疫苗研发

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研发十余年,中国女性终于等来“国产九价”
Nan Fang Du Shi Bao· 2025-06-04 23:58
Group 1 - The first domestically developed nine-valent HPV vaccine, "Cecolin®9," has been approved for market release in China, breaking a long-standing foreign monopoly on the market [2][6] - The incidence and mortality rates of cervical cancer in China have been rising over the past 30 years, with a notable trend towards younger demographics [3] - The nine-valent HPV vaccine provides over 98% protection against persistent infections from HPV types not covered by the bivalent vaccine, with a 100% protection rate against cervical infections [4] Group 2 - The development of the nine-valent HPV vaccine took 18 years, involving significant breakthroughs in technology and extensive clinical trials with over 11,000 participants [4] - The approval of the nine-valent HPV vaccine marks a significant advancement in China's biopharmaceutical sector, establishing the country as the second in the world, after the United States, capable of independently supplying high-cost HPV vaccines [6] - The World Health Organization's global strategy to accelerate the elimination of cervical cancer aligns with China's action plan, which emphasizes promoting HPV vaccination as a key objective [6]
研发费用增加、运营资金承压,康乐卫士去年仍亏损
Bei Ke Cai Jing· 2025-04-30 08:49
Core Viewpoint - 康乐卫士 is currently in a loss-making state with no products commercialized, reporting a revenue of 885,600 yuan in 2024, a decrease of 50.24% year-on-year, and a net profit of -357 million yuan, down 18.51% year-on-year [1] Group 1: Financial Performance - In 2024, 康乐卫士 reported a revenue of 885,600 yuan, a decline of 50.24% compared to the previous year [1] - The net profit attributable to the parent company was -357 million yuan, representing a year-on-year decrease of 18.51% [1] - The operating cash flow was -125 million yuan, indicating a reliance on external financing for working capital [3] Group 2: Research and Development - 康乐卫士 has a total of 9 vaccine candidates in development, including 8 recombinant protein candidates and 1 mRNA candidate [2] - Key products such as the trivalent HPV vaccine and the nine-valent HPV vaccines for both female and male indications have entered Phase III clinical trials [2] - The trivalent HPV vaccine's market approval application has been accepted by the National Medical Products Administration (NMPA) and is included in the priority review process [2] Group 3: Operational Strategy - 康乐卫士 is transitioning towards becoming a commercial pharmaceutical company and has established a production base in Kunming that meets GMP standards, with an annual production capacity of 10 million doses of the trivalent HPV vaccine and 30 million doses of the nine-valent HPV vaccine [2] - The company has introduced a systematic response plan to address the risk of insufficient working capital, which includes accelerating HPV vaccine development and commercialization, optimizing asset utilization, actively seeking financing, and enhancing internal management to reduce costs and increase efficiency [3] Group 4: Recent Developments - In the first quarter of 2024, 康乐卫士 reported a 90.51% decline in revenue, while the net profit attributable to the parent company increased by 18.12% year-on-year [4]