Moderna said on Tuesday the U.S. Food and Drug Administration will not review its approval application for its influenza vaccine. ...

Summary of the Conference Call for Bio Co., Ltd. Industry and Company Overview - The conference call focused on Bio Co., Ltd., specifically its developments in the African Swine Fever (ASF) vaccine sector, which is a critical area in the animal health industry. Key Points and Arguments 1. **Positive Results from ASF Vaccine Trials** Bio Co., Ltd. reported successful results from its subunit ASF vaccine attack experiment, where no deaths occurred among the immunized group under an 8,000 HAD virus attack, indicating a high protection rate. This sets a solid foundation for subsequent clinical trials and approvals [2][3]. 2. **Upcoming Clinical Trials** The company plans to conduct a second attack experiment on April 12, aiming to verify the vaccine's effectiveness throughout its lifecycle. The completion of the second clinical trial is expected by late May or early June [2][3]. 3. **Market Approval Timeline** If the results are favorable, the China National Center for Animal Health (CNCA) may participate in the review process, potentially accelerating the approval timeline. The company anticipates obtaining a temporary production license by mid to late 2026, allowing for large-scale production [2][3]. 4. **Pricing Strategy** The initial pricing for the ASF vaccine is set at 25 RMB per dose, which balances affordability for farmers and the technological uniqueness of the product. The expected gross margin is projected to exceed 50%, indicating strong profitability potential [2][5]. 5. **Competitive Advantages** Bio Co., Ltd. is currently the only company certified by the Chinese Academy of Sciences to conduct clinical trials for the ASF vaccine, providing a significant competitive edge. The involvement of CNCA in the process is expected to expedite market entry [2][6][7]. 6. **Collaboration in Vietnam** The company is collaborating with local firms in Vietnam to promote the ASF vaccine, addressing the issue of local pig populations infected with recombinant viruses. They expect to obtain production licenses within six months and begin sales within 18 months [2][9]. 7. **Future Developments in mRNA Vaccines** Bio Co., Ltd. is also working on an mRNA vaccine for feline infectious peritonitis, projected to be launched domestically by 2028. The company is collaborating with two major U.S. pharmaceutical companies, utilizing a revenue-sharing model that could yield significant returns [3][10]. 8. **Overall Business Outlook for 2026** The company anticipates explosive growth in the ruminant service sector in 2026, driven by the ASF vaccine's market entry. The poultry business remains stable, and overall, the company expects positive trends across its various segments [3][12]. Additional Important Information - The company is currently focusing on testing the vaccine primarily for piglets, with plans for further discussions regarding its application for sows based on feedback from breeding farms [5]. - The competitive landscape includes other companies like Jinyu Biological, which has completed clinical trials but may face delays in large-scale production due to additional trial requirements [8]. - The fourth quarter's specific data on other products like swine foot-and-mouth disease vaccines is pending, but the ASF vaccine is expected to drive sales of existing products [11].