Source: Investment Times
The sales revenue of Frontier Bio’s main drug Iconin within 5 months after its launch in August 2018 was only 1.91 million yuan. Sales in the first quarter of this year were 2.275 million yuan, and the cumulative eight-month total sales revenue was 4.185 million yuan
"Investment Times" researcher Luo Yi
Following Suzhou Zejing Biopharmaceutical Co., Ltd. and Suoyuan Biopharmaceutical (Hangzhou) Co., Ltd. Later, Frontier Biopharmaceutical (Nanjing) Co., Ltd. (hereinafter referred to as Frontier Bio) became another company that applied for listing on the Science and Technology Innovation Board using the fifth set of standards.
Like the first two companies, Frontier Biotech is also an innovative drug development company that is not yet profitable. As of now, its IPO application for the Science and Technology Innovation Board has entered the inquiry stage.
This time, Frontier Biotech plans to publicly issue no more than 89.96 million RMB ordinary shares to raise 2.001 billion yuan for 10 million injectable HIV fusion inhibitors, clinical research and development of Iconin + 3BNC117 combination therapy, and new transdermal analgesia. Clinical research and development of patch AB001, marketing network construction and additional working capital are in progress.
Since the release of the fifth set of standards, the industry has generally believed that this is a tailor-made plan to encourage biopharmaceutical innovation. A report previously disclosed by regulators also showed that compared with traditional pharmaceutical manufacturing companies, the value of innovative pharmaceutical companies in the early stages of growth does not solely depend on profit levels and growth rates, but needs to be combined with their current loss status and trends, as well as each product pipeline. Progress, market space, competition and technology sources to measure its value.
Judging from the situation of Frontier Biology, its main drug Aibovita (trade name: Aikonin) has a sales revenue of only 1.91 million yuan in the five months since its launch in August 2018. In the first quarter of this year, the sales revenue was only 1.91 million yuan. 2.275 million yuan, and the total sales revenue in eight months was 4.185 million yuan.
Sales of RMB 4.185 million within 8 months of launch
At the end of 2017, Frontier Bio took the lead in cooperating with five AIDS drug production and research and development companies to jointly apply for the national "13th Five-Year Plan" major special project on new drug creation, and received project support from the National Health and Family Planning Commission. Then, according to the relevant regulations of the former State Food and Drug Administration, anti-AIDS drug registration applications were included in the scope of limited review and approval. Under the care of the "priority review channel", Aikoning was approved for marketing and accelerated its pace. In May 2018 It was approved in August and officially launched for sale in August. In addition to receiving the attention of relevant departments,
has also become a hot target of various capitals for cutting-edge biology before the launch of new drugs. Since 2016, many institutions such as Shenzhen Venture Capital and Yifeng Venture Capital have followed in the investment. According to a transfer in 2017 by Jiangning Science and Technology Park, the then shareholder of Frontier Bio, it can be estimated that in December 2017, the total equity valuation of Frontier Bio was approximately 1.902 billion yuan. By May 2018, when it was approved for marketing, Frontier Bio's valuation increased to 3.795 billion yuan. The listing prospectus shows that Frontier Biotech’s last round valuation before listing reached 5.396 billion yuan.
However, in contrast to the enthusiasm in the capital market, the popularity of Aikening in the market has been slightly slow. Prospectus data shows that in 2018, Aikening’s sales revenue was only 1.91 million yuan within five months after its listing in August. In the first quarter of this year, its sales were 2.275 million yuan, and the total sales revenue in the eight months was 4.185 million yuan.
As the world's first long-acting drug, Ikonin is administered once a week by injection. Compared with the current mainstream "cocktail therapy" that requires oral medication every day, it seems to be more attractive to patients and has a huge market space. However, careful analysis can reveal that Ikonin is not a drug whose sales can grow rapidly in the short term.
When the new drug Ikonin was released globally, it was positioned as follows: It is suitable for use in combination with other antiretroviral drugs to treat HIV-1 infected patients who have received antiviral drug treatment.
In layman's terms, Aikonin is mainly targeted at patients who have developed multiple resistance to traditional AIDS treatment regimens. It provides an option for patients who have difficulty regaining the effect of most oral drugs currently on the market. It is a "life-saving" for these patients. drug". But from a marketing perspective, sales are indeed difficult to grow rapidly.
Judging from the advantage of once-a-week dosing, Aikonin also includes "inconveniences" that have not yet been broken through. For example, the product is administered intravenously, and patients must go to the hospital to "get a hanging bottle", and Iconin must be used in combination with other drugs. In addition to "infusion once a week", it also requires daily oral administration of lopinavir/ritonavir, which has become an obstacle to the market promotion of Iconin.
The cost of treatment is another important factor affecting the promotion of Aikoning. The current treatment cost of Aikoning is 7,936 yuan per month and 95,232 yuan per year. For patients who need to take medicine for life, the cost of medicine is an important factor affecting their choice. So far, Aikoning has not been included in the national medical insurance.
The anti-HIV drug market in developing countries is expected to grow at a low rate.
The prospectus shows that the areas where Ikonin plans to be commercialized include China and other emerging markets, such as Africa, Southeast Asia, Central Europe and South America.
However, from the perspective of the global AIDS drug market, North America and Central and Western Europe are still the mainstream markets for anti-HIV drugs. According to the CIC Consulting report, the global anti-HIV drug market size increased from US$22.9 billion in 2013 to US$33.96 billion in 2018, with an average annual compound growth rate of 8.2%. Taking 2018 as an example, the anti-HIV drug market size in North America and Central and Western Europe reached US$30.97 billion, accounting for 91.2% of the global market size.
The markets in developing countries that Aconin intends to cover accounted for 4.12% of the overall anti-HIV drug market in 2018, with a market size of approximately US$1.40 billion. It is expected that the market size of anti-HIV drugs in developing countries will grow at a compound annual growth rate of 3.1% from 2019 to 2023, and by 2023, the market size will reach US$1.57 billion.
Industry analysts believe that because the 4E00 series of institutions and organizations, mainly UNAIDS, have lowered the price of anti-HIV drugs sold to the region for the purpose of aid, under the prevention and treatment-oriented plan, the overall market for anti-HIV viruses in developing countries has also There will be no rapid growth.
In this context, it is difficult for Iconin, which is mainly marketed in developing countries, to become a "good medicine" to boost the performance of Frontier Biology in the short term. Therefore, the combination therapy of Iconin + 3BNC117 in the Frontier Biological product pipeline will have a huge impact on the market. The target is global. The U.S. Food and Drug Administration approved the above-mentioned therapy to conduct Phase II clinical trials in 2018. The prospectus of
shows that at present, the company's product pipeline combination therapy and AB001 are in the research and development stage, requiring a large amount of R&D investment. Frontier Biotech suffered losses during the reporting period, and there is a large amount of unfinished funds to make up for the losses. As of March 31, 2019, the cumulative amount of unrecovered losses was 428 million yuan.
Competition among similar products is fierce.
Frontier Bio hopes to increase its market share by promoting Aikening globally. However, long-acting drugs are the trend of anti-AIDS drugs and are also the direction of the world's major pharmaceutical companies. The competition faced by Aikoning will become increasingly fierce.
In March 2018, before the National Food and Drug Administration approved the launch of Iconin, the long-acting drug Trogarzo (ibalizumab-uiyk, TMB-355) of Taiwanese pharmaceutical company Zhongyu New Drug was approved for marketing by the US Food and Drug Administration. There are differences in mechanism between the two, but industry insiders say that Trogarzo has certain advantages over Iconin in terms of efficacy, administration method, and combined use.
The pharmaceutical giant Gilead announced the clinical data (Phase Ib) of its long-acting injectable HIV preparation GS-6207 for the first time in July 2019, proving that ten days after patients received a single dose of the related product, the viral load in the body was greatly reduced. Of course, the company also mentioned that it is considering the combination of GS-6207 and other drugs, so a more detailed long-acting regimen is still under study. Currently, GS-6207 has been granted a breakthrough treatment program by the US FDA (for HIV patients with multiple drug resistance and severe treatment). Its target population is the same as the target patients of Aikoning.
Another pharmaceutical giant, GSK, is also developing HIV products. Its long-acting (once-monthly injection) HIV preparation Cabotegravir/rilpivirine submitted a marketing application to the FDA in April this year.
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