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Recently, Kelun Pharmaceutical has received good news, breprazole oral lytic film has been approved for clinical practice, Tranning Biologics IPO registration has been approved, and the net profit in the first three quarters has increased by 66.
33%.
.
.
At present, Kelun Pharmaceutical has 31 new drugs (19 Class 1 new drugs) in the declared clinical stage or above, and 4 have entered the phase III clinical or NDA stage; 89 varieties have been evaluated (36 firsts), and 35 varieties have won the bid for national collective procurement; 45 new classified products are under review, and 14 have not yet been approved
.
19 Class 1 new drugs are in force, and 14 varieties are rushing to imitate
On October 26, the clinical application of SKB264 for injection of Kelun Pharmaceutical was accepted by CDE, which is the sixth time that the product has been submitted to IND, and a number of indications have been approved for clinical trials
.
On October 19, the company's Class 2 improved new drug brepiprazole oral dissolved film obtained the implied approval for clinical trials for the treatment of psychiatric division/schizodiasis
in adult patients.
In recent years, Kelun Pharmaceutical has continued to increase R&D investment, with R&D expenses of 1.
204 billion yuan
in the first three quarters of 2022.
At present, Kelun Pharmaceutical mainly has 31 new drugs in the declared clinical stage and above, including 19 Class 1 new drugs, 9 Class 2 improved new drugs, and 3 biosimilars, covering tumor, autoimmunity, anesthesia and analgesia, cardiovascular, liver disease and other disease fields, involving PD-L1, TROP-2, JAK, HER2, RET, LAG-3, CLDN18.
2 and other targets, covering small molecules, monoclonal antibodies, bispecific antibodies, ADC and other fields
。
Kelun drug owners are researching new drugs
Source: China Drug Clinical Trial Publicity Database on Intranet
Among the 31 new drugs, titelimab injection (KL-A167) and sildenafil citrate oral soluble film have submitted marketing applications; Recombinant anti-epidermal growth factor receptor (EGFR) human mouse chimeric monoclonal antibody injection and SKB264 for injection are in the phase III clinical stage; KL280006 injection, KL130008 capsules, A166 for injection, KL590586 capsules, etc.
are in the phase II clinical stage
.
Tetlimab injection is the first Class 1 new drug declared for marketing by Kelun Pharmaceutical, and the world's first PD-L1 monoclonal antibody
to submit NDA for nasopharyngeal carcinoma.
The product marketing application has been accepted by CDE on November 19, 2021, and is expected to be approved for marketing
by the end of 2022 or early 2023.
Sildenafil citrate oral dissolved film is the first oral lytic film preparation declared for marketing by Kelun Pharmaceutical, and no products of the same dosage form have been approved for marketing in China, and the company's sildenafil citrate oral collapse tablets have won the first imitation
in China.
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE-5) used to treat erectile dysfunction (ED).
According to data from Intranet, in 2021, the sales scale of sildenafil terminal in China's retail pharmacies (urban physical pharmacies + online pharmacies) exceeded 4 billion yuan for the first time, a year-on-year increase of 28.
55%.
Recombinant anti-epidermal growth factor receptor (EGFR) human mouse chimeric monoclonal antibody injection is a biosimilar of Merck's blockbuster product cetuximab, and head-to-head phase III studies with the original drug are advancing
.
According to Intranet, global sales of Merck and Eli Lilly's Erbitux exceeded $1.
7 billion in 2021; In 2021, the sales of terminal cetuximab in China's public medical institutions exceeded 1.
7 billion yuan, a year-on-year increase of 13.
60%.
SKB264 for injection is an ADC drug targeting human trophoblast cell surface antigen 2 (TROP-2), which is the first domestic TROP2-ADC approved for clinical trials, and was recognized as a breakthrough therapy for the treatment of advanced or metastatic triple-negative breast cancer
in July 2022.
At the same time, the product is the second innovative ADC drug of Kelun Pharmaceutical to achieve double reporting in China and the United States, and is conducting phase II clinical trials
in the United States.
Generics promote innovation, and at present, Kelun Pharmaceutical still has 45 new registration classification generic drug marketing applications under review, which will be regarded as passing the consistency evaluation
after being approved for production.
Among them, 14 varieties have not yet had the first imitation (including the first imitation of dosage form) approved for marketing, and Kelun Pharmaceutical will compete with many enterprises for the first imitation
in China 。
The new registration classification of Kelun Pharmaceutical is under review and there are no varieties approved for the first imitation
Source: MED2.
0 China Drug Evaluation Database
Among the 14 varieties, 7 varieties, including ticagliptin hydrobromide tablets, posaconazole oral suspension, cyclosporine ophthalmic emulsion, palipperidone palmitate injection (3 months), and ceftazidime avibactam sodium / sodium chloride injection for injection
, were exclusively submitted by Kelun Pharmaceutical.
Won 18 blockbuster varieties and 89 varieties were evaluated
Since the beginning of this year, 18 new classified products have been approved for marketing, and the number of approved varieties has exceeded the whole year
of 2021.
Among them, 7 varieties are the first imitation + first in China to be evaluated, including brimonidine timolol eye drops, ceftriaxone sodium / sodium chloride injection for injection, tripagliptin succinate tablets, gadolinol injection, sildenafil citrate oral collapse tablets, medium and long chain fat emulsion / amino acid (16) / glucose (36%) injection, medium and long chain fat emulsion / amino acid (16) / glucose (30%) injection, etc
。
Since 2022, Kelun Pharmaceutical has been approved varieties
Source: MED2.
0 China Drug Evaluation Database
Generic drugs are the foundation of Kelun Pharmaceutical's R&D strategy, and the company has laid out a huge generic drug pipeline, covering ordinary injectable and infusion drugs, ordinary oral preparations, complex generic drugs and other fields
.
As the early layout pipeline enters the cashing period, the number of approved generic drugs in Kelun Pharmaceutical continues to reach a new high
.
The continuous enrichment of the product pipeline helps the company reduce costs through scale and establish market competitive advantage
through product clusters.
In terms of consistency evaluation, at present, 89 varieties of Kelun Pharmaceutical have been evaluated, and injections account for 53%.
Among them, 36 varieties are the first to be evaluated in China, and 15 varieties such as citalopram hydrobromide capsules, vardenafil hydrochloride tablets, tripagliptin succinate tablets, sildenafil citrate oral collapse tablets, gadolinol injection, azithromycin dispersible tablets, brimonidine timolol eye drops and other 15 varieties are exclusively evaluated
.
Kelun Pharmaceutical passed/deemed to pass the consistency evaluation of varieties
In terms of treatment areas, 89 varieties cover 11 therapeutic categories, mainly focusing on systemic anti-infective drugs (31) and blood and hematopoietic system drugs (19).
According to data from Intranet, the market size of terminal systemic anti-infective drugs, blood and hematopoietic system drugs in China's public medical institutions will exceed 150 billion yuan
in 2021.
Among the six batches of chemical drug centralized procurement carried out by the state, Kelun Pharmaceutical won the bid for 1, 5, 4, 4, 11 and 11 varieties respectively, and a total of 35 varieties won the bid for national centralized procurement, and is one of
the leading suppliers of national centralized procurement.
The continuous expansion of newly approved generic drugs and varieties that have passed consistency evaluation have become one of
the important driving forces for the company's revenue and profit growth.
The net profit in the first three quarters increased by 66.
33%! 4 innovative drugs go overseas, and Tranning Biologics will be launched soon
On October 30, Kelun Pharmaceutical released a report for the third quarter of 2022, achieving operating income of 13.
858 billion yuan in the first three quarters, a year-on-year increase of 9.
24%; The net profit attributable to the shareholders of the listed company was 1.
411 billion yuan, a year-on-year increase of 66.
33%.
For the reasons for the growth of the first three quarters, Kelun Pharmaceutical previously said in the performance forecast that the company made every effort to expand the infusion and non-infusion product market, continued to optimize the product structure, increased the sales of newly approved products, and increased profits year-on-year; The market price of the main products of Yili Chuanning Biotechnology Co.
, Ltd.
, a holding subsidiary, rose and profits increased
year-on-year.
In addition, the company's innovative drug SKB264 and early clinical biomolecular tumor project B are exclusively licensed to MSD for a fee, increasing revenue and profit
.
It is remarkable that at present, Kolumbortec has achieved overseas authorization for 4 innovative projects, including KL-A167 (PD-L1 monoclonal antibody), A400 (RET inhibitor, KL590586), SKB264 (TROP2-ADC) and early clinical biomacromolecular tumor project B (ADC), which have received a total of more than 100 million US dollars, contributing revenue and profit
to the company's performance.
The company also has a number of projects at home and abroad authorization work into the stage of business terms negotiation, highlighting the innovative research and development strength and product internationalization potential
.
On October 26, Kelun Pharmaceutical announced that its holding subsidiary Yili Chuanning Biotechnology Co.
, Ltd.
had been approved by the China Securities Regulatory Commission for its
initial public offering and listing on the Growth Enterprise Market (GEM).
Located in Yining Park, Khorgos Economic Development Zone, Xinjiang, Tranning Biotech will complete the entire IPO review process by choosing the opportunity to issue and list, and will become the first listed enterprise
in Yili Prefecture.
Kelun Pharmaceutical mentioned at the third quarter results briefing that part of the funds raised by Tranning Biologics after the listing were used for the follow-up research and development investment of related products of the Shanghai Institute of Materia Medica, and the other part was used to repay the bank liabilities
of Tranning Biologics.
After the listing of Tranning Biologics, it can also make reasonable use of the financing channels of the capital market to further promote better development
.
Data source: Intranet database, company announcement
Note: Intranet's "Terminal Competition Pattern of China's Public Medical Institutions", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, and village clinics; Intranet's "Terminal Competition Pattern of China's Urban Physical Pharmacies", the statistical scope is: urban physical pharmacies at the prefecture level and above nationwide, excluding county and rural pharmacies; Intranet's "Competition Pattern of China's Online Pharmacy Terminals", the statistical scope is: all drug data of online pharmacies nationwide, including Tmall, Jingdong and other third-party platforms and all online pharmacies on private domain platforms; The above sales are calculated
based on the average retail price of the product.
If there is any omission in the data statistics, please correct it!
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