Before 2021, growth hormone can be regarded as one of the most sought after pharmaceutical segments. In the view of investors, this business not only caters to the “height anxiety” of many parents, but also has a gross profit margin comparable to Maotai.
However, in the past year, this track has encountered two negative factors, namely “product abuse query” and centralized mining landing. Take Changchun High And New Technology Industries (Group) Inc(000661) , Anhui Anke Biotechnology (Group)Co.Ltd(300009) as an example, the stock prices of both companies reached an all-time high in May 2021, and then went all the way down.
When the industry is changing, the Anhui Anke Biotechnology (Group)Co.Ltd(300009) side suddenly heard the news of “cross-border layout of covid-19 vaccine”. On April 13, Anhui Anke Biotechnology (Group)Co.Ltd(300009) announced that it planned to cooperate with afana on “covid-19 Omicron and other mutant mRNA vaccine”; On April 21, the Anhui Anke Biotechnology (Group)Co.Ltd(300009) official account showed that the clinical trial of covid-19 antigen reagent of the company was officially launched.
Under the pressure of growth hormone performance, can the cross-border layout bring new growth points? This key question remains to be answered by Anhui Anke Biotechnology (Group)Co.Ltd(300009) .
company net profit decline
According to the annual report of 2021, during the reporting period, Anhui Anke Biotechnology (Group)Co.Ltd(300009) achieved a revenue of 2.169 billion yuan, an increase of 27.47% over the same period of last year; The net profit attributable to the parent company was 207 million yuan, a year-on-year decrease of 42.44%; The net cash flow from operating activities was 592 million yuan, a year-on-year increase of 27.40%.
In view of the reason why the performance in 2021 will increase income but not profit, Anhui Anke Biotechnology (Group)Co.Ltd(300009) the explanation is that the company has withdrawn about 323 million yuan of goodwill impairment reserves for its subsidiaries SOHO Yiming and Sino German Meilian, which reduces the net profit of the company’s consolidated statements in 2021 to about 323 million yuan, resulting in a year-on-year decline in the net profit attributable to the ordinary shareholders of the parent company.
According to the annual report, at present, Anhui Anke Biotechnology (Group)Co.Ltd(300009) has formed a “one master and two wings” development pattern with biomedicine as the main axis and Chinese and Western drugs and precision medicine as the two wings. The company’s main business covers biological products, nucleic acid detection products, polypeptide drugs, modern Chinese patent medicines, chemical synthetic drugs and other industrial fields. From the financial data, the top two businesses “biological products” and “Chinese patent medicine” achieved revenue of 1.295 billion yuan and 519 million yuan respectively, with a contribution rate of more than 80% to the company’s total revenue.
The company’s biological agents include human growth hormone and human interferon, mainly recombinant human growth hormone “ansumeng”. However, for the growth hormone products most concerned by the market, Anhui Anke Biotechnology (Group)Co.Ltd(300009) did not disclose its revenue in detail in any public channel.
In terms of market share, according to the Research Report of Tianfeng Securities Co.Ltd(601162) 2021 in December, the sales proportion of growth hormone sample hospitals of Kinsey pharmaceutical reached 75.82% in the first three quarters of 2021, ahead of Anhui Anke Biotechnology (Group)Co.Ltd(300009) and with obvious advantages.
However, 30 Vontron Technology Co.Ltd(000920) 21 also made many breakthroughs in growth hormone: in terms of indications, ansumeng added two new approved indications of idiopathic short stature (ISS) and Turner syndrome during the reporting period, of which the indication of idiopathic short stature was the first approved in China, and ansumeng also made the listed company the enterprise with the most approved indications of growth hormone in China with eight approved indications. In terms of production capacity, the new production line with an annual output of 20 million human growth hormone for injection in the North District of the company has been officially approved for production. In addition, in order to further improve patient compliance and meet clinical and market needs, ansumeng has been approved by the State Drug Administration to add two specifications: 6iu / 2mg / 0.6ml/bottle and 8iu / 2.66mg/0.8ml/bottle.
growth hormone centralized collection and landing
It is understood that from the perspective of dosage forms of growth hormone, there are three types of powder injection, water injection and long-term dosage forms in the Chinese market. Relying on the price advantage, powder injection has the largest patient group; The price of water injection is high, but it is better than powder injection in activity, antibody occurrence and safety. At present, the market share is still increasing; Due to its late entry into the market and high treatment costs, the long-acting dosage form has the lowest market share. Its biggest advantage is that it only needs to be injected once a week, and the medication is convenient. Therefore, the long-acting dosage form belongs to the consumption upgrading option, and it still needs time for large-scale promotion in the market.
According to the PDB sample hospital sales database, in 2020, the market shares of Jinsai pharmaceutical powder injection, water injection and long-acting dosage forms were 4.37%, 70.81% and 0.94% respectively, accounting for 76.13% of the growth hormone market, followed by manufacturers such as Anhui Anke Biotechnology (Group)Co.Ltd(300009) and unisel, with market shares of 12.48% and 8.81% respectively Anhui Anke Biotechnology (Group)Co.Ltd(300009) occupies a dominant position in the field of powder injection. At present, it accounts for about 44% of China’s powder injection Market, while unisell and kinsay pharmaceutical powder injection account for 31% and 16% respectively. In terms of long-acting dosage forms, only Changchun High And New Technology Industries (Group) Inc(000661) of polyethylene glycol recombinant human growth hormone injection is on the market at present. The phase III clinical trial of Anhui Anke Biotechnology (Group)Co.Ltd(300009) of PEG long-acting water injection was completed as early as 2019, but it has not been put into production yet. At present, it is still in the stage of application for production.
On March 10, 2022, Guangdong Pharmaceutical Trading Center issued a notice on publicizing the results of the proposed selection / selection of diclofenac and other drugs in the first batch of centralized procurement of Guangdong alliance. The results of the proposed selection of centralized procurement showed that compared with the previously disclosed highest valid application price, the powder injection of the three product specifications of kinsay pharmaceutical industry decreased by 52.46% and Anhui Anke Biotechnology (Group)Co.Ltd(300009) decreased by 15.79%; In terms of water needle, China’s three major enterprises collectively abandoned the bid and none participated.
The result of this centralized purchase is not good news for Anhui Anke Biotechnology (Group)Co.Ltd(300009) for the company. Since it occupies half of China’s powder injection Market, the company does not rely on the incremental market provided by centralized purchase, so its willingness to reduce prices is not strong; However, for Kinsey pharmaceutical, its ambition to seize the powder injection Market is self-evident, and it has gained the incremental market at the price of only about Anhui Anke Biotechnology (Group)Co.Ltd(300009) half.
However, some market voices believe that the short-term competition pattern of growth hormone in China is difficult to change according to the competition pattern of former growth hormone water injection and powder injection, as well as the factors such as channel distribution, sales model and medical insurance proportion Anhui Anke Biotechnology (Group)Co.Ltd(300009) also said in the performance exchange meeting on April 13 that for centralized purchase, the company has taken the initiative to reduce the price to a certain extent in combination with the interests of the market, products, prices, patients and shareholders. Taking into account the factors such as centralized purchase area, volume and price, the company’s sales model and sales structure have not been adjusted at present, but the sales strategy will be continuously optimized.
“cross border” layout covid-19 vaccine
The wave of centralized mining has hit, and the logic of the industry has quietly changed. Growth hormone, which previously contributed ultra-high profits, is no longer a “once and for all” golden track, and Anhui Anke Biotechnology (Group)Co.Ltd(300009) also needs to explore new performance growth points.
According to the annual report, the Anhui Anke Biotechnology (Group)Co.Ltd(300009) R & D expenditure in 2021 was 167 million yuan, with a year-on-year increase of 29.34%. The listed R & D projects mainly include “recombinant human HER2 monoclonal antibody for injection” and “recombinant anti VEGF humanized monoclonal antibody injection”. The former is the second variety of trastuzumab biological analogues in China. The application for listing license has been accepted by the State Drug Administration and is expected to be approved for listing within this year; The latter has also completed phase III clinical enrollment and entered the preparation stage of production report.
In response to the problem of strategic transformation, Anhui Anke Biotechnology (Group)Co.Ltd(300009) said at the performance exchange meeting that the company will continue to cultivate the biomedical industry, focus on its main products and pay attention to the research and development of innovative products and technologies. Focus on the main business and focus on the development of genetically engineered drugs: Based on clinical and market orientation, constantly optimize and upgrade existing products, accelerate the promotion of antibody drugs that have entered the registration stage, actively layout cutting-edge technologies such as gene editing and cellular immunotherapy, take the precision medical industry as the company’s new strategic growth point, and comprehensively promote the common development of the company’s biomedicine and precision medical fields.
Although Anhui Anke Biotechnology (Group)Co.Ltd(300009) has made smooth progress in biological drug products such as HER2 and VEGF, and is expected to contribute to greater performance flexibility after listing, some “cross-border” actions of the company outside its main business have also attracted considerable controversy.
On April 13, Anhui Anke Biotechnology (Group)Co.Ltd(300009) announced that in order to actively respond to and meet the current needs of covid-19 epidemic prevention and control, the company plans to cooperate with afana on “covid-19 Omicron and other mutant mRNA vaccine”.
On the day after the announcement, the cooperation attracted the attention of Shenzhen Stock Exchange. Anhui Anke Biotechnology (Group)Co.Ltd(300009) was asked to explain the specific mode of cooperation, whether the company has relevant qualification and production experience in vaccine industrialization, etc. in combination with its main business.
On April 18, Anhui Anke Biotechnology (Group)Co.Ltd(300009) replied to the Shenzhen stock exchange that in terms of cooperation with afana, the company participated in the preparation and verification of some pilot samples in the early stage, and will cooperate to complete the preparation and inspection of clinical samples meeting GMP conditions in the future. The company will cooperate to complete the follow-up production line construction, vaccine product marketing license application, market support and other related work.
It is worth noting that in reply to the letter of concern of Shenzhen Stock Exchange, Anhui Anke Biotechnology (Group)Co.Ltd(300009) said that “the company has not obtained the vaccine production license” and “the company has no vaccine production experience at present”.
Anhui Anke Biotechnology (Group)Co.Ltd(300009) said that although the company has no vaccine production experience at present, it is feasible for the company to cooperate with afana on mRNA vaccine products because mRNA vaccine and genetic engineering drugs currently produced by the company belong to biological products and have certain similarities in product industrialization.
By virtue of “having certain similarities in product industrialization”, can Anhui Anke Biotechnology (Group)Co.Ltd(300009) solve the technical barriers in the field of mRNA vaccine? The outside world doesn’t know for the time being.
It is worth noting that up to now, five covid-19 vaccine products in China have been approved for listing with conditions, and five enterprises, including Suzhou Aibo Biotechnology Co., Ltd., Siwei (Shanghai) Biotechnology Co., Ltd., Zhuhai livanda Biotechnology Co., Ltd., stone Pharmaceutical Group Co., Ltd., Cansino Biologics Inc(688185) Jinyu Bio-Technology Co.Ltd(600201) company, have been approved to carry out mRNA vaccine clinical trials. In the R & D stage, Anhui Anke Biotechnology (Group)Co.Ltd(300009) will face fierce competition.
Anhui Anke Biotechnology (Group)Co.Ltd(300009) said in the reply letter that even if the mRNA vaccine of this cooperation is successfully approved for marketing, there are uncertainties in the subsequent commercialization of the product due to the development and changes of the epidemic situation outside China and other factors.
In the race track of mRNA vaccine, it has neither experience nor license, and faces many opponents with a deep foundation in vaccine research and development. It is conceivable that Anhui Anke Biotechnology (Group)Co.Ltd(300009) relying on mRNA vaccine to seek performance growth point.
On April 21, Anhui Anke Biotechnology (Group)Co.Ltd(300009) wechat official account said that the company’s covid-19 antigen reagent clinical trial was officially launched, and said that it would accelerate the progress of clinical work, race against time, and strive to obtain the registration approval as soon as possible.
It should be noted that by the time of publication, the State Food and Drug Administration had approved 29 covid-19 virus antigen detection reagent products, and Anhui Anke Biotechnology (Group)Co.Ltd(300009) this is also a field of intense competition. Therefore, some investors believe that Anhui Anke Biotechnology (Group)Co.Ltd(300009) a series of operations of “cross-border layout of covid-19 concept” are “rubbing the heat”.
