Core Viewpoint - 康希诺生物's stock rose over 5%, reaching HKD 46.38, with a trading volume of HKD 16.1181 million, following the announcement of the initiation of Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia [1] Group 1: Clinical Development - 康希诺生物 has officially launched Phase I clinical trials for its inhaled tuberculosis vaccine (5-type adenovirus vector) in Indonesia, with the first subject enrolled [1] - The Phase I trial aims to explore the safety and immunogenicity of a single dose of the inhaled tuberculosis booster vaccine in adults aged 18 to 49 [1] Group 2: Financial Performance - 瑞银 has adjusted 康希诺生物's revenue forecasts for 2026 and 2027, increasing the 2026 forecast by 22% and decreasing the 2027 forecast by 9% [1] - 康希诺生物's management reported that the MCV4 vaccine generated revenue of RMB 662 million in the first three quarters of this year, representing a year-on-year growth of approximately 28%, attributed to an expanded age group and ongoing channel penetration [1] - The MCV4 vaccine began exporting to Indonesia in the third quarter, with estimated sales in the millions for this year [1] - The PCV13i vaccine, launched mid-year, has entered approximately 12 provinces, with management aiming to cover half of the provinces by year-end and expand to other markets next year [1]

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, the company reported revenues of $2.5 million, down from $3.1 million in 2024, primarily due to the termination of the BARDA Project NextGen contract [13][15] - Research and development expenses for Q3 2025 were $5 million, compared to $7.4 million in 2024, with a nine-month total of $15.1 million versus $16.1 million in 2024 [13][14] - The overall net loss for Q3 2025 was $6.3 million, compared to $5.8 million in 2024, and the year-to-date net loss was $17 million versus $16.7 million in 2024 [15] Business Line Data and Key Metrics Changes - The company is advancing multiple product candidates, including GEO-MVA, GEO-CM04S1, and Gadeptin, with a focus on addressing unmet healthcare needs [4][11] - GEO-MVA has received guidance from the European Medicines Agency for an expedited development path, allowing the company to bypass earlier clinical trial phases [5][6] - GEO-CM04S1 is recognized as a critical vaccine for immunocompromised adults, with ongoing studies focusing on this population [7][8] Market Data and Key Metrics Changes - There is significant government interest in U.S.-based supply chains for vaccines, reflecting a shift towards onshoring initiatives [6] - The company is experiencing increased interest from industry partners and funding organizations, particularly in relation to its vaccine candidates [4][5] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, with a focus on expedited registration pathways [11][12] - Strategic partnerships and collaborations are being pursued to support the development and commercialization of its product candidates [11][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress and outlook for its product portfolio, highlighting the potential for GEO-MVA to address global vaccine needs [4][5] - The company is actively engaging with stakeholders, including government entities and international organizations, to advance its vaccine programs [6][38] Other Important Information - The company is exploring various funding strategies to support its clinical programs, including strategic partnerships and non-dilutive funding [15] - The focus remains on advancing clinical evaluations for GEO-MVA and GEO-CM04S1, as well as Gadeptin for oncology applications [11][12] Q&A Session Summary Question: Is there a scenario that could lead to MVA being used by governments before clinical trials? - Management indicated that emergency use licensing through WHO may be possible, but not prior to clinical evaluation [19][20] Question: Can you provide insights on potential collaborations or partnerships? - Management stated that they hold worldwide rights for their product assets and are open to proposals from potential partners, focusing on global registration [27][28] Question: What are the plans for the needle-free administration method for GEO-MVA? - The company is evaluating non-traditional delivery methods in collaboration with Vaxxas and is in discussions regarding manufacturing plans [32][34] Question: Which regions are most supportive of the vaccine programs? - Management highlighted significant interest in the Southern Hemisphere for GEO-MVA and ongoing concerns regarding mpox outbreaks in various regions [38][40] Question: Will there be a biosimilar version of Pembro available by the time Gadepin is approved? - Management expressed uncertainty but noted potential interest in developing Gadepin with various immune checkpoint inhibitors [43]

Group 1 - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. and its subsidiary Yihui Biotechnology (Shanghai) Co., Ltd. have successfully initiated Phase I clinical trials for two new influenza vaccines: "Influenza Virus Subunit Vaccine (Adjuvant)" and "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant)" in Hubei province [1] - The World Health Organization (WHO) reports that there are approximately 3 to 5 million severe cases of influenza globally each year, with an average of about 88,000 excess deaths due to respiratory diseases caused by influenza in China from 2010 to 2015 [3] - The overall vaccination rate for influenza in China remains low, with only 3.84% during the 2022-2023 flu season, indicating a significant challenge in establishing an effective immune barrier against influenza [3] Group 2 - The "Adjuvanted Influenza Virus Subunit Vaccine" is designed to meet the vaccination needs of different populations, particularly targeting individuals aged 65 and older, utilizing the company's established platform technology and new adjuvants [4] - The vaccine is administered via intramuscular injection in the deltoid muscle, with low-dose and high-dose groups receiving 0.25ml and 0.5ml per dose, respectively, over a total of one dose on day 0 [4] - Preclinical studies indicate that the adjuvanted influenza virus subunit vaccine significantly enhances antibody levels and neutralizing antibody titers, providing a superior option for the elderly population to combat influenza [4] Group 3 - Zhonghui Biotechnology is focused on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies, with a continuous increase in R&D investment [5] - The company has received clinical approval for several products, including recombinant zoster vaccine, adjuvanted influenza virus subunit vaccine, and lyophilized human rabies vaccine, with multiple innovative vaccine pipelines under development [6] - The company has established large-scale production capabilities, with a first-phase facility covering approximately 68 acres and equipped with international-level GMP production lines for influenza raw materials and formulations [6]

I期临床试验于印度尼西亚开展，目的是在18至49岁的成年人中探究接种一剂吸入用结核病加强疫苗的 安全性和免疫原性。 目前，卡介苗是全球唯一可用于预防结核病的疫苗，在全球范围内被广泛接种，其对预防婴幼儿结核病 发挥重要作用，但卡介苗保护力会随时间减弱，无法通过加强免疫接种增强疫苗的保护效果。针对此不 足，公司研发了第一代全球创新结核病加强疫苗用于卡介苗接种人群，结核病加强疫苗于加拿大完成了 Ia及Ib期临床试验，临床试验数据证明了结核病加强疫苗作为候选疫苗的安全性和作为卡介苗加强疫苗 的有效性，以及黏膜免疫的优越性。 基于吸入用新冠疫苗开发的技术累积，公司建立了完整的吸入药学、质量控制体系，升级第一代产品， 同时增加了抗原组分，开发了吸入用结核病加强疫苗，通过雾化吸入的方式递送，有望可以激发肺部免 疫应答，从而清除结核菌，控制潜伏感染，并可实现预防感染的效果。 智通财经APP讯，康希诺生物(06185)发布公告，公司开发的吸入用肺结核疫苗(5型腺病毒载体)近日于 印度尼西亚正式启动I期临床试验，并完成I期临床试验首例受试者入组。 ...

Core Viewpoint - The company has initiated Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia, marking a significant step in its development of a novel vaccine to enhance protection against tuberculosis [1] Group 1: Vaccine Development - The inhaled tuberculosis vaccine, developed using a 5-type adenoviral vector, has officially started its Phase I clinical trials in Indonesia, with the first subject enrolled [1] - The existing BCG vaccine is the only globally available vaccine for tuberculosis prevention, but its efficacy diminishes over time and cannot be enhanced through booster shots [1] - The company has developed a first-generation innovative tuberculosis booster vaccine aimed at individuals who have received the BCG vaccine, which has shown safety and efficacy in previous clinical trials conducted in Canada [1] Group 2: Technological Advancements - The company has leveraged its technology from the development of inhaled COVID-19 vaccines to establish a comprehensive inhalation pharmaceutical and quality control system [1] - The upgraded inhaled tuberculosis booster vaccine includes additional antigen components and is designed to be delivered via nebulization, potentially stimulating pulmonary immune responses to eliminate tuberculosis bacteria and control latent infections [1]

Core Viewpoint - The company has initiated Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia, marking a significant step in its vaccine development efforts [1] Group 1: Vaccine Development - The inhaled tuberculosis vaccine, developed using a 5-type adenovirus vector, aims to enhance immunity in individuals previously vaccinated with the BCG vaccine [1] - The BCG vaccine is currently the only vaccine available for tuberculosis prevention, but its efficacy diminishes over time, necessitating the development of a booster vaccine [1] - The company has successfully completed Phase Ia and Ib clinical trials in Canada, demonstrating the safety and efficacy of the tuberculosis booster vaccine [1] Group 2: Technological Advancements - The company has leveraged its experience from developing inhaled COVID-19 vaccines to establish a comprehensive inhalation pharmaceutical and quality control system [1] - The upgraded inhaled tuberculosis booster vaccine includes additional antigen components and is designed to be delivered via nebulization, potentially stimulating pulmonary immune responses [1] - This innovative delivery method aims to clear tuberculosis bacteria, control latent infections, and provide preventive effects against the disease [1]

CanSino Biologics Inc. 康希諾生物股份公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6185） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部 或任何部分內容所產生或因依賴該等內容而引致的任何損失承擔任何責任。 基 於 吸 入 用 新 冠 疫 苗 開 發 的 技 術 累 積，本 公 司 建 立 了 完 整 的 吸 入 藥 學、質 量 控 制體系，升級第一代產品，同時增加了抗原組分，開發了吸入用結核病加強疫苗， 通過霧化吸入的方式遞送，有望可以激發肺部免疫應答，從而清除結核菌，控制 潛伏感染，並可實現預防感染的效果。 – 1 – I期臨床試驗於印度尼西亞開展，目的是在18至49歲的成年人中探究接種一劑吸 入用結核病加強疫苗的安全性和免疫原性。 本公司股東及潛在投資者在買賣本公司股份時務請審慎行事。 承董事會命 康希諾生物股份公司 自願公告 吸入用結核病加強疫苗於印度尼西亞 啟 動I期臨床試驗並完成首例受試者入組 本 公 告 由 康 希 諾 生 物 股 份 公 司（「本公司」）自 願 ...

康希诺11月13日公告，公司开发的吸入用肺结核疫苗（5型腺病毒载体）近日于印度尼西亚启动I期临床 试验，并完成首例受试者入组。该疫苗为第一代全球创新的结核病加强疫苗，通过雾化吸入的方式递 送，有望激发肺部免疫应答，控制潜伏感染，并可实现预防感染的效果。 ...

四價流感病毒亞單位疫苗（佐劑） 及三價流感病毒亞單位疫苗（佐劑） 的I期臨床試驗啟動 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Ab&B Bio-Tech CO., LTD. JS 江蘇中慧元通生物科技股份有限公司 （於中華人民共和國成立的股份有限公司） （股份代號：2627） 自願性公告 本公告由江蘇中慧元通生物科技股份有限公司（「本公司」或「中慧生物」，連同其 附屬公司，統稱「本集團」）自願刊發，以告知本公司股東及潛在投資者有關本集 團最新業務發展的資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團近期啟動本集團四價流感 病毒亞單位疫苗（佐劑）及三價流感病毒亞單位疫苗（佐劑）的I期臨床試驗。我們 已於2024年7月就在研四價流感病毒亞單位疫苗（佐劑）及於2024年10月就在研三 價流感病毒亞單位疫苗（佐劑）取得中華人民共和國國家藥品監督管理局的新藥臨 床試驗申請批准。 由於隨著年齡的增長，免疫功能自然下降，流感對老年人，尤其是6 ...

Core Viewpoint - Zhifei Biological has received a clinical trial application acceptance notice for its lyophilized varicella inactivated vaccine from the National Medical Products Administration, allowing it to proceed with clinical trials if no objections are raised within 60 days [1] Company Summary - The vaccine is developed by Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Zhifei Biological [1] - The acceptance number for the clinical trial application is CXSL2500962 [1]