Key Points - **Industry/Company**: The content pertains to a pharmaceutical company involved in vaccine development and clinical trials. - **Core Points and Arguments**: - The company has submitted two product listings for approval. - A second-tier product, the "Elderly Bed," has also been submitted for approval. - In the first quarter of the year, the company filed clinical application materials for five vaccine products. - The materials include an upgraded version of 13 tuberculosis and pneumonia products, 20 tuberculosis and pneumonia products, an inactivated influenza vaccine, and a novel double-deoxyribonucleic acid (DNA) vaccine. - **Other Important Content**: - No additional information is provided beyond the product submissions and clinical trial activities. [1]

Company Overview * **Industry**: Vaccine * **Company**: Aimei Vaccine * **Market Position**: Aimei Vaccine is a leading vaccine company in China with a strong technical platform and full industrial chain. It holds four vaccine production licenses and has five products approved for market sales. * **Key Points**: * Aimei Vaccine has a mature technology platform with five platforms, and is one of the two companies in China approved to establish P3-level human vaccine enterprises. * The company's product pipeline covers the top ten global blockbuster vaccines, with eight commercial products and 21 in development. * Aimei Vaccine has four vaccine production bases across China, with a total of 3+7 research teams and seven production lines. * The company has a strong research and development team, with 39 invention patents and numerous utility model patents. Product Pipeline * **Key Products**: * **Pneumococcal Conjugate Vaccine**: Aimei Vaccine is focusing on the development of pneumococcal conjugate vaccines, including 13-valent, 20-valent, and 24-valent products. * **Meningococcal Conjugate Vaccine**: Aimei Vaccine is developing a new-generation meningococcal conjugate vaccine, as well as a global innovative vaccine product for GBS. * **Influenza Vaccine**: Aimei Vaccine is developing a novel MDCK cell influenza vaccine with a short production cycle and high efficacy. * **Rabies Vaccine**: Aimei Vaccine is developing a novel rabies vaccine with a single or two-dose regimen, as well as a global innovative rabies vaccine. * **Herpes Zoster Vaccine**: Aimei Vaccine is developing a herpes zoster vaccine using the MR technology platform, which has shown excellent cell-mediated immune effects. * **RSV Vaccine**: Aimei Vaccine is developing an RSV vaccine using the MR technology platform, which has shown good cross-protection effects against multiple strains. * **Hand, Foot, and Mouth Disease Vaccine**: Aimei Vaccine is developing a bivalent vaccine that covers both the 71st serotype and the A16 serotype, which is a global innovative vaccine product. * **Development Progress**: * Aimei Vaccine has submitted the registration application for 13-valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine. * The clinical application materials for 23-valent pneumococcal conjugate vaccine and inactivated rabies vaccine have been submitted. * The clinical application materials for herpes zoster vaccine and RSV vaccine have been submitted. * The bivalent hand, foot, and mouth disease vaccine has obtained a clinical approval. Financial Performance * **Revenue**: Aimei Vaccine's revenue is mainly derived from its existing products, including rabies vaccine and hepatitis B vaccine. * **Research and Development**: Aimei Vaccine has a strong focus on research and development, with research and development expenses accounting for 53.6% of its sales revenue. * **Profitability**: Aimei Vaccine aims to achieve profitability in 2024, depending on the control of research and development expenses. Future Outlook * **Internationalization**: Aimei Vaccine is actively promoting the internationalization of its products, focusing on developing countries. * **Innovation**: Aimei Vaccine will continue to invest in research and development, focusing on innovative vaccine products and the MRN technology platform. * **Growth**: Aimei Vaccine aims to achieve a second growth curve in the next 3-5 years, driven by the launch of new products and the expansion of its market share.

Financial Data and Key Metrics Changes - The company reported a compound annual growth rate (CAGR) of over 50% in R&D expenses from 2020 to 2023, with R&D expenses reaching 636 million in 2023, a 27.2% increase from 2022 [15][16] - R&D investment accounted for 50.6% of total revenue, the highest among vaccine companies with commercialized products [16] Business Line Data and Key Metrics Changes - The company has eight commercialized vaccine products and 21 in development, with plans to increase the number of commercialized products to eight within the next one to two years [6][14] - The main products include hepatitis B vaccines, which account for 80% of revenue from the second category of vaccines, and rabies vaccines, which contribute 30% to total sales [23][18] Market Data and Key Metrics Changes - The company holds a market share of 20% in the rabies vaccine sector, maintaining the second position in the market [23] - The adult hepatitis B vaccine market is expected to grow significantly, driven by government initiatives targeting the screening and vaccination of the adult population [19][22] Company Strategy and Development Direction - The company aims to become a global leader in the vaccine industry, focusing on continuous innovation and development of major vaccine products [52][54] - The strategy includes leveraging advanced technology platforms, such as the MR technology platform, to develop new vaccines and enhance production capabilities [30][54] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the future clinical progress of the company, highlighting the submission of multiple vaccine applications to regulatory authorities [13][14] - The company anticipates significant market opportunities, estimating a potential market size of 400 billion for its products, which could lead to explosive growth [53][54] Other Important Information - The company is recognized as the largest hepatitis B vaccine manufacturer globally and the second-largest rabies vaccine manufacturer [53] - It has established four licensed vaccine production facilities and three research institutes, positioning itself as a key player in the vaccine industry [53] Q&A Session Summary Question: What is the company's outlook on the adult hepatitis B vaccine market? - Management indicated that the adult hepatitis B vaccine market is expected to open up significantly due to government initiatives aimed at screening and vaccination, with a focus on the 86 million individuals carrying the hepatitis B virus in China [19][22] Question: How does the company plan to enhance its product pipeline? - The company plans to submit applications for three major vaccine products this year, with all production facilities completed and ready for commercialization upon regulatory approval [14][15]

Key Points - **Industry/Company Involved**: Aimei Vaccine, a pharmaceutical company - **Core Points and Arguments**: - The conference is a summer online strategy meeting hosted by Huahai Medicine, with the main host being Chief Analyst谭国超 from Huahai Medicine. - The focus of the meeting is an exchange with Aimei Vaccine, with participation from the company's leadership, including Vice President and Chief Investment Officer刘灵 and Vice President and CFO牛立新. - The discussion is divided into two main parts [1]. - **Other Important Content**: - No additional information provided beyond the structure of the meeting [1].

欢迎各位投资者参加本次华安医药联合路演中举办的这样一个夏季线上策略会咱们本场会议主持人是华安医药首席谭国超老师本场是上市公司艾米疫苗的交流很荣幸能够邀请到了公司的领导副总裁兼首席投资官董米刘林总以及公司的副总裁兼CFO牛立新牛总咱们今天的交流主要分为两个部分 第一部分为公司介绍第二部分是问答环节那么首先我们请公司领导刘灵总用20到30分钟的时间对公司的经营情况最新进展等做一个讲解有请刘总各位投资人大家上午好下面我给大家介绍一下公司的一个整体的经营情况和一些公司的进展 我们爱美疫苗是在行业里面保持着每年有5种产品通过国家综检院的批签发那么全国34家疫苗制造商里边爱美就在46张生产许可证当中拥有4张疫苗生产许可证那么截止到去年为止全国只有28家疫苗企业有产品获得综检院的批签发上市那么拥有5块以上的企业是5家爱美、国药终生、科兴和沃森 那么在行业里面爱美现在是拥有了全部5种经过验证的人用疫苗技术平台那么也是维二列入到国家发改委四五规划当中被批准建立P3级别的实验室的人用疫苗企业管线上我们现在已经有8款商业化的疫苗产品和21款在野的疫苗产品覆盖了全球前10大中邦疫苗的产品 那么我们在全国拥有5家疫苗执政工厂,5块以上 ...

Vaccine Product Portfolio and Pipeline - AimBio has 8 commercially available vaccine products and 21 vaccine products in the pipeline, covering the top 10 global vaccine varieties[6] - AIM Vaccine has 14 clinical approvals and 21 clinical trials, with 5 Phase III trials in the final stages[9] - The company plans to submit market registration applications for 3 upgraded products in 2024: 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal vaccine[9] - AIM Vaccine is advancing 21 blockbuster vaccines, including 20-valent and 24-valent pneumococcal conjugate vaccines, and mRNA rabies vaccine[9] - The mRNA RSV vaccine and mRNA shingles vaccine are key global blockbuster products under development[9] - The company obtained 14 clinical approvals by the end of 2023 and conducted 21 clinical trials, with 5 in Phase III clinical trials[12] - The company expects 3 products to be registered and launched in 2024, with 7 products to be submitted for clinical trials[12] - The company submitted pre-approval materials for the 13-valent pneumococcal conjugate vaccine (PCV13) to the National Medical Products Administration[12] - The company completed Phase III clinical trials for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the serum-free iterative rabies vaccine[12] - The company received clinical approval for the innovative EV71-CA16 bivalent hand, foot, and mouth disease vaccine[12] - The company's mRNA iterative rabies vaccine is the first non-COVID mRNA vaccine product accepted in China[12] - The company has commercialized 8 vaccines targeting 6 disease areas, with 21 vaccines in development for 14 disease areas, and has obtained 14 clinical approvals for 9 varieties[15] - The 13-valent pneumococcal conjugate vaccine (PCV13) has completed Phase III clinical trials and submitted a pre-application for market registration to the National Medical Products Administration[15] - The 23-valent pneumococcal polysaccharide vaccine (PPSV23) has completed Phase III clinical trials and is undergoing serum testing, with statistical unblinding imminent[15] - The serum-free iterative rabies vaccine completed Phase III clinical trials in September 2023 and is undergoing serum testing, with statistical unblinding imminent[15] - The quadrivalent meningococcal conjugate vaccine (MCV4) has completed Phase I clinical trials and initiated Phase II subject enrollment[15] - The quadrivalent meningococcal polysaccharide vaccine (MPSV4) has initiated Phase IV clinical subject enrollment[15] - The bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine has completed domestic Phase I and II clinical trials, with overseas Phase III trials in the final stages[15] - The company has submitted pre-applications for clinical trials for the 20-valent pneumococcal conjugate vaccine (PCV20), Hib conjugate vaccine, tetanus vaccine, quadrivalent MDCK cell influenza vaccine, and high-potency human diploid cell rabies vaccine[15] - The company's PCV13 vaccine completed Phase III clinical trials and submitted a pre-application for market registration, with plans to complete market application in 2024[23] - The company's PCV20 vaccine plans to submit a CTA in 2024, and PCV24 vaccine plans to submit a CTA in 2025[22] - The company's PPSV23 vaccine completed Phase III clinical trials and plans to submit a market registration application in 2024[22] - The company's MCV4 vaccine has completed Phase II clinical enrollment and plans to initiate Phase III in 2024[22] - The global PCV13 vaccine shortage is estimated at 180 million doses, and the company's PCV13 vaccine could become a major supplier upon market approval[24] - The company's PCV13 vaccine Phase III clinical trial involved 3,780 participants aged 6 weeks to 71 months[23] - The PCV13 vaccine market in China is projected to exceed RMB 20 billion by 2030, with current penetration at 25.9% compared to over 80% in the US[23] - The company's mRNA rabies vaccine is under clinical trial application review, with plans to submit a CTA for mRNA shingles vaccine in 2024[22] - The company has completed the construction of GMP workshops for pneumonia vaccines, meeting international standards, and has produced Phase III clinical samples for 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine[25] - The company plans to complete the market application for its serum-free iterative rabies vaccine by 2024, and expects to submit a clinical trial application for its high-titer human diploid cell rabies vaccine in 2024[26] - The company's mRNA rabies vaccine is the first non-COVID mRNA vaccine accepted for clinical trial application in China, showing significant advantages in reducing vaccination doses and accelerating antibody production[26] - The company has completed the construction of workshops for serum-free iterative rabies vaccine and high-titer human diploid cell rabies vaccine, with equipment debugging and validation underway[27] - The company's mRNA technology platform has been validated by over 10,000 clinical trial cases, with mRNA rabies vaccine demonstrating higher safety and efficacy compared to traditional vaccines[28] - The company is developing mRNA RSV and mRNA shingles vaccines, with clinical trial applications expected to be completed in 2024[28] - The company's MCV4 vaccine for meningococcal disease has completed Phase I clinical trials with 120 participants and has initiated Phase II trials[29] - The company is developing the world's first EV71-CA16 bivalent hand, foot, and mouth disease vaccine, which has entered the clinical stage[30] - The company utilizes five validated human vaccine platform technologies, including mRNA, genetic engineering, and combination vaccines, and is exploring AI applications in vaccine development[31] - The company's R&D team consists of three vaccine research institutions (Aimei Explorer, Aimei Lifanda, Aimei Innovator) and four vaccine production subsidiaries (Aimei Integrity, Aimei Action, Aimei Honor, Aimei Persistence), each focusing on different vaccine platform technologies such as bacterial vaccines, mRNA vaccines, and gene-engineered vaccines[32] - The company is advancing the development of 13-valent pneumococcal conjugate vaccine and quadrivalent meningococcal conjugate vaccine, both listed as high-priority pre-qualification products by WHO (2024-2026)[43] - The company's GMP workshops for iterative pneumococcal and rabies vaccine series have been completed in batches, meeting international standards, with Phase III clinical samples of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine produced in these workshops[43] Market and Sales Performance - The company's sales cover all 31 provinces, autonomous regions, and municipalities in China, reaching over 2,000 county-level CDC centers[6] - The company achieved operating revenue of approximately RMB 1,187.5 million in 2023, a decrease of 6.1% compared to 2022[13] - Revenue from Class I vaccine sales in 2023 was RMB 72.796 million, down from RMB 115.322 million in 2022[14] - Revenue from Class II vaccine sales in 2023 was RMB 1,114.672 million, slightly down from RMB 1,148.716 million in 2022[14] - The company's products cover all 31 provinces, autonomous regions, and municipalities in China, reaching over 2,000 county-level disease control centers[11] - The company's main business revenue in 2023 was RMB 1,187.5 million, a decrease of RMB 76.6 million (6.1%) compared to 2022, primarily due to a decline in sales of Class I hepatitis B vaccines and Class II rabies vaccines, partially offset by an increase in sales of Class II hepatitis B vaccines[45] - The company's gross profit in 2023 was RMB 901 million, a decrease of RMB 126.6 million (12.3%) compared to 2022, with a gross margin of 75.9%, down 5.4 percentage points from 2022, mainly due to decreased production volume and increased unit product costs[47] - The company's sales and distribution expenses in 2023 were RMB 494 million, a slight increase of RMB 0.8 million (0.2%) compared to 2022[51] - The company's other income and gains in 2023 were RMB 51.7 million, an increase of RMB 2.1 million (4.1%) compared to 2022, mainly due to increased gains from asset disposals[48] - The company recorded impairment losses on property, plant, and equipment of RMB 61.1 million in 2023, primarily due to the write-down of idle factory buildings, machinery, and other assets[54] - The company's financial asset impairment losses in 2023 were RMB 4.2 million, a decrease of RMB 23 million (84.6%) compared to 2022, mainly due to a significant reduction in bad debt provisions for accounts receivable[53] - Impairment losses on goodwill and intangible assets amounted to RMB 1,512.2 million and RMB 211.4 million respectively, primarily due to the revaluation of mRNA vaccine products and market changes[55] - The company's financing costs increased by 70.6% to RMB 43.8 million in 2023, driven by higher bank loan interest[57] - The company recorded a tax credit of RMB 320.4 million in 2023, a 57.4% increase compared to 2022, due to higher pre-tax losses[58] - The company's net loss for 2023 was RMB 1,950.2 million, a 745.6% increase from 2022, mainly due to impairment losses and increased R&D expenses[59] - Cash and cash equivalents decreased by 7.7% to RMB 736.4 million in 2023, primarily due to reduced revenue and increased R&D spending[60] - Capital expenditures decreased by 64.8% to RMB 301.6 million in 2023, as major vaccine industrialization projects were largely completed[63] - The company's total financial liabilities increased by 28.4% to RMB 1,795.6 million in 2023, driven by higher bank borrowings[64] - The capital-to-debt ratio rose to 46.2% in 2023, up 22.3 percentage points from 2022, due to increased bank loan balances[64] - The company's inventory increased by 1% to RMB 509.9 million in 2023, reflecting a slight rise in stock levels[61] - Trade receivables decreased by 4.5% to RMB 1,005.1 million in 2023, as sales revenue slightly declined[62] - The company had 1,624 employees as of December 31, 2023, compared to 1,576 employees in 2022, with total employee benefit expenses (including director remuneration) of RMB 362.4 million in 2023, down from RMB 608.0 million in 2022[68] - The company allocated HKD 38.747 million (42.30%) of IPO proceeds for the development of mRNA technology platform-related vaccines, with the full amount utilized by December 2023[71][72] - HKD 6.412 million (7.00%) of IPO proceeds were allocated for the development of pneumonia vaccine candidates (PCV13, PCV20, PPSV23), fully utilized by June 2023[71][72] - HKD 32.060 million (35.00%) of IPO proceeds were allocated for the construction of new production facilities, with HKD 13.210 million utilized and HKD 18.850 million remaining as of December 31, 2023[71] - The company plans to complete the utilization of the remaining HKD 18.850 million for the Ningbo mRNA vaccine production facility by December 31, 2024[71] - HKD 4.590 million (5.00%) of IPO proceeds were allocated for sales and marketing activities, fully utilized by January 2023[71][72] - The company proposed the issuance of up to 242,212,519 non-listed RMB ordinary shares to qualified investors and existing shareholders, pending regulatory approval[73] - The company's total IPO proceeds amounted to HKD 91.610 million, with HKD 72.760 million utilized and HKD 18.850 million remaining as of December 31, 2023[71] - The company issued 9,714,000 H shares at HKD 16.16 per share on October 6, 2022, and partially exercised the over-allotment option for 1,348,600 H shares at the same price on October 28, 2022, raising net proceeds of approximately HKD 91.61 million[97] - As of December 31, 2023, the company's share capital consisted of 718,888,888 domestic shares (59.36%) and 492,173,711 H shares (40.64%)[98] - The company had no distributable reserves as of December 31, 2023[99] - The company's dividend policy considers factors such as financial performance, cash flow, business conditions, future operations, capital requirements, and shareholder interests[99] - The company leased approximately 1,979 square meters of office space in Shanghai from its controlling shareholder and executive director, Mr. Zhou Yan, with an annual rent of RMB 9,540,000 for the first year, increasing by RMB 0.5 per square meter for the second and third years[102] - The company confirmed that its controlling shareholder, Mr. Zhou Yan, had no competing interests outside the company's business as of December 31, 2023[103] - No directors or their associates were engaged in any business competing with the company during the reporting period[104] - Zhou Yan holds 210,135,235 domestic shares, representing 29.23% of the domestic share class and 17.35% of the total shares[109] - Zhou Yan also holds 23,254,765 H-shares, representing 4.72% of the H-share class and 1.92% of the total shares[109] - Zhou Jie holds 40,000,000 domestic shares, representing 5.56% of the domestic share class and 3.30% of the total shares[109] - Zhou Xin holds 40,000,000 domestic shares, representing 5.56% of the domestic share class and 3.30% of the total shares[109] - Jia Shaojun holds 25,000,000 domestic shares, representing 3.48% of the domestic share class and 2.06% of the total shares[109] - Wang Aijun holds 25,000,000 domestic shares, representing 3.48% of the domestic share class and 2.06% of the total shares[109] - Wang Aijun also holds 25,000,000 H-shares, representing 5.08% of the H-share class and 2.06% of the total shares[109] - Jia Shaojun holds 10,310,000 H-shares, representing 2.09% of the H-share class and 0.85% of the total shares[109] - The company has a total of 1,211,062,599 shares issued, including 718,888,888 domestic shares and 492,173,711 H-shares[110] - Tibet Chizhi Heart Enterprise Management Co., Ltd. holds 200,000,000 domestic shares, representing 27.82% of the domestic share category and 16.51% of the total shares[113] - Yang Aihua holds 44,300,000 domestic shares and 55,700,000 H-shares, representing 6.16% and 11.32% of the respective share categories, and 3.66% and 4.60% of the total shares[113] - Shanghai Xunjing Enterprise Management Center holds 44,300,000 domestic shares and 55,700,000 H-shares, representing 6.16% and 11.32% of the respective share categories, and 3.66% and 4.60% of the total shares[113] - Tibet Yingfeng Industrial Co., Ltd. holds 44,300,000 domestic shares and 55,700,000 H-shares, representing 6.16% and 11.32% of the respective share categories, and 3.66% and 4.60% of the total shares[113] - Ningbo Beilun State-owned Capital Operation Co., Ltd. holds 54,051,428 H-shares, representing 10.98% of the H-share category and 4.46% of the total shares[113] - Ningbo Economic & Technological Development Zone Holding Co., Ltd. holds 54,051,428 H-shares, representing 10.98% of the H-share category and 4.46% of the total shares[113] - Ningbo Bonded Zone Holding Co., Ltd. holds 54,051,428 H-shares, representing 10.98% of the H-share category and 4.46% of the total shares[114] - Chang Wei and Zhang Kuo each hold 40,000,000 H-shares through controlled entities, representing 8.13% of the H-share category and 3.30% of the total shares[114] - Qingdao Chunteng Venture Capital Partnership holds 40,000,000 H-shares, representing 8.13% of the H-share category and 3.30% of the total shares[115] - China Merchants Bank Co., Ltd. and its affiliates hold 29,031,000 H-shares, representing 5.90% of the H-share category and 2.40% of the total shares[115] - Zhaoshang Bank holds 83.20% equity in Zhaoshang International Financial Co., Ltd through its wholly-owned subsidiary Zhaoshang International Financial Holdings Co., Ltd[117] - Zhaoshang International Capital Management (Shenzhen) Co., Ltd manages two partnerships holding 13,834,800 H shares and 15,196,200 H shares respectively[117] - Lhasa Meihua, a wholly-owned subsidiary of Meihua Biological Technology Group, directly holds 25,000,000 H shares[117] - Zhuhai Hengqin Ruifan Technology Partnership holds 32.2% equity in Aimei Lifanda[118] - Zhuhai Hengqin Qijing Technology Partnership holds 11.0% equity in Aimei Lifanda[118] - Zhuhai Ruijin Technology Partnership holds 6.6% equity in Aimei Lifanda[118] - The maximum number of shares that can be issued under the Pre-IPO Employee Share Incentive Plan is

Company Update - Zhou Yan, the Chairman, Executive Director, CEO, and controlling shareholder of AIM Vaccine (06660), has further increased his holdings of the company's H-shares through the open market from January 12, 2024, to April 15, 2024 [1] - Since November 14, 2023, Zhou Yan has cumulatively increased his holdings of the company's H-shares using his own funds, totaling HKD 10,420,212 [1] - Zhou Yan does not rule out the possibility of further increasing his holdings of the company's shares at an appropriate time [1] Operational and Financial Status - The company's operations, financial status, and sales of existing products are all normal as of the announcement date [1] - The development of the company's vaccine pipeline is progressing as planned [1] Shareholding and Regulatory Compliance - Following the recent share increase, the company still meets the sufficient public float requirement under Rule 8.08 of the Listing Rules [1] - The recent share increase did not trigger a mandatory offer obligation under the Takeovers Code [1] - The recent share increase did not result in any change in the company's control [1] Management Confidence - The Board believes that Zhou Yan's continuous share purchases using his own funds reflect his judgment of the company's intrinsic value and future growth potential [1] - Zhou Yan's actions demonstrate his confidence in and recognition of the company's future development, which is conducive to the realization of the company's long-term strategic layout [1]

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分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 AIM Vaccine Co., Ltd. 艾美疫苗股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：06660） 截至2023年12月31日止年度 全年業績公告 財務摘要 | --- | --- | --- | --- | |----------------------|------------------|-----------------|-------| | | | | | | | 截至 12 月 31 年 | 日止年度 年 | 變動 | | 主要收益表項目 | 2023 人民幣千元 | 2022 人民幣千元 | % | | | | | | | 收入 | 1,187,468 | 1,264,073 | -6.1 | | 毛利 | 901,016 | 1,027,659 | -12.3 | | 母公司擁有人應佔虧損 | (1,301,005) | (319,601) | 307 ...

Financial Performance - For the six months ended June 30, 2023, the company reported total revenue of RMB 540.5 million, a decrease of 8.6% compared to RMB 591.6 million in the same period of 2022[6]. - The company's main business revenue for the first half of 2023 was RMB 540.5 million, a decrease of RMB 51.1 million or 8.6% compared to RMB 591.6 million in the same period of 2022[28]. - The company's gross profit for the first half of 2023 was RMB 432.6 million, down RMB 49.0 million or 10.2% from RMB 481.6 million in the first half of 2022[30]. - The gross margin for the first half of 2023 was 80.1%, a decline of 1.3% from 81.4% in the first half of 2022[30]. - The company reported a loss before tax of RMB 309,879 thousand, compared to a loss of RMB 132,310 thousand in the previous year, indicating a significant increase in losses[85]. - The net loss attributable to equity holders of the parent for the period was RMB 250,369 thousand, compared to a profit of RMB 44,877 thousand in the same period last year[85]. - The company's loss for the first half of 2023 was RMB 257.4 million, an increase in loss of RMB 308.3 million or 605.3% compared to a profit of RMB 50.9 million in the first half of 2022, mainly due to significantly increased R&D expenses and a decrease in tax credit[40]. - The company incurred a pre-tax loss of RMB 309,879,000 for the six months ended June 30, 2023, compared to RMB 132,310,000 in the prior year[89]. - The company reported a net loss of RMB 250,369,000 for the six months ended June 30, 2023, compared to a loss of RMB 44,877,000 for the same period in 2022[88]. Revenue Breakdown - The sales breakdown for key products includes: Vero cell rabies vaccine at RMB 324.1 million (60.0%), hepatitis B vaccine at RMB 180.1 million (33.3%), and inactivated hepatitis A vaccine at RMB 21.5 million (4.0%) for 2023[6]. - The recombinant hepatitis B vaccine has generated 33.3% of the company's revenue for the six months ending June 30, 2023[8]. - The human rabies vaccine (Vero cells) accounted for 60.0% of the company's revenue for the six months ending June 30, 2023[10]. - The sales revenue of the MPSV4 vaccine reached RMB 14.7 million for the six months ending June 30, 2023[11]. - Revenue from vaccine sales was RMB 540,470,000, with all revenue recognized at a point in time[100]. Research and Development - The company has 23 vaccine candidates in the pipeline targeting 14 disease areas, with nine products having obtained 14 clinical approvals[7]. - The company has developed a robust pipeline of vaccines utilizing its proprietary mRNA technology platform, responding rapidly to emerging COVID-19 variants[16]. - The company’s R&D pipeline aligns with national policies, covering all encouraged vaccine technologies, with significant progress expected in 2023[26]. - The company’s internal R&D team is responsible for all stages of vaccine development, including preclinical research and clinical trials[20]. - The company has initiated Phase III clinical trials for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) as of August 2023[20]. Clinical Trials and Approvals - The overseas Phase III clinical trial for the bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine is nearing completion, while the bivalent EV71-CA16 hand-foot-mouth disease vaccine has entered clinical trials[7]. - The company has initiated Phase III clinical trials for the lyophilized rabies vaccine in July 2023 and plans to start Phase III trials for the quadrivalent meningococcal conjugate vaccine in 2024[7]. - The bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine is in the final stages of a Phase III clinical trial in Pakistan, with plans for domestic registration based on combined clinical data expected in 2023[14]. - The 13-valent pneumococcal conjugate vaccine (PCV13) is expected to submit a drug registration application in Q1 2024, with approval anticipated in H2 2024[17]. - The EV71-CA16 bivalent hand, foot, and mouth disease vaccine is set to initiate Phase I clinical trials in Q4 2023, marking it as the first vaccine targeting both EV71 and CA16 strains[18]. Production and Capacity - The company operates four licensed factories and covers 31 provinces, autonomous regions, and municipalities in China[5]. - The company’s production capacity includes 25 million doses for rabies vaccine, 45 million doses for recombinant hepatitis B vaccine, and 5.3 million doses for inactivated hepatitis A vaccine[22]. - The company has completed the construction and equipment validation for its mRNA COVID-19 vaccine production workshop as of June 30, 2023[23]. - The company plans to establish new production facilities in the coming years to meet the strong demand for its existing vaccine products[23]. - The new production line for the hemorrhagic fever vaccine passed GMP inspection in June 2022, allowing for resumed production[12]. Financial Position and Liabilities - As of June 30, 2023, cash and cash equivalents totaled RMB 754.9 million, a decrease of RMB 42.9 million or approximately 5.4% from RMB 797.8 million as of December 31, 2022, primarily used for R&D expenses[41]. - Total financial liabilities as of June 30, 2023, amounted to RMB 1,687.5 million, an increase of RMB 288.8 million or 20.6% from RMB 1,398.7 million as of December 31, 2022, mainly due to increased bank borrowings[45]. - The capital debt ratio as of June 30, 2023, was 30.3%, an increase of 6.4% from 23.9% as of December 31, 2022, primarily due to an increase in bank loan balances[46]. - The company has obtained bank loans amounting to RMB 500 million for the construction of a new production facility, but has failed to meet certain loan covenants[77]. - The company’s total liabilities increased, with a significant rise in trade payables and other payables[89]. Shareholder Information - As of June 30, 2023, the total number of shares issued was 1,211,062,599, including 718,888,888 domestic shares and 492,173,711 H shares[58]. - The company has a significant shareholder, Mr. Zhou Yan, holding 29.23% of the domestic shares, equating to 17.35% of the total shares[57]. - The company has a significant concentration of ownership, with major shareholders holding over 5% of the total shares, indicating potential influence over corporate decisions[60]. - The company’s major shareholders include Zhuhai Hengqin Ruifan Technology Partnership, which holds 32.2% of the equity in Lifanda Bio[66]. - The company has established a long-term incentive mechanism to attract and retain talent through the employee stock incentive plan[69]. Market Outlook and Strategy - The Chinese vaccine market is projected to grow from RMB 303.6 billion in 2021 to RMB 431.4 billion by 2030, including COVID-19 vaccines[25]. - The company has set a future outlook with a revenue guidance of 2.5 billion RMB for the full year 2023, reflecting a 20% growth target[127]. - The company is expanding its market presence, targeting new regions in Southeast Asia, with plans to establish partnerships with local distributors by mid-2024[125]. - The company is implementing a new marketing strategy focused on digital channels, which is projected to increase customer engagement by 35%[127]. - The company has invested 150 million RMB in new technology for vaccine production, aiming to increase production capacity by 40%[126]. Compliance and Governance - The company is subject to the Securities and Futures Ordinance, requiring disclosure of substantial shareholders and their interests[60]. - The company maintains compliance with regulatory requirements regarding the disclosure of shareholdings and interests[60]. - The roles of the Chairman and CEO are currently held by the same individual, which the board believes facilitates effective execution of strategic plans[77]. - The interim financial statements were approved for publication by the board of directors on August 29, 2023[124]. - The company has not identified any incidents of employees violating written guidelines regarding insider trading during the reporting period[79].

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分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 AIM Vaccine Co., Ltd. 艾美疫苗股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：06660） 截至2023年6月30日止六個月之 中期業績公告 財務摘要 | --- | --- | --- | --- | |----------------------|----------------|------------------------------|-------| | | 截至 \n2023 年 | 6 月 30 日止六個月 \n2022 年 | 變動 | | 主要收益表項目 | 人民幣千元 | 人民幣千元 | % | | 收入 | 540,470 | 591,567 | -8.6 | | 毛利 | 432,648 | 481,625 | -10.2 | | 母公司擁有人應佔虧損 | 250,369 | 44,877 | 457.9 | 1 董事會欣然公佈本集團 ...