Investment Rating - The report does not explicitly state an investment rating for the vaccine industry Core Insights - The overall trend in the vaccine industry shows a decline in batch approvals for most vaccine types in Q1 2025, with some exceptions showing recovery or growth in demand [7][29][46] Summary by Category Multi-Component Vaccines - In Q1 2025, multi-component vaccines saw a total of 17 batch approvals, a decrease of 26% compared to the previous year [11][15] - The five-component vaccine maintained its batch approval at 17, while the four-component vaccine had no approvals [15][12] Pneumonia Vaccines - Total batch approvals for pneumonia vaccines in Q1 2025 were 23, down 30% year-on-year [19][21] - The 13-valent pneumonia vaccine had 19 approvals, remaining stable, while the 23-valent vaccine saw a significant drop to 4 approvals, down 71% [24][19] HPV Vaccines - HPV vaccine approvals increased to 57 batches in Q1 2025, a growth of 63% [29][27] - The two-valent HPV vaccine saw a remarkable increase of 367%, with all approvals coming from Wantai Biological Pharmacy [29][32] Influenza Vaccines - Influenza vaccine approvals totaled 29 batches, a significant increase of 263% year-on-year [34][38] - The three-valent influenza vaccine had 28 approvals, while the four-valent vaccine had only 1 approval, down 67% [38][41] Rabies Vaccines - Batch approvals for rabies vaccines increased to 223 in Q1 2025, a growth of 37% [46][48] - The freeze-dried rabies vaccine accounted for the majority of approvals, with Chengda Biological achieving 105 approvals, a 110% increase [48][46] Varicella Vaccines - Varicella vaccine approvals slightly decreased to 83 batches, down 2% [53][54] - The largest contributor was Baike Biological, with 33 approvals, marking a 38% increase [54][53] Hib Vaccines - Hib vaccine approvals fell to 7 batches, a decrease of 50% [59][58] EV71 Vaccines - EV71 vaccine approvals continued to decline, with only 4 batches approved, down 69% [64][63] Rotavirus Vaccines - Rotavirus vaccine approvals totaled 21 batches, a decrease of 46% [68][67] DTP Vaccines - DTP vaccine approvals increased to 18 batches, a growth of 167% [72][73] Meningitis Vaccines - Meningitis vaccine approvals totaled 85 batches, down 34% [78][79] - The AC polysaccharide vaccine accounted for 55 approvals, a decrease of 47% [84][79] Hepatitis B Vaccines - Hepatitis B vaccine approvals increased to 87 batches, a growth of 28% [91][90] IPV Vaccines - IPV vaccine approvals totaled 22 batches, a decrease of 33% [93][92]

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 | 2025年4月30日 狀態: 新提交 | | --- | | 截至月份: | 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5月8日 I. 法定/註冊股本變動 FF301 II. 已發行股份及/或庫存股份變動 | 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 | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | 已發行股份總數 | | | 上月底結存 | | | 132,670,900 | 0 | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | 0 | | | | 本月底結存 | | | 132,670,900 | 0 | | 132,670,900 | | 1. 股份分類 | 普通股 | 股份類別 | H | ...

Core Viewpoint - The impact of the U.S. "reciprocal tariffs" on Chinese pharmaceutical companies is limited, with many companies reporting normal operations and minimal effects on their business [1][2][4][7][12]. Group 1: Company Responses - Heng Rui Pharmaceutical reported that overseas sales account for only 2.56% of its revenue, indicating that U.S. tariffs have a minimal impact on its business [1]. - Han Yu Pharmaceutical stated that it has a diversified market presence across North America, Asia, Europe, and South America, which mitigates risks from single market policy changes [2]. - Bai Yang Pharmaceutical noted that its supply chain is globally diversified, and the impact of tariffs is minimal [3]. - WuXi AppTec acknowledged that tariffs will have some impact but emphasized their optimized supply chain and management practices to minimize effects [4]. - Kangtai Biological confirmed that it has no products exported to the U.S. and is focusing on markets along the Belt and Road [5]. Group 2: Industry Trends - The medical device industry in China is rapidly developing, with companies like Mindray Medical actively seeking alternatives for U.S. imported raw materials [5]. - Companies are increasingly focusing on domestic production and local supply chains to counteract potential tariff impacts [6][8]. - The vaccine industry in China is evolving, with companies like CanSino Biologics transitioning from followers to leaders in vaccine technology [8][9]. - The overall sentiment among Chinese pharmaceutical companies is that the current tariff situation presents an opportunity for domestic substitution and innovation [10][12].

Core Viewpoint - 康希诺 has shown significant improvement in its financial performance, with a notable reduction in losses and a positive revenue growth trajectory, indicating a potential recovery from the impacts of the COVID-19 pandemic [2][3][4]. Financial Performance - In Q1 2025, 康希诺 reported revenue of 1.074 billion yuan, a year-on-year increase of 20.02%, while the net loss attributable to shareholders was 11.55 million yuan, down from a loss of 170 million yuan in the same period last year [2]. - The company achieved a substantial reduction in losses due to several factors, including the absence of one-time special losses from the previous year, increased market share of its meningococcal products, and additional government subsidies [2][4]. - For the full year 2024, 康希诺's revenue grew by 137.01% to 846 million yuan, with a narrowed net loss of 379 million yuan [3]. Market Position and Competitiveness - 康希诺's performance stands out in a challenging vaccine market, where most domestic vaccine manufacturers reported declines in revenue [4][3]. - The company’s meningococcal vaccine, 曼海欣, has become a key revenue driver, contributing significantly to its Q1 2025 revenue [7][10]. - Despite the overall decline in the meningococcal vaccine market, 康希诺's products have shown growth, with 曼海欣's approval and sales expected to continue expanding [9][10]. Product Pipeline and Future Prospects - 康希诺 has two approved meningococcal vaccines, with 曼海欣 being the primary revenue contributor, and is actively pursuing market expansion both domestically and internationally [6][10]. - The company is also awaiting approval for its 13-valent pneumococcal conjugate vaccine, which could further enhance its product portfolio, although competition in this segment is strong [11]. - The future growth potential of 康希诺 remains uncertain, as its current and upcoming products may not provide significant long-term growth opportunities [11].

康希诺生物股份公司 关于召开2024年年度股东大会的通知 本公司董事会及全体董事保证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。 重要内容提示： 一、 召开会议的基本情况 （一） 股东大会类型和届次 2024年年度股东大会 证券代码：688185 证券简称：康希诺 公告编号：2025-014 （四） 现场会议召开的日期、时间和地点 召开日期时间：2025 年 6 月 4 日 13 点 30 分 召开地点：天津市河东区卫国道 126 号天津东凯悦酒店二层悦宾厅 1 （五） 网络投票的系统、起止日期和投票时间。 网络投票系统：上海证券交易所股东大会网络投票系统 网络投票起止时间：自2025 年 6 月 4 日 至2025 年 6 月 4 日 采用上海证券交易所网络投票系统，通过交易系统投票平台的投票时间为股 东大会召开当日的交易时间段，即 9:15-9:25，9:30-11:30，13:00-15:00；通过互 联网投票平台的投票时间为股东大会召开当日的 9:15-15:00。 （六） 融资融券、转融通、约定购回业务账户和沪股通投资者的投票程序 股东大 ...

Financial Performance - The company's revenue for Q1 2025 was CNY 137,160,578.06, representing a year-over-year increase of 20.02% compared to CNY 114,282,281.78 in the same period last year[4]. - The net loss attributable to shareholders for the period was CNY 11,545,431.51, a significant improvement from a loss of CNY 170,095,866.61 in the previous year[4]. - Total operating revenue for Q1 2025 was ¥137,160,578.06, an increase of 20.00% compared to ¥114,282,281.78 in Q1 2024[18]. - Net profit for Q1 2025 was a loss of ¥11,545,431.51, an improvement from a loss of ¥174,882,984.28 in Q1 2024[19]. - The total comprehensive loss for Q1 2025 was ¥11,549,283.95, an improvement from a loss of ¥174,560,182.55 in Q1 2024[19]. Cash Flow - The net cash flow from operating activities was a net outflow of CNY 13,801,882.53, which is an improvement of CNY 94,393,791.82 compared to the previous year's outflow[7]. - Cash flow from operating activities showed a net outflow of ¥13,801,882.53 in Q1 2025, compared to a net outflow of ¥108,195,674.35 in Q1 2024[21]. - Cash flow from investing activities resulted in a net outflow of ¥437,359,085.65 in Q1 2025, contrasting with a net inflow of ¥275,011,228.44 in Q1 2024[22]. - Cash and cash equivalents at the end of Q1 2025 were ¥1,055,668,836.98, down from ¥2,374,907,374.57 at the end of Q1 2024[22]. Research and Development - Research and development (R&D) expenses totaled CNY 88,924,234.66, a decrease of 28.48% from CNY 124,328,450.39 in the same period last year, with R&D expenses accounting for 64.83% of revenue, down 43.96 percentage points[4][7]. - Research and development expenses were ¥72,712,590.56 in Q1 2025, down 25.00% from ¥96,745,611.33 in Q1 2024[18]. - The company continues to focus on enhancing R&D efficiency and integrating resources across different pipelines to drive future growth[7]. Assets and Liabilities - The total assets at the end of the reporting period were CNY 7,820,387,409.65, a decrease of 1.73% from CNY 7,958,132,235.38 at the end of the previous year[5]. - The company's current assets totaled CNY 4,134,286,329.53, down from CNY 4,282,490,715.65, indicating a decrease of about 3.45%[13]. - The company's total liabilities were CNY 2,921,615,159.54, down from CNY 3,048,260,581.65, showing a reduction of around 4.17%[15]. - The total equity attributable to the owners of the parent company was CNY 4,898,772,250.11, slightly decreasing from CNY 4,909,871,653.73, a change of about 0.23%[15]. Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 17,828[9]. - The company has not reported any significant changes in its major shareholders or their participation in margin trading activities[11]. Profitability Metrics - The weighted average return on equity improved by 3.04 percentage points to -0.24% from -3.28% in the previous year[4]. - The company's gross profit margin improved by 23.14 percentage points due to optimized production capacity and cost control measures[7]. - The company's inventory increased to CNY 322,559,055.80 from CNY 283,414,610.09, marking an increase of approximately 13.80%[13]. - The company's short-term borrowings decreased to CNY 213,622,195.45 from CNY 377,348,417.32, a reduction of about 43.45%[15]. - The company's long-term borrowings increased to CNY 1,114,926,712.74 from CNY 1,098,538,320.81, reflecting an increase of approximately 1.49%[15].

Core Viewpoint - The impact of the U.S. tariff policy on Chinese pharmaceutical companies is relatively limited, with many companies reporting normal operations and minimal effects from the tariffs [1][2][3][4][5]. Company Responses - Heng Rui Pharmaceutical stated that overseas sales account for only 2.56% of its revenue, indicating that U.S. tariffs will have a minimal impact on its business [1]. - Han Yu Pharmaceutical emphasized its diversified market layout, which mitigates risks from single market policy changes, and reported no significant impact from the tariffs [2]. - WuXi AppTec acknowledged that tariffs would have some effect but deemed it manageable, highlighting their optimized supply chain and global presence [3]. - Kang Tai Biological reported no exports to the U.S. and is focusing on markets along the Belt and Road, indicating a strategic shift to other regions [4]. - Mindray Medical confirmed that while some raw materials are imported from the U.S., they are taking measures to ensure supply safety and view the tariff impact as a one-time issue [4]. Industry Trends - The Chinese vaccine industry is rapidly developing, with companies like CanSino Biologics transitioning from followers to leaders in vaccine technology, focusing on domestic innovation [6][7]. - The overall sentiment among companies is that the tariff policy presents an opportunity for domestic product substitution, with many firms prepared to adapt to changing market conditions [5][8]. - Companies are increasingly focusing on technological innovation and expanding into emerging markets to counteract potential supply chain disruptions caused by tariffs [5][6][7].

Revenue and Profitability - The company's revenue for the first quarter reached RMB 137,160,578.06, representing a year-on-year increase of 20.02% compared to RMB 114,282,281.78[6]. - The net loss attributable to shareholders for the quarter was RMB 11,545,431.51, a significant improvement from a loss of RMB 170,095,866.61 in the same period last year, narrowing the loss by 88.41%[14][15]. - The gross profit margin improved by 23.14 percentage points due to optimized production capacity and cost reduction measures[16]. - The basic and diluted earnings per share for the quarter were both RMB (0.05), compared to RMB (0.69) in the same period last year[6]. - The company confirmed a net loss attributable to shareholders after excluding non-recurring gains and losses of RMB 55,234,681.60, compared to RMB 178,676,681.71 in the previous year[6][15]. - In Q1 2025, the company reported a total comprehensive loss of CNY 11,549,283.95, compared to a loss of CNY 169,773,064.88 in Q1 2024, indicating a significant improvement[32]. Research and Development - Research and development expenses totaled RMB 88,924,234.66, a decrease of 28.48% from RMB 124,328,450.39 in the previous year, with R&D expenses accounting for 64.83% of revenue[8]. - The proportion of R&D investment to operating income decreased by 43.96 percentage points, while total R&D investment decreased by 28.48% year-on-year, despite a 20.02% increase in operating income, indicating improved R&D efficiency[17]. - The company is focusing on integrating R&D resources and enhancing potential synergies across different pipelines to control R&D expenditures effectively[17]. Cash Flow and Financial Management - The company reported a net cash flow from operating activities of RMB (13,801,882.53), compared to RMB (108,195,674.35) in the previous year, indicating improved cash flow management[6]. - The net cash flow from operating activities for the reporting period was a net outflow of ¥13,801,882.53, a decrease of ¥94,393,791.82 compared to the same period last year, with operating cash inflow increasing by ¥59,603,047.08 due to higher sales revenue and collections of the brand Manhaixin®[17]. - Cash inflow from operating activities increased to CNY 235,251,379.47 in Q1 2025, up from CNY 175,648,332.39 in Q1 2024, reflecting a growth of approximately 34%[34]. - The company recorded cash outflow from investing activities of CNY 437,359,085.65 in Q1 2025, compared to an inflow of CNY 275,011,228.44 in Q1 2024, indicating a shift in investment strategy[36]. - The company incurred total cash outflows from financing activities of CNY 334,582,241.70 in Q1 2025, compared to CNY 168,104,615.34 in Q1 2024, indicating increased financing activities[36]. Assets and Liabilities - The total assets at the end of the reporting period were RMB 7,820,387,409.65, a decrease of 1.73% from RMB 7,958,132,235.38 at the end of the previous year[8]. - Total liabilities as of March 31, 2025, were RMB 2,921,615,159.54, down from RMB 3,048,260,581.65 as of December 31, 2024[26]. - Total equity attributable to shareholders as of March 31, 2025, was RMB 4,898,772,250.11, slightly down from RMB 4,909,871,653.73 as of December 31, 2024[26]. - The company reported other income of RMB 45,863,689.09 in Q1 2025, a significant increase from RMB 8,591,840.84 in Q1 2024[30]. Shareholder Information - The top ten shareholders held a total of 39.55% of shares, with HKSCC NOMINEES LIMITED being the largest shareholder with 97,857,297 shares[19]. - The company has not reported any changes in the participation of major shareholders in securities lending activities during the reporting period[21].

Financial Performance - The company reported a basic earnings per share of -0.0500 yuan for Q1 2025, a significant improvement of 92.75% compared to -0.6900 yuan in Q1 2024 [1] - Revenue for Q1 2025 was 1.37 billion yuan, representing a 20.18% increase from 1.14 billion yuan in Q1 2024 [1] - The net profit for Q1 2025 was -0.12 billion yuan, showing a 92.94% improvement from -1.7 billion yuan in Q1 2024 [1] - The return on equity for Q1 2025 was -0.24%, a notable improvement from -3.28% in Q1 2024 [1] Shareholder Information - The top ten unrestricted shareholders collectively hold 17,638.31 million shares, accounting for 71.28% of the circulating shares, with a decrease of 81.52 million shares compared to the previous period [2] - HKSCC NOMINEES LIMITED remains the largest shareholder with 9,785.73 million shares, representing 39.55% of the total share capital [3] - The advanced manufacturing industry investment fund (limited partnership) saw a decrease of 81.52 million shares [3] Dividend Distribution - The company has announced that there will be no distribution or transfer of dividends this time [4]

Core Viewpoint - The performance of several vaccine companies in China is significantly declining in 2024 due to industry policy adjustments, decreased public willingness to vaccinate, and changing market demands, leading to a challenging environment for the industry [1] Financial Performance - The average revenue of vaccine companies in 2024 is 7.131 billion yuan, down 21.63% from 9.099 billion yuan in 2023, while the average net profit is 788 million yuan, a decrease of 35.60% from 1.222 billion yuan in 2023 [1] - Companies like Zhifei Biological, Wantai Biological, and Hualan Biological reported revenue declines exceeding 50%, while Watson Biological, Baike Biological, and Jindike saw declines of over 30% [1] - Kangxino's revenue increased by over 130% due to its quadrivalent meningococcal conjugate vaccine, benefiting from the resolution of global public health events [1] Price Competition Impact - The price war among vaccine products, particularly HPV, influenza, and pneumonia vaccines, has severely impacted net profits, with Wantai Biological, Kangtai Biological, Hualan Biological, and Zhifei Biological experiencing declines of 91.49%, 76.59%, 76.10%, and 74.99% respectively [2] - Wantai Biological's revenue for 2024 is 2.245 billion yuan, down 59.25%, and its net profit is 106 million yuan, down 91.49% [6] - Watson Biological's revenue is 2.821 billion yuan, a decline of 31.41%, with a net profit of 142 million yuan, down 66.10% [6] Market Dynamics - The domestic vaccine market is becoming increasingly competitive, with many companies focusing on traditional products and facing challenges from product homogeneity and market saturation [3] - The overall vaccination rate in China is low, with only about 3% for influenza vaccines, indicating significant growth potential in the market despite current pressures [7] R&D and Innovation - Companies are increasing R&D investments, with Zhifei Biological investing 1.391 billion yuan in 2024, and several companies allocating over 20% of their revenue to R&D [8] - New vaccine technologies, including mRNA and DNA vaccines, are emerging, which could lead to breakthroughs in disease prevention and treatment [9] International Expansion - Many vaccine companies are pursuing international markets, with Kangxino and Baike Biological successfully exporting products to various countries [10][11] - Watson Biological reported overseas revenue of 570 million yuan in 2024, a year-on-year increase of approximately 98% [11] - The global human vaccine market is projected to grow significantly, with emerging markets providing opportunities for Chinese vaccine companies due to their competitive pricing [12][13]