O'Cycon is in full swing! Won 4 blockbuster first imitations and 20 rated varieties

Under the impact of the epidemic and the epidemic, Aosaikang accelerated the innovation and transformation, and the R&D investment in 2022H1 increased by 21.
35% over the same period last year, accounting for 24.
81%
of the revenue 。 Since 2019, the company has 9 varieties (including 4 first imitations) approved for the first time, and 20 varieties have been evaluated (7 are the first/exclusive); Focusing on innovative drugs and high-barrier complex preparations, Aosaikang has 45 projects under research, 13 new drugs (7 Class 1 new drugs) are in the stage of approved clinical and above in China, and the first Class 1 new drugs can be marketed; In terms of generic drugs, 16 new classified declared varieties are under review, and 9 have not been approved for the first imitation (including the first imitation of dosage form), of which 7 are exclusive/first declared
by Ossecoon.

 

4 blockbuster first imitations were approved, and 20 varieties were evaluated

 

Aosaikang is one of the leading PPI injections in China, with 5 of the 6 listed PPI injections
.
In recent years, Aosaikang has expanded from a single product line of gastroenterology PPI to anti-infection, anti-tumor, diabetes and other therapeutic fields year by year, and the dosage form has also been extended
from a single injection to an oral preparation.

 

According to Intranet data, since 2019, Ossecon has 9 generic drugs approved for the first time, of which 4 are first imitations (including dosage form first imitations), including delarosib dispersible tablets, posaconazole injection, posaconazole enteric-coated tablets (exclusive agent) and salogliptin tablets
.
In addition, temozolomide for injection was the second approved, and daptomycin for injection (350 mg) was the exclusive specification
.

 

Since 2019, O'Saikang has been approved varieties

Note: With * as the first imitation (including the first imitation of the dosage form)

 

Source: MED2.
0 China Drug Review Database

 

Delarosus dispersible tablets, posaconazole injection, and posaconazole enteric-coated tablets are the first batch of generic drugs encouraged by the state, of which delarosus is the only effective drug for the treatment of iron overload, and posaconazole is a new generation of triazole antifungal drugs; Saxagliptin tablets are DPP4 inhibitors and are the first oral hypoglycemic drug
approved for marketing by Orsetron.

 

At present, 20 varieties of Orsecon have passed or are deemed to have passed the consistency evaluation, focusing on the digestive system and metabolites (8 varieties) and anti-tumor and immunomodulators (7 varieties) in two major therapeutic areas; The first / exclusive evaluation of 7 varieties, of which dexradoxen for injection, saxagliptin tablets, posaconazole injection, desaloxaz dispersible tablets, etc.
are the first imitation + the first review
.

 

O'Cellon has been judged variety

Note: Belt* is the first/exclusive review

 

Source: MED2.
0 China Drug Review Database

 

Aosaikang actively responded to the drug collection organized by the state and effectively reduced the drug burden of
patients with practical actions.
At present, the company has a total of 12 varieties selected in the national collection, including 2 in the fourth batch, 6 in the fifth batch, and 4 in the seventh batch
.

 

Among the varieties that have been evaluated by the company, 6 have not yet been included in the national collection, of which the number of enterprises that have been evaluated by levobipicaine hydrochloride injection has reached 4, meeting the threshold
for selection and selection.
According to Intranet data, levobupivacaine hydrochloride injection is not sold in the terminals of urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) in China, and the market share of Aosaikang is also small
.

 

13 new drugs are on the road, and the first Class 1 new drug is about to be launched

 

Focusing on the four major areas of digestive system, anti-tumor, anti-infection, and chronic diseases, Aosaikang continued to increase its research and development efforts, and the R&D investment increased year by year, and the R&D intensity (R&D investment accounted for the proportion of revenue) gradually increased
.
In the first half of 2022, the company invested 251 million yuan in research and development, an increase of 21.
35% over the same period last year, accounting for 24.
81%
of revenue.

 

2018-2022H1 R&D investment of Aosaikang (:100 million yuan)

Source: Company Announcement

 

At present, Aosaikang mainly has a total of 45 research projects, focusing on the research and development of small molecule targeted innovative drugs and biological innovative drugs in the field of tumor immunity, and has achieved the strategic transformation
of research and development strategies positioned in clinical urgent needs, focusing on innovative drugs and high-end first generic drugs.

 

According to the data of Intranet, at present, there are 13 new drugs (7 new drugs of class 1) in China that are in the approved clinical and above stages, including ASK120067 tablets, ASKB589 injection, ASKG712 injection and other 1 class new drugs, dexlanzole for injection, dextrolipoic acid tromethamine injection, glibenclamide for injection and other improved new drugs
.

 

O'Saikang is researching new drugs in China

Source: Intranet China Drug Clinical Trial Publicity Database

 

In terms of chemical innovative drugs, ASK120067 tablets submitted a listing application in November 2021, and have completed clinical on-site verification and registration on-site verification, which is expected to become the company's first new drug
approved for listing.
This is a three-generation EGFR-TKI, and the domestic approved target drugs include ositinib, ametinib, vometinib and so on
.
In recent years, the sales scale of protein kinase inhibitors dominated by tinib drugs in China's three major terminal markets (see the end of this article for statistical details) has increased year by year, reaching 38.
86 billion yuan in 2021, an increase of 18.
2%
year-on-year.

 

In addition, ASK0912 for injection in Phase I clinical use is a cyclic peptide antibiotic, and Oxycon reached a technology development agreement with the Chinese Academy of Medical Sciences in 2019; ASKC852 tablets that have been approved for clinical practice belong to ALK5 inhibitors, and no drugs with the same target have been approved at home and abroad, and the domestic varieties under research include GFH018 tablets (phase II clinical) of Jinfang Pharmaceutical Co.
, Ltd.
, YL-13027 tablets (phase I clinical) of Shanghai Yingli Pharmaceutical Co.
, Ltd
.

 

In terms of bioinnovative drugs, ASKB589 injection, which is undergoing Phase I and II clinical trials, is humanized Claudin18.
2 monoclonal antibody, which kills tumor cells
through ADCC and CDC 。 At present, no drugs with the same target at home and abroad have been approved for listing, and Aosaikang is in the first echelon of research and development; ASKG315 for injection that has entered phase I clinical practice belongs to the recombinant human interleukin-15-Fc fusion protein, and no drugs with the same target have been approved for listing at home and abroad, and the highest progress of new drugs under research in China is in phase II clinic; The ASKG712 injection that is undergoing Phase I clinical treatment is VEGF/Ang2 double antibody, and the company has reached a cooperation with Affamed, and the new drug has completed the first patient administration
of Phase I clinical in the United States.

 

9 varieties grabbed the first imitation, and 2 injections hit the first one to be evaluated

 

In terms of generic drugs, at present, Aosaikang has 2 varieties submitting supplementary applications for consistency evaluation, namely rabeprazole sodium for injection and oxaliplatin for injection, and the sales of 2 varieties in China's public medical institutions terminals in 2021 will exceed 1.
5 billion yuan and 3 billion yuan respectively, and no enterprises have been evaluated or regarded as applicable
.

 

In terms of new classification declaration, at present, 16 varieties of Orsaycon are under review with the new classification, of which 9 have not been approved for the first imitation (including the first imitation of the dosage form), and the varieties such as carbotinib malate tablets, derafloxacin for injection, and fornetopipitan for injection are blank
in the domestic market.

 

The new classification of Aosaikang has been declared and there are no first imitations of approved varieties

Source: MED2.
0 China Drug Review Database

 

7 varieties are exclusive/first declared by Opicon Con, of which dexclépeprazole sodium and levipan toprazole sodium are the dominant configurations of rabeprazole sodium and pantoprazole sodium respectively, if approved for listing, it will help consolidate Orsecon's position
in the PPI field.

 

In recent years, the sales of etripepa ethanolamine tablets in the six major markets of China's three major terminals (:10,000 yuan)

Source: Intranet Database

 

The most fiercely contested exetropopid ethanolamine tablets are the first FDA-approved oral drugs for thrombocytopenia (ITP), with global sales of more than $2 billion in 2021, while sales in China's three major terminal markets exceeded 800 million yuan, an increase of 67.
4%
year-on-year.

 

Source: Intranet database, company announcements, etc.
Note: Intranet "China's three major terminals 6 major market competition pattern", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
Statistics as of September 26, if there is any omission, welcome to correct!