R&D progress is remarkable, new industry layout is orderly, and the advantages of Sinovac Pharmaceutical are fully demonstrated

On October 28, Sinovac Pharmaceutical (stock code: 688136) released its 2022 third quarter report
.
In the first three quarters, the company achieved operating income of 944 million yuan, an increase of 5.
33% over the same period of the previous year, with the rapid expansion of overseas business in recent years, the company's overseas market sales revenue increased by 65.
84%
year-on-year.
At the same time, R&D investment continued to increase, with a year-on-year increase of 63.
46%.

Under the forward-looking strategic layout, Sinovac Pharmaceutical adheres to long-term value, achieves expected results in overseas commercialization and corporate governance, and is entering a good situation
for R&D and new industrial layout.

Insight into market demand and firmly increase investment in R&D

R&D and innovation is an important driving force for the sustainable development of
science and technology enterprises.
As a company listed on the Science and Technology Innovation Board, Sinovac Pharmaceutical understands that innovation is the inevitable way
.
However, the development of innovative drugs is a high-investment, high-risk, long-term process, but in order to achieve the long-term development of the enterprise and broaden the future upside, Sinovac Pharmaceutical's annual R&D investment has increased sharply since its listing, showing extraordinary determination
。 In 2020, its annual R&D investment was 60.
1107 million yuan, an increase of 30.
20% over 2019, and its R&D investment increased significantly to 123 million yuan in 2021, an increase of 62.
8401 million yuan compared with 2020, an increase of 104.
54%; As of the end of the third quarter reporting period this year, its R&D investment has reached 124 million, a year-on-year increase of 63.
46%.

Kexing Pharmaceutical's R&D investment has always believed that "long winds and waves will break sometimes", and it is gradually reaping results
.
Since the beginning of this year, a number of research and development have made substantial progress, and clinical applications have been approved
one after another.
Including anti-new crown small molecule drug SHEN26 capsules, pegylated recombinant human granulocyte stimulating factor injection, human interferon α2b effervescent capsules, human interferon α2b spray, etc
.

At present, the clinical trial of SHEN26 is proceeding in an orderly manner, and the administration of multiple dose groups of phase I clinical studies has been completed, showing good safety
in healthy subjects.
In terms of effectiveness, SHEN26 has carried out investigator-initiated clinical studies (efficacy and safety study of SHEN26 capsules in COVID-19 patients) in Shenzhen Third People's Hospital to further accelerate and improve the preparation
of key clinical studies 。 SHEN26 was first discovered by Professor Zhang Xumu of Southern University of Science and Technology and Professor Guo Deyin of Sun Yat-sen University, and developed by Shenzhen Kexing Pharmaceutical Co.
, Ltd.
, Shenzhen Antai Wei Biopharmaceutical Co.
, Ltd.
and Pingshan Biomedical Research Institute of Southern University of Science and Technology, which has comprehensive advantages such as broad spectrum, good oral effect, simple chemical structure and low difficulty of synthesis, which is conducive to cost control and drug popularization
.
At present, there are only a few approved new crown oral drugs in the world, and there is an urgent need for oral drugs that take into account efficacy and price, and the prospects of SHEN26 are promising
.

Released at the same time as the quarterly report, it is the latest disclosure of the good news
that the clinical application for human interferon alfa 2b spray has been approved.
The product is indicated for the treatment of primary or recurrent skin herpes simplex (oral lip sores and genital herpes) caused by viruses, increasing the concentration of drugs at the lesion site through targeted local administration, easy to use and carry, good patient compliance, and has obvious clinical advantages
.
At present, only one company of the product has been approved for listing, and Sinovac Pharmaceutical is expected to compete for the second domestic production
.

This year, the clinical application has been submitted and accepted for the "human interferon α1b inhalation solution" project, which is indicated for pediatric respiratory syncytial viral lower respiratory tract infection (pneumonia, bronchiolitis), and the dosage form is an inhalation preparation
.
At present, the number of inhaled generic drugs that have passed the consistency evaluation in China is very small, nearly eighty or ninety percent of the market mainly relies on imports, and the innovative drugs that use biologics for inhalation therapy are currently not on the market, and if Sinovac makes progress fast enough, it will take the lead in filling this market gap
.

In addition, some time ago closely disclosed for the treatment of cervicitis caused by the virus, with or without vaginitis human interferon α2b vaginal effervescent capsules, the product of this indication in the domestic only one company human interferon α2b vaginal effervescent capsules approved for marketing, Sinovac Pharmaceutical The product will rush to the second domestic one
.
The advancement of the research and development of multiple antiviral pipeline series drugs will help improve the dosage forms of the company's interferon products, reflect Sinovac's forward-looking R&D strategy, strengthen the company's competitiveness in the antiviral field, and further consolidate the leading position
of Sinovac's recombinant protein drugs in the antiviral field.

Up to now, Sinovac's main research and development areas are autoimmune diseases, degenerative diseases, vaccines, etc.
, and the technology types include new recombinant proteins, new bispecific antibodies, extracellular vesicle delivery drugs, etc
.
After vigorous investment in recent years, Sinovac's R&D pipeline innovation and advanced have been significantly improved
.

The industrial layout is forward-looking and far-sighted

In 2022, while adhering to the platform development model of "innovation + internationalization", Sinovac Pharmaceutical will focus on long-term value mining and actively seek breakthroughs
in the field of cutting-edge biotechnology.
In terms of cultivating new industries, Sinovac strategically lays out the genetic engineering vector vaccine pipeline around the overall idea of zoonotic prevention and control, and in March 2022, Sinovac Pharmaceutical funded the establishment of Shenzhen Sinovac Animal Protection Biotechnology Co.
, Ltd.
to cultivate and incubate a new animal vaccine industry
.

Research shows that although the scale of China's veterinary biological products industry continues to expand, there are still problems of
low industry concentration and weak scale effect.
According to the operating data of several leading listed companies in animal protection, the total market share of six listed companies such as Bio Shares, Zhongmu Co.
, Ltd.
and Rip Biotechnology is less than 40%, and the concentration of veterinary biological products industry is relatively scattered
.
With the recent years in China, higher requirements have been put forward in the supervision of veterinary drugs, the healthy development of breeding and animal husbandry, which may promote the rapid improvement
of industry standards and technology.
In terms of animal supplies, vaccines mainly improve the body's immunity to viruses through vaccination injection, which has the effect of reducing drug residue compared with drug treatment, which is an important part
of animal protection work.
At the same time, in the direction of pets, due to the gap in technical level, the current domestic pet vaccine consumption is dominated by imported brands, and more than 90% of the domestic pet vaccine market is controlled
by many international manufacturers.
This leaves a huge opportunity for domestic substitution for domestic companies, and in terms of research and development, domestic companies have not yet had truly breakthrough products on the market
.
Therefore, whether it is poultry or pets, the animal protection market has considerable
prospects.
According to the statistics and forecast of QYR, the global veterinary vaccine market sales reached $8.
3 billion in 2021 and are expected to reach $12.
6 billion in 2028, with a compound annual growth rate of 6.
1% (2022-2028).

According to the disclosed information, at present, Sinovac Animal Protection has completed the establishment of 17 R&D pipelines and the construction of carriers in the direction of pet vaccines and economic animal
vaccines.
Vector vaccines can quickly obtain vaccine candidate strains against circulating strains, greatly shortening the vaccine research and development time, and is of great
significance for the prevention and control of infectious diseases.
Moreover, vector vaccines can exist in vivo for a long time and stably express antigen proteins, induce long-lasting immune responses, and have obvious
technical advantages.

Product registration has accelerated the process of going to sea in an all-round way

In recent years, the overseas market demand for high-quality biopharmaceuticals has strengthened, and Sinovac Pharmaceutical has actively established strategic cooperation
with domestic and foreign biotechnology companies by relying on more than 20 years of commercialization experience, global three-dimensional marketing network and channel resources, and rapid overseas registration capabilities.
In the past two years since its listing, Sinovac Pharmaceutical has continued to make efforts to commercialize overseas through product introduction, and has now passed the access and sales of nearly 40 overseas countries, holding a total of more than 60 drug access certificates from overseas countries and
regions.
The company's overseas market sales revenue increased by 65.
84%
year-on-year.

According to the announcement, the infliximab for injection introduced by the company has submitted registration documents in 17 countries such as Singapore, Brazil, Indonesia, and Saudi Arabia, compared with the semi-annual report, 4 new countries have submitted registration; The bevacizumab drug introduced by the company has been registered in 14 countries including the Philippines, Singapore, Indonesia, and Saudi Arabia, and compared with the semi-annual report, 3 new countries have submitted registration; Another major product, albumin paclitaxel project, has obtained the "Notice of Acceptance"
of drug marketing application from the National Medical Products Administration and the European Medicines Agency.
Paclitaxel is one of the most commonly used oncology chemotherapy drugs in clinical practice, and albumin paclitaxel is a new special targeted preparation of paclitaxel, which has the unique advantages
of stronger anti-tumor effect, lower hematotoxicity and severe allergic reactions, and no pretreatment before use than traditional paclitaxel preparations.
At present, the company is fully promoting the construction of production lines, quality system certification, customer development and other work
as expected.

It is reported that in the third quarter of this year, Sinovac Pharmaceutical also introduced a blockbuster product - Hisun Biologics' adalimumab injection
.
It is understood that adalimumab injection is the world's first fully human anti-tumor necrosis factor ɑ (TNF-ɑ) monoclonal antibody approved for marketing, first developed by the American pharmaceutical company giant AbbVie, and Hisun Biologics adalimumab injection (trade name: Anjianning) also performs well in the domestic market, according to Hisun Biologics announcement, Anjianning was approved for marketing at the end of 2019, the second adalimumab biosimilar approved for marketing in China, the indications are ankylosing spondylitis, Rheumatoid arthritis and plaque psoriasis
.
According to statistics from Intranet, in 2021, the third year of Anjianning's listing, it will achieve sales of more than 200 million, and its market share in similar products is second only to the original drug, with excellent
results.
At present, Sinovac Pharmaceutical and Hisun Biopharmaceutical Co.
, Ltd.
have signed the "Adalimumab Overseas Market Exclusive License Cooperation Agreement", and the first batch of signing cooperation areas includes Saudi Arabia, Malaysia, South Africa, Egypt and other 7 countries
.

It is worth mentioning that in South America, Southeast Asia, Africa and other regions that are generally ignored by leading pharmaceutical companies, Sinovac Pharmaceutical has become a "lone brave in emerging market development", and its sales channels have been fully covered in emerging markets with a population of more than 100 million or the top 30 GDP, and Sinovac's erythropoietin products have also ranked in the forefront
of domestic export sales of similar products for more than ten consecutive years.