格隆汇12月19日丨康希诺生物(06185.HK)发布公告，公司研发的吸附无细胞百(组分)白破("DTcP")b型流 感嗜血杆菌(结合)("Hib")-ACYW135群脑膜炎球菌(结合)("MCV4")联合疫苗("DTcP-Hib-MCV4联合疫 苗")于近日正式启动I期临床试验，并完成首例受试者入组。 基于公司的产品管线布局，结合市场对多联疫苗的需求，并形成差异化竞争，公司拟研发DTcP-Hib- MCV4联合疫苗。I期临床试验为评价DTcP-Hib-MCV4联合疫苗在2月龄至6岁人群中接种的安全性及免 疫原性。 ...

康希诺生物股份公司（以下简称"公司"）的吸附无细胞百（组分）白破b型 流感嗜血杆菌（结合）-ACYW135群脑膜炎球菌（结合）联合疫苗（以下简称 "DTcP-Hib-MCV4联合疫苗"）于近日正式启动I期临床试验，并完成首例受试者 入组。 一、产品基本情况 随着中国上市疫苗品种的不断增加，越来越多剂次疫苗使用，给家长、孩子 和接种医生也带来了一系列的现实问题，如增加儿童接种的痛苦、增加卫生部门 的接种成本、降低幼儿接种的依从性、增加疑似异常反应的可能，以及加重了疫 苗管理的困难和成本等。因此，开发并推广同时预防多种疾病的联合疫苗成为新 疫苗研发的趋势，联合疫苗具有良好的临床开发前景。 证券代码：688185 证券简称：康希诺 公告编号：2025-046 康希诺生物股份公司 自愿披露关于吸附无细胞百（组分）白破b型流感嗜血杆菌 （结合）-ACYW135群脑膜炎球菌（结合）联合疫苗 启动I期临床试验并完成首例受试者入组的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 基于公司的产品管线布局，结合市场对多联疫苗的需求，并形 ...

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。 CanSino Biologics Inc. 承董事會命 康希諾生物股份公司 Xuefeng YU 董事長 DTCP–HIb–MCV4聯合疫苗 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 作 出。 本 公 司 欣 然 宣 佈，本 公 司 研 發 的 吸 附 無 細 胞 百（組 分）白 破（「DTcP」）b型流感 嗜 血 杆 菌（ 結 合 ）（「Hib」）-ACYW135群 腦 膜 炎 球 菌（ 結 合 ）（「MCV4」）聯 合 疫 苗 （「DTcP-Hib-MCV4聯合疫苗」）於 近 日 正 式 啟 動I期 臨 床 試 驗，並 完 成 首 例 受 試 者 入組。 基於本公司的產品管線布局，結合市場對多聯疫苗的需求，並形成差異化競爭， 本公司擬研發DTcP-Hib-MCV4聯合疫苗。I期臨床試驗為評價DTcP-Hib-MCV4聯 合 疫苗 ...

康希诺公告，公司的吸附无细胞百（组分）白破b型流感嗜血杆菌（结合）-ACYW135群脑膜炎球菌 （结合）联合疫苗（简称"DTcP-Hib-MCV4联合疫苗"）于近日正式启动I期临床试验，并完成首例受试 者入组。 ...

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Core Viewpoint - The HPV vaccine market has shifted dramatically from scarcity and high prices to aggressive price competition, leading to significant revenue declines for many companies in the vaccine industry [3][4][11]. Price Competition and Market Changes - The price of the bivalent HPV vaccine has dropped from 245 yuan to 27.5 yuan, a nearly 90% decrease, while the nine-valent HPV vaccine is being offered in "buy one, get one free" promotions [3]. - The flu vaccine market has also seen price reductions, with the trivalent vaccine dropping to 5.5 yuan and the quadrivalent vaccine decreasing from 128 yuan to 88 yuan [3]. - In the first three quarters of 2025, only 5 out of 14 domestic vaccine companies reported revenue growth, while 10 companies, including industry leader Zhifei Biological, experienced significant profit declines [2][3]. Structural Issues in the Industry - The industry's performance decline is attributed to structural problems rather than cyclical fluctuations, with price wars compressing profit margins and leading to a situation where revenue growth does not translate into profit [4][5]. - The lack of innovation and reliance on technology replication has resulted in oversupply and a lack of differentiation among products, making price competition inevitable [6][9]. Innovation as a Key to Recovery - Companies that focus on innovation, such as CanSino with its quadrivalent meningococcal vaccine, have shown resilience, achieving revenue growth and profitability despite the overall market downturn [6][7]. - The market is willing to pay a premium for differentiated products that offer better protection and safety, indicating that true innovation is essential for avoiding price competition [7]. Challenges to Original Innovation - The high costs and long timelines associated with developing new vaccines, along with regulatory uncertainties, deter companies from pursuing original innovation [9]. - The current regulatory framework is more suited to traditional technologies, creating barriers for new vaccine platforms [9]. Industry Response and Future Directions - The China Vaccine Industry Association has initiated a campaign to oppose "involutionary" competition and promote high-quality development in the vaccine sector [10]. - Companies are encouraged to focus on unmet clinical needs and explore international markets to alleviate domestic competition pressures [10]. - There is a need for improved public awareness and vaccination services to enhance demand and increase vaccination rates, particularly for flu vaccines [10]. Conclusion - The price competition in the vaccine industry is a result of homogeneous competition and represents a transitional phase for industry upgrade [11]. - Successful examples of innovative companies and emerging industry consensus indicate a potential path forward, emphasizing the importance of clinical value over price competition [11].

Core Viewpoint - The export of Chinese vaccines is experiencing a recovery, with significant international contracts and an upward trend in export value, driven by increased average prices and a shift towards innovative products [1][9][19]. Group 1: Export Growth and Market Dynamics - Sinovac has signed a long-term contract with the Brazilian Ministry of Health to supply approximately 60 million doses of varicella and rabies vaccines over the next decade, valued at over $700 million [1][21]. - In 2024, China's human vaccine export value is projected to reach $212 million, marking a 6% year-on-year increase and the first growth since 2022 [1]. - The average export price of Chinese human vaccines is expected to rise by 9.42% in 2024, with a 34.04% increase compared to the same period in 2019 [9]. Group 2: Product Development and Innovation - Chinese vaccine companies are expanding their product lines from basic vaccines to more competitive innovative vaccines, with a focus on higher-value categories [8]. - Various vaccines, including the 13-valent pneumococcal vaccine and quadrivalent meningococcal conjugate vaccine, are accelerating entry into international markets [10]. - The HPV vaccine from Wantai Biologics has seen a threefold increase in exports, reaching approximately 15 million doses in 2025 [12]. Group 3: Challenges and Competitive Landscape - The domestic vaccine market is under pressure, with a decline in the number of vaccine approvals from 5,343 in 2021 to 4,202 in 2024, influenced by economic downturns and reduced vaccination willingness [14]. - The competition in the vaccine development space is intense, with many companies pursuing similar vaccine types, leading to a crowded pipeline [17]. - The export strategy is also influenced by cost structures, as companies aim to lower supply costs and improve production efficiency through increased output [18]. Group 4: Strategic Opportunities and Localization - There is a structural opportunity for Chinese vaccine companies to enter markets that are underserved by multinational corporations, particularly in low- and middle-income countries [19]. - Successful international expansion requires not only product sales but also the establishment of localized systems to support long-term growth [20]. - Companies are shifting from simple export models to more integrated approaches, including local production and technology transfer agreements [20].

Summary of Conference Call Records Industry Overview - The medical device industry is experiencing overall performance pressure in 2025, but third-quarter revenues have shown a year-on-year increase, with a narrowing decline in net profit attributable to the parent company, primarily due to domestic medical insurance cost control and geopolitical influences. It is expected that normal growth rates will resume in 2026 [1][3][8]. Key Points on Medical Device Sector - **Domestic Market Dynamics**: The slowdown in hospital bidding in 2024 is impacting revenue realization, with an expected boost from the "old-for-new" policy by the end of 2025. The In Vitro Diagnostics (IVD) sector is under pressure due to centralized procurement price adjustments and tax reimbursements [1][4]. - **International Market Challenges**: Companies are strengthening their overseas presence, but initial high costs are pressuring short-term profits. The impact of US-China tariffs on low-value consumables is significant, with expectations of price recovery in the glove industry from late 2025 to 2026 after inventory digestion [1][4][11]. - **Performance Metrics**: In the first three quarters of 2025, the medical device sector reported revenues of 145.7 billion yuan, a year-on-year decline of 2.4%, and a net profit of 26.5 billion yuan, down 14.4%. However, the third quarter showed a positive revenue trend and a narrowing profit decline [3][15]. Specific Sector Insights - **IVD Sector**: The IVD sector saw a year-on-year decline of 14.5% in the first three quarters, but the third quarter showed improvement with revenues of 11.02 billion yuan, benefiting from the implementation of centralized procurement and the release of DRG/DIP 2.0 [16]. - **High-Value Consumables**: This segment experienced a revenue growth of 6.6% year-on-year, with orthopedics showing a significant growth rate of 18.7%. The recovery in cardiovascular surgeries is driving sales, and the ophthalmology sector presents potential due to low penetration rates [17]. - **Medical Equipment**: The medical equipment sector's revenue remained flat, but profit growth was slightly higher. The imaging equipment sector is benefiting from the "old-for-new" projects, with a notable recovery in the endoscope segment [15]. Vaccine Sector Performance - The vaccine sector faced significant pressure, with revenues declining nearly 50% and profits turning negative. However, there is a quarter-on-quarter improvement trend. Future focus includes the recovery of traditional vaccines and the launch of new pipeline products, such as the domestically produced nine-valent HPV vaccine [2][23]. Life Sciences Upstream Sector - The life sciences upstream sector's performance remained stable, with a year-on-year profit growth of 68% in the third quarter, driven by recovering terminal demand and improved gross margins. The sector is benefiting from the expansion of the biopharmaceutical market and policy support [24]. Regulatory Environment and Challenges - The current regulatory environment emphasizes innovation while ensuring safety and efficacy. Domestic companies face challenges in international certifications, particularly with the FDA and CE, due to quality control issues [20][21][22]. Future Outlook - The industry outlook for 2026 includes a focus on self-sufficiency, innovative devices, and accelerated realization of centralized procurement categories. The recovery of orthopedic products is already evident, and international expansion remains a key area of interest [5][7][19].

Core Insights - Increasing number of Chinese vaccine companies are expanding their international presence, leveraging opportunities from the Belt and Road Initiative to enhance market layouts in developing countries [1] - In 2024, China's human vaccine export value is projected to reach $212 million, marking a 4.92% year-on-year growth and the first positive growth since 2022, following fluctuations due to COVID-19 [2] - The average export price of human vaccines increased by 9.42% in 2024, reflecting a 34.04% rise compared to the same period in 2019, indicating a shift towards higher value products [3] Export Growth - Major markets for China's vaccine exports in 2024 include Morocco, Pakistan, and Egypt, with exports to Pakistan increasing by 111.46% [2] - Companies like CanSino Biologics and Watson Biotech are actively pursuing overseas commercialization, with CanSino's products reaching Indonesia and Watson reporting overseas revenue of $214 million in the first half of 2025 [5] - As of mid-2025, WanTai Biologics has obtained market access for its HPV vaccine in 23 countries, indicating a growing international footprint [5] Challenges and Opportunities - Chinese vaccine companies face challenges such as market saturation and increased competition in domestic markets, prompting a shift towards international markets [6] - The global vaccine market is characterized by a concentration of major players, with opportunities arising from the lack of local production capabilities in many developing countries [7] - Despite the challenges, there is optimism for significant growth in vaccine exports as companies prepare for international commercialization [8]

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 康希諾生物股份公司 呈交日期: 2025年12月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06185 | 說明 | H 股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 132,670,900 | RMB | | 1 RMB | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 132,670,900 | RMB | | 1 RMB | | 132,670,900 | | 2. 股份分類 | 普通股 | 股份類別 ...