Vaccine Portfolio and Development - AIM Vaccine has 8 commercialized vaccines and 22 vaccine products under development, covering all 31 provinces, autonomous regions, and municipalities in China, reaching over 2,000 county-level CDC centers[4] - The company is advancing 22 vaccine candidates across 14 disease areas, with key products like the bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine in Phase III trials in Pakistan[5] - The company has commercialized 8 vaccines targeting 6 disease areas, with Hepatitis B and rabies vaccines being the leading products[10] - The company has 22 vaccines in development targeting 14 disease areas, with 9 varieties having obtained 13 clinical approvals[10] - The company's product portfolio includes both EPI (Expanded Program on Immunization) and non-EPI vaccines, leveraging five validated human vaccine platform technologies[8] - The company plans to submit multiple clinical trial applications in 2023, aiming to advance several pre-clinical candidates into clinical trials[5] - Key products like the bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine and 13-valent pneumococcal conjugate vaccine are expected to launch between 2023 and 2025[5] - The bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine is currently in Phase III clinical trials overseas, with an expected emergency launch in 2023[18][19] - The monovalent Omicron BA.5 mRNA COVID-19 vaccine plans to submit a CTA in 2023, with an expected launch in 2023[18] - The EV71-CA16 bivalent hand, foot, and mouth disease vaccine is expected to start Phase I clinical trials in Q3 2023, with a projected launch in 2026[18][21] - The 13-valent pneumococcal conjugate vaccine (PCV13) is in Phase III clinical trials, with an expected NDA submission in Q1 2024 and launch in 2024[18][20] - The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is expected to enter Phase III clinical trials in Q2 2023, with a projected launch in 2024[18][23] - The ACYW135 group meningococcal polysaccharide conjugate vaccine (MCV4) started Phase I clinical trials in Q1 2023, with Phase II expected to start in Q3 2023[22] - The freeze-dried human rabies vaccine (serum-free Vero cell) is expected to start Phase III clinical trials in Q3 2023[23] - The mRNA human rabies vaccine plans to submit a CTA in 2023, with a projected launch after 2026[18] - The quadrivalent influenza vaccine (MDCK cell) plans to submit a CTA in 2024, with a projected launch after 2026[18] - The mRNA respiratory syncytial virus (RSV) vaccine plans to submit a CTA in Q2 2024, with a projected launch after 2026[18] - The company's PCV13 vaccine completed Phase III clinical trials for primary immunization in 2022[10] Production and Manufacturing - The company's four licensed factories have a combined annual production capacity of 91.3 million doses of vaccine bulk, all passing GMP inspections in 2022[4] - The company operates four licensed manufacturing facilities and covers 31 provinces, autonomous regions, and municipalities in China with its vaccine products[8] - The company's four licensed production facilities have a combined production capacity of 91.3 million doses annually, with facilities located in Ningbo, Dalian, Taizhou, and Ningbo[26] - The Ningbo Rong'an mRNA COVID-19 vaccine production workshop completed construction, equipment debugging, and validation by the end of 2022, and has produced samples for Phase III clinical trials[27] - The company plans to establish new production facilities in the coming years to meet strong market demand for its existing vaccine products[27] - The company's new bacterial vaccine industrialization project includes completed construction of pneumonia series vaccine and DTP-Hib combined vaccine workshops, currently undergoing validation[27] - The company's licensed production facilities passed all GMP inspections conducted by the National Medical Products Administration or its local agencies in 2022[25] - The company's production facilities are equipped with advanced equipment from leading international and domestic brands, ensuring stable and high-quality supply through optimized production planning and automation[26] - The company's new production line for hemorrhagic fever vaccine passed GMP inspection in June 2022[16] Financial Performance - Revenue for 2022 decreased by 19.5% to RMB 1,264.1 million, primarily due to delayed procurement and vaccination of non-COVID vaccines amid the pandemic[8] - Freeze-dried human rabies vaccine (Vero cell) remained the top-selling product, contributing 61.5% of total revenue in 2022, though sales dropped from RMB 937.4 million in 2021 to RMB 777.0 million[9] - Hepatitis B vaccine (Hansenula yeast) accounted for 34.6% of total revenue, with sales declining from RMB 523.3 million in 2021 to RMB 436.8 million in 2022[9] - The company's main business revenue in 2022 was RMB 1,264.1 million, a decrease of 19.5% compared to RMB 1,570.1 million in 2021, primarily due to the impact of the COVID-19 pandemic[32] - The company's gross profit in 2022 was RMB 1,027.7 million, a decrease of 20.6% compared to RMB 1,294.7 million in 2021, with a gross margin of 81.3%, down 1.2% from 82.5% in 2021[35] - The company's sales cost in 2022 was RMB 236.4 million, a decrease of 14.2% compared to RMB 275.4 million in 2021, mainly due to reduced sales volume[33] - The company's other income and gains in 2022 were RMB 49.6 million, a decrease of 7.4% compared to RMB 53.6 million in 2021, primarily due to reduced government subsidies and foreign exchange gains[36] - The company's operating expenses in 2022 totaled RMB 1,444.2 million, including RMB 493.2 million in sales and distribution expenses, RMB 450.8 million in administrative expenses, and RMB 500.3 million in R&D expenses[37] - R&D expenditure in 2022 increased by 62.8% to RMB 500.3 million, driven by progress in mRNA COVID-19 vaccine, serum-free rabies vaccine, and pneumonia vaccine development[38] - Sales and distribution expenses rose by 7.2% to RMB 493.2 million in 2022, primarily due to increased employee compensation, partially offset by reduced promotional activities due to COVID-19[39] - Administrative expenses decreased by 61.4% to RMB 450.8 million in 2022, mainly due to a significant reduction in employee compensation-related share-based payments[40] - Financing costs surged by 140.1% to RMB 25.7 million in 2022, primarily due to increased bank loan interest[41] - Income tax expenses decreased by 394.3% to a credit of RMB 203.5 million in 2022, driven by lower taxable income and a tax rate reduction for a subsidiary[42] - Impairment losses on financial assets increased by 241% to RMB 27.2 million in 2022, mainly due to higher bad debt provisions for receivables[43] - Net loss in 2022 decreased by 65.9% to RMB 230.6 million, primarily due to reduced employee compensation-related share-based payments[44] - Cash and cash equivalents increased by 23.4% to RMB 797.8 million as of December 31, 2022, driven by the completion of an initial public offering[45] - Inventory increased by 37.4% to RMB 504.7 million as of December 31, 2022, due to higher raw material stockpiling and lower sales of rabies vaccines[46] - Capital expenditure decreased by 25% to RMB 856.6 million in 2022, mainly due to reduced spending on vaccine industrialization projects[48] R&D and Innovation - R&D expenses increased from approximately RMB 300 million in 2021 to RMB 500 million in 2022, a significant rise in investment for vaccine development[5] - The company has five validated human vaccine platform technologies, including mRNA vaccines, genetically engineered vaccines, and combined vaccine technologies, with at least one approved product or one vaccine in clinical trial application or clinical stage under each platform[24] - The company's internal R&D team manages all stages of vaccine development, from preclinical research to clinical trials, regulatory filings, and manufacturing process development, supported by three vaccine research institutes and four production subsidiaries[24] - The company's R&D focus includes mRNA vaccines, genetically engineered vaccines, and combined vaccine technologies, with specialized teams dedicated to each platform[24] - The company's R&D activities are led by a world-class team of scientists, including Dr. Peng Yucai, who specializes in mRNA drug development, and Mr. Zhang Fan, who has over 10 years of experience in vaccine development[24] Market and Industry Overview - China's vaccine market grew from RMB 25.1 billion in 2015 to RMB 76.1 billion in 2021, and is expected to further increase to RMB 215.7 billion by 2030 (excluding COVID-19 vaccines). Including COVID-19 vaccines, the market is projected to grow from RMB 303.6 billion in 2021 to RMB 431.4 billion by 2030[29] - As of December 31, 2022, a total of 3,478.094 million doses of COVID-19 vaccines were administered in mainland China[29] - The company is the second-largest vaccine group in China and the largest private vaccine group by batch issuance volume in 2021[4] - The company is one of the first two human vaccine companies in China to receive P3 laboratory construction permits under the 14th Five-Year Plan[4] Corporate Governance and Leadership - Guan Wen, aged 56, has been serving as the Executive Director and Executive President of the company since June 2021, assisting the CEO in internal management[60] - Jia Shaojun, aged 60, has been the Executive Director since June 2021 and assumed the role of Chief Operating Officer in March 2023[60] - Zhou Jie, aged 59, has been a Non-Executive Director since June 2021 and previously served as the Chairman of the Board from December 2016 to September 2020[63] - Zhou Xin, aged 54, has been a Non-Executive Director since June 2021 and holds a 99.99% stake in Woye Biotechnology (Liaoning) Co., Ltd[63] - Zhao Jichen, aged 59, has been a Non-Executive Director since June 2021 and previously served as Executive Director and Vice President at Ping An Bank[64] - Wang Aijun, aged 50, has been a Non-Executive Director since June 2021 and is the Chairman of Meihua Biological Technology Group[64] - Ker Wei Pei, aged 66, has been an Independent Non-Executive Director since September 2020 and serves as the Audit Committee Chairman of Zhejiang Expressway[66] - Guo Xiaoguang, aged 50, was appointed as an Independent Non-Executive Director in February 2021[66] - Guo served as General Manager of Huaxi Jinzhi Investment Co., Ltd. from September 2017 to February 2021[67] - Ouyang has been an independent non-executive director of Ping An Insurance (Group) Company of China since August 2017[68] - Wen was awarded the National Science and Technology Progress Award by the State Council of China in November 2015 for her research on SARS pathogen and prevention[68] - Song has been the Chairman of the Supervisory Committee since February 2021[69] - Ma has over 25 years of experience in financial accounting, treasury, corporate finance, and tax affairs[69] - Niu has been the Chief Financial Officer since October 2015, responsible for the company's financial management[70] - Liu has served as the Chief Investment Officer since March 2022, overseeing the company's investment management and external information disclosure[70] - Liu holds a W.P. Carey Executive MBA degree, obtained in May 2018[70] - Niu holds a W.P. Carey Executive MBA degree, obtained in May 2020[70] - Liu has been a director of Livanda Biotech since May 2021[70] Legal and Regulatory Matters - The company faces legal claims totaling approximately RMB 12.539 million related to disputes with a marketing service provider, with a recorded liability of RMB 4.496 million. A first-instance judgment in July 2022 required the company to pay RMB 4.483 million, and an appeal is pending as of December 31, 2022[52] - Another legal claim involves a creditor's subrogation lawsuit, with a claimed amount of approximately RMB 80.198 million. A first-instance judgment in October 2022 required the company's subsidiary to pay RMB 28.697 million plus interest, and an appeal is ongoing as of December 31, 2022[52] Environmental, Social, and Governance (ESG) - The company has established detailed internal rules on environmental protection, including emissions of waste gas, wastewater, solid waste, and noise control, and has complied with applicable Chinese environmental laws and regulations during the reporting period[77] - The company's ESG report covers the period from January 1, 2022, to December 31, 2022, and includes all subsidiaries and research institutions[179] - The company's board has established an ESG governance framework and set group emission reduction targets and an "Energy Conservation Regulation"[180] - The company actively communicates with stakeholders, including shareholders, employees, government agencies, suppliers, customers, and the community[181] - Stakeholder engagement methods include general meetings, public disclosures, roadshows, management meetings, and community activities[182] - Total exhaust emissions in 2022 were approximately 1,166.5 kg, with an emission density of 92.3 kg per RMB 100 million in revenue[188] - Nitrogen oxides (NOx) accounted for 1,082.6 kg of emissions, with a density of 85.6 kg per RMB 100 million in revenue[189] - Total greenhouse gas emissions in 2022 were approximately 53,586.0 tons of CO2 equivalent, with an emission density of 4,239.0 tons of CO2 equivalent per RMB 100 million in revenue[190] - Direct greenhouse gas emissions totaled 148.82 tons of CO2 equivalent, with a density of 11.77 tons per RMB 100 million in revenue[191] - Indirect greenhouse gas emissions from electricity usage were 52,856.4 tons of CO2 equivalent, with a density of 4,181.3 tons per RMB 100 million in revenue[192] - The company emitted 148,557.3 tons of non-hazardous waste, primarily wastewater, with a density of 11,752.0 tons per RMB 100 million in revenue[194] - The company aims to reduce greenhouse gas emissions by 10% in 2023 compared to 2022 levels[195] - The company consumed approximately 54,000 liters of gasoline, 65.693 million kWh of electricity, and 793,000 cubic meters of water in 2022[197] - The company's energy consumption density in 2022 was 0.4 liters of gasoline per 100 million RMB revenue, 519.7 kWh of electricity per 100 million RMB revenue, and 6.3 cubic meters of water per 100 million RMB revenue[198] - The company used 66.6 tons of plastic, 109.5 tons of paper, 0.2 tons of metal, and 50.8 tons of other materials (including glass) for product packaging in 2022[199] - The company aims to reduce electricity consumption by 5% in 2023 compared to 2022[200] Shareholder and Investor Relations - The company's H股 was listed on the Hong Kong Stock Exchange on October 6, 2022, with an issue price of HK$16.16 per share, raising a net amount of approximately HK$91.61 million[74][82] - The company's largest customer accounted for 2.1% of total sales, while the top five customers combined accounted for 6.3% of total sales[80] - The largest supplier accounted for 11.5% of total purchases, and the top five suppliers combined accounted for 27.1% of total purchases[80] - The company's total issued share capital as of December 31, 2022, was 1,211,062,599 shares, with 59.36% being domestic shares and 40.64% being H shares[83] - The company did not recommend paying a final dividend for the twelve months ended December 31, 2022[78] - The company's main business is the research, development, production, and commercialization of human vaccines in China[75] - The company has no distributable reserves as of December 31, 2022 (same as December 31, 2021)[84] - The company's dividend policy emphasizes maintaining sufficient cash reserves to meet funding needs, future growth, and shareholder value[85] - The company's controlling shareholder, Mr. Zhou Yan, leased properties to the company with a total area of 1,979 square meters in Shanghai, with an annual rent of RMB 9,540,000 for the first year[88] - Mr. Zhou Yan holds 210,135,235 domestic shares, representing 29.23% of the domestic share class and 17.35% of the total shares[95] - Mr. Zhou Yan also holds 23,254,765 H-shares, representing 4.72% of the H-share class and 1.92% of the total shares[95] - Mr. Zhou Jie and Mr. Zhou Xin each hold 40,000,000 domestic shares, representing 5.56% of the domestic share class and 3.30% of the total shares[95] - Ms. Wang Aijun holds 25,000,000 domestic shares and 25,000,000 H-shares, representing 3.48% and 5.08% of the respective share classes, and 2.06% of the total shares[95] - Mr. Jia Shaojun holds 25,000,000 domestic shares and 10,310,000 H-shares, representing 3.48% and 2.09% of the respective share classes, and 2.06% and 0.85% of the total shares[95] - Zhou Yan

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 芯盖度 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2022年12月31日止年度 全年業績公告 財務摘要 | --- | --- | --- | --- | |----------------------|----------------|-----------------------------|-------| | | 截至 \n2022 年 | 12 月 31 日止年度 \n2021 年 | 變動 | | 主要收益表項目 | 人民幣千元 | 人民幣千元 | % | | 收入 | 1,264,073 | 1,570,129 | -19.5 | | 毛利 | 1,027,659 | 1,294,700 | -20.6 | | 母公司擁有人應佔虧損 | (319,601) | (692,774) | ...