Livzon innovative drugs sold over 5 billion!

Medical Network News, September 2 At the end of August, Livzon announced the first half of this year's results.
Revenue was 6.
236 billion yuan, an increase of 22.
38% year-on-year.
Net profit was 1.
062 billion yuan, an increase of 5.
75% year-on-year.
Highly concerned, the company's annual net profit is predicted to be in the range of 1.
970 billion to 2.
043 billion yuan, an increase of 14.
87% to 19.
13%
.
Under the normalization of epidemic prevention and control, the domestic and global demand for new crown vaccines continues to rise.
Livzon has established a project to develop a recombinant new coronavirus fusion protein vaccine (V-01) in 2020 and recently submitted a phase III clinical application to the Philippines FDA for approval At present, the footprint has covered more than 10 countries in the world, and this product is expected to become the company's new breakthrough in the field of biological medicine
.

　Innovative drugs have been sold over 5 billion in 14 years.
This microsphere has become a TOP1 brand.
In the
first half of 2021, Livzon’s chemical preparation products achieved sales revenue of 3.
731 billion yuan, an increase of 61.
12% year-on-year, accounting for 60.
23%
.
Among them, the innovative drug ilaprazole series products and leuprolide acetate microspheres for injection of high-barrier complex preparations continue to grow rapidly.
The total sales revenue accounts for 62.
97% of the sales revenue of chemical preparations, which have become the two core driving forces of the company's performance
.

　　Figure 1: Sales of ilaprazole series products (unit: 100 million yuan) Source: company annual report Livzon’s 1.
1 new drug ilaprazole enteric-coated tablets were approved for marketing in early 2007 and entered the national medical insurance catalog in 2017.
At the end of the same year, the company's Class 2 new drug, ilaprazole sodium for injection, was approved to be listed, and it became a product of the National Medical Insurance Negotiation Catalogue in 2019
.
According to the company's annual report data, after several years of polishing and accumulation after being approved for listing, the sales of ilaprazole enteric-coated tablets successfully exceeded 100 million yuan in 2014, and it has grown into a new growth point for the company's performance; in 2018, the injection formulation was officially launched.
Enter the market and promote the rapid expansion of sales of the entire variety.
In 2020, it will exceed the 1 billion yuan mark, and the growth rate in the first half of 2021 will be as high as 130%
.
Judging from the sales data published in 2014-2021H1, the current cumulative sales revenue of ilaprazole series products has exceeded 5.
8 billion yuan.
If the unannounced data in previous years are added, the cumulative sales revenue of this product is expected to be 6 billion yuan.
Yuan level
.
According to data from Menet.
com, in 2020, the total sales volume of the six top-selling PPI preparations in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) exceeds 30 billion yuan, which is superimposed on the epidemic Affected by the price reduction of centralized procurement, omeprazole, rabeprazole, pantoprazole, esomeprazole, and lansoprazole all declined to varying degrees, while ilaprazole increased against the trend 78.
5%
.
With the continuous drive of medical insurance, the market penetration rate of ilaprazole has much room for improvement
.
Figure 2: Livzon’s sales of leuprolide acetate microspheres for injection (unit: 100 million yuan) Source: company’s annual report The original research company of leuprolide microspheres was Takeda Pharmaceutical, Japan, and the global sales peak of this product appeared in 2015 It amounts to 124.
4 billion yen
.
The original research product entered the Chinese market in 2000.
In 2009, Beijing Boent Pharmaceutical's leuprolide acetate sustained-release microspheres for injection and Shanghai Livzon Pharmaceutical's leuprolide acetate microspheres for injection were approved for marketing, breaking The pattern of original research products dominating the domestic market exclusively
.
After leuprorelin microspheres entered the medical insurance catalogue in 2009, the advantages of domestic brands gradually became apparent.
In the terminal of public medical institutions in China, Takeda Pharmaceuticals controlled the overall market situation before 2016.
Since 2017, domestic brands broke through the shackles and began to lead the market.
Livzon won the championship of Leuprolide Microsphere in 2019 and gradually expanded its leading advantage
.
Livzon’s leuprorelin microspheres are high-barrier preparations.
As a domestic brand, they have been deeply cultivated in the market for many years and have won the trust of doctors and patients.
The follow-up growth momentum of Ruilin Microspheres is also worth looking forward to
.
Livzon spares no effort in the deep polishing of the two core varieties.
At present, the phase III clinical trial of ilaprazole sodium for injection to prevent stress ulcer bleeding in critically ill patients is underway.
In the future, it is expected to be stimulated by new indications.
Further increase the overall sales revenue; and leuprolide acetate microspheres for injection (3-month sustained release) have also completed phase I clinical trials, and completed the phase III clinical genetics office filing
.

　R&D investment has increased by another 50%, and this new microsphere is expected to become the first domestic product
　　 .
Figure 3: Livzon R&D investment (unit: 100 million yuan) Source: Company annual report Livzon has continued to increase R&D investment in recent years.
The total R&D related expenditure was approximately RMB 545 million (close to the full-year expenditure in 2017), an increase of 55.
87% year-on-year, and accounting for 8.
74% of the company's total revenue (6.
87% in the same period last year)
.
Benefiting from large-scale R&D investment, Livzon has also realized the accelerated transformation of innovation achievements
.
Due to the high barriers to the development and industrialization of microspheres, there are only a few domestic pharmaceutical companies focusing on the development of microsphere preparations.
Livzon has gained a good market share with the marketed leuprolide acetate microspheres for injection.
The reputation of many microsphere preparations under development is also industry-leading
.

　　Table 1: The latest status of microsphere preparations declared by Livzon Source: Mynet database, the company's semi-annual report Judging from the current clinical progress, triptorelin acetate microspheres for injection are expected to become the company's next new microsphere product approved
.
This product is a gonadotropin releasing hormone agonist injected intramuscularly once a month.
The indications are metastatic prostate cancer, endometriosis (stage I to IV), womenPretreatment of infertility, preoperative uterine fibroids, and precocious puberty, compared with ordinary triptorelin acetate injection, it has the characteristics of longer onset time and reduced frequency of medication, which can reduce patient pain and medication burden, and improve medication tolerance And accessibility.
At present, there is no imported or domestic preparation of triptorelin acetate microspheres for injection in the domestic market.
Livzon is expected to become the first in China, and the sales scale of triptorelin in China’s public medical institutions in 2020 Up to 1.
4 billion yuan
.
Livzon mentioned in the semi-annual report that the future research and development of the company's microsphere platform will focus on the three major areas of anti-tumor, anti-psychotic, and endocrine regulation, combining imitation and innovation
.
While increasing the consistency research and improved research and development of imitation products, strengthen the development of other long-acting preparations such as in-situ gel technology and macromolecular modification
.
At present, the company's microsphere platform reserves the research varieties including long-acting ophthalmic drugs, long-acting macromolecular drugs, embolization radiation microsphere tumor drugs, etc.
, achieving a relatively complete short, medium and long-term R&D pipeline layout
.
The biopharmaceutical field that Livzon has invested heavily in the past few years has also been reported frequently.
Recombinant human chorionic gonadotropin for injection was approved for marketing in April 2021.
It is expected to start contributing revenue in the second half of the year.
Earlier, Merck Snow was the only market in the market.
Lannuo's recombinant human chorionic gonadotropin injection was approved for import
.

　　Table 2: The latest progress of Livzon's key biological drugs.
Source: Mynet database, the company's semi-annual report.
Recombinant humanized anti-human IL-6R monoclonal antibody injection is in the process of listing and is expected to hit the first domestic product.
This product is Tozhu For monoclonal antibody biosimilars, only Roche's original research products have been approved for import in China
.
The global sales of the original research products in 2020 will be close to 2.
9 billion Swiss francs, and the total sales in the terminals of Chinese public medical institutions and physical pharmacies in Chinese cities have exceeded 270 million yuan, a year-on-year increase of 100%.
The market potential cannot be underestimated.

.
Under the normalization of epidemic prevention and control, the domestic and global demand for new crown vaccines continues to rise.
The latest development of the recombinant new coronavirus fusion protein vaccine (V-01) that Livzon established in 2020 has also attracted market attention, and the products are domestically available.
The ongoing phase I/II clinical trials performed well, with excellent safety and immunogenicity.
At present, the company is preparing to start a global multi-center phase III clinical study, and the vaccine commercialization workshop has been completed and put into use
.
On August 27, the company announced that the vaccine submitted to the Philippine FDA for Phase III clinical application was approved, and the first subject was enrolled on August 25
.
At present, more than 10 countries have submitted applications for phase III clinical trials, and Livzon has directly invested more than 146 million yuan in research and development expenses in this project
.
Livzon mentioned in the semi-annual report that the company's biological drug R&D pipeline involves new antibodies, multispecific antibodies, and recombinant protein drugs in the fields of tumors, reproduction, and immune diseases.
At the same time, it is also constantly advancing the ADC technology platform and new CAR- T technology and other platforms are built, and with domestic macromolecular biopharmaceutical research and development companies, first-class scientists at home and abroad, and the Institute of Biophysics of the Chinese Academy of Sciences, many products under development are accelerating the speed of clinical advancement
.

　　Do not abandon, do not give up! "Strengthening internally and externally" in the traditional Chinese medicine sector
, the exclusive Chinese medicine Shenqi Fuzheng injection, which was once the mainstay of the company's performance, has experienced ups and downs in recent years, affecting the company's performance in the traditional Chinese medicine preparation sector.
However, in 2020, under the stimulus of the epidemic, Livzon Another exclusive variety of antiviral particles bucked the trend and soared, which once again aroused the attention of the company's traditional Chinese medicine preparations sector
.
In the first half of 2021, Livzon's traditional Chinese medicine preparation products achieved sales revenue of 610 million yuan, a year-on-year decrease of 4.
52%, and the proportion of the company's total revenue fell to 9.
85%
.
Among them, the sales revenue of Shenqi Fuzheng injection was 299 million yuan, a year-on-year increase of 11.
27%, and the sales revenue of antiviral particles was 228 million yuan, a year-on-year decrease of 24.
57%.

.
Livzon said that the company has supplemented the clinical evidence-based medicine research evidence of Shenqi Fuzheng injection, focused on the field of tumor treatment, strengthened academic promotion, and expanded coverage of county-level medical institutions; the online brand spread of antiviral particles continued to increase, focusing High-traffic media, online communication and interaction, and chain pharmacy empowerment have achieved good promotion effects
.
In recent years, the company has made every effort to deploy high-barrier preparations and biological medicine sectors, leaving not many resources for the Chinese medicine sector.
At present, it is obviously not enough to rely on the performance of listed products.
Livzon also mentioned the company's research and development of Chinese medicine products in the semi-annual report.
New ideas: focus on promoting the research and development of new products such as ancient classic Chinese medicine compound new medicine, Musk Shuhuoling gel (improved new medicine), XFDX granules (new Chinese medicine compound medicine derived from clinical experience), as well as the technology of marketed varieties Research work such as change filing and technological advancement
.
According to data from Meinnet.
com, Musk Shuhuoling is an exclusive product of its subsidiary Sichuan Everbright Pharmaceutical.
In 2020, it will be ranked TOP3 in the brand list of Chinese public medical institutions for traumatic injury solution and in Chinese urban physical pharmacies.
The brand of agent is ranked in TOP6, and the potential of the improved dosage form of this product can be expected
.
In terms of external resources, what has attracted the attention of the market is that Livzon used its own funds of 724 million yuan to acquire a 40.
00% stake in Tianjin Tongrentang held by Tianjin Tasly Health Industry Investment Partnership (Limited Partnership) in March this year
.
Livzon said that, on the one hand, Tianjin Tongrentang is mainly engaged in the research and development, production and sales of Chinese patent medicines, and the company can cooperate with it in the development of Chinese medicine business; on the other hand, Tianjin Tongrentang has stable business performance, unique products and good development.
Potential, and preparations for listing, Livzon can also achieve corresponding investment income through its cash dividends or initial public offerings
.

　　Concluding Remarks
Livzon, which started from Chinese medicine, has completed its transformation.
Currently, it has its own characteristic products in innovative drugs and high-end preparations.
The field of biological medicine will also usher in many blockbuster new products.
In addition, chemical raw materials and in vitro diagnostic reagents The rapid development of the company also makes the company’s performance "rising step by step"
.
At present, most brokerages have rated it as Overweight or Buy, and the capital market still has high expectations for it
.
Source: the company's semi-annual report, announcements, and data from Meinenet.
Note: The terminal competition pattern database of physical pharmacies in China's cities covers 293 prefectures and cities across the country (excluding physical pharmacies in counties and villages), and continuously monitors the entire category.
Edition city entity pharmacy database
.
The above sales are calculated based on the average retail price of the product at the terminal
.