Core Insights - The Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire is now fully operational, licensed to supply British-made COVID-19 vaccines to the UK population [1] - This facility is a key component of Moderna's ten-year strategic partnership with the UK Government, aimed at enhancing health resilience and promoting economic growth [1] - The MITC will produce mRNA respiratory vaccines for the UK public, supporting the National Health Service (NHS) seasonal vaccination programs [1]

Meanwhile, an RFK Junior back vaccine panel now pushing for new restrictions on a combination shot for children, changing the current recommendations that allow children under four to receive the MMR vaccine. And this morning, uh the uh hepatitis B vaccine vote also was put off. They cited a lack of data, a vote expected later, also on COVID shot recommendations.All right, let's try and make sense of all this. Missouo healthcare sector strategist Jared Holles joins us here at Post 9. I guess from an investo ...

Vaccine Industry Insights - A new RFK Junior-backed vaccine panel is advocating for restrictions on the MMR vaccine for children under four, with a vote on hepatitis B vaccine recommendations postponed due to insufficient data [1] - Concerns have been raised regarding the profitability of vaccine companies like Merck, Moderna, and Pfizer, with a general sentiment that the value of vaccines has diminished [3][4] - Moderna is facing significant challenges, including a potential revenue decline and a lawsuit that could cost the company between $2 billion to $3 billion, which it may struggle to afford [8][9] Regulatory Environment - The FDA is perceived to be actively working on drug approvals, although there are concerns about the lack of expected approvals impacting investor sentiment [6][7] - There is a growing apprehension regarding potential price controls on pharmaceuticals as the administration approaches midterm elections, which could negatively affect the industry [10][11] Advertising and Market Dynamics - The advertising landscape for pharmaceuticals is under scrutiny, with concerns about how direct-to-consumer advertising impacts the industry, although investors currently do not view it as a major concern [12][13] - Despite the challenges, the biotech sector is viewed positively, with indications that drug development is increasing and the overall climate is improving [14][15]

Crowds of current and former CDC staffers and their supporters lined the streets of Atlanta yesterday to recognize the officials who resigned in protest after the ousting of CDC director Susan Manarez. Now, we're learning more about more details about what led to that firing and to the exodus that followed. As NS NBC News reports, an escalating conflict over an influential vaccine committee was one of the final straws.Health and Human Services Secretary Robert F. Kennedy Jr. . had reconstituted the committe ...

Financial Data and Key Metrics Changes - The company reported revenue of RMB 446 million for 2025, representing a 48% year-over-year growth, although the first half was impacted by supply constraints [12][14] - Revenue from Nephicon alone reached RMB 520 million in August, indicating a strong recovery from earlier supply issues [13] - Full year revenue guidance for 2025 is set between RMB 1.6 billion to RMB 1.8 billion, with Nephicon expected to contribute RMB 1.2 billion to RMB 1.4 billion [13][14] - The gross margin on a cash basis was 76.4%, slightly lower than 2024 due to price reductions after NRDL inclusion, but expected to recover above 80% in the long run [14] - The non-IFRS net loss was approximately RMB 147 million, down 31% year-over-year, indicating improved operational efficiency [14] Business Line Data and Key Metrics Changes - Nephicon generated RMB 825 million in revenue from January to August, with strong market demand leading to a significant uptick in sales after regulatory approval [4][5] - The autoimmune disease franchise, particularly Velsipiti, is progressing well with NDA reviews and expected early 2026 approval [7][8] - XERAVA in the anti-infective segment showed steady growth, with revenue increasing by 37% year-over-year [23] Market Data and Key Metrics Changes - The company aims to expand Nephicon's market coverage to 1,000 hospitals, targeting approximately 30,000 new patients [18][20] - The estimated market for IgAN in China includes about 5 million patients, with significant growth potential as the company expands its reach [19][20] - The ulcerative colitis market is projected to grow, with peak sales for Velsipiti expected to reach RMB 5 billion [34] Company Strategy and Development Direction - The company is focused on a dual strategy of commercialization and in-house discovery, with significant investments in R&D to support long-term growth [35][72] - Plans include localizing production for various products and preparing for NRDL negotiations to enhance market access [72] - The company is also exploring partnerships and in-licensing opportunities to bolster its product pipeline and market presence [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving operational profitability earlier than previously guided, now targeting Q4 2025 [15] - The company is optimistic about the upcoming regulatory approvals and market launches, which are expected to drive revenue growth [71][72] - Management highlighted the strong clinical data supporting their products, which positions them favorably in the market [82] Other Important Information - The company completed a strategic investment of USD 30.9 million in I Mab, becoming the largest shareholder with a 16.1% stake [12][70] - The company is advancing its proprietary mRNA technology platform, which is expected to enhance its R&D capabilities and product offerings [48][49] Q&A Session Summary Question: Peak sales for Etrasimod - Management noted that the potential for Etrasimod is higher than previously stated due to strong clinical data and an underdeveloped market, with preparations underway for commercial launch [80][82][86] Question: Development plans for EVER-one - Management confirmed that they are in the design stage for pivotal trials and are planning to initiate these studies in 2026, with ongoing discussions for potential partnerships [89][90][92]

Core Insights - Pfizer and BioNTech received FDA approval for their LP.8.1-adapted monovalent COVID-19 vaccine for adults aged 65 and older, and for individuals aged 5 to 64 with underlying health conditions [1][2][3] Group 1: FDA Approval and Vaccine Details - The FDA's approval is based on extensive evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including data from clinical trials for children aged 5 to 11 [2] - The LP.8.1-adapted vaccine is designed to generate improved immune responses against multiple circulating SARS-CoV-2 sublineages compared to previous vaccine adaptations [2][4] - The LP.8.1 sublineage was selected following FDA guidance, marking it as the preferred option for the upcoming fall 2025 vaccination season [3][6] Group 2: Distribution and Supply - Shipping of the LP.8.1-adapted vaccine will commence immediately, ensuring availability in pharmacies, hospitals, and clinics across the U.S. [3][6] - To date, 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed globally, demonstrating a favorable safety and efficacy profile [4] Group 3: Company Background - Pfizer and BioNTech utilize BioNTech's proprietary mRNA technology for their COVID-19 vaccines, with BioNTech holding marketing authorization in various regions [4][18] - BioNTech is also engaged in developing a diverse portfolio of oncology product candidates alongside its COVID-19 vaccine efforts [18]

From @WSJopinion: mRNA technology has enormous potential, but the Trump team is throwing out the President’s Operation Warp Speed baby with the Biden bath water https://t.co/XNHvnZJgUt ...

happy to have you here. Um, so it was the summer of 2016. It was June 2016 and it was a terrible crime.Um, it happened in a small legal office, a legal office that specialized in uh, real estate and in immigration matters. Um, at this little legal office, somebody saw smoke coming out of the stairwell at that office. They called the fire department.Um, firefighters showed up and they did what brave firefighters do. They charged right into that burning building. Firefighters immediately found the source of t ...

Over two million lives have been saved because of mRNA technology. It helped us develop CO 19 vaccines in record time. People are going to die because we're cutting short funding for this technology. People are going to die because we are cutting short funding for this technology.That person is Dr. . Jerome Adams. If he looks familiar to you at all, that's because he was surgeon general in Donald Trump's first presidential term, saying now that people are going to die because of a newlyannounced decision by ...

Policy Change & Funding Shift - HHS（美国卫生与公众服务部）部长 Robert F Kennedy Jr 将转移近 5 亿美元的联邦资金，不再用于开发基于 mRNA 技术的疫苗 [1] - BARTA（生物医学高级研究与发展管理局）已开始终止总额略低于 5 亿美元的 22 份合同 [3] Scientific & Expert Opinions - 一位免疫学家称此决定对科学来说是糟糕的一天 [3] - mRNA 疫苗被认为挽救了生命，2021 年未接种疫苗者住院和死亡的可能性是接种疫苗者的 12 倍，2022 年是 6 倍 [5] - mRNA 技术不仅对 COVID 和传染病有效，还可用于癌症和基因治疗 [7] - mRNA 疫苗可能导致心肌炎，但罕见、短暂且可自愈，而病毒引起的心肌炎可能导致住院、重症监护和死亡 [7] Concerns Regarding mRNA Vaccine Efficacy - Kennedy 认为 mRNA 疫苗对上呼吸道感染（如 COVID 和流感）的疗效不佳，因为病毒会发生变异，导致疫苗失效 [8] - mRNA 只编码病毒蛋白的一小部分，通常是单一抗原，一次突变就可能使疫苗失效 [8] - Kennedy 声称疫苗会鼓励新的突变，并可能延长疫情 [9] Counterarguments & Scientific Rebuttals - 病毒的变异与疫苗无关，疫苗问世前就已存在 [10] - 中国使用的全病毒灭活疫苗效果较差，抗体反应和长期免疫效果都不如 mRNA 疫苗 [11] - 研发通用流感疫苗已经进行了 50 年，但尚未成功 [12][13]