甘李药业股份有限公司 2024 年第三季度报告 证券代码：603087 证券简称：甘李药业 甘李药业股份有限公司 2024 年第三季度报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： 公司董事会、监事会及董事、监事、高级管理人员保证季度报告内容的真实、准确、完整，不存 在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务信息 的真实、准确、完整。 第三季度财务报表是否经审计 □是 √否 1 / 13 甘李药业股份有限公司 2024 年第三季度报告 一、 主要财务数据 | --- | --- | --- | --- | --- | --- | |----------|---------------------------------------|-------------------|---------------------------------------|---------------------------| ...

Financial Performance - Revenue for the first half of 2024 reached 13.15 billion yuan, a year-on-year increase of 6.92%[2] - Net profit attributable to shareholders of the listed company was 2.99 billion yuan, a year-on-year increase of 122.80%[2] - Revenue for the first half of 2024 reached 1,314,892,845.25 yuan, a 6.92% increase compared to the same period last year[19] - Net profit attributable to shareholders of the listed company was 298,904,095.07 yuan, a significant increase of 122.80% year-over-year[19] - Operating income for the reporting period was 1.315 billion yuan, an increase of 6.92% year-on-year[22] - Net profit attributable to shareholders of the listed company increased significantly to 299 million yuan, driven by gains from changes in the fair value of financial assets and investment income[22] - The company achieved a revenue of 1,314.89 million yuan in the first half of 2024, a year-on-year increase of 6.92%, with domestic sales revenue reaching 1,188.33 million yuan, up 10.70% year-on-year[45] - The company's net profit attributable to shareholders was 298.90 million yuan in the first half of 2024, a significant year-on-year increase of 122.80%[45] - Total revenue for the first half of 2024 reached 1,314,892,845.25 RMB, a 6.9% increase compared to 1,229,765,113.65 RMB in the same period of 2023[161] - Net profit attributable to the parent company's shareholders in H1 2024 was 298,904,095.07 RMB, a 122.8% increase from 134,155,242.69 RMB in H1 2023[161] - Basic earnings per share (EPS) for H1 2024 was 0.51 RMB, up 112.5% from 0.24 RMB in H1 2023[162] R&D and Innovation - R&D investment in the first half of 2024 was 2.77 billion yuan, accounting for 21.05% of revenue[2] - The company's GLP-1 receptor agonist GZR18 showed a 17.29% weight reduction in Phase IIb clinical trials[2] - The company's GZR101 injection, a novel premixed dual insulin formulation, is under development for the treatment of diabetes[11] - GZR18 injection, a once-weekly GLP-1RA, has been approved for clinical trials targeting type 2 diabetes and obesity/overweight[12] - The company is developing GZR4 injection, a once-weekly ultra-long-acting insulin formulation for diabetes treatment[12] - GLR1023 injection, a biosimilar targeting IL-17A, is in development for the treatment of moderate to severe plaque psoriasis[12] - The company's GZR18 tablet, an oral peptide formulation using novel absorption technology, is under development for type 2 diabetes[12] - The company is developing GZR18, GZR4, and GZR101 injections for diabetes treatment, aiming to enrich patient options and increase market share[34] - The company is researching a GLP-1RA weekly formulation for overweight/obesity, potentially enabling bi-monthly dosing and creating new profit growth opportunities[34] - The company's product pipeline includes research in eukaryotic and prokaryotic protein engineering, oncology, cardiovascular, and metabolic diseases[34] - The company's GZR18 injection for type 2 diabetes and obesity/overweight weight management entered Ib/IIa phase clinical trials in 8 months and II phase in 12 months, demonstrating high efficiency in project advancement[37] - The company's GZR101, GZR4, and GZR18 injections, as well as GZR18 tablets, are all in clinical trial stages, with GLR1023 injection accelerating towards phase I clinical trials[37] - The company's insulin products, including glargine, lispro, and aspart insulin injections, have received EMA approval for commercialization in the EU, marking the first time a domestic insulin analog has passed EMA GMP inspection[37] - The company's glargine, lispro, and aspart insulin injections have been accepted by the FDA for review in the US, with preliminary feedback received and ongoing improvements being made[37] - The company's GZR18 injection, a long-acting GLP-1RA, completed Phase I clinical trials in the US in March 2022[43] - GZR18 injection showed an average weight loss of 17.8% (QW) and 12.8% (Q2W) in Chinese obese subjects over 35 weeks, compared to a 0.7% weight gain in the placebo group[46] - GZR18 tablet completed the first dosing in a Phase I clinical trial for type 2 diabetes in April 2024, aiming to improve bioavailability and patient compliance[47] - GZR4 injection, a fourth-generation insulin analog, demonstrated 2-3 times better glucose-lowering effects compared to Icodec in preclinical studies[47] - GZR101 injection, a fourth-generation premixed dual insulin formulation, completed the first dosing in a head-to-head Phase II trial against Degludec/Aspart in December 2023[47] - GZR101, a dual insulin formulation, has completed two Phase I clinical studies and entered Phase II globally, showing potential for 72-hour glucose control with no significant peak after 24 hours at steady state[48] - GLR1023, a biosimilar of Secukinumab, received clinical trial approval in July 2023 and is expected to address the global psoriasis market, which has a prevalence of 2-3% and generated $4.98 billion in global sales in 2023[48] - Empagliflozin, an SGLT-2 inhibitor, had its market application accepted in July 2023, targeting a global market with $18.9 billion in sales in 2023 and projected growth to $2030[48] - Linagliptin, a DPP-4 inhibitor, had its market application accepted in May 2024, targeting a global market with $2.585 billion in sales in 2023 and a 22% growth in China[49] Market and Sales - The company secured 46.86 million units in the insulin procurement agreement, a 32.6% increase from the previous procurement[2] - The company's third-generation insulin analogs accounted for 30% of the total procurement volume for third-generation insulin[2] - The company completed high-quality product supply to countries with high insulin demand, promoting international market revenue growth[2] - The company's production facilities passed the EU GMP inspection, marking a significant step in internationalization[2] - Domestic preparation sales revenue increased by 10.36% to 1.147 billion yuan[22] - The company sold securities investments worth 644 million yuan, resulting in a total gain of 141 million yuan from fair value changes and disposal[22] - The fair value of the company's remaining securities investments at the end of the reporting period was 261 million yuan[22] - The company's products cover long-acting, rapid-acting, and premixed insulin functional segments, with a focus on diabetes diagnosis and treatment[26] - The national centralized procurement demand for third-generation insulin in 2024 is 168 million units, accounting for 70% of the total demand, a 36% increase compared to the previous procurement[30] - Second-generation insulin accounts for 30% of the total demand in 2024, a 12% decrease compared to the previous procurement[30] - The company's main products, including Glargine Insulin Injection and Aspart Insulin Injection, were selected as Category A in the national insulin procurement, with prices of 65.30 RMB and 25.90 RMB respectively[31] - The company secured a procurement volume of 3.534 million units in the 2022 insulin centralized procurement, gaining access to nearly 10,000 new medical institutions and capturing a significant share from foreign competitors[33] - In the 2024 insulin follow-up procurement, the company obtained a first-year agreement volume of 4.686 million units, a 32.6% increase from the previous procurement, with its third-generation insulin products accounting for 37% of the total third-generation insulin allocation[34] - The company's third-generation insulin procurement demand in the 2024 follow-up procurement reached 1.68 billion units, representing 70% of the total demand, a 36% increase from the first procurement, while second-generation insulin demand decreased by 18%[33] - The company expanded its grassroots market team by recruiting nearly 1,000 medical representatives to enhance terminal market coverage and provide better academic services[33] - Domestic insulin sales are steadily increasing due to the acceleration of third-generation insulin replacing second-generation and domestic products replacing imports, driven by the national centralized procurement policy[35] - The company has established a robust supply chain system, ensuring continuous and timely product supply, and has gained market recognition through excellent quality control processes[35] - The company successfully secured bids for six insulin products in the national insulin procurement, gaining higher agreement volumes and entering nearly 2,000 new medical institutions[45] - The company passed the EMA pre-approval GMP inspection in May 2024, showcasing its potential as an industry leader[43] - The company's international strategy focuses on expanding its global team, investing in local markets, and promoting local distribution to diversify its international presence[42] - The company has established stable business relationships with international pharmaceutical companies and is accelerating the registration of medical devices in emerging markets[44] - The company's first FDA-approved product is the disposable insulin pen needle (Xiu Lin Needle®)[43] - The global GLP-1RA market is expected to reach $155.6 billion by 2030, with significant growth potential in China[46] - GZR18 injection is positioned to become the world's first GLP-1RA bi-weekly formulation, with no similar products currently on the market[46] - The company has a robust commercialization strategy with a 2,000+ member academic promotion team and strong brand presence in the diabetes treatment market[47] - The company has sufficient land and facility reserves to meet future supply demands for both domestic and global markets[47] - The company's pre-mixed insulin products, Su Xiulin® 25 and Rui Xiulin® 30, have seen rapid growth due to China's centralized procurement policy, accelerating the replacement of second-generation insulin with third-generation insulin[48] - The company's insulin procurement demand for 2024 increased by 151% to 41.77 million units, with third-generation insulin accounting for 24% of the total demand, up 10 percentage points from the previous procurement cycle[50] - The company's meal-time and pre-mixed insulin products saw growth rates of 381% and 564%, respectively, in the 2024 insulin procurement cycle[50] - The price line for Class A products in the insulin market shows consistency between second-generation insulin and third-generation meal-time and premixed insulin analogs, with prices at 25.93 yuan per unit[51] - The national insulin procurement results for 2024 show that Novo Nordisk secured a significant portion of the market with 2,103.11 million units of meal-time insulin analogs at 35.55 yuan per unit[52] - Gan & Lee Pharmaceuticals achieved a substantial procurement volume of 1,701.56 million units for basal insulin analogs at 65.30 yuan per unit[53] - The total procurement demand for premixed insulin analogs in 2024 reached 7,294.65 million units, with Novo Nordisk leading with 3,458.28 million units at 35.55 yuan per unit[54] - Tonghua Dongbao secured a procurement volume of 639.49 million units for meal-time human insulin at 25.93 yuan per unit[55] - The total procurement demand for basal human insulin in 2024 was 119.75 million units, with Tonghua Dongbao accounting for 44.27 million units at 25.93 yuan per unit[56] - The company's first-year procurement demand for this round of centralized procurement is 41.77 million units, an increase of 25.13 million units compared to the previous round, with a growth rate of 151%[62] - The company's procurement agreement volume for this round of centralized procurement is 46.86 million units (base volume of 36.19 million units and allocated volume of 10.67 million units), an increase of 11.52 million units compared to the previous round, with a growth rate of 32.6%[64] - The company's first-year procurement demand for basal insulin analogs increased by 4.25 million units compared to the previous round, the highest growth among all products[57] - The company's first-year procurement demand for mealtime and premixed insulin analogs increased by 381% and 564%, respectively, compared to the previous round[59] - The company's market coverage has expanded to 37,000 medical institutions by the end of 2023, with an additional 2,000 new medical institutions added in this round of centralized procurement[65] - The company's third-generation insulin analogs accounted for 30% of the total third-generation insulin agreement volume, with a base volume of 34.38 million units and an allocated volume of 9.17 million units[64] - The total first-year procurement demand for this round of centralized procurement is 242 million units, an increase of 28 million units compared to the previous round, with a growth rate of 13%[60] - The price range for third-generation basal insulin analogs narrowed from a previous gap of 30.49 yuan to 13.78 yuan, promoting market competition and accessibility[57] - The company's third-generation insulin analogs accounted for 70% of the total first-year procurement demand, up from 58% in the previous round[61] - The company's third-generation basal insulin analogs saw the highest growth in first-year procurement demand, increasing by 19.75 million units compared to the previous round[61] - International sales revenue increased by 15.90% year-over-year, with optimized product structure and a breakthrough in the export volume of Aspart 30 Insulin Injection[68] - The company successfully entered the Latin American market as a MAH in Bolivia and Mexico, and launched Aspart 30 Insulin Injection in Bangladesh, marking significant progress in overseas localization[67] - The company passed the EMA pre-approval GMP inspection in May 2024, becoming the first domestic insulin analog injection to meet EU GMP standards, enabling commercial production of insulin products in the EU[68] - The company's three innovative drugs, GZR18, GZR4, and GZR101, showcased breakthrough data at the 84th ADA Scientific Sessions, enhancing global academic attention and market competitiveness[68] - The company accelerated the construction of the Linyi production base in Shandong, which includes biopharmaceutical, chemical drug, and medical device facilities, to meet growing market demand and expand global commercialization[69] - The company strengthened supply chain resilience through improved information management, supplier collaboration, and cost optimization, ensuring stable product supply and competitive pricing[71] - The company completed the submission for production of Lispro Insulin Injection and Protamine Zinc Recombinant Lispro Insulin Mixed Injection (25R) at the Shandong facility, with feedback received from the regulatory authority[69] - The company emphasized quality management, passing the EMA GMP inspection and optimizing quality systems to ensure compliance with international standards and enhance product safety[72] Cash Flow and Financial Position - Net cash flow from operating activities improved to 66,235,604.55 yuan, compared to a negative cash flow of -58,165,721.17 yuan in the same period last year[21] - Total assets as of the end of the reporting period were 11,952,557,407.70 yuan, a 2.03% increase from the end of the previous year[21] - The company's total equity attributable to shareholders of the listed company increased by 2.18% to 10,977,088,892.82 yuan compared to the end of the previous year[21] - Basic earnings per share increased by 112.50% to 0.51 yuan per share compared to the same period last year[22] - Diluted earnings per share also increased by 112.50% to 0.51 yuan per share compared to the same period last year[22] - Non-recurring gains and losses amounted to 171.997 million yuan, primarily from gains on financial assets and government subsidies[23] - Total liabilities increased by 19.9% to 688,718,956.65 RMB in H1 2024 compared to 574,335,901.27 RMB in H1 2023[160] - Total equity attributable to the parent company's shareholders grew by 2.6% to 11,930,707,803.72 RMB in H1 2024 from 11,627,383,916.05 RMB in H1 2023[160] - R&D expenses in H1 2024 were 266,476,949.60 RMB, a 1.7% increase from 261,962,985.39 RMB in H1 2023[161] - Sales expenses rose by 5.5% to 490,979,157.99 RMB in H1 2024 compared to 465,243,177.81 RMB in H1 2023[161] - The company's financial income improved significantly, with financial expenses decreasing to -41,637,912.64 RMB in H1 2024 from -54,143,382.04 RMB in H1 2023[161] - Fair value gains surged to 154,127,142.24 RMB in H1 2024, a 1456.5% increase from 9,902,075.97 RMB in H1 2023[161] - The company's total assets increased by 3.4% to 12,619,426,760.37 RMB in H1 2024 from 12,201,719,817.32 RMB in H1 2023[160] - Operating cash flow increased to RMB 66.24 million in H1 2024, compared to a negative RMB 58.17 million in H1 2023[164] - Sales revenue from goods and services reached RMB 1.33 billion in H1 2024, up from RMB 1.16 billion in H1 2023[164] - Investment cash inflow totaled RMB 4.65 billion in H1 2024, a significant increase from RMB 2.79 billion in H1 2023[164] - Net cash outflow from investment activities was RMB 198.23 million in H1 2024, compared to a net inflow of RMB 12.00 million in H1 2023[164] - Cash and cash equivalents decreased by

股 票 研 究 公 司 更 新 报 告 证 券 研 究 报 告 | | | | | | | |---------------------------------|-----------------------------------------|------------------------------------------|----------------------------|-----------|------------| | [Table_Industry] | | | | 医药 | /必需消费 | | (603087) | | | [Table_Invest] 评级: | | 增持 | | | 业绩超预期,海内外业务齐发力 | | [Table_Target] 目标价格: | 上次评级: | 增持60.03 | | —— | 甘李药业 2024H1 | 业绩预增公告点评 | [当前价格: Table_CurPrice] | 上次预测: | 60.0342.22 | | 丁丹](分析师) | 甘坛焕(分析师) | 姜铸轩(研究助理) | | | | | 0755-23976735 dingda ...

证券代码：603087 证券简称：甘李药业 公告编号：2024-058 甘李药业股份有限公司 2024 年半年度业绩预增公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： 1. 本期业绩预告适用于实现盈利，且净利润与上年同期相比上升 50%以上 的情形。 2. 甘李药业股份有限公司（以下简称"公司"）预计 2024 年半年度实现归属 于母公司所有者的净利润为 29,000.00 万元到 33,000.00 万元，与上年同期（法定 披露数据）相比，将增加 15,584.48 万元到 19,584.48 万元，同比增加 116.17%到 145.98%。 3. 公司预计 2024 年半年度实现归属于母公司所有者的扣除非经常性损益的 净利润为 11,000.00 万元至 14,000.00 万元,与上年同期（法定披露数据）相比， 将增加 777.89 万元到 3,777.89 万元，同比增加 7.61%到 36.96%。 一、本期业绩预告情况 （一）业绩预告期间 2024 年 1 月 1 日至 2024 年 6 月 ...

三代的预控预导出的增长是也非常明显然后从行业施加率的角度来看的话呃2024年一道数集采的这个当中呃接采的续约当中国产企业的需求总量是合计达到了45%呃是较低龙集采的时候是有14个点的提升呃也可以看到国产替代的这个趋势是在加速 公司这一笼的集财市占率的话是在达到了17%也叫上一笼这个集财的这个份额也是将近3倍然后在整个行业当中的话也是排名第二仅次于诺豪诺德然后从这个三代一道素与二代一道素的对比来看的话这个产品迭代升级的趋势也非常明显 这次集采续约当中三代的采购需求总量是1.68亿值是同比是叫上龙集采增长了36%三代一导速占比整体一导速的需求量是达到了70%是提升了12个百分点在三代一导速的采购量当中公司的市占率是24%相对上一次是提升了10个点 所以在国产替代叠加三代替代对于在一个产品趋势下更新的这个渗透的整个的一个比导速市场的市场占有率是一个比较大的一个提升然后从价格的角度来看的话这一轮的集采中选规则也是更加温和这次去标的这个价差基本上是在20块钱以内 然后相对于上一次的这个基材加差的话大概是在23到30块钱左右这次加差的这个明显缩小也会促进市场更加有趣的竞争在这个更窄的一个价格幅度内各个企业的竞争的话也会更 ...

国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 股 票 研 [Table_Industry] 医药/必需消费 究 甘 李药业(603087) [评Tab级le_I：nve st] 增持 GZR18 减重数据亮眼，研发管线加速推进 上 次评级: 增持 [目Tab标le_T价arg格et] ： 60.03 ——甘李药业跟踪点评 上 次预测: 59.78 [当Ta前bl价e_格Cu：rP rice] 50.94 公 [table_A ut丁ho丹rs] ( 分析师) 甘坛焕(分析师) 姜铸轩(研究助理) 司 0755-23976735 021-38675855 021-38674878 [ Table_Date] 2024.06.23 dingdan@gtjas.com gantanhuan028803@gtjas.com jiangzhuxuan029022@gtjas.com 更 登 记编号 S0880514030001 S0880523080007 S0880123100004 新 本报告导读： 报 [交Ta易ble数_M据ar ...

三代的预控预导出的增长是也非常明显然后从行业施加率的角度来看的话呃2024年一道数集采的这个当中呃接采的续约当中国产企业的需求总量是合计达到了45%呃是较低龙集采的时候是有14个点的提升呃也可以看到国产替代的这个趋势是在加速 公司这一笼的集财市占率的话是在达到了17%也叫上一笼这个集财的这个份额也是将近3倍然后在整个行业当中的话也是排名第二仅次于诺豪诺德然后从这个三代一道素与二代一道素的对比来看的话这个产品迭代升级的趋势也非常明显 这次集采续约当中三代的采购需求总量是1.68亿值是同比是叫上龙集采增长了36%三代一导速占比整体一导速的需求量是达到了70%是提升了12个百分点在三代一导速的采购量当中公司的市占率是24%相对上一次是提升了10个点 所以在国产替代叠加三代替代对于在一个产品趋势下更新的这个渗透的整个的一个比导速市场的市场占有率是一个比较大的一个提升然后从价格的角度来看的话这一轮的集采中选规则也是更加温和这次去标的这个价差基本上是在20块钱以内 然后相对于上一次的这个基材加差的话大概是在23到30块钱左右这次加差的这个明显缩小也会促进市场更加有趣的竞争在这个更窄的一个价格幅度内各个企业的竞争的话也会更 ...

公司研究 | 首次报告 甘李药业 603087.SH 买入 （首次） 基本盘量价齐升，出海与创新迎来突破 股价（2024年06月14日） 47.06元 目标价格 61.12元 52周最高价/最低价 62.9/32.1元 总股本/流通A股（万股） 60,120/53,226 A股市值（百万元） 28,293 核心观点 国家/地区 中国 行业 医药生物 ⚫ 集采影响释放，续标量价齐升迎新一轮成长。作为国产三代胰岛素领先企业，公司 报告发布日期 2024年06月17日 长期以来业绩增长优异，2023年，公司实现营收26.1亿元（+52%），归母净利润 3.4亿元，扭亏为盈。随着2022年胰岛素第一轮国采执行以来的影响出清以及 1周 1月 3月 12月 2024年第二轮集采续标落地，公司国内业务未来3年采购周期内的增长确定性加 绝对表现% -0.4 -4.08 10.39 26.94 强。本次集采续约中，公司产品中标量价齐升，采购需求总量较上轮集采增长 相对表现% 0.51 -0.92 10.97 35.29 151%，中选均价增长31%，盈利能力有望改善。 沪深300% -0.91 -3.16 -0.58 -8.3 ...

股 票 研 究 [Table_industryInfo] 医药/必需消费 [ Table_Main[ 甘TIna 李fbole] 药 _T 业itle (] 6 03087) [评Tab级le_：Inv est] 增持 上次评级： 增持 欧盟 GMP 检查通过，研发管线加速推进 目标价格： 60.03 上次预测： 60.03 公 ——甘李药业跟踪点评 当前价格： 48.49 司 丁丹(分析师) 甘坛焕(分析师) 姜铸轩(研究助理) 2024.05.31 更 0755-23976735 021-38675855 021-38674878 [交Ta易bl数e_据M arket] 新 dingdan@gtjas.com gantanhuan028803@gtjas.com jiangzhuxuan029022@gtjas.com 证书编号 S0880514030001 S0880523080007 S0880123100004 52周内股价区间（元） 33.10-59.60 报 总市值（百万元） 29,152 告 本报告导读： 总股本/流通A股（百万股） 601/532 流通B股/H股（百万股） 0/0 产品出海取 ...

[Table_StockInfo] 持有 2024年 05月 05日 （维持） 证券研究报告•2023年年报&2024年一季报点评 当前价： 50.04元 甘李药业（603087） 医药生物 目标价： ——元（6个月） 业绩符合预期，接续集采中标未来盈利可期 投资要点 西南证券研究发展中心 [T ab事le件_S：um公m司a发ry布] 2023 年报&2024 年一季报，2023 年实现收入 26.1 亿元 [分Ta析bl师e_：Au杜th向or阳] （+52.3%），归母净利润为 3.4 亿元（+177.4%），扣非归母净利润 3 亿元 执业证号：S1250520030002 （+162.8%）。2024Q1公司实现收入 5.6亿元（+0.4%），归母净利润 9600万 电话：021-68416017 元（+95%），扣非归母净利润1717万元（-42.9%） 邮箱：duxy@swsc.com.cn  2023年业绩符合预期。分季度来看，Q1/Q2/Q3/Q4分别实现收入5.6/6.7/6.8/7 分析师：王彦迪 亿元，同比-19.1%/+363.9%/+68.1%/+47.8%，各个季度收入呈环比逐 ...