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康泰生物(300601):PCV13获土耳其GMP认证 海外布局持续推进
Xin Lang Cai Jing· 2025-07-16 02:39
Core Viewpoint - The company’s PCV13 vaccine recently received GMP certification from the Turkish drug regulatory authority, indicating that the product meets the necessary conditions for entry into the Turkish market, which is expected to further open up the Turkish market and lay a solid foundation for expansion into surrounding markets in the Middle East and Africa [1][2][3] Event - On July 1, the company announced that its wholly-owned subsidiary, Minhai Biotech, received GMP certification for its 13-valent pneumococcal conjugate vaccine (PCV13) from the Turkish drug regulatory authority, confirming that the production facilities, processes, quality control, and quality management systems comply with Turkey's stringent drug production quality management standards [2] Company Expansion - The company has been continuously advancing its overseas business expansion, having reached cooperation agreements with over ten countries regarding the registration, promotion, commercialization, and technology transfer of products such as PCV13, PPSV23, varicella live attenuated vaccine, and quadrivalent vaccine [3] - The first batch of PCV13 finished products is expected to be successfully exported to Indonesia by August 2024. The recent GMP certification from Turkey signifies that the product is now eligible for entry into the Turkish market, which may further open up the international market for PCV13 and contribute to the company's overseas revenue growth [3] Sales Performance - In Q1 2025, the company achieved operating revenue of 645 million yuan, a year-on-year increase of 42.85%. The net profit attributable to the parent company was 22 million yuan, a year-on-year decrease of 58.51%. The net profit excluding non-recurring gains and losses was 17 million yuan, a year-on-year increase of 17.56%. The revenue and net profit excluding non-recurring items increased mainly due to steady sales of PCV13 and hepatitis B vaccines, along with contributions from new products such as human diploid rabies vaccine and varicella vaccine [4] - The decline in net profit attributable to the parent company was primarily due to a decrease in non-recurring gains such as government subsidies [4] Future Outlook - The company is optimistic about maintaining steady growth in performance driven by the sales of conventional vaccine products in the second half of the year, as it actively strengthens terminal sales and optimizes channel inventory while promoting the market entry of new products [4] - The company forecasts operating revenues of 2.963 billion yuan, 3.446 billion yuan, and 3.816 billion yuan for 2025 to 2027, representing year-on-year growth rates of 11.8%, 16.3%, and 10.8%, respectively. The net profit attributable to the parent company is expected to be 209 million yuan, 381 million yuan, and 526 million yuan, with corresponding year-on-year growth rates of 3.4%, 82.6%, and 38.3% [5]