In the future, several enterprises with both hard power and commercialization ability will emerge from the science and innovation board.
Recently, Maiwei Biology (688062) released the annual performance forecast for 2021: it is expected to realize the net profit attributable to the owner of the parent company from -666482100 yuan to -782392100 yuan in 2021, an increase of 23.9368 million yuan to 139.8467 million yuan compared with the loss in the previous period, a year-on-year increase of 3.73% to 21.76%. During the reporting period, all products under research of the company were in the research and development stage, and commercial sales had not been carried out, and the sales revenue of the company's products had not been realized. During the reporting period, the company's main business income was mainly technical service income.
Previously, Maiwei biological had an IPO on the science and Innovation Board on January 18, but it broke at the opening. It has also become another breaking biomedical stock on the science and innovation board after Yahong medicine in 2022.
Public information shows that Maiwei biology is an innovative biopharmaceutical company with the layout of the whole industry chain. Its main business is the R & D, production and sales of biological products for treatment, and its main products are antibody drugs. Specifically, antibody drugs including human therapeutic monoclonal antibodies, bispecific / bifunctional antibodies and ADC drugs, as well as long-acting or specially modified cytokine recombinant protein drugs. Although the enterprise itself controls the production of popular drugs and special drugs, it is not satisfactory in terms of market performance.
According to the prospectus of Maiwei biology, from 2018 to the first half of 2021, Maiwei biology achieved revenue of 37.3757 million yuan, 29.4257 million yuan, 5.3022 million yuan and 6.7822 million yuan respectively. The net profits in the same period were - 238 million, - 929 million, - 644 million and - 340 million yuan respectively, with a cumulative loss of 2.151 billion yuan in four years.
In contrast, Maiwei's investment in R & D continues to grow, with R & D expenses reaching 169 million yuan, 363 million yuan and 581 million yuan in 2018, 2019 and 2020 respectively.
insufficient commercialization capacity and confused valuation
It seems that new shares have been issued more frequently in the medical sector.
Among the new shares that landed on the science and innovation board in 2021, 12 were broken on the first day of listing. They were all new shares after the new regulations on IPO inquiry under the registration system came into effect (from September 18). In addition to Pingao shares and Chunli medical, they also included: Nanmo biology, Baiji Shenzhou, Dizhe medicine, Liaoning Chengda Biotechnology Co.Ltd(688739) , Shareate Tools Ltd(688257) , Wayz Intelligent Manufacturing Technology Co.Ltd(688211) , Sinocat Environmental Technology Co.Ltd(688737) , Xindian software, Hangzhou Kaierda Welding Robot Co.Ltd(688255) , Jiahe Meikang. Four of them are biopharmaceutical companies. The investors of Liaoning Chengda Biotechnology Co.Ltd(688739) lost the most on the first day of listing, with a loss of RMB 1-15600.
\u3000\u3000 "The development of innovative drugs is phased. For example, Maiwei is an innovative drug enterprise in the first stage, which mainly solves the process of China's relevant drugs from scratch. It is too early to judge that innovative drugs are 'cold' at this stage. The process from non-profit to profit needs to be tested by the market. Even enterprises such as Junshi and Xinda that have realized real income , their commercialization ability has not been fully verified. However, we believe that in the future, several enterprises with both hard power and commercialization ability will emerge from the science and innovation board. " A pharmaceutical primary market investor in South China told the 21st Century Business Herald reporter.
Coincidentally, on January 18, Lu Haisheng, regional director of the market development department of Shanghai Stock Exchange, publicly said: the landing ability of enterprise commercialization is an indicator that the science and Innovation Board attaches great importance to in the future, and the IPO ideas of pharmaceutical enterprises will be gradually adjusted in the future.
In addition to the time required to verify the commercialization of soft power, the capital market also showed an uncertain attitude towards the expected valuation of similar enterprises.
Capital began to be interested in pharmaceutical enterprises and took the initiative to embrace unprofitable biomedical enterprises, so more innovative pharmaceutical enterprises poured into the market. For investors, how to commercialize and fulfill their commitments has become an unavoidable topic.
The intensive landing of Chinese biomedicine in the capital market is inseparable from the new listing regulations of Hong Kong stock 18a in 2018 and the launch of the science and Innovation Board of Shanghai Stock Exchange. The opening of the scientific innovation board undoubtedly gives capital the opportunity to invest in biomedical enterprises and the opportunity for many non-profit companies to be listed. Like the 18a enterprises in Hong Kong stock market, the listing time can be expected, which provides great convenience for enterprises. From 2020 to 2021, the number of innovative drug companies listed on the science and innovation board and the amount of financing are also slowly catching up with the total number of biomedical enterprises such as 18a.
Despite local fluctuations, in the context of the epidemic, the medical and health industry is still a race track for many enterprises. The opening fluctuation does not affect the investment in innovative drugs, which remains at a high level.
Talking about the breaking trend of the opening of many innovative drug enterprises, The aforementioned investors told the 21st Century Business Herald reporter: "At present, there are three reasons why the overall situation is not good: first, the time node is poor, and the market sentiment has been bad since the sky high price of Dizhe medicine opened the market, which has affected investors one after another; second, the poor performance of Hong Kong stock 18a has transmitted negative emotions to the mainland market; third, the most core, that is, the current secondary market, including investors, has little pricing for 18a company and similar enterprises Clear. The unclear pricing and the time required to verify the commercialization ability lead to the current downturn of the whole market, at present, the actual pricing of such enterprises in the whole market is also in a confused state. How to balance the hard power and commercialization ability of enterprises is also a tangled point in the current market. ”
However, many Biopharmaceutical Enterprises are still in the R & D stage and have not been put into the market to make profits. At the same time, many profitable products are not independent innovative products, but the production of biological similar drugs. This leads to investors' uncertainty about the future commercial development of the enterprise, and can not guarantee the differentiation advantage after subsequent marketization.
Biological analogues, also known as biosimilars, are a kind of biological drugs similar to the approved biological original drugs (including vaccines, blood and blood components, somatic cells, gene therapy, tissue and recombinant therapeutic proteins, etc.).
Only in 2019 did China begin to have domestic biological drugs approved for listing. Subsequently, a large number of enterprises joined the production, resulting in serious homogenization of biological similar drugs in the market, and the competition among pharmaceutical enterprises is in the white hot stage. The differentiated development of biological pharmaceutical enterprises in the future may depend on their own R & D of innovative drugs.
how can new shares break the situation when the competition of innovative drugs intensifies?
According to public information, Maiwei biology mainly focuses on the research and development of antibody drugs, covering the fields of autoimmunity, tumor, metabolism, ophthalmology, infection and other diseases. The company has approved and developed 15 varieties, including 4 kinds of biological similar drugs.
Among them, 9mw0113 in the first echelon is a biological similar drug, which belongs to the field of autoimmunity and is mainly suitable for rheumatoid arthritis.
9mw0311 and 9mw0321, which have been submitted for marketing license in the second echelon, are also biological similar drugs. 9mw0311 belongs to the field of metabolism, which is suitable for osteoporosis in postmenopausal women with high risk of fracture, and 9mw0321 belongs to the field of tumor, which is suitable for preventing bone related events in patients with tumor bone metastasis.
Maiwei biology's investment in R & D has a high repetition rate, which is also a problem in the whole industry. For example, 9mw0113 is recombinant human anti TNF- α Monoclonal antibody injection is a biological analogue of the drug xiumeile (also known as amumab). 9mw0113 is expected to be the fifth approved biological analogue of adalimumab in China, but it has a late market time, does not have a first mover advantage, and there is great competition for drugs with indications of rheumatoid arthritis. The existing infliximab, gollimumab Etanercept and other drugs have occupied a certain market share.
According to the new version of the national medical insurance catalogue released in early December 2021, all the eight indications of the Adamu single antigen drug xiumeile listed in China have entered the national medical insurance catalogue. If xiumeile biological similar drugs are included in the centralized purchase, the price will have room for decline, the profitability may be reduced again, the competition among Biopharmaceutical Enterprises will be further intensified, and the gap between enterprises will be further widened. Finally, only enterprises with innovative technologies and capable of producing innovative drugs can survive. The development of innovative drugs is a marathon.
The situation of cluster research and development also appears in the field of car-t and gene therapy. According to statistics, the number of clinical trials of car-t cell therapy in China has reached 335 in 2020, which has increased tenfold in five years. Among them, car-t clinical trials targeting CD19 account for more than 40%, while more than half of the more than 600 car-t clinical trials come from China. What needs to be recognized is that these research experiments are "pseudo innovation" of foreign known targets and "inner volume" of Chinese innovative drugs.
The high target repetition rate means that at present, the original innovation of Chinese pharmaceutical enterprises is not enough. At present, more of them still follow up the hot frontier quickly, and clinical research still focuses on the target and action mechanism to be listed, which reflects the difference of basic research ability outside China. In terms of top scientific research institutions, China has changed from 5 to 9 in 2015, but there is a big gap compared with the 52 top life science and medical research institutions in the United States.
However, it is noteworthy that innovative drug enterprises are still favored by the capital market. The subsequent market investment will be more specialized and differentiated, and the commercialization ability can be tested in the market, which is also the development opportunity of innovative drug enterprises in the future.
Policy support has promoted the development of innovative drugs. The guiding principles for clinical value oriented clinical research and development of antitumor drugs issued by the drug evaluation and approval center (CDE) of the State Food and Drug Administration pointed out that the problems of Chinese innovative drug targets, "me too" (similar innovative drugs) proliferation, low-level duplication and lack of real innovation require drug enterprises to "take patient needs as the core and clinical value as the orientation" for new drug research and development. This series of documents shows that the state attaches importance to original innovative drugs,
In addition, authorization cooperation has further promoted the development of innovative drugs. Authorization cooperation is divided into two parts: purchase license and grant license. This has also become a popular product introduction in the pharmaceutical field in recent years. In addition, pharmaceutical outsourcing service (CXO) contributes to the research and development of innovative drugs in an all-round way. It has covered all links from drug discovery to final commercial production. If the layout is controlled from the whole life cycle of the product, it will help to shorten the time of new drug research and development and reduce the cost and risk of research and development.
