Securities code: Sichuan Kelun Pharmaceutical Co.Ltd(002422) securities abbreviation: Sichuan Kelun Pharmaceutical Co.Ltd(002422) Announcement No.: 2022034
Sichuan Kelun Pharmaceutical Co.Ltd(002422) 2021 annual report summary
1、 Important note: the summary of this annual report comes from the full text of the annual report. In order to fully understand the company’s operating results, financial status and future development plan, investors should carefully read the full text of the annual report in the media designated by the CSRC. In addition to the following directors, other directors attended the meeting of the board of directors to consider the annual report in person
Name of director not present in person position of director not present in person reason for not attending the meeting name of the entrusted person
Tips on non-standard audit opinions □ applicable √ not applicable to the profit distribution plan of common shares or the plan of converting accumulation fund into share capital in the reporting period considered by the board of directors √ applicable □ not applicable whether to convert accumulation fund into share capital □ yes √ no
The company’s profit distribution plan for ordinary shares reviewed and approved by the board of directors is: take 1406276982 as the base, distribute cash dividends of 4.26 yuan (including tax) to all shareholders for every 10 shares, send bonus shares of 0 shares (including tax), and do not use the accumulation fund to increase the share capital. Preferred stock profit distribution plan for the reporting period adopted by the board of directors □ applicable √ not applicable II. Basic information of the company 1. Company profile
Stock abbreviation Sichuan Kelun Pharmaceutical Co.Ltd(002422) stock code Sichuan Kelun Pharmaceutical Co.Ltd(002422)
Shenzhen Stock Exchange
Contact person and contact information secretary of the board of directors securities affairs representative
Name: Feng Hao, Huang Xin
Office address: No. 36, Baihua West Road, Qingyang District, Chengdu
Fax (028) 86132515 (028) 86132515
Telephone company switchboard: (028) 82860516 company switchboard: (028) 82860516
Tel.: (028) 82860678 Tel.: (028) 82860678
E-mail [email protected]. [email protected].
2. Introduction to main business or products during the reporting period
(I) overview
2021 is the first year of implementing the 14th five year plan and starting a new journey of building a modern socialist country in an all-round way. This year, covid-19 virus continued to wreak havoc all over the world, and local outbreaks in China fluctuated repeatedly. At the same time, the development of global pharmaceutical technology is still showing an explosive trend. The China Meheco Group Co.Ltd(600056) industry policy reform has been further promoted, the pharmaceutical industry has been greatly impacted, and the industry competition has become increasingly fierce.
In the environment of more complex external environment and continuous deepening of reform in the pharmaceutical industry, the company adheres to the development strategy of “three engine drive, innovative growth” and strives to implement the 20 character operation and management policy of “full innovation, full staff marketing, saturated production, reducing costs and creating a blue ocean”. In 2021, all production enterprises and sales areas of the company made every effort to do a good job in production and operation while actively responding to the government’s epidemic prevention and reform policies, The company’s overall operating performance in 2021 was significantly higher than that in 2020.
During the reporting period, the company achieved an operating revenue of 17.277 billion yuan, a year-on-year increase of 4.94%; The gross profit was 9.617 billion yuan, an increase of 686 million yuan, a year-on-year increase of 7.68%; The net profit attributable to the listed shareholders was RMB 1.103 billion, an increase of 3.203 billion year-on-year. The main reasons for the changes in operating performance are:
(1) In 2021, although some parts were still affected by the fluctuation of the epidemic, the company made every effort to expand the market of infusion and non infusion preparations, and the operating revenue and profit increased year-on-year;
(2) In recent years, the approved generic drugs of the company continued to increase in volume, and the operating revenue and profit increased rapidly;
(3) The company actively optimized the financing structure, reduced the average financing interest rate and financial expenses;
(4) The company continued to vigorously promote the “innovation driven” strategy, and the R & D expenses increased year-on-year;
(5) The subsidiary CHUANNING biology lost production due to the impact of local epidemic, and the operating revenue and profit decreased year-on-year;
(6) With the expansion of the company’s business scale, the corresponding management expenses such as salary, depreciation and entertainment expenses increase;
(7) The shareholding proportion of minority shareholders of the subsidiary Botai biology increased, and the loss of minority shareholders increased significantly year-on-year.
In 2021, 33 products of the company were approved for listing and 30 products were declared for production. From 2017 to December 31, 2021, 94 products of the company were approved for listing and 52 products were in the stage of declaration for production. The company mainly promotes the clinical research of 12 innovative drugs and implements key projects and key breakthroughs. The company insists on access first, deeply participates in national and local centralized procurement, and gives full play to the product cluster advantages of the company’s sequential listing of generic drugs, so as to realize rapid large-scale sales of new products and improve profitability.
Figure 1 R & D investment and drug approval of the company
The company’s patent achievements in R & D and innovation maintained a steady growth. In 2021, 351 patents were applied for and 195 patents were authorized; As of December 31, 2021, 4162 foreign patents have been applied for and 2258 patents have been authorized.
In 2021, as the only enterprise in Sichuan Province, the company was selected as a national industry education integration enterprise to play a demonstration and leading role; The “national environmental protection antibiotic residue harmless treatment and resource utilization engineering technology center” constructed by the company’s subsidiary Yili CHUANNING has been accepted by the Ministry of ecological environment, and Yili CHUANNING’s antibiotic residue harmless treatment and resource utilization has been in the forefront of the industry; Hunan Kelun was awarded the “2021 intelligent manufacturing demonstration factory” by the Ministry of industry and information technology, which has outstanding advantages in many intelligent manufacturing scenes and has become a national pilot enterprise of pharmaceutical manufacturing; The project of “Sichuan high-end preparation engineering technology research center” of Kelun pharmaceutical research was approved, marking a solid step in the construction of Kelun high-end preparation innovation technology platform.
(II) R & D
1. Innovative R & D Industry
Innovation driven transformation is the core task of the development of the pharmaceutical industry. Under the background of the state encouraging innovation, China Meheco Group Co.Ltd(600056) innovation has entered the fast lane. During the 13th Five Year Plan period, China’s R & D level of new drugs also leaped by leaps and bounds. A large number of new targets and new mechanism drugs were distributed, which greatly shortened the time difference with similar foreign products. A number of products were registered and declared simultaneously at home and abroad, and more and more new drugs were authorized abroad.
In terms of drug management, supporting the promulgation of the measures for the administration of drug registration and the measures for the supervision and administration of drug production in 2020 and the transformation and implementation of ICH guiding principles, the National Drug Evaluation Center successively issued more than 70 research technical guidelines in 2021. Guided by the unmet clinical needs, the evaluation standards at all stages of new drug development have been continuously improved and improved.
According to the incomplete statistics of the public data of the National Drug Evaluation Center, there were 870 clinical acceptance numbers of class 1 new drug applications for chemical drugs in 2021, an increase of 57.3% over 553 acceptance numbers in the same period in 2020; In 2021, there were 466 clinical acceptance numbers of class 1 new drug applications for therapeutic biological products, an increase of 95.8% over 238 acceptance numbers in the same period in 2020. In the highly competitive innovation and R & D environment, on the basis of adhering to the strategy of “imitation promotes innovation and innovation drives the future”, collen will further improve the R & D and innovation system, improve the evaluation mechanism of the whole R & D process, introduce and train high-level R & D talents, actively carry out external innovation cooperation and continuously improve R & D efficiency.
After the implementation of the injection consistency evaluation policy, the injection has been evaluated successively in 2021, the scope of centralized purchase continues to expand, and the drug centralized purchase policy has entered the stage of normalization and institutionalization, which will further reconstruct the competition pattern of generic drugs and innovative drugs, and significantly affect the industrial structure of the pharmaceutical industry. Therefore, the company will actively promote the application progress of high-end generic drugs with core value and maintain the smooth progress of injection consistency evaluation; At the same time, with the help of policy dividends, we will focus on the unmet clinical needs of patients, aim at the cutting-edge technology of global medicine, strive to seek breakthroughs and accelerate innovation and transformation. 2. R & D work in 2021
Over the past nine years, Colleen has launched research on more than 300 drugs for the Chinese and foreign markets, including 276 generic drugs and improved innovative drugs with cluster, difficulty, characteristics and cost advantages, and 63 innovative small molecule and biotechnology drugs with me better characteristics.
In 2021, driven by the internal and external environment, with the guiding ideology of “internal reform and opening to the outside world”, collen systematically benchmarked the advanced industry with the open mentality of “seeing the good and thinking of the good”, carried out a series of fruitful reforms, improved the company’s internal control and management system, strengthened cost, efficiency and market awareness, made remarkable team progress and significantly improved R & D efficiency.
2.1 research progress of generic drugs of collen
Adhering to the market value and policy oriented and total cost leading strategy, since the transformation in 2012, the R & D of Kelun generic drugs has successfully realized the transformation from simple infusion to comprehensive, comprehensive and connotative development. Imitation and consistency evaluation have successively started the research of 276 products. Since 2017, 94 products have been approved, which took 9 years to further consolidate the industry leading position in China’s infusion market. Only in the field of parenteral nutrition and therapeutic infusion, 34 production approvals have been obtained; At the same time, in the field of oral preparations, drug loaded fat milk and other fields, 36 products have been sequentially produced, and the advantages of products cluster in the fields of cancer, parenteral nutrition, bacterial infection and body fluid balance have been established. They have begun to enter into the fields of cardiovascular and cerebrovascular diseases, anesthesia, analgesia, male specialty, diabetes, angiography, hepatitis B and other diseases, and are gradually strengthening.
Based on China’s policy environment, future competition pattern and international situation, difficulty, characteristics, speed and cost have become the key to the success of generic drugs. Combined with reality, collen will continue to optimize the project initiation strategy, promote the project initiation and pipeline evaluation of topic selection with unmet clinical needs as the guidance and business transformation as the ultimate goal, and adjust the R & D strategy in time while deepening the advantageous fields and expanding the direction of new topic selection, Eliminate the projects without competitive advantage in the existing pipelines, concentrate resources, comprehensively strengthen the promotion of varieties under research, and strive to become a real winner under the new situation of centralized mining. In 2021, Colleen firmly implanted the quality first strategy and cost first strategy into the generic drug R & D system, guided by the market, strengthened cost accounting, and achieved 33 approved production, 3 approved clinical and 30 declared production during the reporting period; In the fifth batch of national centralized procurement in 2021, Kelun won the bid for a total of 11 products, and the number of winning bids ranked first. Kelun has become one of the top suppliers of national centralized procurement.
During the reporting period (January 1, 2021 to December 31, 2021), 33 drugs were approved for marketing, including the approval of ceftazidime for injection / 5% glucose injection and the production report of cefmetazole sodium for injection / sodium chloride injection, marking the beginning of the substantive output stage of the powder liquid double chamber bag technology platform laid out by collen for many years. The successive approval of iodopanol injection and disodium gadolinate injection, and the production report of gadolinium butoxide injection mean that the Kelun contrast agent product cluster has entered the stage of large-scale production. The application of sildenafil citrate non orally soluble membrane not only realizes the breakthrough of membrane agent platform products, but also further enriches and strengthens the product pipeline in the field of Kelun andrology.
Table 2 drugs (products) with production approval of generic drugs during the reporting period
Serial number name registration classification function indication / indication status
Anda
1 compound amino acid (15aa-ii) / glucose (10%) chemical class 3 parenteral nutrition was approved for production
First imitation of electrolyte injection
two ω – 3 fish oil medium / long chain fat emulsion injection chemicals category 4 parenteral nutrition approved for production
2nd house
3 sunitinib malate capsule chemical class 4 anti-tumor approved for production
4. Levofloxacin tablets are approved for production as class 4 anti infective chemicals
5 propofol, tenofovir tablets, fourth types of hepatitis B approved for production
6 moxifloxacin hydrochloride eye drops chemical class 4 anti infection approved for production
7 alfatinib maleate, chemical drugs, class 4, antitumor
