Exclusive injections soar 400% biopharmaceity! Lizhu earns 1 billion yuan in half a year

September 10, Lizhu Group announced that the company after 5 years of research and development of injection acetate octreotide micro-ball was approved clinically, the product is a long-lasting slow release preparation, currently only import approval, the company invested a cumulative research and development costs of about 26.96 million yuan.
In the first half of 2020, Lizhu Group's exclusive product injection with acetate bright propylene rhapsody micro-ball achieved revenue of 536 million yuan, an increase of 17.26%, the company's micro-ball platform in the research of new products with acetate querin micro-ball, injection with acetaminophen micro-ball is expected to be listed after 2022, as a new boost to performance.
the first half of this year, the outbreak affected the global economy, Lizhu Group has handed over operating income, net profit double-up report card, which bursts against the trend, the second half of what will be launched? Half-year net profit broke 1 billion, exclusive injections soared 4 times data show that in the first half of 2020 A-share market pharmaceutical manufacturing 258 listed companies, net profit of more than 1 billion yuan only 14, Lizhu Group successfully squeezed into the operating income, net profit double growth of the list of eight pharmaceutical companies.
company's first-half operating income was RMB5,095 million, up 3.16% YoY, and net profit was RMB1.005 billion, up 35.97% YoY.
figure 1:2020H1 sales of hundreds of millions of preparation products (units: 100 million yuan) Source: The company announced that the company's performance growth is mainly contributed by the exclusive product Aprassin, of which intestinal tablet revenue of 409 million yuan, down 10.45 percent year-on-year, but injection of eprasium sodium through the second half of last year's health care negotiations into the national health insurance catalog, began to achieve rapid growth, revenue reached 255 million yuan, an increase of 437 million yuan 85%; Injection acetate bright propylene rhyme micro-ball revenue of 536 million yuan, bucking the trend to achieve 17.26% growth; antiviral particles affected by the increased demand for treatment of the new crown epidemic, achieved revenue of 302 million yuan, up 78.24% YoY;
Chinese medicine injection large varieties of ginseng positive injection is the exclusive product of Lizhu Group, was also the company's Fengyun products, affected by the policy, sales have declined significantly in recent years, sales in 2018 in the region of about 1 billion yuan, 2019 fell to 800 million yuan, the first half of 2020 only 269 million yuan.
The outbreak led to a surge in reagents, the subsidiary to independently listed Lizhu Group in the first half of 2020 to obtain revenue, net profit double harvest results, in addition to the rapid growth of fist product sales, diagnostic reagents and equipment sector results are also very dazzling.
In mid-March 2020, the new coronavirus (2019-nCoV) IgM/IgG anti-check-checking kit (collide gold method) of the subsidiary Lizhu Reagent was approved for listing in China, and subsequently obtained EU CE certification, with EU market access conditions, and applied for import registration in several countries.
With the large-scale outbreak of overseas outbreaks, the export market demand for new crown inspection reagent products increased significantly, providing important support for the group's overall performance growth, the first half of the diagnostic reagents and equipment sector achieved sales revenue of 889 million yuan, up 143.35 percent year-on-year, accounting for the proportion of the Group's total revenue rose to 17.45 percent, and due to higher export unit prices, gross margin increased to 76.48 percent overall.
figure 2: Lizhu Group diagnostic reagents and equipment sector revenue situation (unit: 100 million yuan) Source: The company's annual report with the smooth export of new crown reagent products brought dividends, subsidiary Lizhu reagents also set up an overseas sales division, for the future other reagent products to expand overseas markets to lay the foundation.
as of June 30, 2020, a total of 15 products have completed the registration of EU CE.
in reagent research and development, in the first half of 2020, the reagent box (chemical luminescence method), HBV nucleic acid testing reagent, HCV nucleic acid testing reagent (one-step method), 60-speed single-person chemistry Light-emitting analyzer, myocarditis 5 project self-anti-medical test kit (magnetic bar code immunofluorescence method), vasculitis 3 auto-anti-medical test kit (magnetic bar code immunofluorescence method), anti-nuclear anti-medical test kit (magnetic bar code immunofluorescence method) (ANA-17) have been registered.
On August 10, 2020, Lizhu Group announced plans to spin off Lizhu Reagent to list on A-share, after the spin-off, the company's equity structure will not change, Lizhu Group still holds 39.43 percent of Lizhu Reagent, will maintain control of Lizhu Reagent.
This spin-off will help Lizhu reagents broaden their financing channels, further build brand influence in the field of IVD (in-body diagnostics), enhance operational efficiency and profitability, and help the Group to further focus on its main focus and actively carry out innovative pharmaceutical and high-barrier generics research and development.
In recent years, with the improvement of medical security input and consumption level, China's in-body diagnostic reagent industry has entered a long-term, data show that in 2018 China's in-body diagnostic reagent market size reached 60.4 billion yuan, 2020 driven by the new crown epidemic, the performance of the relevant listed pharmaceutical companies have been "complementary", the annual market size is expected to reach a new high.
we will see how high the market value of Lizhu's reagents will eventually be when they are launched.
Biopharmaceuser into the harvest period: 2 new drugs of class 1 were approved clinically, 1 "first in China" will soon be listed Lizhu Group's total research and development expenditure in the first half of the year about 350 million yuan, an increase of 1.63% YoY, accounting for 6.87% of total revenue, maintaining a relatively stable intensity of research and development investment.
In the first half of this year, mixed sugar electrolyte injections were approved for sale, and Mienet data show that the total terminal market size of the product in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) in 2019 exceeded 600 million / Kramycin tablets) one of the important components of nitrosin tablets through consistent evaluation, two micro-ball products approved clinical, are the first to declare, wherein the injection of alecophenic micro-ball in phase I clinical research stage, two therapeutic biological products 1 new drugs approved clinical, the same anti-tumor and immunomodulation agents, is preparing to start Phase I clinical.
Table 1: 2020 to date Lizhu approved the situation of heavy products Source: Mininet MED2.0 China Drug Review Database In recent years, Lizhu Group in the key layout of micro-ball platform, August 26, 2020 the company announced that it intends to There is funds to Lizhu micro-ball company to increase capital of 209 million yuan, Lizhu Pharmaceutical Factory with its own micro-ball preparation-related productive assets to Lizhu micro-ball capital increase of 139 million yuan, to Lizhu micro-ball as the company's micro-ball-related products as the main research and development and production platform. Form
2:2019 so far Lizhu in the review of the listing application and consistent evaluation of supplementary application sources: Minet MED2.0 China Drug Review Database currently only Merck Sherano's recombinant human velvet injection was approved for import, domestic pharmaceutical companies, Lizhu Group for the first declaration of injection recombinant human velvet styrofosis listed, and in the review and approval.
The original product is intended for women who undergo ultra-ovulation prior to receiving assisted reproductive technology such as in vitro fertilization (IVF), and injection of the product triggers eventual follicle maturation and yellowing after stimulating follicle growth;
Lizhu Group in the semi-annual report mentioned that the injection of recombined human velvet promoter in early June 2020 passed the drug registration and production site verification, registration inspection is in progress, in addition, the product's overseas sales preparations have been opened, in the registration preparations, but also in South Korea, Russia, Egypt, South Africa, the United States and other regions to carry out preliminary business negotiations.
generics, the three products under review from 2019 to date are expected to achieve new breakthroughs in the injection of sodium dancerin, injection with acetate citric acid, and acetylcysteine inhalation solution.
injection of danqulin sodium as a rare disease drug used to treat malignant high fever, Lizhu Group in 2015 according to the (original) chemical category 3.3 declared clinical and approved in 2017, in February 2019 declared class 3 imitation listing, in April of the same year was successfully included in the priority review process, at present only Lizhu Group declared listing, take the first imitation is a large probability event.
injection with acetate West Currick original research enterprises for Merca East, the current domestic has been approved by Shenzhen Hanyu Pharmaceuticals, but no enterprise evaluation, currently according to the new classification of the listing of only Lizhu Group, if successfully approved to become the first enterprise to be evaluated.
sales of acetate in China's public medical institutions in 2019 are close to 250 million yuan.
acetyl cysteine inhaler no enterprise evaluation, currently according to the new classification of declared listing and review of enterprises in addition to Lizhu Group also Kangyuan Pharmaceuticals, Wu Traditional Chinese Medicine Group and other 5, the first evaluation of the final cost of who home? In 2019, acetylcysteine inhalers will have terminal sales of more than 800 million yuan in public medical institutions in China.
conclusion 2020, Lizhu Group will promote the development of the Eprasium portfolio in medical institutions for hospitals above level II, continue to expand the sales scale of Eprasin, and make every effort to ensure the smooth approval of recombined human velvet for injection, as well as a comprehensive Plan the market layout of the product after the market, diagnostic reagents and equipment, and strive to complete the market layout of blood irradiators, self-exempt multiple instruments, 60-speed luminescence instruments, nucleic acid equipment and supporting reagents as planned, laying the foundation for sales growth in 2021.
: Company's annual report, MiNet database review data statistics as of September 15, 2020, if there are errors, please point out.
original title: exclusive injections soared 400%, biological medicine harvest! Lizhu made 1 billion in half a year, 2020 impact this first imitation