Cinda Bio (02627) 2025 Interim Performance Report: Accelerating Commercialization and Achieving Breakthroughs in Research Pipeline Step by Step

On August 28, Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (hereinafter referred to as Zhonghui Bio; stock code: 02627) issued its first interim performance announcement after listing. The financial report shows that the company's core product, the quadrivalent influenza virus subunit vaccine - Huilikon Xin has achieved significant commercialization effectiveness, with revenue achieving a leap in growth, narrowing losses compared to the same period last year, and the research pipeline advancing as planned, with globalization gradually taking shape. The data shows that Zhonghui Bio's operating performance in the first half of the year has shown a significant improvement trend. The company achieved operating income of 71.12 million yuan in the first half of the year, an increase of 918.91% year-on-year. This significant growth is mainly attributed to the accelerated commercialization process of one of the company's core products, the quadrivalent influenza virus subunit vaccine (Huilikon Xin), and a one-time positive impact from the calibration adjustment of sales returns estimated in 2024. In terms of cost control, the company's sales costs decreased by 18.3% year-on-year, while the gross profit margin increased to 85.5%; the loss narrowed by 22% year-on-year, demonstrating a continuous improvement in profitability. Dual advancement of core products, significant clinical transformation effects As the commercialization pillar of the company, the quadrivalent influenza virus subunit vaccine (Huilikon Xin) has continued to deepen its market penetration. As the first and only domestically approved quadrivalent influenza subunit vaccine, since its commercialization started in September 2023, with excellent safety and immunogenicity, the batch issuance qualification rate has always been maintained at 100%. Through strengthening academic promotion and disease control channel construction, the product's coverage has expanded to 30 provinces, with the number of cooperating county-level disease control centers exceeding 1100, resulting in a rapid increase in market penetration. In terms of indication expansion, Huilikon Xin's strategy of covering the entire population has made key progress. The indication for infants aged 6-35 months has been submitted for NDA acceptance by the National Medical Products Administration in June 2024, and is expected to be approved in the third quarter of 2025, filling the market gap for subunit influenza vaccines in young children in China; the adjuvanted vaccine for people aged 65 and above has received clinical approval, which optimizes the immune response effect for the elderly population, further improving the product matrix. In terms of the research pipeline, the freeze-dried human rabies vaccine (human diploid cell) has entered the clinical sprint stage. This product uses the "safest cell culture medium" recommended by the World Health Organization, with a higher safety advantage compared to traditional Vero cell vaccines. It has already completed Phase I clinical trials and demonstrated good safety characteristics. Commercial production process transfer, process scale-up, process validation, and sample planting for Phase III clinical trials have all been completed. The vaccine also simultaneously develops Essen five-dose, Zagreb four-dose, and simplified four-dose immunization regimens, which can meet the vaccination needs in different scenarios and significantly improve market adaptability. Gradient layout of the research and development pipeline, acceleration of global commercialization layout Zhonghui Bio has built a diversified pipeline matrix covering 11 vaccines in development, forming a development pattern of "late-stage clinical, mid-stage clinical, early-stage clinical, pre-clinical," with multiple key milestones expected to be reached intensively from 2025 to 2026. In the field of influenza vaccines, the trivalent influenza virus subunit vaccine for the age group of 3 years and above, as well as the NDA for the age group of 6-35 months have been accepted; the trivalent influenza adjuvanted vaccine for people aged 65 and above has received clinical approval, continuously consolidating the technical advantages in the field of influenza vaccines. In other high-demand areas, the company's pipeline progress is progressing orderly: the 23-valent pneumococcal polysaccharide vaccine (PPSV23) has entered the preparation stage for Phase III clinical samples; the recombinant herpes zoster vaccine (CHO cells) has entered Phase II clinical trials; the recombinant RSV vaccine (CHO cells) received IND approvals from the National Medical Products Administration and the FDA in August 2025, marking the alignment of research and development standards with international standards. The mRNA technology platform layout is accelerating, with RSV-mRNA vaccines undergoing preclinical research and intended to be classified as a new drug in both China and the United States. Preclinical projects for varicella attenuated live vaccines, adsorbed tetanus toxin vaccines, among others, are also progressing as planned, expanding the breadth and depth of the research and development pipeline. In terms of research and development, the company maintains stable investment, with research and development expenses totaling 98.848 million yuan in the first half of the year. The core research and development team is led by scientists with nearly 35 years of industry experience, and 46.1% of the research and development personnel have doctoral or master's degrees, providing solid talent support for pipeline advancement. In terms of commercialization layout, in addition to building its own sales and marketing team domestically, in the international market, leveraging the staggered flu seasons in South America, Southeast Asia, and China to efficiently release production capacity. The company obtained a registration certificate in Macau in 2024, and the registration process in the Philippines has started smoothly. In 2025, the company plans to enter the markets of Indonesia, Thailand, and Uruguay, and in 2026, expand to Canada, Singapore, Mexico, and Hong Kong, gradually forming a global sales network. Looking ahead, with the approval of the low-age indication for the influenza vaccine, the entry of the rabies vaccine into Phase III clinical trials, and the gradual investment of funds into the market, the company is expected to continue to strengthen its competitive advantage in the high-growth vaccine track, injecting new vitality into industry innovation.