KELUN PHARMA(002422)2024-04-24 13:48Dividend Distribution - The company plans to distribute a cash dividend of 8 yuan per 10 shares, totaling 1,590,876,008 shares[2] Risk Factors - The company faces risks including industry policy changes, market risks, environmental risks, R&D innovation risks, and quality control risks[2] Subsidiaries and Branches - The company has multiple subsidiaries and branches, including Sichuan Kelun Pharmaceutical Co., Ltd., Hunan Kelun Pharmaceutical Co., Ltd., and Jiangxi Kelun Pharmaceutical Co., Ltd.[5] - The company's subsidiaries are involved in various sectors such as pharmaceutical manufacturing, drug research, and medical trade[5] - The company has a significant presence in regions like Sichuan, Hunan, Jiangxi, and Yunnan through its subsidiaries[5] - The company's subsidiaries include specialized entities like the Sichuan Kelun Pharmaceutical Research Institute and the Suzhou Kelun Pharmaceutical Research Institute[5] - The company has a diverse portfolio of subsidiaries, including those focused on biotechnology, agricultural development, and medical technology[5] - The company's subsidiaries are engaged in both domestic and international markets, with entities like Kelun International Development Co., Ltd.[5] - The company's subsidiaries are involved in various stages of the pharmaceutical supply chain, from research and development to sales and distribution[5] - The company's subsidiaries include entities focused on packaging, such as Heilongjiang Kelun Pharmaceutical Packaging Co., Ltd.[5] - Kelun Pharmaceutical has subsidiaries such as Kelun International Medicine, Qingshan Likang Medicine, and Kelun Botai Biopharmaceutical[6] Company Information - Kelun Pharmaceutical's stock code is 002422, listed on the Shenzhen Stock Exchange[9] - The company's registered address is at the South Second Road, Xindu Satellite City Industrial Development Zone, Chengdu, with a postal code of 610500[9] - Kelun Pharmaceutical's office is located at No. 36 Baihua West Road, Qingyang District, Chengdu, with a postal code of 610071[9] - The company's website is http://www.kelun.com, and the email address is kelun@kelun.com[9] - The Board Secretary is Feng Hao, and the Securities Affairs Representative is Wang Mengran[10] - The company's legal representative is Liu Gexin[9] - Kelun Pharmaceutical's annual report is disclosed on the Shenzhen Stock Exchange website and major financial newspapers[12] - The company has not changed its main business or controlling shareholders since its listing[13] Financial Performance - Revenue for 2023 reached RMB 21.45 billion, a 12.69% increase compared to the adjusted 2022 revenue of RMB 19.04 billion[15] - Net profit attributable to shareholders in 2023 was RMB 2.46 billion, a 44.03% increase from the adjusted 2022 figure of RMB 1.71 billion[15] - Operating cash flow surged by 70.68% to RMB 5.34 billion in 2023, compared to RMB 3.13 billion in 2022[15] - Total assets grew by 6.57% to RMB 36.45 billion at the end of 2023, up from RMB 34.21 billion in 2022[16] - Shareholders' equity increased by 25.03% to RMB 19.67 billion in 2023, compared to RMB 15.73 billion in 2022[16] - Basic earnings per share rose by 38.52% to RMB 1.69 in 2023, up from RMB 1.22 in 2022[15] - Weighted average return on equity improved to 14.07% in 2023, up 2.37 percentage points from 11.70% in 2022[15] - Government subsidies received in 2023 amounted to RMB 159.82 million, a decrease from RMB 178.43 million in 2022[21] - The company's total revenue for 2023 was 21.46 billion yuan, with a year-on-year increase of 7.38%[92] - The revenue from the infusion products segment was 10.11 billion yuan, accounting for 47.12% of total revenue, with a year-on-year growth of 6.96%[91] - The revenue from non-infusion products was 9.06 billion yuan, accounting for 42.21% of total revenue, with a year-on-year growth of 7.85%[91] - The revenue from R&D projects increased significantly by 105.95% to 1.55 billion yuan[91] - International business revenue surged by 84.80% to 2.59 billion yuan, accounting for 12.06% of total revenue[91] - The gross profit margin for the pharmaceutical manufacturing industry was 53.45%, with a slight increase of 0.98% compared to the previous year[92] - The sales volume of infusion products increased by 10.60% to 4.38 billion bottles/bags, while production volume increased by 11.58% to 4.47 billion bottles/bags[94] - The company's direct sales revenue was 9.89 billion yuan, accounting for 46.11% of total revenue, with a year-on-year growth of 9.45%[91] - The cost of R&D projects increased by 197.37% to 748.82 million yuan, reflecting the company's increased investment in innovation[95] R&D and Innovation - Kelun Pharma has invested a cumulative total of 12.3 billion yuan in R&D innovation since 2013[26] - Kelun Pharma has 646 varieties of pharmaceutical products with 1022 specifications, including 135 varieties of infusion products with 297 specifications[33] - Kelun Pharma has 47 varieties (67 specifications) selected in the national centralized drug procurement, making it one of the top suppliers[26] - Kelun Pharma's self-developed Keli Bag® has 270 patents and has won the National Science and Technology Progress Award[24][25] - Kelun Pharma's production line has obtained GMP certification from Japan's PMDA, allowing sales in Japan[25] - Kelun Pharma has 6 enterprises selected as green factories in the Ministry of Industry and Information Technology's green manufacturing system construction demonstration[23] - Kelun Pharma has established a large-scale industrial production system in the antibiotic intermediate field, with products such as thiocyanate erythromycin and cephalosporin intermediates ranking among the top globally[25] - Kelun Pharma has 308 varieties of drugs listed in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2023 edition)[33] - Kelun Pharma has 135 varieties of drugs included in the National Essential Drug List (2018 edition)[33] - Kelun Pharma has 67 varieties of drugs listed in the OTC drug catalog[33] - The company signed an innovative R&D project cooperation agreement with MSD, resulting in increased revenue and profits[37] - The company increased its R&D expenses year-on-year, continuing to advance its "innovation-driven" strategy[38] - The company has established a comprehensive R&D system with multiple technology categories and full-function platforms, focusing on high-end generics and innovative research[43] - The company's R&D efficiency improved significantly, with 45 generic drugs approved for production and 4 approved for clinical trials in 2023[49] - The company's cumulative number of products selected in national centralized drug procurement reached 47 (67 specifications) by the 9th round[50] - Kelun Pharma's new drug approvals include Ethylsulfonic Acid Nintedanib Soft Capsule for systemic sclerosis-related interstitial lung disease and progressive fibrosing interstitial lung disease, becoming the second approved manufacturer[52] - Fumarate Vonoprazan Tablets for acid-related gastrointestinal diseases were approved for production, making Kelun the third manufacturer[52] - Kelun Pharma's Cefmetazole Sodium/Sodium Chloride Injection for bacterial infections was approved for production, also as the third manufacturer[52] - Gadobutrol Injection for diagnostic imaging was approved for production, with Kelun being the third manufacturer[52] - Enzalutamide Soft Capsule for tumors was approved for production, making Kelun the third manufacturer[52] - Kelun Pharma's Citicoline Sodium Injection passed the consistency evaluation as the first manufacturer, targeting consciousness disorders after craniocerebral trauma and brain surgery[52] - Lactated Ringer's Injection (Hunan Kelun) passed the consistency evaluation as the first manufacturer, used for fluid balance[52] - Amino Acid Glucose Injection passed the consistency evaluation as the first manufacturer, targeting parenteral nutrition[52] - Kelun Pharma's ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acid (16)/Glucose (30%) Injection for parenteral nutrition is under production application as the first generic[54] - Rotigotine Transdermal Patch for Parkinson's disease is under production application as the first generic[54] - 6 clinical studies were approved by NMPA in 2023, including 1 first-time clinical approval and 5 new or combination therapy approvals[58] - SKB410 for advanced solid tumors received clinical approval in February 2023[58] - SKB264/MK-2870 combined with Osimertinib for EGFR-mutated non-small cell lung cancer received clinical approval in January 2023[58] - KL590586 capsule (A400) for medullary thyroid cancer received clinical approval in July 2023[58] - SKB264 for EGFR-TKI treatment-failed EGFR-mutated non-squamous non-small cell lung cancer received clinical approval in July 2023[58] - SKB264 combined with A167 for HR+/HER2- breast cancer received clinical approval in September 2023[58] - 30+ innovative drug projects are under development, focusing on oncology, autoimmune, inflammatory, and metabolic diseases[57] - Injection of Paclitaxel (Albumin-bound) has been approved for market launch[56] - Bupivacaine Liposome Injection has been submitted for production approval[56] - Multiple products, including Aripiprazole Long-Acting Injection and Brexpiprazole Oral Film, are undergoing clinical studies[56] - SKB264 received its fourth Breakthrough Therapy Designation (BTD) in March 2024 for first-line treatment of unresectable locally advanced, recurrent, or metastatic PD-L1 negative TNBC patients[60] - SKB264's Phase III registration study for TNBC completed enrollment in August 2023 and met its primary endpoint[63] - SKB264's New Drug Application (NDA) for TNBC was accepted by the NMPA in December 2023 and included in the priority review and approval process[63] - SKB264's Phase II expansion study data for TNBC was presented at the SABCS conference in December 2023[64] - SKB264's Phase III registration study for HR+/HER2- breast cancer (2L+) was initiated in November 2023[65] - A166's NDA for HER2+ breast cancer (3L+) was accepted by the NMPA in May 2023, and its Phase III study for HER2+ breast cancer was initiated in June 2023[69] - A140's market application was accepted by the NMPA in September 2023, making it the first domestic cetuximab biosimilar to apply for market approval[59] - A400's Phase II study for NSCLC was initiated in Q2 2023, and its Phase I data for RET-altered advanced solid tumors was presented at the ASCO annual meeting in June 2023[70] - SKB264's Phase II study for EGFR-mutant NSCLC (2L) and Phase II registration study (3L) were approved and initiated enrollment in the second half of 2023[66] - SKB264's Phase II basket study for NSCLC, including a cohort combining with osimertinib, was approved by the NMPA in January 2023[68] - The company's R&D pipeline includes A400 for RET fusion-positive solid tumors, A296 (STING agonist) in Phase I, and A223 (JAK1/2 inhibitor) for rheumatoid arthritis and alopecia areata in Phase II[71] - The company's R&D personnel increased to 2,612 in 2023, up 2.27% from 2,554 in 2022[114] - R&D investment reached 1,952,595,769 yuan in 2023, a 7.59% increase from 1,814,894,798 yuan in 2022[115] Sales and Marketing - The company's sales model has shifted from service-oriented to business expansion-oriented, supported by a nationwide sales layout[36] - The company's marketing strategy shifted from product sales to brand marketing, focusing on patient-centered and clinical value-oriented approaches[77] - The company's infusion business achieved sales revenue of 10.109 billion yuan, a year-on-year increase of 6.96%, with sales volume reaching 4.378 billion bottles/bags, up 10.60% year-on-year[78] - Levofloxacin Sodium Chloride Injection, a new consistency evaluation product, generated sales revenue of 488 million yuan, a year-on-year increase of 8.01%, ranking first in market share among selected companies in the national centralized procurement[78] - Moxifloxacin Hydrochloride Sodium Chloride Injection saw a sales volume increase of 175.11% year-on-year due to market recovery and expanded centralized procurement regions[78] - The parenteral nutrition segment sold over 20 million bags in 2023, with the three-chamber bag "Duozhen" achieving sales of 6.13 million bags[78] - Non-infusion drug sales revenue decreased by 6.93% to 3.955 billion yuan[80] - Sales revenue of male health product (Dapoxetine Hydrochloride Tablets) dropped by 84.07% to 34 million yuan[80] - Sales revenue of Kangfuxin Liquid declined by 36.17% to 227 million yuan[80] - Sales revenue of Escitalopram Oxalate (Bailuote) fell by 43.57% to 194 million yuan[80] - Sales volume of Albumin-bound Paclitaxel for Injection (Kerui Fei) increased by 93.19% despite a 32.74% drop in sales revenue[81] - Empagliflozin Tablets (Ketang En) sales revenue surged by 79.46% to 224 million yuan[81] - Plastic water needle sales reached 652 million units, up 20.78%[81] - Antibiotic intermediates and APIs revenue grew by 23.78% to 4.843 billion yuan[84] - Overseas revenue increased by 83.97% to 2.572 billion yuan[86] - Total operating revenue rose by 12.69% to 21.454 billion yuan[90] - The company's total revenue for 2023 was 21.46 billion yuan, with a year-on-year increase of 7.38%[92] - The revenue from the infusion products segment was 10.11 billion yuan, accounting for 47.12% of total revenue, with a year-on-year growth of 6.96%[91] - The revenue from non-infusion products was 9.06 billion yuan, accounting for 42.21% of total revenue, with a year-on-year growth of 7.85%[91] - The revenue from R&D projects increased significantly by 105.95% to 1.55 billion yuan[91] - International business revenue surged by 84.80% to 2.59 billion yuan, accounting for 12.06% of total revenue[91] - The gross profit margin for the pharmaceutical manufacturing industry was 53.45%, with a slight increase of 0.98% compared to the previous year[92] - The sales volume of infusion products increased by 10.60% to 4.38 billion bottles/bags, while production volume increased by 11.58% to 4.47 billion bottles/bags[94] - The company's direct sales revenue was 9.89 billion yuan, accounting for 46.11% of total revenue, with a year-on-year growth of 9.45%[91] - The cost of R&D projects increased by 197.37% to 748.82 million yuan, reflecting the company's increased investment in innovation[95] Corporate Governance - The company's board of directors consists of 7 members, including 3 independent directors, and has established five specialized committees to provide professional opinions for decision-making[162] - The company has a complete supply, R&D, production, and sales system, operating independently and making decisions autonomously without interference from controlling shareholders[167] - The company's assets are independent and complete, with no instances of being occupied by shareholders or related parties[168] - The company has an independent and complete labor, personnel, and salary management system, with senior management and financial personnel working exclusively for the company[169] - The company has established functional departments that are independent in personnel, office space, and management systems, free from interference by shareholders or other entities[170] - The company has an independent financial department with dedicated personnel, an independent financial accounting system, and operates independently without sharing bank accounts with controlling shareholders or related parties[171] - The participation rate of investors in the 2023 First Extraordinary General Meeting was 48.47%[172] - The participation rate of investors in the 2023 Second Extraordinary General Meeting was 46.68%[172] - The participation rate of investors in the 2022 Annual General Meeting was 46.68%[173] - The participation rate of investors in the 2023 Third Extraordinary General Meeting was 46.68%[173] - Chairman Liu Gexin holds 379,128,280 shares, with no changes during the reporting period[174] - Director and General Manager Liu Sichuan holds 8,346,286 shares, with no changes during the reporting period[174] - Vice President and Board Secretary Feng Hao increased his holdings by 37,000 shares, totaling 511,068 shares[175] - Vice President and CFO Lai Degui increased his holdings by 37,000 shares, totaling 525,698 shares[175] - The total number of shares held by directors, supervisors, and senior executives at the end of the period was 389,740,199[175] - Director Shao Wenbo resigned on March 1, 2024, due to personal reasons[176] - Liu Gexin, born in 1951, is the Chairman and Party Secretary of the company, with a postgraduate degree and senior engineer title. He has been the Chairman since 1996 and has received numerous awards and honors, including the National Labor Model in 2005 and the National Science and Technology Progress Award in 2015[177] - Liu Sichuan, born in 1984, is the Director and General Manager of the company, with a master's degree. He has been the General Manager since 2015 and has received several awards, including the National Advanced Individual in the Fight