Major Events - Heng Rui Medicine (01276) plans to globally issue 224.5 million H-shares, expected to be listed on May 23 [1] - MIRXES-B (02629) will conduct an IPO from May 15 to May 20, aiming to globally issue 46.62 million shares [1] - Green Tea Group (06831) received 317.54 times subscription for its public offering in Hong Kong, with a final issue price of HKD 7.19 per share [1] - CSPC Pharmaceutical Group (01093) signed an exclusive licensing agreement with Cipla for the commercialization of Irinotecan Liposome Injection in the United States [1] - CanSino Biologics (06185) received clinical trial approval for its inhaled tuberculosis booster vaccine in Indonesia [1] - Fuhong Hanlin (02696) has been included in the MSCI Global Small Cap Index [1] - Financial One Account (06638) received a privatization offer from Ping An Group (02318) at a premium of approximately 23.10% [1] Financial Reports - Alibaba-W (09988) reported revenue and net profit growth for the fiscal year 2025, with net profit attributable to shareholders increasing by 62% to CNY 129.47 billion [1] - NetEase-S (09999) announced Q1 results with net profit attributable to shareholders at CNY 10.301 billion, a year-on-year increase of 34.94%, and a quarterly dividend of USD 0.135 per share [1] - Geely Automobile (00175) released Q1 results showing a significant increase in profit attributable to shareholders of CNY 5.672 billion, up 263.59% year-on-year [1] - Beike-W (02423) reported a total transaction volume growth of 34.0% year-on-year in Q1, with net revenue increasing by 42.4% [1] - Minhua Holdings (01999) announced annual results with profit attributable to shareholders of HKD 2.063 billion, a decrease of 10.41% year-on-year [1] - Shoucheng Holdings (00697) reported Q1 results with profit attributable to shareholders of HKD 213 million, an increase of 80.5% year-on-year [1] - Fourth Paradigm (06682) showed strong performance in core business with total revenue of CNY 1.077 billion in Q1, a year-on-year growth of 30.1% [1]

证券代码：688185 证券简称：康希诺 公告编号：2025-015 康希诺生物股份公司 自愿披露关于吸入用肺结核疫苗（5型腺病毒载体） 于印度尼西亚获得临床试验批准的公告 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。 康希诺生物股份公司（以下简称"公司"）开发的吸入用肺结核疫苗（5型 腺病毒载体）（以下简称"吸入用结核病加强疫苗"）于近日获得印度尼西亚食 品药品监督管理局（Badan Pengawas Obat dan Makanan, Republik Indonesia, "BPOM"）签发的临床试验批准。 一、产品基本情况 二、临床试验相关情况 该 I 期临床试验目的是在 18-49 岁的成年人中探究接种一剂吸入用肺结核疫 苗（5 型腺病毒载体）的安全性和免疫原性。 三、风险提示 疫苗研发是一项复杂严谨的科学活动，难度大、周期长，在上市销售前需要 申请临床试验、进行临床试验、申请药品注册上市许可等，临床试验进程和结果 及产品上市进度具有不确定性，公司信息以公司指定披露媒体以及上海证券交易 所网站刊登的公告为准。敬 ...

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]

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].

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].

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]

登录新浪财经APP 搜索【信披】查看更多考评等级 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、准确性和完整性承担个别及连带责任。 重要内容提示： ●会议召开时间：2025年4月30日（星期三）16:00-17:00 ●会议召开地点：上海证券交易所上证路演中心 （一）会议召开时间：2025年4月30日（星期三）16:00-17:00 （二）会议召开地点：上证路演中心 （三）会议召开方式：上证路演中心网络互动 三、 参加人员 （网址：http://roadshow.sseinfo.com） ●会议召开方式：上证路演中心网络互动 ●投资者可于2025年4月23日（星期三）至4月29日（星期二）16:00前登录上证路演中心网站首页点 击"提问预征集"栏目或通过公司投资者关系邮箱（ir@cansinotech.com）进行提问。公司将在说明会上 对投资者普遍关注的问题进行回答。 康希诺生物股份公司（以下简称"公司"）已于2025年3月26日发布2024年年度报告，并将于2025年4月30 日发布2025年第一季度报告。为便于广大投资者更全面深入地了解公司经营成果 ...

Financial Performance - Total revenue for 2024 reached RMB 824.884 million, a significant increase from RMB 345.182 million in 2023, representing a growth of 139.2%[7] - The company reported an operating loss of RMB 403.39 million for 2024, an improvement compared to the operating loss of RMB 2.035 billion in 2023[7] - The company reported a gross profit of approximately RMB 580.5 million, recovering from a gross loss of RMB 876.0 million in 2023[63] - Revenue from the cerebrospinal meningitis vaccine product reached RMB 793.8 million in 2024, up from RMB 561.7 million in 2023[60] - Other income decreased by 44.5% to approximately RMB 109.5 million in 2024, primarily due to a reduction in government subsidies[64] - Financial income decreased from approximately RMB 563 million for the year ended December 31, 2023, to approximately RMB 222 million for the year ended December 31, 2024, primarily due to a reduction in financial income of approximately RMB 362 million[70] - Income tax expense for the year ended December 31, 2024, was approximately RMB 25 million, a decrease from approximately RMB 115 million in 2023, due to the write-off of deferred tax assets[71] Assets and Liabilities - Total assets decreased to RMB 7.958 billion in 2024 from RMB 9.319 billion in 2023, a decline of 14.6%[7] - The company’s total liabilities decreased to RMB 3.048 billion in 2024 from RMB 4.031 billion in 2023, a reduction of 24.4%[7] - The company’s total equity decreased to RMB 4.910 billion in 2024 from RMB 5.287 billion in 2023, a decline of 7.1%[7] - Non-current assets were reported at RMB 3.676 billion in 2024, down from RMB 4.138 billion in 2023, indicating a decrease of 11.1%[7] - Cash and cash equivalents decreased by 24% from approximately RMB 20,470 million as of December 31, 2023, to approximately RMB 15,565 million as of December 31, 2024, mainly due to cash outflows from operating activities and loan repayments[87] - Total current liabilities decreased from approximately RMB 25,918 million as of December 31, 2023, to approximately RMB 17,720 million as of December 31, 2024, reflecting a reduction in borrowings and other payables[87] Vaccine Development and Commercialization - The sales revenue from the four-valent meningococcal conjugate vaccine, Manhaixin®, and the bivalent meningococcal conjugate vaccine, Meinaixi®, amounted to approximately RMB 793.8 million in 2024, reflecting a year-on-year growth of 41.3%[9] - The company plans to expand the age range for the Manhaixin® vaccine from children aged 3 months to 3 years to those aged 3 months to 6 years, pending regulatory approval[9] - The company is set to launch a new product, a 13-valent pneumonia combined vaccine, in 2025, with the registration application already accepted in 2024[10] - The company has initiated Phase II/III clinical trials for a component DTP vaccine for adolescents and adults, and the registration application for the infant DTP vaccine has been accepted and prioritized for review[10] - The company has received over $19 million in funding for the development of a recombinant poliovirus vaccine, highlighting its role in improving global public health[12] - The company has obtained product registration for its vaccine in Indonesia and is conducting clinical trials for safety and immunogenicity in the 18-55 age group[13] - The company is collaborating with the National Institute of Biotechnology Malaysia to advance the development of an mRNA polyvalent influenza vaccine[13] - The company aims to establish long-term strategic partnerships based on its diverse product pipeline and is preparing for WHO prequalification to explore international procurement opportunities[14] - The company has transformed from a biotechnology company to a biopharmaceutical company, enhancing its self-sustaining capabilities as more products enter commercialization[14] - The company has a broad vaccine portfolio addressing over ten disease areas, with five commercialized products as of the report date[18] Research and Development - The company has improved the production technology of the investigational PCV13i vaccine, achieving good safety and immunogenicity in its Phase III clinical trial[29] - The company has received GMP certification for its Ad5-EBOV vaccine, which is the first Ebola vaccine approved in China for emergency use[28] - The company is advancing its pipeline of innovative vaccines, including mRNA-based influenza vaccines and other combination vaccines[20] - The company's new drug application for PCV13i has been accepted by the National Medical Products Administration, with expectations to obtain approval by 2025[30] - The PBPV vaccine, currently in Phase I clinical trials, shows good safety in adults and the elderly, with significant antibody responses observed[32] - The infant DTcP vaccine's new drug application has been accepted, with ongoing Phase III clinical trials and a summary report already obtained[35] - The tetanus vaccine has initiated Phase III clinical trials, with a new drug application expected to be approved in the first half of 2026[40] - The company has secured exclusive global rights from McMaster University for the development of a tuberculosis booster vaccine, with promising results from Phase I trials[41] - The PBPV vaccine aims to provide broader coverage than existing PPV23 and PCV13 products, targeting over 90 serotypes of pneumonia[31] - The company plans to strengthen clinical data for the infant DTcP vaccine in 2025 to expedite the review process[35] Corporate Governance - The company emphasizes the importance of independent judgment and oversight from its board members, enhancing corporate governance standards[106][107][108] - The board comprises members with diverse backgrounds in finance, healthcare, and management, contributing to a well-rounded decision-making process[109][110] - The company is focused on maintaining high standards of corporate governance through experienced independent directors and supervisors[112] - The company has adopted all applicable provisions of the corporate governance code as per the Hong Kong Listing Rules Appendix C1[120] - The company confirmed that all directors and supervisors complied with the standard code during the reporting period[121] - The company has established specific service contracts for all directors, with terms lasting until the current board's three-year term expires[133] - The nomination committee will identify suitable candidates to fill any board vacancies based on required skills and experience[134] - The company will continue to assess whether the roles of chairman and CEO should be separated in the future[129] - The company has maintained compliance with the requirement of having at least three independent non-executive directors on the board[130] - The board of directors is responsible for leading and monitoring the company, ensuring effective internal controls and risk management systems[136] Market Strategy and Expansion - The company plans to enhance its marketing efforts and strengthen professional academic promotion to increase public awareness of vaccines[57] - The company aims to expand its market presence in Southeast Asia, the Middle East, and Latin America through strategic acquisitions and partnerships[58] - The company is actively expanding its commercialization efforts, focusing on key clinical decision-makers and vaccination points to enhance market presence[55] - The company has a robust strategy for market expansion and product development in the biopharmaceutical sector[102] - The company is committed to providing high-quality, innovative, and accessible vaccines globally as part of its mission[183] Human Resources and Corporate Culture - The company has established a training program for new employees to enhance understanding of corporate culture and compliance[184] - The company aims to maintain a gender ratio among employees, with male employees accounting for 48.6% and female employees accounting for 51.4%[165] - The board currently consists of 7 members, including 3 executive directors, 1 non-executive director, and 3 independent non-executive directors, with 1 female director and 6 male directors[163] - The company is committed to achieving gender equality on the board as a long-term goal[164] - The company has established a whistleblowing policy that encourages reporting of misconduct, ensuring confidentiality and protection for whistleblowers[170] - The company emphasizes a corporate culture focused on innovation, quality, and responsibility, with a vision of "Innovation without end, a world without epidemics"[183]