This is worth reading in full 👇Champagne Joshi (@JoshWalkos):So the calls for RFK Jr. to resign didn’t come out of nowhere. A leaked April 3 “BIO Vaccine Policy Steering Committee” memo shows industry insiders openly plotting to “go to The Hill and lobby that it is time for RFK Jr. to go.” https://t.co/BFrc6CdiGQ ...

Summary of Key Points from the Conference Call Industry Overview - **Industry Focus**: The conference call primarily discusses the healthcare sector in China, particularly the medical technology (Medtech), in vitro diagnostics (IVD), retail pharmacies, hospitals, vaccines, and insulin markets [1][2]. Core Insights and Arguments Medtech - **Key Areas of Focus**: 1. Progress of capital equipment value-based procurement (VBP) and the trade-in policy [1] 2. Channel destocking trends [1] 3. Import substitution trends post-VBP, including intraocular lenses (IOLs) and IVD [1] - **VBP Impact**: The June bidding value data showed a year-on-year growth rate of 49%, but a month-on-month decline of 3%, indicating lower unit prices due to VBP [10]. IVD Market - **Weak Demand**: The IVD sector continues to face challenges, with a projected 20% year-on-year decline in the CLIA reagent market size for 2025 [19]. - **AmoyDx Performance**: AmoyDx is expected to grow against the trend due to its strong presence in compliant in-hospital sales channels, benefiting from the anti-corruption campaign [21]. Insulin Market - **Domestic Substitution**: The insulin industry has seen significant growth, particularly for insulin analogs from companies like Gan & Lee and THDB, which reported rapid revenue growth in 1Q25 [22]. Retail Pharmacies - **Market Pressure**: Retail pharmacies are under pressure due to strict reimbursement policies and weak consumer spending. However, there is a potential market-clearing trend expected by year-end [31]. Hospitals - **New Product Feedback**: Hospitals are seeing new product introductions, such as the new version of SMILE surgery and new PIOL products, which are expected to drive consumption recovery [1]. Vaccine Market - **Anti-Corruption Campaign**: The ongoing anti-corruption campaign within the CDC system is impacting vaccine demand and distribution channels [1]. Financial Performance and Estimates Earnings Revisions - **Mindray**: Annual earnings estimates revised down by 2.1% to 5.0% for 2025E-27E due to industry headwinds in medical equipment and IVD [2][37]. - **United Imaging**: Revenue and earnings forecasts adjusted down to reflect lower-than-expected bidding data [39]. - **SNIBE**: Earnings estimates revised down by 1.4% to 7.1% for 2025E-27E due to policy headwinds in the IVD sector [40]. Revenue Growth Expectations - **High Growth Companies**: THDB and Gan & Lee are expected to achieve the highest revenue growth due to a low base from VBP renewal in 2Q24 [6]. - **Mindray's Decline**: Mindray's China business is expected to decline by 26% year-on-year in 2Q25 due to IVD weakness [9]. Other Important Insights - **Trade-in Policy Concerns**: The trade-in stimulus fund is expected to run out, leading to a decline in applications and a reduced stimulus effect in the second half of 2025 [10]. - **Market Dynamics**: The healthcare market is experiencing a shift with increasing government support for procurement and a focus on innovative products [47][48]. Conclusion - The healthcare sector in China is facing various challenges, including policy headwinds, weak demand in certain segments, and the impact of ongoing reforms. However, there are also opportunities for growth, particularly in innovative products and domestic substitution trends. Companies like AmoyDx, Gan & Lee, and THDB are positioned to benefit from these trends, while others like Mindray and SNIBE are facing headwinds that may impact their performance in the near term.

Core Insights - Vaxart, Inc. reported positive topline results from a Phase 1 clinical trial for its second-generation oral pill norovirus vaccine constructs, showing significant increases in norovirus blocking antibodies compared to first-generation constructs [3][4][5] - The second-generation constructs demonstrated a 141% increase in GI.1 and a 94% increase in GII.4 norovirus blocking antibodies, indicating potential for improved protection against infection [4][8] - All vaccine candidates were found to be safe and well-tolerated, with no serious adverse events reported [4][8] Clinical Trial Details - The Phase 1 trial involved 60 healthy volunteers, randomized to receive either first-generation constructs, an equivalent dose of second-generation constructs, or a lower dose of second-generation constructs [4] - The primary endpoint was the measurement of norovirus blocking antibody assay (NBAA) titers at Day 0 and Day 28, with significant increases observed in the second-generation constructs [4][8] - The study results showed a geometric fold response (GMFR) increase from 2.2 to 5.4 for GI.1 and from 1.9 to 3.7 for GII.4 at the higher dose [8] Future Plans - Vaxart plans to publish the complete results of the study in a peer-reviewed journal and is considering a Phase 2b safety and immunogenicity study, potentially starting in the second half of 2025 [6][9] - The company aims to conduct an End of Phase 2 meeting with the U.S. FDA, with a Phase 3 trial anticipated to begin as early as 2026 [9] Industry Context - Norovirus is a leading cause of acute gastroenteritis worldwide, with approximately 685 million infections globally each year, resulting in significant economic burden estimated at $60 billion [11] - There is currently no approved vaccine for norovirus, highlighting the unmet need for effective vaccination solutions in the market [11][7] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform, which allows for storage and shipping without refrigeration [14] - The company is also working on oral vaccines for other diseases, including COVID-19 and influenza, and has filed broad patent applications for its technology [14]

Core Insights - Vaxart, Inc. announced the publication of complete data from a Phase 2b challenge study of its first-generation oral pill norovirus vaccine candidate, which met five of its six primary endpoints, demonstrating safety, efficacy, and immunogenicity [1][4] - Machine learning analyses identified functional blocking antibody and fecal IgA as robust correlates of protection, which will inform the development of Vaxart's second-generation norovirus vaccine candidate currently in a Phase 1 clinical trial [1][2] Study Details - The Phase 2b challenge study enrolled 165 healthy adults, randomized to receive either the vaccine candidate targeting norovirus GI.1 genotype or a placebo, with a primary objective to determine vaccine efficacy against norovirus infection and gastroenteritis [3] - Key findings included a 30% relative reduction in norovirus infection for the vaccine group compared to placebo (p=0.003) and a 21% relative reduction in norovirus gastroenteritis, although not statistically significant (p=0.178) [4] Immunogenicity and Safety - The vaccine significantly increased serum IgA, IgG, and norovirus-blocking antibodies (p<0.001 for all endpoints), and stimulated mucosal-homing B cells, increasing norovirus-specific antibodies in saliva, nasal lining fluid, and intestine [4] - The vaccine was reported to be safe and well-tolerated, with no serious vaccine-related events or dose-limiting toxicities, and most adverse events were mild [4] Future Development - Vaxart initiated a Phase 1 trial comparing its first- and second-generation norovirus vaccine candidates in March 2025, aiming to enhance immunogenicity and protection [1][5][6] - The company believes that a safe and effective norovirus vaccine is essential for global health and is confident in its oral pill vaccine platform [6]