Coron is on the hook!

Highlights

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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29 new drugs are on the way, and the first class 1 new drug will be launched soon

In recent years, Kelun Pharmaceutical has vigorously promoted the "innovation-driven" strategy.
Since 2022, the company has submitted clinical applications for a number of Class 1 new drugs, including SKB378/HBM9378 injection (a fully human monoclonal antibody targeting TSLP), KL340399 injection Fluid (STING agonist),

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

Kelun Pharmaceutical R&D investment (unit: 100 million yuan)

Source: Listed company announcement

According to the data of Minet.
com, there are currently 29 innovative drugs (excluding new indications for new drugs on the market) in Kelun Pharmaceuticals that are in the clinical application stage and above, of which 21 are Category 1 new drugs

Some innovative drugs under development by Kelun Pharmaceuticals

Source: Minet China Drug Clinical Trials Publicity Library

In terms of biological drugs , a new category 1 drug, tetelimumab injection (PD-L1 monoclonal antibody), has submitted a marketing application and is expected to become the company's first category 1 new drug approved; among the other category 1 new drugs under development, there are 3 ADC drugs, of which A166 for injection targets HER2, and the global marketed ADC drugs with the same target are Roche’s trastuzumab (global sales of 1.
982 billion Swiss francs in 2021), SKB264 for injection and SKB315 for injection respectively target For TROP2 and Claudin18.
2, there is currently 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.

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

The improved new drug focuses on high-end preparations.
The oral dissolving film of sildenafil citrate 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.

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 R&D has successfully transformed 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 for production and 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
.

Over-evaluation of Kelun Pharmaceuticals

Note: with * is the first/exclusive review

Source: MED2.
0 China Drug Evaluation Database

Judging from the date of the review conclusion, the number of varieties that have been reviewed by Kelun Pharmaceuticals is increasing year by year, and will enter the outbreak period in 2021; from the perspective of treatment categories, 71 varieties cover 11 major treatment categories, focusing on systemic anti-infective drugs (25 varieties).
), blood and hematopoietic system drugs (16 varieties); from the point of view of dosage form, the varieties reviewed by Kelun Pharmaceutical are concentrated in 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 over-evaluated varieties listed
.

Kelun Pharmaceuticals plans to be included in the seventh batch of varieties

Source: Shanghai Sunshine Pharmaceutical Purchasing Network, Minet Database

From the perspective of competition, omeprazole injection is the most competitive.
Currently, 25 companies have met the conditions.
The terminal sales of this product in China's public medical institutions will exceed 5 billion yuan in 2020.
From the perspective of product competition, Kelun Pharmaceutical Co.
, Ltd.
In Omeprazole Injection, Tirofiban Injection, Erlotinib Oral Regular Release, Sunitinib Oral Regular Release, Afatinib Oral Regular Release, Oseltamivir Oral Regular Release, A Nine varieties of lenvatinib sulfonate capsule, tenofovir alafenamide oral normal-release dosage form, and iopamidol injection account for less than 1% of the market, and the market is waiting to be developed
.

55 new products are eyeing the 20 billion market, and 25 varieties are sprinting for the first imitation

In terms of consistency evaluation application, there are currently 17 supplementary application varieties for consistency evaluation under review by Kelun Pharmaceuticals, of which 13 have not been reviewed by the company.
Lactated Ringer's Injection, Nimodipine Injection, and 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 first/exclusively declared by the company
.

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 not yet approved the first imitation product under review

Source: MED2.
0 China Drug Evaluation Database

As a leading infusion company in China, Kelun Pharmaceutical has aggressively attacked high-end three-chamber bag products.
At present, there are 5 products that are the first in China, including medium and long chain fatty emulsion/amino acid (16)/glucose (36%) injection, medium and long chain Fat emulsion/amino acid (16)/glucose (30%) injection, omega-3 fish oil medium long-chain fatty emulsion/amino acid (16)/glucose (36%) injection, omega-3 fish oil medium long chain fatty emulsion/amino acid (16)/glucose (30%) injection and omega-3 fish oil medium long-chain fatty 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: Mi Intranet database, announcements of listed companies, etc.