Coron is full of firepower!

A few days ago, Kelun Pharmaceutical released the third quarter report, the company's performance has resumed growth, and innovation results have gradually emerged
.
According to data from Minaiwang, Kelun Pharmaceutical currently has 25 innovative drugs (17 Class 1 new drugs) in the clinical application and above stage, covering popular targets such as PD-L1, ADC, RET, and double antibodies; generic drugs focus on the first imitation , 21 of the new classification application varieties have not been approved for the time being, and the high-end three-chamber bag products will be harvested; 64 varieties have been reviewed (26 are the first ones), and the amount of multiple centralized procurement varieties is flying
.
17 new class 1 drugs are coming, attacking biosimilar drugs and high-end preparations.
On October 30, Kelun Pharmaceutical disclosed its third-quarter report.
In the first three quarters of 2021, the company achieved operating income of 12.
69 billion yuan, a year-on-year increase of 8.
8%; The profit was 850 million yuan, a year-on-year increase of 69.
2%; R&D expenses were 1.
19 billion yuan, a year-on-year increase of 18.
97%
.
With the implementation of centralized procurement and the gradual elimination of the negative impact of the epidemic, the revenue of Kelun Pharmaceutical's infusion products has resumed strong growth, and the number of approved generic drugs has continued to increase in recent years
.
In addition, the company's R&D efforts continue to increase, and innovation results are gradually emerging, which is expected to bring both valuation and performance improvements
.
According to data from Meinenet, there are currently 25 innovative drugs in Kelun Pharmaceuticals (excluding new drugs that are already on the market to develop new indications) in the clinical application and above stage, of which 17 are Class 1 new drugs
.
The source of the innovative drugs being developed by Kelun Pharmaceuticals: China's drug clinical trial announcement by Meinenet.
The innovative drugs under research by Kelun Pharmaceuticals are mainly anti-tumor drugs, covering the nervous system, anti-infection, autoimmunity and other therapeutic areas; target of action point, the company layout and popular target for cutting-edge therapies, including PD-L1, ADC, JAK, RET, and other anti-double
.
In the field of anti-tumor, Kelun Pharmaceutical has a variety of Class 1 new drugs, new drugs with improved dosage forms, and biosimilar drugs under development.

.
Four new class 1 drugs have entered phase II (including phase I+II) clinical trials, and two are ADC drugs, of which A166 for injection targets HER2, and the global marketed drug with the same target is Roche's enmetrastuzumab (2020 Annual global sales of 1.
745 billion Swiss francs), and SKB264 for injection targeting TROP2, currently no drug with the same target has been approved for marketing in the world
.
Among the two biosimilar drugs, the recombinant anti-epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody injection is a biosimilar of cetuximab, which is currently undergoing phase III clinical trials.
This is an EGFR-targeting drug.
IgG1 monoclonal antibody, the original research product has global sales of more than 1.
5 billion U.
S.
dollars in 2020
.
Two new dosage forms of improved drug docetaxel for injection (albumin-bound type) and irinotecan hydrochloride liposome injection are both in phase I clinical trials
.
According to data from Menet.
com, the market size of docetaxel and irinotecan in China's public medical institutions will exceed 3.
5 billion yuan and 1.
5 billion yuan respectively in 2020
.
In the field of anti-infection, 2 types of anti-hepatitis B drugs.
The KL060332 capsule, which is in phase I clinical trials, belongs to the hepatitis B virus nucleocapsid assembly regulator, which can effectively and broadly inhibit the proliferation of various genotypes of hepatitis B virus.
There is no drug with the same mechanism in the world.
Approved for marketing; KL210122 tablets, which have been approved for clinical use, are a new generation of tenofovir (TFV) prodrugs with mature targets and clear mechanisms of action
.
In the field of nervous system, KL280006 injection is a peripheral K opioid receptor agonist and is currently undergoing phase II clinical trials for acute pain indications; KL100137 fat emulsion injection is a GABAa receptor agonist and is intended to be used for anesthesia induction and anesthesia maintenance of anesthesia sedation
.
In terms of autoimmune diseases, KL130008 capsule is a JAK inhibitor, and phase II clinical trials for rheumatoid arthritis indications are underway
.
Globally marketed drugs with the same target include Pfizer's tofacitinib, Incyte/Novartis' ruxolitinib, Incyte/Lilly's baricitinib, etc.

.
64 varieties have been evaluated, and the amount of multiple collection varieties has been flying together.
Recently, the consistency evaluation of Kelun Pharmaceuticals welcomes new progress: hydroxyethyl starch 130/0.
4 sodium chloride injection is the first to be evaluated, ceftazidime for injection/ Glucose injection and gadolinium disodium injection have been approved for production and deemed to have been reviewed, both of which are the first in China
.
According to data from Meinenet, there are currently 64 products of Kelun Pharmaceutical that have passed or deemed to have passed the consistency evaluation, of which 26 are the first/exclusive evaluation, vardenafil hydrochloride tablets, compound amino acid (15AA-Ⅱ)/glucose ( 10%) electrolyte injection, amino acid (16)/glucose (48%) electrolyte injection and other varieties are the first imitation + first review
.
Based on the starting date of the status, the number of products reviewed by Kelun Pharmaceutical has been increasing year by year.
In 2021, it has entered the outbreak period.
So far, 33 varieties have been reviewed; from the perspective of treatment categories, 64 varieties cover 11 treatment categories, concentrated on the whole body Use anti-infective drugs (23 varieties), blood and hematopoietic system drugs (14 varieties)
.
Kelun Pharmaceutical has reviewed the varieties.
Note: with * is the first review, ** is the exclusive review source: Meinenet MED2.
0 Chinese drug review database rich over-reviewed varieties make Kelun Pharmaceutical repeatedly in the centralized procurement There are gains
.
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 respectively
.
The quantity and amount of selected varieties from a number of centralized procurement have risen simultaneously
.
For example, the fluconazole and metronidazole selected in the second batch of centralized procurement will increase the terminal sales of urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) respectively in 2020.
59.
45%, 1365.
45%; Tofacitib and Dapoxetine selected in the third batch of centralized procurement are both incremental varieties.
Among them, Kelun Pharmaceutical's market share of Dapoxetine has increased from 0% in 2019 to 2021.
58.
07% of year H1
.
In addition, in the fourth and fifth batches of centralized procurement, Kelun Pharmaceutical also selected a number of incremental varieties, including propofol medium and long-chain fat emulsion, empagliflozin, linezolid, ceftazidime, and omega-3 Fish oil medium/long-chain fat emulsion, medium/long-chain fat emulsion (C8-24), ceftriaxone, etc.
, these varieties are expected to increase in volume and contribute to the company's performance
.
21 varieties are the first to be imitated, and high-end three-cavity bag products will welcome the application for consistency evaluation during the harvest period.
At present, Kelun Pharmaceutical has 18 varieties that have submitted supplementary applications for consistency evaluation, and 15 of them have not yet been reviewed.
, Levofloxacin Hydrochloride Sodium Chloride Injection, Ambroxol Hydrochloride Sodium Chloride Injection, Sodium Lactate Ringer Injection, Potassium Chloride Injection, Anticoagulant Sodium Citrate Solution, Mannitol Injection, Compound Sodium Chloride Varieties such as injection, amino acid glucose injection, azithromycin dispersible tablets, etc.
are declared by the company first/exclusively
.
In terms of new classification application (including clinical application), the company currently has 45 varieties under review, 21 of which have not been approved for the first imitation (including the first imitation of dosage forms) in China, and 16 are the first/exclusive application by Kelun
.
Kelun Pharmaceuticals has declared and has no first imitation approved product under review.
Source: Meinenet MED2.
0 China Drug Evaluation Database 5 high-end three-chamber bag products sprint the first domestic product, 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 medium and long chain fat emulsion/amino acid (16)/glucose (36%) Injection, omega-3 fish oil medium and long-chain fat emulsion/amino acid (16)/glucose (30%) injection and omega-3 fish oil medium and long-chain fat emulsion/amino acid (16)/glucose (16%) injection
.
At present, Kelun Pharmaceutical has approved 4 parenteral nutrition three-chamber bag products, all of which have been approved for the first time in China
.
Source: Mi Nei.
com database, announcements of listed companies, etc.
Note: Statistics are as of November 1.
If there are any omissions, please correct me!