understand the growth of THE INVESTMENT VALUE of BIOSET.
Evidence-based in vivo screening methods are used to simultaneously generate and screen more than 1,000 potentially undiscovered antibody drug targets for human diseases, most of which have not yet been discovered in clinical trials, and about 300 of these potential targets have entered the clinical stage. According to Beosaitu, "Thousands of Rats" is expected to become the origin of a large number of first-of-its-kind antibodies or best-in-class antibodies against new and/or difficult drug targets, and accelerate clinical development.
It is worth mentioning that through the authorization of RenMice mice and the external cooperation of antibody development in the form of "thousands of rats and ten thousand antibodies", BIOSAITU has reached cooperation with well-known biotechnology or pharmaceutical research and development enterprises at home and abroad such as Junshi Biology, Rongchang Pharmaceutical, Xencor and so on.
At present, BIOSA has established a pipeline of selected antibody drug products with 12 drug assets, including four clinical assets, six preclinical stage assets and two granted assets. There are also five ongoing clinical trials and seven planned clinical trials.
Its product pipeline at the clinical stage includes: 1. YH003, a humanized IgG2 agonistic monoclonal antibody with the potential to become best-in-class targeting CD40; YH001, a humanized anti-CTLA-4 IgG1 monoclonal antibody with the potential to be the best in its class; YH002, a monoclonal antibody with the potential to become the best-in-class anti-OX40 IgG1 monoclonal antibody in China; YH004, a safe humanized anti-4-1BB IgG1 monoclonal antibody.
Biosaitu's product pipeline and the development of drug candidates for each clinical phase and selected preclinical stage:
According to the prospectus, the company's revenue in 2019, 2020 and the first four months of 2021 was 170 million yuan, 254 million yuan and 70.178 million yuan, respectively, and the corresponding net losses were 306 million yuan, 477 million yuan and 171 million yuan, respectively. Over the past two years, the cumulative loss was $954 million, mainly for research and development expenses and general and administrative expenses.
During the Reporting Period, BIOSAITU's R&D expenditure was MOP159 million, MOP276 million and MOP135 million, while the general and administrative expenses were MOP140 million, MOP245 million and MOP58.785 million, respectively. BIOSET's net current liabilities as of December 31, 2019 were $738 million. As of December 31, 2020 and April 30, 2021, its net current assets were $819 million and $546 million, respectively, compared with $737 million as of June 30.
Since its inception, BIOSA has also continued to raise funds. Just in June 2021, BIOSETU also announced the completion of a new round of financing of tens of millions of dollars, including Qingchi Capital, CPE Yuanfeng, Octagon Capital and Aobo Capital.
According to BIOSET, its business and prospects depend largely on the success of the Thousand Rats Program. It is understood that its current benefits mainly come from preclinical research services related to gene editing, preclinical pharmacological pharmacodynamic evaluation, model animal sales and antibody development. The Company does not currently have any products approved for commercial sale, nor has it received any proceeds from the sale of its products. The Company recorded an operating loss during the period of business records.
BIOSAITU revealed that the company will continue to increase the development of new drugs. With independent intellectual property rights of the RenMice platform and the full-chain drug research and development platform, it plans to continue to explore monoclonal antibodies, bispecific antibodies and ADC therapies, focusing on oncology and self-disease free disease treatment, focusing on transforming from a research-and-development-based biotechnology company to a fully integrated biopharmaceutical company. However, due to the continued promotion of the development pipeline and the expansion of the clinical development program, BIOSETU is expected to generate more R&D expenditure and administrative expenses, and the loss in 2021 will increase compared with 2020.
"Guinea pig" enterprises gathered on the market, set up Yaokang, Nanmo Biological...
According to Frost & Sullivan data, since the approval of the first monoclonal antibody muromonab in 1986, the FDA and EMA have approved 144 monoclonal antibodies for marketing, involving about 60 drug targets. However, there are thousands of potential antibody drug targets in the human body, most of which are still to be further discovered and developed. Due to the lack of understanding of the mechanism of action of these potential drug targets, traditional antibody discovery and screening methods face significant challenges.
Compared with traditional methods, BIOSAITU pointed out in the prospectus that its own thousands of rats have significantly accelerated the drug development process, for example, the time required from preclinical discovery to PCC has been reduced from an average of 5.5 years to 12 to 18 months. The traditional approach takes years to use early target-by-target research, in vitro detection development, target validation, antibody humanization, pilot screening and optimization research, compared to thousands of rats to save time and effort. More importantly, there is also an expected solution to the challenges of traditional approaches in developing the effectiveness and safety of clinical applications.
Biosaitu revealed in the prospectus that the company has established a world-class model animal production center, including three animal facilities, covering a total area of about 55,500 square meters, supplying 800,000 gene-edited mice a year. The large animal facility enables it to have a large number of gene-edited mice, mouse models of disease, and older and companion animals with significant cost advantages.
The enthusiasm for the development of innovative drugs is high, driving the demand for upstream experimental animal models. According to Frost & Sullivan, the mouse model market is growing steadily. The global mouse model market size is expected to grow at a CAGR of 9.2% from 2020 to 2025 and further at a CAGR of 7.0% from 2025 to 2030, reaching $17.8 billion by 2030.
In China, the mouse model market size is expected to grow at a CAGR of 26.6% from 2020 to 2025 and further at a CAGR of 14.9% from 2025 to 2030, reaching approximately RMB19.5 billion in 2030.
Like THE LOT, there are also companies such as Jicui Yaokang and Nanmo Biologics aiming at the "guinea pig" test track. Although the strategic directions of the three companies are different, they are mainly in the rat business. Jicui Pharmaceutical Kang and Nanmo Biotech have submitted IPO prospectuses on the Science and Technology Innovation Board.
Founded in September 2000, Nammodel is mainly engaged in genetically modified animal models and related technical services, and its business involves model organisms including mice, rats, zebrafish, nematodes, etc., of which gene-modified mouse models are the mainstay.
On August 6, the review status of Nammo Bio's listing on the Science and Technology Innovation Board has been changed to submission for registration. Nanmo Biotech plans to raise 400 million yuan in this IPO, which will be used for the biological research and development base project, the gene modification model resource library construction project, the humanized antibody mouse model research and development project, and the drug effect platform construction project based on gene modified animal models.
The other company, Jicui Yaokang, founded in 2017, is mainly engaged in the research and development, production, sales and related technical services of experimental animal mouse models. At the same time, it is also a joint construction unit of the National Genetic Engineering Mouse Resource Bank recognized by the Ministry of Science and Technology.
In June this year, the IPO of Jicui Yaokang Science and Technology Innovation Board was accepted, and the company plans to raise 820 million yuan for mouse breeding and animal model research and development and transformation platform.
The service customers of Jicui Pharmaceutical Health include Hengrui Pharmaceutical, BeiGene, Cinda Biologics and other well-known pharmaceutical companies. It accounts for the top overall proportion in major market segments such as finished mouse sales, mouse model customization services and mouse breeding, and is in the second position in the industry. According to the 2019 data, Charles River's subsidiary in China, Witong Lihua, accounted for 13.7% of the market, ranking first; Jicui Yaokang accounted for 6% of the market, ranking second. Slack and Spaeffer accounted for 5.5% and 5.1% respectively, ranking third and fourth.
While BeiGene-based new drug R&D companies are still losing money, some companies that sell mice have made a lot of money. From 2018 to 2020, the operating income of Jicui Pharmaceutical Health increased from 53.29 million yuan to 260 million yuan, and the CAGR was 122%. From a loss of 6.04 million yuan to a profit of 30.3 million yuan, Jicui Pharmaceutical Kang further increased to a profit of 71.11 million yuan in 2020; during the same period, the revenue of Nanmo Bio was 121 million yuan, 155 million yuan and 196 million yuan, respectively, and the corresponding net profit was 15.1112 million yuan, 23.2499 million yuan and 44.5559 million yuan.
Article reference: "Three "rats" make a big fuss about the science and technology innovation board", "Nanmo Biological Science and Technology Innovation Board IPO: "Guinea pigs" enterprises are listed together, the market share is not advantageous", "Jicui Yaokang "selling mice" can also land on the science and technology innovation board? Also attracted Damo, CDH, Hillhouse and Sequoia? etc.
(Note: The information and charts in the text are from the BIOSA Prospectus.) ）