Sinovac Pharmaceutical joins hands with Tonghua Dongbao to add new products to overseas commercialization

On December 6, Sinovac Biopharmaceutical Co.
, Ltd.
(hereinafter referred to as "Sinovac") and Tonghua Dongbao Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Tonghua Dongbao") signed the "Liraglutide Overseas Market Exclusive License Cooperation Agreement", Sinovac Pharmaceutical will obtain the exclusive commercialization license rights
of liraglutide in 17 countries in emerging markets.

The cooperation between Sinovac and Tonghua Dongbao is an important step
for the two companies to focus on high-quality biological drugs, give full play to their respective experience advantages, and achieve global commercialization of domestic diabetes products liraglutide.
At the same time, Sinovac Pharmaceutical also took this opportunity to further enrich its product line and expand the hot track
of endocrine diseases.

In the global diabetes market, GLP-1 receptor agonists (hereinafter referred to as "GLP-1RA") market size is second only to insulin, according to the annual reports of various companies, the market sales of GLP-1RA drugs in 2021 are about 16 billion US dollars, and show a rapid growth trend
.
According to Novo Nordisk's 2021 annual report, global sales of liraglutide (for diabetes indications) were DKK 15.
054 billion (approximately USD 2.
286 billion).

LIRAGLUTIDE IS A HUMAN GLUCAGON-LIKE PEPTIDE-1 (GLP-1) ANALOGUE, THE FIRST ORIGINAL PRODUCT DEVELOPED BY NOVO NORDISK, FIRST LAUNCHED IN THE EU IN 2009, UNITED STATES IN 2010, AND APPROVED TO ENTER THE CHINESE MARKET
IN 2011.
In December 2014, the FDA approved its weight loss indications
.
Liraglutide has been expanding its market share due
to its good safety and high-quality hypoglycemic effect.

The marketing authorization registration application of the product of this cooperation between the two parties has been accepted by the State Food and Drug Administration on June 8, 2022, with a specification of 3ml:18mg (pre-filled injection pen) subcutaneous injection, which is the second domestic liraglutide injection declared for marketing
.
With high product standards and strict quality control, it is a high-quality biological drug
that can compete with similar products overseas.

Aiming at the 100 billion market and accelerating the expansion of the track

It is understood that the commercialization rights of the cooperative products cover Latin America, the Middle East and North Africa region, Southeast Asia and South Africa, including a total of 17 countries
.
According to data from the International Diabetes Federation (IDF) in 2021, the average prevalence in these countries is 13.
8%.

Among them, the prevalence of diabetes is higher than the global prevalence level in 12 countries, with a total of about 129 million patients, accounting for 24% of the global total, and 9 countries have diabetes-related expenditures accounting for more than US$ 1000 per person
in total health expenditure.

According to IDF Diabetes Atlas, there are 537 million adults aged 20-79 years with diabetes worldwide, with a prevalence of 10.
5%.

Diabetes incidence rates are high in emerging markets, but diabetes awareness, diagnosis, and control rates in emerging markets vary greatly from
those in Europe and the United States due to limited resources, poor access to health services, and prioritization of other diseases.

Sinovac adheres to "human-oriented innovation", focuses on unmet clinical needs, and joins hands with Tonghua Dongbao, a leading domestic diabetes drug company, to jointly go overseas to form a joint force of the strong and Hengqiang, which will not only help the company enter the field of endocrine diseases in overseas markets, but also lay the foundation
for the future international long-term cooperation between the two sides.

For overseas emerging markets, high-quality biological drugs with competitive price advantages occupy market space in advance, fill the gap of high-quality biological drugs in emerging markets, improve drug accessibility, improve the quality of life of patients, bring new hope to patients with financial difficulties, and ultimately contribute to human health
.

The strength of overseas commercialization is highlighted

In recent years, with the strengthening of overseas high-quality biopharmaceutical market demand, Sinovac Pharmaceutical has actively established strategic cooperation
with domestic and foreign biotechnology companies by relying on more than 20 years of accumulated 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 continuously promoted overseas commercialization through product introduction, and the company has now passed the access and sales of nearly 40 overseas countries, and holds more than 60 drug access certificates
from overseas countries and regions.
In the first three quarters of this year, a number of high-quality drugs introduced by Sinovac Pharmaceutical have frequently reported good news
in channel expansion and overseas registration progress.
The company's sales revenue in overseas markets increased by 65.
84%
year-on-year.

In addition, in South America, Southeast Asia, Africa and other regions that are generally ignored by leading pharmaceutical companies, Sinovac Pharmaceutical has achieved full coverage of emerging market countries with a population of more than 100 million or the top 30 GDP countries, and Sinovac's erythropoietin products have also ranked in the forefront
of domestic export sales of similar products for more than ten consecutive years.

Sinovac Pharmaceutical has always been guided by market demand and adheres to the "three highs and one fast" standard of "high clinical value, high technical level, high international quality management and registration standards, and rapid commercialization" to carry out the introduction of commercial projects
.
Actively exploring overseas markets is not only the full play of Sinovac's comparative competitive advantage of more than 20 years of overseas commercialization experience, but also the only way
to achieve long-term, stable and sustainable development.