转自：证券时报 人民财讯10月27日电，华海药业(600521)10月27日公告，公司于近日收到国家药品监督管理局核准签发 的卡格列净片的《药品注册证书》，本品与盐酸二甲双胍联用：当单独使用盐酸二甲双胍血糖控制不佳 时，可与盐酸二甲双胍联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制；本品与盐酸二 甲双胍和磺脲类药物联用：当联用盐酸二甲双胍和磺脲类药物血糖控制不佳时，可与盐酸二甲双胍和磺 脲类药物联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制。 ...

华海药业公告，公司近日收到国家药监局核准签发的卡格列净片《药品注册证书》。卡格列净片主要用 于改善成人2型糖尿病患者的血糖控制。根据米内网数据预测，该药在2024年国内市场销售金额约为3.7 亿元。截至目前，公司在该药研发项目上已投入研发费用约564万元。此次注册证书的获得将进一步丰 富公司产品线，提升市场竞争力，对公司经营业绩产生积极影响。 ...

Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Views - The company's H1 2025 revenue reached 524 million yuan, a year-on-year increase of 21.3%, and net profit attributable to shareholders was 98 million yuan, up 21.9% [4]. - The company is progressing well in innovative drug development, with multiple catalysts expected within the year [4]. - The report anticipates stable profitability, with an expected increase in R&D investment in H2 2025, while maintaining controllable expense ratios [7]. Financial Summary - Total revenue projections for 2025 are estimated at 1,065 million yuan, with a year-on-year growth rate of 22.6% [6]. - The net profit for 2025 is projected to be 192 million yuan, reflecting an 8.8% year-on-year growth [6]. - The gross margin for H1 2025 was 83.8%, slightly down by 0.8 percentage points year-on-year [7]. Business Segments - The generic drug business showed revenue growth alongside structural optimization, with diabetes and hypertension drugs accounting for 98.6% of revenue in H1 2025 [7]. - The innovative drug segment is advancing, with the DYX116 project in Phase I clinical trials and DYX216 expected to submit an IND application by the end of 2025 [7]. - The company aims to obtain approximately seven new drug approvals annually from 2025 to 2027 [7].

Investment Rating - The investment rating for the company is "Outperform" (maintained) [2][4]. Core Views - The company has received approval for the innovative drug DYX116 for weight loss indications, accelerating its pipeline, with a projected net profit increase of 22% in H1 2025 [2][4]. - The company reported H1 2025 revenue of 525 million yuan, a year-on-year increase of 21.29%, and a net profit of approximately 97.8 million yuan, up 21.94% year-on-year [4]. - The sales volume of diabetes and hypertension products has steadily increased, with significant contributions from key products, and the company is set to benefit from the tenth batch of centralized procurement starting in March 2025 [5][6]. Financial Summary - Revenue projections for 2025-2027 have been revised upwards, with expected net profits of 194 million yuan, 214 million yuan, and 244 million yuan respectively, translating to EPS of 1.65, 1.82, and 2.08 yuan per share [4][8]. - The company’s gross margin is expected to remain strong, with estimates of 83.8% in 2025, and net profit margin projected at 19.1% [8][11]. - The company’s total market capitalization is approximately 4.927 billion yuan, with a current share price of 42.00 yuan [2].

Group 1: Investor Relations Activity Overview - The investor relations activity took place from June 12 to June 13, 2025, at the Westin Hotel in Beijing [4] - Attendees included major securities firms and funds such as Shenwan Hongyuan, Huano Investment, and CITIC Securities [4] - Company representatives included the Vice General Manager, Board Secretary, and Financial Officer, Mr. Wang Qibing [4] Group 2: Research and Development Budget - The estimated R&D budget for 2025 is CNY 163 million, with CNY 85 million allocated for innovative drugs and CNY 78 million for generic drugs [6] - The R&D focus will be on chronic disease treatments related to metabolic disorders, including diabetes and hypertension [6] Group 3: Drug Approval and Development - As of 2025, the company has obtained 4 drug registration certificates, including drugs like Sacubitril/Valsartan and Dapagliflozin [7] - Innovative drug DYX116 is in Phase I clinical trials, with expectations to complete by the end of 2025 [7] - DYX216, another innovative drug for resistant hypertension, has identified potential preclinical candidates [7] Group 4: Performance and Growth Factors - The company maintains steady growth due to strong marketing strategies and sales performance [8] - Sales of products like "Furuitong" and "Bokaiqing" continue to grow, contributing to overall performance [8] - Improved product gross margin due to increased production and reduced raw material costs [8] - Enhanced internal management and cost control measures have improved overall profitability [8]