Osaikang is showing off!

A few days ago, Medical Network reported on February 26 that Osaikang was the first company to submit a listing application for Ceritinib capsules
.
No generic drugs have been approved for this product .
Aosaikang is a leading domestic PPI injection company.
In recent years, it has gradually increased investment in research and development, and innovative drugs + high-end first imitations have blossomed
.
At present, the company has 8 products that have been evaluated (5 are the first), and 2 injections have won the bid for the fourth batch of centralized procurement; 13 new registered classifications are under review, and 11 have not been approved for the first imitation; 7 innovative drugs have been unveiled, lung cancer Class 1 new drugs can be expected to be launched
.

The first company with an over-evaluation rate of over 60% and two major injections
ready to release Osaikon is a leading domestic PPI injection company, with 5 of the 6 listed PPI injections
.
According to data from Minai.
com, in the first half of 2020 , omeprazole sodium for terminal injection and esomeprazole sodium for injection in urban public hospitals , county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions for short) In the competitive landscape of lansoprazole for injection and rabeprazole sodium for injection, Osaican ranks among the top three
.
The company’s listed 5 PPI injections have all submitted supplementary applications for consistency evaluation, and 4 of them have successfully passed the evaluation (3 are the first ones)
.
Up to now, 8 Osaikon varieties have passed or deemed to have passed the consistency evaluation, of which 5 were the first to have been evaluated, and Nedaplatin for Injection and Omeprazole Sodium for Injection were the exclusive ones
.
Table 1: Osaikang's over-evaluation status Source: Meinenet MED2.
0 Chinese Drug Evaluation Database.
From the perspective of dosage form, 7 of Osaikang's reviewed products are injections.
According to data from Meinenet, there are currently 228 injections (in terms of drugs).
Name + company name) passed or deemed to have passed the consistency evaluation.
Among the TOP10 injection over-evaluated companies, Osaikang, Hengrui, and Renfu ranked sixth
.
The results of the fourth batch of national centralized procurement bids were officially announced on February 8.
For the first time Osaikon participated in the centralized procurement, two injections successfully won the bids, namely pantoprazole sodium for injection (2.
77 yuan/bottle) and Parrell for injection Coxib sodium (2.
75 yuan/bottle), the company's market share in these two injections is relatively low
.
Six companies won the bid for pantoprazole sodium for injection, and Osaikon won over 20 million yuan in purchases
.
In recent years, Osaikang has expanded from a single PPI product line in Gastroenterology to the treatment of drug-resistant bacterial infections, tumors, and diabetes.
The dosage form has also been extended from a single injection to an oral preparation.
This shows that the company attaches great importance to the research and development of new products
.
The semi-annual report data shows that in the first half of 2020, Osaikang invested 220 million yuan in research and development, an increase of 51.
71% year-on-year, accounting for 13.
32% of sales revenue
.
As of the end of the reporting period, there are a total of 59 major research projects, of which 12 are in the listing application stage and 14 are in the clinical trial stage
.

　　Eleven varieties rushed for the first imitation, and 9 blockbuster injections were under review.

On February 23, Osaikang received the CDE acceptance for the application for the listing of Ceritinib capsules submitted for imitation of category 4, making it the first in China
.
This product has not been approved for the first imitation, and only Novartis’s original research products are on sale.
In the first half of 2020, the sales of public medical institutions in China exceeded 200 million yuan, a year-on-year increase of 141.
42%
.
The first high-end imitation is the key area of ​​Osaikang's layout.
At present, the company has 15 varieties submitted for listing or clinical applications under the new registration classification, and 2 of them have been approved for production and deemed to have been reviewed
.
Among the 13 varieties under review, except for Engligliflozin tablets and piperacillil capsules, none of the other varieties have been approved for the first imitation (including the first imitation of the dosage form).

.
Table 2: Osaikang's new classification products under review.
Note: With *no first copy approval.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database Ceritinib Capsules, Fornettopitum Palonosus for Injection Joan, Eltrombopag ethanolamine tablets, deferasirox dispersible tablets, posaconazole injection, dexrabeprazole sodium for injection and other varieties were first declared by Osaikon
.
Osaikang’s first reported production of Eltrombopag ethanolamine tablets is the first ITP oral drug approved by the FDA.
In 2019, global sales exceeded 1 billion U.
S.
dollars.
It is expected that the sales in physical pharmacies in Chinese cities will be close to 300 million yuan in 2020 ; Dexrabeprazole sodium and levpantoprazole sodium are the advantageous configurations of rabeprazole sodium and pantoprazole sodium respectively.
If they are approved for marketing, they will help to consolidate Osaican's leading position in PPI injections
.
Delarox dispersible tablets and posaconazole injection are the first batch of nationally encouraged generic drugs
.
Deferarox is currently the only effective drug for the treatment of iron overload, with global sales of 975 million U.
S.
dollars in 2019; posaconazole is a new generation of triazole antifungal drug with global sales of 662 million U.
S.
dollars in 2019
.
Posaconazole enteric-coated tablets have been approved for marketing and are the first imitation in China.
Osaikon has obtained the exclusive marketing rights.
Posaconazole injection has not yet been approved for import.
Osaikon’s products are based on the "drugs one year before the patent expires.
" "Production application" is included in the priority review
.
In terms of consistency evaluation, Osaikang has submitted 15 supplementary applications for consistency evaluation, all of which are injections, and 6 of them have been successfully reviewed.
Among the 9 injections under review, 4 of them have not yet been reviewed by the company.
Among them, injections are used.
You Lei Zuo Sheng is Osai Kang's exclusive variety.
In 2019, its sales in China's public medical institutions exceeded 700 million yuan
.
Table 3: Osaikang Consistency Evaluation of Varieties Under Review Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
　　7 innovative drugs were unveiled, and the first class of lung cancer drugs are expected to be on the market
On January 26, Osaikang announced that the clinical application for the import of a new class 5.
1 drug, ferric maltol capsules, was accepted by the State Food and Drug Administration.
The new drug was developed by Shield TX (UK) Limited and was approved by EMA and FDA in 2016 and 2019.
Approved to be marketed for the treatment of iron deficiency in adults
.
Osaikang obtained the exclusive development, production and marketing rights of maltol iron capsules and its expandable dosage forms and indications in China through authorization
.
Iron maltol is a new non-salt complex formed by iron and maltol with stable chemical properties and has a unique absorption mechanism
.
A series of clinical trials have confirmed that iron maltol capsules are an oral drug for the treatment of iron deficiency in adults with low incidence of adverse reactions , high bioavailability, low iron overload, and good tolerance
.
According to data from Mi Nei.
com, the market size of terminal iron preparations in China's public medical institutions and Chinese urban physical pharmacies exceeded 4 billion yuan in 2019, an increase of about 12% year-on-year, and the potential patient group and market size are relatively large
.
Through independent research and development and the introduction of varieties, the pipeline of Osaikang's innovative drug research and development has gradually improved
.
Up to now, the company has 7 key innovative drugs under research, focusing on small-molecule targeted innovative drugs, and deploying bio-innovative drugs around the field of tumor immunity, including ASK120067 tablets, ASKB589 injection and other Class 1 new drugs, and dexlansola for injection Improved new drugs such as azole and glibenclamide for injection
.
Table 4: Osaikang's key research product source: Meinenet China Drug Clinical Trials Public Library ASK120067 is a third-generation EGFR inhibitor targeting T790M for the treatment of non-small cell lung cancer.
It is currently undergoing phase III clinical trials
.
The world's first third-generation EGFR inhibitor is AstraZeneca's osimertinib, with global sales of US$3.
189 billion in 2019
.
Although the first domestic third-generation EGFR inhibitor has been taken by Hausen Pharmaceuticals, due to the huge market space and not many similar products on the market, ASK120067 has the potential to become a blockbuster product if it is approved for listing.

.
ASKB589 injection is a new anti-tumor biological drug independently developed by Osaikang with independent intellectual property rights.
It mainly kills tumor cells through ADCC and CDC.
It is intended to be used for gastric and gastroesophageal junction adenocarcinoma, pancreatic cancer and other indications.
No similar products have been approved for listing
.
Source: Mynet database, announcement of listed companies.
Note: Statistics are as of February 24.
If there are any omissions, please correct me!