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Yuandong Biotechnology's R&D investment rose by another 30%, and the collective collection variety led the market

 Last Update: 2022-10-31
 Source: Internet
 Author: User

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Recently, Yuandong Biotech announced the results of the first three quarters of this year, with both revenue and net profit increasing, with revenue reaching 898 million yuan and net profit of 195 million yuan
.
Riding on the wind of collective procurement, the company has become a leader in a number of products, and three non-exclusive products are expected to participate in this year's medical insurance negotiations, adding new performance growth points
to the company.
The company's R&D investment increased by another 30%, about 193 million yuan, accounting for 21% of revenue, innovation achievements gradually appeared, 3 Class 1 new drugs are progressing smoothly, and the first ANDA is about to be launched, helping the company open up the international market
.

The status of the industry is constantly improving! 14 product sprints, grabbing 3 major 100 billion markets

Founded in 2009 and listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange in 2020, Yuandong Biotech currently focuses on the musculoskeletal system and cardiovascular and cerebrovascular systems
.
According to data from Intranet, in the first half of 2022, at the terminals of urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions), Yuandong Biotech's musculoskeletal system and cardiovascular and cerebrovascular system drugs contributed more than 39% and 19% of the company's performance
, respectively.

At the end of China's public medical institutions, the market size of musculoskeletal system drugs is at the level of
30 billion yuan.
In recent years, Yuandong Biotech has grown rapidly, with its market share rising from 0.
03% in 2013 to 1.
66% in the first half of 2022, with amazing
explosiveness.
From the ranking point of view, the company squeezed into the list of TOP20 enterprises in this category for the first time in 2021, ranking fourteenth, and the ranking remained unchanged in the
first half of 2022.

Figure 1: Sales of Ibandronate sodium injection of Yuandong Biologics (10,000 yuan)

Source: Intranet terminal competition pattern of public medical institutions in China

Ibandronate injection is the company's leading product
in the musculo-skeletal system.
In 2021, at the terminal of China's public medical institutions, Ibandronate injection has become more than 1 billion single products, and with the rapid growth in recent years, Yuandong Biotech has become a leader in this product in the first half of 2022, mastering nearly 30% of the market
.
The company also has ibuprofen injection, parecoxib sodium for injection and etoricoxib tablets in this category, and won the blockbuster new product sulgamglucose sodium injection in June this year
.
The original company's global sales of Sugamglucin exceeded US$1.
5 billion in 2021 and exceeded RMB300 million
in 2021 in China's public medical institutions.

Bisoprolol fumarate tablets are the company's leading product in the cardiovascular and cerebrovascular system drug market, with sales of more than 200 million yuan in 2021 and becoming the top 1 domestic brand
of the product in the first half of 2022.
The company also has fasudil hydrochloride injection in this category, and in May this year, phenylephrine hydrochloride injection was approved according to the new classification, which is the second domestic (the first to be evaluated).

Table 1: Yuandong Biologics reported and reviewed new products

Source: MED2.
0 China Drug Evaluation Database

Among the new generic drugs currently reported and under review, there are 7 products involving the cardiovascular and cerebrovascular systems, and enalapril maleate oral solution, nicodil for injection and arolol hydrochloride tablets are expected to strive for the approval of the
first three.

The company has 5 digestive system and metabolic drugs, of which palonosetron hydrochloride injection is a newly approved product (marketing authorization holder) this year, and essomeprazole magnesium enteric-coated dry suspension is expected to compete for the first imitation
in China.

The company has 6 nervous system drugs, of which sodium valproate injection concentrated solution and vigabatron oral solution are newly approved products this year, and butoranol tartrate injection is expected to compete for the second domestic production in the review and approval
.

Yuandong Biotech once mentioned in its annual report that the company takes the first generic or difficult to imitate (the first three listed) as the research and development goal of generic drugs, and uses the first-mover advantage to gain more market share
.
From the current production and review products, the company will have the first imitation or difficult-to-imitation products in the three hundred billion markets of cardiovascular and cerebrovascular system, digestive system and metabolism and nervous system, and the company's advantages are expected to be further broadened
.

Policy dividends boost performance! Leading 4 winning products, non-exclusive products will welcome the volume of medical insurance

Up to now, Yuandong Biotech has been evaluated/treated as 23 products, among which ibandronate sodium injection, memantine hydrochloride sustained-release capsules, ibuprofen injection, repaglinide metformin tablets (I.
), repaglinide metformin tablets (II.
), phenylephrine hydrochloride injection and naloxone hydrochloride injection are the first to be evaluated
.

Table 2: Yuandong Biotech has won the bid for products procured by China

Source: Intranet terminal competition pattern of public medical institutions in China

Bisoprolol fumarate tablets, fasudil hydrochloride injection, ibandronate sodium injection and citrate coffee / coffee / because of the injection are the company's stock varieties, after the implementation of the second and fifth batches of national procurement, the company's market share has increased significantly, and in the first half of 2022, it has become a leader
in fasudil hydrochloride injection 。 The seventh batch of national procurement will be implemented in November this year, the company currently has a high market position in Ibandronate sodium injection and citrate coffee / coffee / coffee / in injection, Yuandong Bio believes that with the completion of collective procurement of varieties accounting for a large proportion of the company's revenue, the risk of collective procurement of existing varieties has been released, and it is optimistic about the future development prospects
.

Etoricoxib tablets, glycopyrronium bromide injection, dabigatran etexilate capsules, memantine hydrochloride sustained-release capsules and tenofovir propofovir fumarate tablets are the company's recently listed "barefoot varieties", which are expected to be increased through centralized procurement
.
Judging from the market data in the first half of 2022, Yuandong Biotech has become a TOP1 enterprise relying on Coxib tablets, with a market share of more than
45%.

Yuandong Bio has been evaluated and has not yet entered the national procurement catalogue of products, sodium valproate injection concentrated solution has been evaluated by 8 domestic pharmaceutical companies, Shugenin glucose sodium injection has formed a "original research + 5 evaluation" pattern, the probability of entering the next batch of national procurement is relatively high, as the company's "barefoot variety", if successfully won the bid in the future
.

Table 3: Products that Yuandong Biotech is expected to enter the 2022 edition of the medical insurance catalog

Source: One-click search on Intranet

In 2022, the countdown to the adjustment of the medical insurance catalogue has begun, and 3 non-exclusive products of Yuandong Biotech have passed the formal review, which are the off-list condition 1 (newly approved drugs from 2017 to the first half of 2022), if they are successfully "insured", or welcome a wave of volume
.

R&D investment increased by another 30%! 3 new Class 1 drugs are in full swing, and the first ANDA is about to be launched

Figure 2: R&D investment of Yuandong Biotech in recent years (100 million yuan)

Source: the company's annual report, third quarterly report

Yuandong Biotech continues to maintain a high proportion of R&D investment to build its core competitiveness, with R&D investment accounting for more than 20% of revenue in 2021, and rising to 21.
47% in the first three quarters of 2022, ranking among the best in the
industry.
At present, the company's R&D investment is concentrated in high-end generic drugs (accounting for about 70%), innovative drugs and biological drugs (accounting for a total of 30%), the company said that with the increase of new drug clinical projects, the proportion of subsequent R&D investment in innovative drugs will increase year by year, and the company is accelerating innovation and transformation
.

Figure 3: Yuandong Biologics has been approved for clinical class 1 new drugs

Source: New version of the Intranet database

At present, Yuandong Biotech has more than 10 Class 1 new drugs under research, of which 3 have been approved for clinical trials and are making rapid
progress.
The phase III clinical trial of oral long-acting DPP4 inhibitor yogliptin tablets for type 2 diabetes mellitus is underway, and the first subject was enrolled in January this year
.
Phase II clinical data show that yogliptin tablets reduce glycosylated hemoglobin with significant effect and high safety compared with similar DPP4 inhibitors, and the new drug may become the first long-acting oral hypoglycemic drug
listed in China.

CX3002 tablet is a new type of oral factor Xa inhibitor co-developed by the company, intended to prevent acute deep vein thrombosis, compared with the same target drug, its mechanism of action is clear and the efficacy is outstanding, the new drug for the prevention of acute deep vein thrombosis phase I clinical has been completed
.

Biopharmaceutical Class 1 new drug EP-9001A injection is a new mechanism of action of humanized monoclonal antibody drug, targeting human nerve growth factor (NGF), by selectively targeting binding and inhibiting NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain, which can effectively relieve pain while avoiding addiction, the phase I clinical trial of the new drug for bone metastasis cancer pain is underway, and the first subject has been enrolled in May this year
.

The internationalization of Yuandong Biologics' preparations will usher in a new breakthrough in the near future, and the company's application for nalmefine hydrochloride injection submitted to ANDA in May this year has been accepted, and it is expected that the FDA will complete on-site verification by the end of the year and complete the listing
in 2023.
Yuandong Biotech may become the second generic drug manufacturer approved for marketing in the United States, and the product will also become the company's first approved ANDA
.

It is reported that the international layout of Yuandong Biotech focuses on the field of characteristic antidotes, and the company continues to carry out in-depth development, gradually establish an opioid antidote technology platform, and further develop high-barrier injections and nasal spray series products
.
The company has newly established two nasal sprays EP-0112T and EP-0113T with high technical difficulties, which will enrich the product pipeline in the field of characteristic antidotes and accelerate the implementation of
the company's internationalization strategy.

epilogue

Yuandong Biotech is in a rapid growth stage where the existing varieties have basically completed the centralized procurement and the "barefoot" winning varieties have contributed an increase, and this year is expected to usher in another medical insurance dividend to further improve the company's performance
.
The research and development of innovative drugs is progressing smoothly, the internationalization of preparations has ushered in a major breakthrough, and the company's layout in domestic and foreign markets has been comprehensively broadened
.
Most securities companies are optimistic about the company's development, and it is expected that the annual revenue in 2022 will exceed 1.
1 billion yuan, and the net profit will exceed 260 million yuan, and the growth rate will remain in double digits
.

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