Coron is on the hook!

Recently, Kelun Pharmaceutical has made new progress in research and development: the marketing application of troglitatin succinate tablets has entered the approval process, and the omega-3 fish oil fat emulsion injection has been submitted for production.
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In recent years, Kelun Pharmaceutical has vigorously promoted " "Innovation-driven" strategy, the company currently has 29 innovative drugs (21 category 1 new drugs) in the clinical application stage and above, and the first category 1 new drug will be launched soon; in terms of generic drugs, 55 new categories of drugs under review are closely following.
20 billion market, of which 25 have not been approved for the first imitation (including the first imitation of the dosage form); 71 varieties have been reviewed (28 first), and 13 varieties are planned to be included in the seventh batch of centralized procurement
.
29 new drugs are on the way, and the first Class 1 new drug is on the market.
Fully human monoclonal antibody targeting TSLP), KL340399 injection (STING agonist),
etc.
According to the quarterly report of Kelun Pharmaceutical, the company's R&D expenses in the first three quarters of 2021 reached 1.
189 billion yuan, an increase of 18.
97% over the same period last year; R&D expenses accounted for 9.
37% of total revenue, and the R&D intensity was strengthened year by year
.
As of July 31, 2021, Kelun Pharmaceutical has a total of 85 innovative projects under research, including 38 innovative small molecules and 47 biotech drugs
.
Kelun Pharmaceutical’s R&D investment (unit: 100 million yuan) Source: Listed company announcement Minet data shows that currently Kelun Pharmaceutical has 29 innovative drugs (excluding new drugs that have been listed to develop new indications) that are in the stage of clinical application and above , 21 of which are Class 1 new drugs
.
From the perspective of therapeutic areas, the company's new drugs under research are mainly anti-tumor, and at the same time, it has deployed in the fields of liver disease, cardiovascular, anesthesia, analgesia, autoimmunity and other diseases, forming disease clusters and product iteration advantages
.
Source of some innovative drugs under research by Kelun Pharmaceuticals: Minet.
com China Drug Clinical Trials Publicity Library In terms of biological drugs, a class 1 new drug Tetlimumab injection (PD-L1 monoclonal antibody) has submitted a marketing application and is expected to become the company's first Among the other category 1 new drugs under development, there are 3 ADC drugs, of which A166 for injection targets HER2, and the globally marketed ADC drug with the same target is Roche's enmetrastuzumab (2021).
Annual global sales are 1.
982 billion Swiss francs), SKB264 for injection and SKB315 for injection target TROP2 and Claudin18.
2 respectively.
At present, there is no ADC drug with the same target approved for marketing in the world
.
A number of biosimilars are under development.
Recombinant anti-epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody injection is a biosimilar of cetuximab.
Phase III clinical trials are currently underway.
The terminal sales of medical institutions exceeded 1.
5 billion yuan; the recombinant anti-VEGFR2 fully human monoclonal antibody injection is a biosimilar of ramucirumab, which has now entered the phase I clinical trial, and the global sales of the original research products in 2021 will exceed 1 billion US dollars
.
In terms of chemical drugs, three new Class 1 drugs are in Phase II clinical trials (including Phase I+II), and KL280006 injection is a peripheral K opioid receptor agonist for acute pain.
At present, there is no drug of the same type approved in China
.
According to data from Minet.
com, in 2020, the market for chemical drug terminal painkillers in China's public medical institutions will exceed 10 billion yuan
.
The improved new drug focuses on high-end preparations.
The sildenafil citrate oral dissolving film has been declared for listing, and it is expected to become the company's first approved oral dissolving preparation; docetaxel for injection (albumin-bound), Rinotecan liposome injections are all in phase I clinical trials.
According to Minet.
com, the market size of terminal docetaxel and irinotecan in Chinese public medical institutions will exceed 3.
5 billion yuan and 1.
5 billion yuan respectively in 2020
.
28 varieties have been reviewed for the first time, and 13 varieties to be collected are eye-catching.
On February 24, Kelun Pharmaceutical announced that the company's parenteral nutrition preparation compound amino acid (15) dipeptide (2) injection passed the consistency evaluation
.
According to data from Minet.
com, the sales volume of this product in public medical institutions in China will be close to 500 million yuan in 2020, with a year-on-year increase of more than 10% in the first half of 2021
.
Since its transformation in 2012, Kelun Pharmaceutical's generic drug research and development has successfully achieved a transformation from simple infusion to comprehensive, comprehensive and connotative development
.
From 2021 to the present (calculated based on the date of review conclusion), the company has approved 18 generic drugs that are newly classified and reported for production and are deemed to have been reviewed, which further strengthens the company's product pipeline in the fields of parenteral nutrition, oncology, and antiviral
.
At present, 71 varieties of Kelun Pharmaceutical have passed or are deemed to have passed the consistency evaluation, of which 28 are the first/exclusive evaluation, vardenafil hydrochloride tablets, amino acid (15) peritoneal dialysate, compound amino acid (15AA-II) / Glucose (10%) Electrolyte Injection, Compound Amino Acid (16AA-II) / Glucose (48%) Electrolyte Injection and other varieties are the first imitation + the first review
.
Kelun Pharmaceutical's over-evaluation Note: The first/exclusive over-evaluation source with *: Minet MED2.
0 China Drug Evaluation Database From the review conclusion date, Kelun Pharmaceutical's over-evaluated varieties are increasing year by year, and will enter in 2021 Outbreak period; from the perspective of treatment categories, 71 varieties cover 11 major categories of treatment, focusing on systemic anti-infective drugs (25 varieties), blood and hematopoietic system drugs (16 varieties); in terms of dosage forms, Kelun Pharmaceutical Co.
, Ltd.
Over-rated varieties focus on injections (34 varieties)
.
The rich variety of over-evaluated products has made Kelon Pharmaceutical gain many harvests in centralized procurement
.
Among the five batches of centralized procurement that have been implemented, the number of varieties selected by the company are 1, 5, 4, 4, and 11, with a total of 25 varieties
.
A few days ago, the seventh batch of centralized procurement began to report, and Kelun Pharmaceutical has 13 varieties that have been reviewed.

.
Sources of varieties that Kelun Pharmaceutical intends to include in the seventh batch of centralized procurement: Shanghai Sunshine Pharmaceutical Purchasing Network, Minet.
com database From the perspective of competition, omeprazole injection is the most competitive.
At present, 25 companies have met the conditions.
In 2020, the terminal sales of China's public medical institutions will exceed 5 billion yuan; from the perspective of product competition, Kelun Pharmaceutical is in omeprazole injection, tirofiban injection, erlotinib oral normal-release dosage form, sunitinib Oral normal release dosage form, afatinib oral normal release dosage form, oseltamivir oral normal release dosage form, lenvatinib mesylate capsules, tenofovir alafenamide oral normal release dosage form, iopamidol injection 9 varieties The market share is less than 1%, and the market is waiting to be developed
.
55 new products are focusing on the market of 20 billion yuan, and 25 varieties are sprinting for the first imitation consistency evaluation application.
At present, there are 17 supplementary application varieties for consistency evaluation under review by Kelun Pharmaceutical, of which 13 have not yet been reviewed by enterprises.
Ge injection, nimodipine injection, potassium chloride injection, sodium citrate solution for anticoagulation, mannitol injection, compound sodium chloride injection, amino acid glucose injection, azithromycin dispersible tablets and other varieties are provided by the company First/exclusive declaration
.
In terms of new classification application (including clinical application), Kelun Pharmaceutical currently has 55 varieties under review.
According to Minet.
com data, the total sales volume of 55 varieties in public medical institutions in China in 2020 will be close to 20 billion yuan, of which toluenesulfonic acid.
The sales of Sorafenib Tablets, Palonosetron Hydrochloride Injection, Linezolid Glucose Injection, Pemetrexed Disodium for Injection, Moxifloxacin Hydrochloride and Sodium Chloride Injection have exceeded 1 billion yuan
.
No first imitation of 25 varieties (including the first imitation of dosage forms) has been approved in China
.
From the perspective of global sales, sugammadex, regorafenib, obeticholic acid, gadobutrol, sacubitril valsartan, eltrombopag ethanolamine and other varieties have relatively bright sales performance
.
Kelun Pharmaceutical has declared and has no first copy approved.
The products are the first in China, including medium and long chain fat emulsion/amino acid (16)/glucose (36%) injection, medium and long chain fat emulsion/amino acid (16)/glucose (30%) injection, omega-3 fish oil Long-chain fat emulsion/amino acid (16)/glucose (36%) injection, omega-3 fish oil medium long-chain fat emulsion/amino acid (16)/glucose (30%) injection and omega-3 fish oil medium long-chain fat emulsion / amino acid (16) / glucose (16%) injection
.
Diabetes medication is also the focus of Kelun Pharmaceutical’s layout.
The first imitated ticagliptin hydrobromide tablets and troglitatin succinate tablets are both DPP4 inhibitors, and both are first/exclusively declared by the company
.
According to the data of Minet.
com, since 2020, Kelun Pharmaceuticals has approved 4 oral hypoglycemic drugs for marketing and deemed to have been reviewed.
They are DPP4 inhibitor linagliptin and sitagliptin phosphate, and SGLT2 inhibitor.
Canagliflozin and Empagliflozin
.
In the field of contrast media, in June 2021, Kelun Pharmaceutical's first contrast media iopamidol injection was approved for marketing, and the second contrast media gadoxetate disodium injection was won in September of the same year
.
At present, the marketing applications of gadobutrol injection and gadoterol injection are still under review, and they are sprinting for the first imitation
.
Source: Minet database, announcements of listed companies, etc.
Note: The statistics are as of March 9.
If there are any omissions, please correct me!