| 证券代码：002422 | 证券简称：科伦药业 | 公告编号：2023-096 | | --- | --- | --- | | 债券代码：127058 | 债券简称：科伦转债 | | 四川科伦药业股份有限公司 关于子公司核心产品SKB264(MK-2870)用于治疗既往经二线及以上标 准治疗的不可手术切除的局部晚期、复发或转移性TNBC患者的Ⅲ期 临床试验达到主要研究终点的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记载、误导性陈 述或重大遗漏。 四川科伦药业股份有限公司（以下简称"公司"或"科伦药业"）董事会从 公司控股子公司四川科伦博泰生物医药股份有限公司（以下简称"科伦博泰生 物",股票代码：6990.HK）获悉，独立数据监查委员会（IDMC）达成结论，注射 用SKB264（又称MK-2870）对比研究者选择方案用于治疗既往经二线及以上标准 治疗的不可手术切除的局部晚期、复发或转移性三阴性乳腺癌（TNBC）患者的随 机、对照、开放性、多中心Ⅲ期临床试验（以下简称"该试验"）已达到主要研 究终点，即独立审查委员会（IRC）评估的无进展生存期（PFS）。在预先设定的 期中分析中， ...

| 证券代码：002422 | 证券简称：科伦药业 | 公告编号：2023-095 | | --- | --- | --- | | 债券代码：127058 | 债券简称：科伦转债 | | 四川科伦药业股份有限公司 （2）粉体室：1.5g（按C16H16N4O8S计）；液体室：100ml∶0.9g 申请事项：药品注册（境内生产） 注册分类：化学药品4类 关于子公司注射用头孢呋辛钠/氯化钠注射液获得药品注册批准的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记载、误导性陈述或重 大遗漏。 四川科伦药业股份有限公司（以下简称"公司"或"科伦药业"）子公司湖南科伦 制药有限公司的化学药品"注射用头孢呋辛钠/氯化钠注射液"于近日获得国家药品监 督管理局的药品注册批准，现将相关情况公告如下： 一、药品基本情况 1. 药品名称：注射用头孢呋辛钠/氯化钠注射液 剂型：注射剂 规格：（1）粉体室：0.75g（按C16H16N4O8S计）；液体室：100ml∶0.9g 《2021 WSES/GAIS/SIS-E/WSIS/AAST全球临床路径：腹腔内感染》等国内外权威指南 或专家共识推荐使用。注射用头孢呋辛 ...

Group 1: R&D Pipeline Overview - 33 drugs are currently under research, with 14 in clinical trials and 4 ADCs entering clinical phases [2] - 1000+ patients are involved in Phase 3 clinical trials, with 166 drugs entering single-arm registration applications [2] - Milestones for 2023 include the initiation of single-arm trials for RET+ NSCLC and the advancement of multiple drugs towards NDA submissions [2] Group 2: Q&A Highlights - SKB264 is being developed for EGFR mutation-positive NSCLC, with a focus on PFS as the primary endpoint in Phase 3 trials involving 356 patients [3] - The company is exploring the combination of SKB264 with PD-1 inhibitors, emphasizing safety and efficacy [4] - The ongoing collaboration with MSD is aimed at optimizing clinical development and biomarker analysis [5] Group 3: Product Development and Market Strategy - The company plans to establish a commercialization team targeting breast cancer and lung cancer, with an expected team size of 1000 by 2025 [5] - The ADC production process is complex, with a strong CMC team ensuring core production capabilities are maintained in-house [5] - The company is confident in the growth of the Chinese innovative drug market, driven by an aging population and increasing healthcare investments [5]

四川科伦药业股份有限公司投资者关系活动记录表 编号：0065 | | □特定对象调研 □分析师会议 | | --- | --- | | 投资者关系活 | □媒体采访 √业绩说明会 | | | □新闻发布会 □路演活动 | | 动类别 | □现场参观 | | | □其他：电话调研 | | 参与单位名称 | 本次业绩说明会以网络互动方式在同花顺路演平台召开（网址： | | 及人员姓名 | https://board.10jqka.com.cn/rs/pc/detail?roadshowId=1004568）。 | | 时间 | 2023 年 4 月 27 日 15：00-16：00 | | 地点 | 线上 | | | 公司董事长刘革新，独立董事任世驰，副总经理兼营销中心总经理樊文弟， | | | 副总经理丁南超，副总经理兼财务总监赖德贵，副总经理兼董事会秘书冯 | | 上市公司接待 | 昊，科伦博泰副总经理兼首席战略官冯毅，科伦博泰首席财务官兼董事会 | | 人员姓名 | 秘书周泽剑，科伦药物研究院总经理赵栋，保荐代表人杨光远参加了本次 | | | 说明会。 | | | 公司就投资者对生产经营、研发进展、业绩情况 ...

Financial Performance - The company's revenue for Q1 2023 reached ¥5,601,800,088, representing a 24.98% increase compared to ¥4,482,032,531 in the same period last year[3] - Net profit attributable to shareholders was ¥810,322,186, a significant increase of 178.10% from ¥291,374,063 in the previous year[3] - Basic earnings per share rose to ¥0.56, up 180.00% from ¥0.20 in the same quarter last year[3] - Total comprehensive income for Q1 2023 was CNY 907,228,688, significantly higher than CNY 251,103,116 in Q1 2022[21] - Operating profit for the quarter was CNY 1,123,086,114, compared to CNY 333,467,173 in the previous year, marking a substantial increase[20] Cash Flow - The net cash flow from operating activities surged to ¥1,511,963,345, marking a dramatic increase of 3,488.95% compared to ¥42,128,261 in Q1 2022[3] - Total cash inflow from operating activities reached ¥6,988,169,723, compared to ¥4,994,414,494 in the same period last year, indicating a year-over-year growth of approximately 39.9%[23] - Cash outflow for operating activities was ¥5,476,206,378, up from ¥4,952,286,233, representing an increase of about 10.6%[23] - The company reported cash inflow from investment activities of ¥845,957,925, significantly higher than ¥379,149,814 in the previous year, marking a growth of approximately 123.5%[23] - The net cash flow from investment activities was negative at -¥474,721,399, worsening from -¥133,544,768 year-over-year[23] - Cash inflow from financing activities totaled ¥2,598,445,100, down from ¥4,922,444,738, indicating a decline of about 47.3%[23] - The net cash flow from financing activities was ¥166,550,914, a sharp decrease from ¥2,420,954,041 in the previous year[23] - The ending balance of cash and cash equivalents was ¥5,874,530,504, an increase from ¥5,122,279,640 year-over-year[23] - The company’s cash and cash equivalents increased by ¥1,202,980,668 during the quarter, compared to an increase of ¥2,322,270,851 in the same period last year[23] Assets and Liabilities - Total assets at the end of the reporting period were ¥36,105,504,505, reflecting a 5.82% increase from ¥34,118,379,816 at the end of the previous year[3] - The total liabilities amounted to CNY 17,510,071,026, a slight increase from CNY 17,230,414,051 in the previous year[19] - The company’s total equity rose to CNY 18,595,433,479, compared to CNY 16,887,965,765 in Q1 2022, reflecting a growth of 10%[19] - The company reported a decrease in sales expenses to CNY 1,159,695,620, down from CNY 1,206,013,558 in Q1 2022[20] - The company’s total liabilities decreased by 46.30% for non-current liabilities due within one year, amounting to ¥1,089,488,231[6] Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 35,017, with no preferred shareholders having restored voting rights[9] - Major shareholder Liu Gexin holds 25.77% of shares, totaling 379,128,280 shares, with 284,346,210 shares subject to trading restrictions[11] - Shareholder Hong Kong Central Clearing Limited holds 6.50% of shares, totaling 95,622,508 shares, all of which are unrestricted[12] - The top ten shareholders collectively hold a significant portion of the company's shares, indicating strong institutional interest[11] - The total number of shares held by the top ten unrestricted shareholders is 339,000,000 shares[12] Investment Management - The company has entrusted financial management with a total amount of 99,500,000 RMB, including 94,500,000 RMB in bank wealth management products and 5,000,000 RMB in large-denomination certificates of deposit[14] - The expected annualized return rate for structured deposits is 3.10% and 3.20%, with actual returns of 12.74 and 13.59 respectively[15] - The company has a total of 62,000,000 RMB in unexpired balances from entrusted financial management[14] - The company has no overdue amounts from entrusted financial management, indicating effective financial oversight[14] - The company is actively managing its investments through structured deposits, reflecting a strategic approach to capital allocation[15] Structured Deposits - Total structured deposits amounted to CNY 99,500 million, with a total interest of CNY 488.89 million for the reporting period[16] - The highest interest rate for structured deposits was 3.43%, offered by Chengdu Bank Shuangliu Gongxing Branch[16] - The total interest earned from structured deposits was CNY 313.58 million, with a significant portion from deposits maturing in the next few months[16] - The average interest rate across all structured deposits was approximately 3.20%[16] - The largest single structured deposit recorded was CNY 12,500 million, with an interest rate of 3.00%[16] - The total interest from structured deposits at Chengdu Bank Shuangliu Gongxing Branch reached CNY 89.56 million[16] - The structured deposits from the Transportation Bank Chengdu Xindu Branch totaled CNY 20,000 million, with an average interest rate of 3.05%[16] - The report indicates a focus on maintaining capital protection while offering floating returns on structured deposits[16] - The company plans to continue expanding its structured deposit offerings to enhance liquidity management[16] - The financial strategy includes leveraging high-interest structured deposits to optimize overall asset returns[16] Research and Development - R&D expenses increased to CNY 491,663,537, representing a 17.8% rise from CNY 417,052,131 in Q1 2022[20] - Kelun's innovative drug TROP2-ADC (SKB264) has been included in the list of "breakthrough therapy varieties" by the National Medical Products Administration, highlighting its potential in treating advanced NSCLC[17] Other Developments - The company received an upfront payment of USD 17.5 million from Merck for seven ongoing ADC projects, indicating progress in its collaboration with the pharmaceutical giant[17] - The company’s subsidiary, Kelun Botai, has submitted an application for an overseas IPO (H shares) to the China Securities Regulatory Commission, which has been accepted[17] - The company participated in the eighth batch of national centralized drug procurement, with seven products expected to win bids, indicating a strategic move to enhance market presence[17]

| 证券代码：002422 | 证券简称：科伦药业 | 公告编号：2023-061 | | --- | --- | --- | | 债券代码：127058 | 债券简称：科伦转债 | | 四川科伦药业股份有限公司 1 者通过上述参与方式进入"科伦药业2022年度业绩网上说明会"页面进行提问， 公司将在本次业绩说明会上对投资者普遍关注的问题进行回答。 投资者可以通过以下两种方式参与：1）电脑端登录同花顺路演平台，进入 直播间 https://board.10jqka.com.cn/rs/pc/detail?roadshowId=1004568 进行提问；2） 使用同花顺手机炒股软件扫描下方二维码进入路演直播间进行提问互动交流。 出席本次年度业绩说明会的嘉宾有： 董事长刘革新先生；独立董事任世驰先生；副总经理兼营销中心总经理樊文 弟先生；副总经理丁南超先生；副总经理兼财务总监赖德贵先生；副总经理兼董 事会秘书冯昊先生；科伦博泰副总经理兼首席战略官冯毅先生；科伦博泰首席财 务官兼董事会秘书周泽剑先生；科伦药物研究院总经理赵栋先生；长江证券保荐 代表人杨光远先生。 为广泛听取投资者的意见和建议，提升交流的针对性，现就 ...

Financial Performance - The total revenue for Sichuan Kelun Pharmaceutical Co., Ltd. in 2022 was reported at 10.5 billion RMB, representing a year-on-year increase of 15%[8]. - The company achieved a net profit of 1.8 billion RMB in 2022, which is a growth of 12% compared to the previous year[8]. - The company's operating revenue for 2022 was ¥18.91 billion, an increase of 9.46% compared to ¥17.28 billion in 2021[15]. - Net profit attributable to shareholders for 2022 reached ¥1.71 billion, reflecting a significant growth of 54.98% from ¥1.10 billion in 2021[15]. - The company reported a net cash flow from operating activities of ¥3.13 billion, which is a 9.85% increase from ¥2.85 billion in 2021[15]. - The company has set a revenue target of 12 billion RMB for 2023, reflecting a growth forecast of 14%[8]. - The company reported a significant increase in sales, with a growth rate exceeding 15 times in the Hubei province during the tenure of the marketing manager[178]. - The company achieved a net profit margin of 18% for 2022, reflecting effective cost management strategies implemented throughout the year[196]. Research and Development - The company has allocated 500 million RMB for R&D in 2023, emphasizing the development of new technologies in pharmaceutical manufacturing[8]. - The company has invested over 10.3 billion yuan in R&D innovation since 2013, with 12 subsidiaries recognized as national high-tech enterprises[27]. - The company launched over 400 drug research projects, including 380 generic and improved innovative drugs, and 33 innovative drugs[50]. - The company is committed to enhancing its R&D capabilities and expanding its market presence through innovative therapies and strategic clinical developments[96][97]. - Research and development expenses increased by 30% to 1.2 billion yuan, reflecting the company's commitment to innovation and new technology[173]. - The company aims to enhance its R&D system to address unmet clinical needs, focusing on differentiated products and cost advantages to support sales growth amid ongoing price pressures in the pharmaceutical sector[142]. Product Development and Market Expansion - The company plans to launch three new products in 2023, focusing on innovative drug delivery systems and biosimilars[8]. - Sichuan Kelun aims to increase its market share in Southeast Asia by 25% over the next two years through strategic partnerships and local collaborations[8]. - The company is focusing on expanding its presence in the oncology and anti-infection markets, with several new products targeting these therapeutic areas[54]. - The company is actively developing new products, with multiple drugs such as Sorafenib and Regorafenib in the production application stage, indicating a strong pipeline for oncology treatments[55]. - The company is exploring market expansion opportunities in Southeast Asia, targeting a revenue contribution of 5% from this region by 2024[173]. - The company plans to expand its market presence in parenteral nutrition products through academic promotion and terminal hospital development in 2023[74]. Risk Management - The company faces various risks including industry policy changes, market risks, environmental risks, R&D innovation risks, and quality control risks[2]. - The company has implemented a comprehensive risk management system to maximize project output value and ensure compliance with quality standards[138]. - Environmental risks are actively managed through comprehensive pollution control measures and emergency response plans, ensuring compliance with environmental regulations[143]. Corporate Governance - The board of directors consists of 8 members, including 3 independent directors, complying with legal regulations and the company's articles of association[152]. - The company respects and maintains the legitimate rights and interests of stakeholders, implementing various management systems to balance interests among shareholders, creditors, customers, suppliers, and employees[154]. - The company has established multiple information disclosure management systems to ensure compliance with relevant laws and regulations, enhancing transparency[156]. - The company has engaged with approximately 125 institutional investors online to discuss R&D, marketing, and capital operations[146]. Strategic Initiatives - The company is exploring potential acquisitions in the biotechnology sector to enhance its product portfolio and market presence[8]. - The company has implemented new strategies to improve operational efficiency, aiming to reduce costs by 8% across its manufacturing processes[173]. - The company aims to leverage its strong product pipeline to enhance revenue streams and improve overall financial performance in the coming years[54]. - The company is committed to enhancing its ESG initiatives, with plans to invest 100 million RMB in sustainability projects by 2025[8]. Shareholder Engagement - The company held its 2021 annual general meeting with a 50.32% investor participation rate on May 5, 2022, and a temporary meeting with 53.08% participation on September 13, 2022[161]. - The company has consistently reported losses on foreign exchange forward contracts, with losses ranging from -46.85 million CNY to -75.08 million CNY across various contracts[116]. Financial Management - The company raised a total of RMB 300,000 million through the issuance of convertible bonds, with a net amount of RMB 2,980,053,990.56 after deducting issuance costs[121]. - The company has not experienced any significant changes in project feasibility during the reporting period[123]. - The company has maintained compliance with the planned use of raised funds and has received clear consent from the supervisory board and independent directors for its financial activities[123].

Group 1: Research and Development - The company focuses on both generic and innovative product lines, with a significant emphasis on infusion drugs and new drug delivery technologies [2] - The R&D investment is substantial, with a structured approach to product lines in short, medium, and long-term phases aimed at achieving a competitive edge in new drug development [3] - The growth rate of large-volume infusion products is approximately 5-10%, driven by upgrades in packaging and optimization of product structure [3] Group 2: Market and Competition - The company plans to leverage its existing marketing network and learn from successful sales experiences of other companies [3] - The concentration of large-volume infusion production is expected to increase, with 90% of industry capacity held by leading companies, indicating a trend towards more orderly competition [4] - There are challenges in the domestic environmental regulations affecting antibiotic production, with land use and high fixed asset investment being significant barriers [3] Group 3: Financial and Operational Insights - The company is currently in a loss-making state due to underutilization of capacity, leading to high fixed asset depreciation costs [4] - The company is considering integrating intermediate and raw material drug sectors in the future, contingent on stable development [4] - The company anticipates that the rigid demand for large-volume infusions will persist despite national policy restrictions [3]

Group 1: Financial Support and Stability - The major shareholder provides financial support to the company, ensuring a stable operating environment and maintaining a good debt-to-equity ratio [2] - The company has over 1 billion in unused financing capacity, indicating strong financial health [2] - The major shareholder's financial assistance is aimed at enhancing the company's cash flow and ensuring liquidity [2] Group 2: Business Development Engines - The company identifies three main engines for growth: the infusion sector, the antibiotic industry chain, and innovation [3] - The infusion sector has completed over 100 new GMP certifications, indicating a focus on product quality and compliance [3] - The antibiotic industry aims to integrate the entire production chain, from raw materials to finished products, enhancing market competitiveness [3] Group 3: Research and Development - The research institute has nearly 500 personnel, ensuring a strong talent pool for innovation [4] - The company commits approximately 6% of its capital annually to R&D, supporting continuous product development [4] - The company plans to leverage both domestic and international resources to enhance its R&D capabilities [4] Group 4: Market Trends and Product Strategy - New packaging solutions, such as the three-chamber bag, are expected to capture significant market share, with over 50% of new packaging contributing to profitability [5] - The market potential for new packaging is estimated at around 3 billion units, indicating a substantial opportunity for growth [5] - The company aims to replace traditional plastic bottles with new packaging, which is anticipated to improve profit margins [5] Group 5: Challenges and Responses - The company faces challenges with rising accounts receivable turnover days due to changes in bidding processes and growth in non-infusion sectors [3] - The first quarter typically shows lower gross margins due to seasonal factors, including year-end bonuses and equipment maintenance [3] - The company is taking corrective actions to address any potential credit rating downgrades, ensuring transparency and compliance with audit requirements [5]

R&D Structure and Strategy - The research institute has undergone significant changes since the new director's arrival, shifting from a pure imitation strategy to a more innovative approach, dividing into four major functional areas and 17 technical departments [2][3]. - The four major functional areas include: 1. Product selection and project initiation, with an information department and a business development (BD) department to gather global preclinical research data [3]. 2. Pharmaceutical research, focusing on quality, synthesis, and formulation studies [3]. 3. Evaluation department, which includes pharmacology and clinical departments for drug efficacy and safety assessments [3]. 4. Administrative support functions, including project management and registration departments [3]. Workforce and Goals - The research institute currently employs approximately 470 people, with a target to reach 1,000 employees in the next 2-3 years [3]. - The institute has established a "five-in-one" research system across different regions in China to leverage local talent and resources [3]. Project Classification and Focus Areas - Projects are classified into three categories based on importance, with Category A being the most critical [4]. - The main research directions include: 1. Brand generic drugs, targeting drugs that are available abroad but not in China [4]. 2. New drug delivery systems, which are currently a global research hotspot [4]. 3. Biotech drugs, including innovative and brand generic drugs [4]. 4. Innovative small molecules and US generic drugs [4]. Regulatory Environment and Market Dynamics - The approval process for new drugs is expected to improve, with hopes for a three-year review period for new drug applications [5]. - The domestic market is characterized by a focus on quantity over price, contrasting with foreign markets where pricing is more critical [6][9]. Production and Environmental Considerations - The company is investing in environmental solutions to address odor issues and optimize production processes [12]. - The second phase of production is expected to have a capacity of 3,000 tons, with plans for trial production in the third quarter [12][13]. Sales and Market Strategy - The sales team is being strengthened to support the introduction of new products, particularly in the clinical phase [11]. - The company aims to enhance profitability in the infusion segment by focusing on high-end products and adjusting the product mix [10].