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三诺生物:二代产品国内获批、FDA审批受理,CGM海内外催化剂有序兑现
300298Sinocare(300298) 华福证券·2024-12-27 03:59

Investment Rating - Buy (Maintained Rating) [8][15] Core Views - The company's second-generation CGM (Continuous Glucose Monitoring) product has been approved domestically and is under FDA review, with catalysts both domestically and internationally expected to drive growth [5] - The second-generation CGM product features improved performance and user experience, utilizing third-generation direct electron transfer technology, which offers advantages such as low potential, oxygen independence, fewer interferences, better stability, and higher accuracy [5] - The product is designed for integration with Automated Insulin Delivery (AID) systems and targets the US market, which is the largest CGM market globally, with significant growth potential post-registration [4][14] - The company has secured a 7-year distribution agreement with a major European distributor, and both semi-automated and fully automated production lines are operational, positioning the company to capitalize on the global CGM market [6] Financial Performance and Projections - Revenue is projected to grow from 4,059 million RMB in 2023 to 5,928 million RMB in 2026, with a CAGR of 19% [7][10] - Net profit attributable to the parent company is expected to increase from 284 million RMB in 2023 to 635 million RMB in 2026, with a CAGR of 24% [7][10] - EPS is forecasted to rise from 0.50 RMB in 2023 to 1.13 RMB in 2026 [7][10] - The company's gross margin is expected to remain stable at around 54%, with net profit margin improving from 4.8% in 2023 to 11.0% in 2026 [10] Market and Industry Insights - The US CGM market is projected to grow from 2.7 billion USD in 2020 to 15.4 billion USD in 2030, with a CAGR of 19% [4] - The European CGM market is expected to expand from 1.2 billion USD in 2020 to 7.8 billion USD in 2030 [4] - The company's CGM product has received regulatory approval in China and is under FDA review in the US, with significant commercialization potential in the US market [13][14] Operational and Strategic Developments - The company has received regulatory approval for its CGM system in China, including an 8-day version for medical institutions and a 15-day version for home use [13] - The FDA has accepted the company's CGM product for substantive review, marking a key milestone in its US market entry [13] - The company has established both semi-automated and fully automated production lines, enhancing its capacity to meet global demand [6]