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    Home > Active Ingredient News > Drugs Articles > Haohai biology may become the first pharmaceutical manufacturing enterprise listed on the science and Technology Innovation Board

    Haohai biology may become the first pharmaceutical manufacturing enterprise listed on the science and Technology Innovation Board

    • Last Update: 2019-07-17
    • Source: Internet
    • Author: User
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    Even in the case of early policy support and favorable market, it is still not easy for Biopharmaceutical Enterprises to break through the scientific and technological innovation board On July 15, the Municipal Committee of science and Technology Innovation Board approved the application for IPO of Shanghai Haohai Biotechnology Co., Ltd (hereinafter referred to as "Haohai biotechnology") at the 15th review meeting This is the fourth biopharmaceutical enterprise after Xinmai medicine, Nanjing minimally invasive medicine and microchip biology According to the classification of science and technology innovation board, Xinmai medical and Nanjing minimally invasive medical are professional equipment manufacturing In addition, there has been no movement for the micro core biology that will submit the registration application earlier Haohai biology is likely to become the first pharmaceutical manufacturing enterprise listed on science and technology innovation board At present, in the whole category of medicine, Nanwei medical and Xinmai medical, which are mainly medical devices, are listed the fastest The two stocks have been opened for purchase on July 9, and the issue price has been determined one after another The results of offline preliminary placement and online winning have also been published It only took three months for Xinmai medical and Nanwei medical to go on sale But other biomedical companies are in a slightly awkward situation As of the Haohai biological cross conference, the science and technology innovation board has accepted the listing applications of 32 biomedical related enterprises Most of them are still in the "inquired" stage Previously, as one of the six sectors encouraged by the science and technology innovation board, the industry generally believed that the science and Technology Innovation Board would have a positive impact on the biomedical industry, especially the introduction of the fifth set of standards, which is regarded as the standard tailored by unprofitable biotechnology enterprises "Science and technology innovation board brings new opportunities for biomedical enterprises", "science and technology innovation board accepts several more enterprises, and biomedical industry is favored".. But after the market is optimistic, the momentum of biomedical companies in science and technology innovation board is gradually flat 01 Haohai biology went through three twists and turns from April 18, when its listing application was accepted, to yesterday's meeting, Haohai biology spent nearly three months and experienced three rounds of inquiries According to the prospectus of Haohai biology, the main business of Haohai biology is to apply biomedical material technology and genetic engineering technology to research, develop, produce and sell medical devices and drugs The main products are divided into four parts: Ophthalmology, plastic and cosmetic surgery and wound care, orthopedics, anti adhesion and hemostasis, including drugs and medical devices In 2016, 2017 and 2018, Haohai biology achieved operating revenue of 861 million yuan, 1.354 billion yuan and 1.558 billion yuan respectively, with year-on-year growth of 57.27% and 15.06% respectively in 2017 and 2018; net profit of 311 million yuan, 400 million yuan and 455 million yuan respectively, with year-on-year growth of 28.78% and 13.77% respectively in 2017 and 2018 Haohai biological's performance growth in recent two years is inseparable from the continuous acquisition of the IOL industry chain enterprises After listing in Hong Kong stock market in 2015, Haohai biology was once known as "the first share of hyaluronic acid" Since then, a series of acquisitions have been carried out continuously for two years In October 2016, Haohai biology spent 30.582 million yuan to complete the acquisition of 100% equity of Henan cosmos; in December 2016, it spent 70 million yuan to acquire 100% equity of Zhuhai egger; in November 2016, it spent 360 million yuan to acquire 60% equity of Shenzhen new industry, the exclusive distributor of lenstec intraocular lens products; in May 2017, it spent 216 million yuan to acquire con, the world's largest independent optometry material manufacturer Tamac The continuous acquisition has made Haohai biology occupy 30% of the market share of intraocular lens in China in 2017, and intraocular lens has also become the main product of the company, contributing about 27% of the revenue Haohai biology has been looking for A-share listing opportunities before rushing to the science and technology innovation board, but it has not been successful in the past two times If the final Technology Innovation Board of Haohai biology is listed successfully, Haohai biology will reach the "a + H" share listing However, if Haohai bio wants to be listed successfully, it needs to solve the specific arrangements for the supplementary disclosure of relevant investment funds and income return, as well as the sources of repayment funds and potential risks in the review opinion of the Municipal Committee After all, the meeting doesn't mean "there is no risk" The micro core creatures that passed the meeting on June 5 are still in the "submit registration" status 02 according to the official website of the "stuck" micro core biology exchange, micro core biology was the first to pass the audit meeting of the Municipal Committee of science and technology innovation board on June 5, and submitted an application for registration on June 11 At that time, the industry generally believed that the micro core was expected to hit the "first share of bio medicine in science and Technology Innovation Board" On July 1, the first batch of scientific and technological innovation board officially listed enterprises list was announced, and the hot micro core biology was not in the first batch of list With the list of "release" issued by CSRC, there is still no trace of micro core organisms According to the provisions of the science and technology innovation board, the CSRC shall, within 20 working days, make a decision on whether or not to approve the registration of the issuer's registration application That is to say, the first batch of micro core organisms that should have been approved before July 8 is now hopeless From "the first share of science and technology innovation board biomedicine" to "the first share under the registration system", the market guesswork wind direction is almost a 180 degree turn After the halo faded, it revealed many problems that may be a stumbling block for its listing First of all, as a new drug R & D enterprise, the high cost of sales of microchip biology has become one of the reasons that have been questioned recently From 2016 to 2018, the R & D cost of micro core biology was 29.017 million yuan, 35.2158 million yuan and 42.1012 million yuan respectively Sales expenses accounted for 28.59%, 28.94% and 34.62% of operating revenue respectively At the same time, the proportion of R & D expenses in operating revenue is declining From 2016 to 2018, the R & D expenses of micro core biology accounted for 33.99%, 31.87% and 28.51% of the operating revenue respectively, showing a downward trend year by year The year-on-year growth rate of sales expenses of micro core biology in 2018 was 59.84%, far higher than the 19.55% growth rate of R & D expenses However, according to the public data, the R & D investment of micro core biology accounted for 55.85% of the operating revenue in 2018, which also led to the capitalization and expense of the R & D investment of micro core biology In the reply to the second round of inquiry letter, the first question asked by Shanghai Stock Exchange is "capitalization and expensization of R & D expenditure", which involves 12 different small issues, such as the cumulative R & D investment of micro core bio listed drugs and products of R & D pipeline At that time, in the reply letter, microchip Bio said that "the capitalization and expensization of the company's R & D expenditure comply with the accounting standards and regulations, and there is no case that the expenditure that should be included in the management expense and sales expense is included in the R & D expense or development expense, or the expenditure that should be included in the R & D expense is included in the development expense." Under the premise of meeting the accounting standards, Shanghai Stock Exchange will release the micro core organisms smoothly Secondly, as the company's main source of profit, the "weight" of sidaban is increasing year by year Especially after entering the medical insurance catalogue in 2017, the sales volume of this variety increased by 66% In 2016, 2017 and 2018, the total sales revenue and overseas patent licensing revenue of xidaban was about 85.2996 million yuan, 111 million yuan and 147 million yuan In 2018, xidaban has accounted for more than 92% of the revenue share of micro core organisms However, cidabamide's first indication, "recurrent or refractory peripheral T-cell lymphocarcinoma", is one of the rare diseases, with a relatively small number of patients, which means that the market size is also limited At the same time, its announcement also shows that the capacity utilization rate of sidaban has also dropped to 27.24% from 35.30% last year Single product accounts for a high proportion, which will lead to the low financial anti risk ability of enterprises Therefore, micro core biology is also constantly enriching its product lines to reduce risks According to the prospectus, at present, there are 14 research projects in the reserve of microcellular organisms, among which 8 candidate drugs involved are new molecular entities with novel mechanism, and all of them are self-developed From the perspective of R & D pipeline, microcellular organisms have established product lines at different stages in three major treatment fields of tumor, metabolic disease and immune disease In addition to the marketed sidabamide, there is also a class I new drug, ciglitazone sodium, which has completed the phase III clinical trial, and a class I new drug, cioloni, which has carried out a number of phase II clinical trials for indications 03 why do you call it a good call? As one of the six industries encouraged by science and technology innovation board, biomedical enterprises are undoubtedly the main force of application since science and technology innovation board began to accept listing applications in late March this year On March 8, Fudan Zhangjiang announced that it planned to apply for the issuance of shares on the science and technology innovation board, which opened the prelude for domestic biomedical enterprises to rush to the science and technology innovation board According to the data on the official website of science and technology innovation board, as of July 15, science and technology innovation board has accepted 32 listing applications of enterprises in biomedical related fields, accounting for nearly 22% of the total number of 148 enterprises accepted by science and technology innovation board, most of which selected the first set of standards The fifth set of standards of science and technology innovation board has always been considered as the standard tailored for unprofitable Biotechnology Enterprises: the estimated market value is not less than 4 billion yuan, the main business or products need to be approved by the relevant departments of the state, the market space is large, and the phased results have been achieved Pharmaceutical enterprises need to have at least one core product approved to carry out phase II clinical trials, and other enterprises that meet the positioning of scientific and technological innovation board need to have obvious technical advantages and meet the corresponding conditions Compared with the previous Hong Kong stock exchange standard of "HK $1.5 billion + phase II clinical" for unprofitable Biopharmaceutical Enterprises, this does not seem to be easier The fifth set of standards is also considered as the "most difficult" standard in the industry At present, there are only two enterprises that choose the fifth set of standards, namely Zejing pharmaceutical and baiaotai The two enterprises have one common feature: during the reporting period, the company has no products on the market and has lost money for years At present, baiaotai has the third phase clinical application of avazumab and bevacizumab, while danafinil, a deuterium substitute of Zejing pharmaceutical, has also entered the third phase clinical application Although the two companies have their own advantages in each major product, it is still unclear whether the meeting will go smoothly due to the difficulty of new drug research and development, high failure rate, and no sales revenue as support at present From the perspective of two listed pharmaceutical enterprises, cardiac pulse medicine is a subsidiary of domestic cardiac stent leading minimally invasive medicine, which is divided into scientific and technological innovation board, occupying the second largest share in the domestic market of aortic vascular interventional medical devices; while Nanwei medicine is an old minimally invasive medical device enterprise established nearly 20 years ago, which develops endoscopic optical coherence tomography system (eoct )It has been approved by the FDA of the United States and has entered the special approval channel for innovative medical devices of the State Food and drug administration Compared with the real pharmaceutical companies applying for listing on the science and technology innovation board, the risks of the two medical device companies in terms of profitability are relatively smaller A common feature of Biopharmaceutical Enterprises that pay attention to "original" is high R & D expenditure, but there is great uncertainty about whether they can get corresponding income Even if the R & D is successful, we still have to face a series of problems, such as the limitation of drug patent period, market development, expansion of indications, etc., so perhaps the uncertainty of the profits of bio pharmaceutical enterprises will become the focus of the CSRC Therefore, even in the case of early policy support and favorable market, it is not so easy for Biopharmaceutical Enterprises to break through the scientific and technological innovation board.
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