R&D and Clinical Trials - The company is focusing on its strategic pipeline and accelerating the R&D of key varieties, particularly the REC603 HPV 9-valent vaccine, which is currently in a phase III efficacy trial[13]. - The phase III trial for REC603 is being conducted in three provinces: Henan, Yunnan, and Shanxi, with significant progress noted at the 18th month visit and ongoing observations at the 24th month[14]. - The design of the phase III clinical trial protocol aligns with the newly enacted Technical Guidelines for the Clinical Trials of Human Papillomavirus Vaccines, indicating a leading sample size and advantages in clinical site selection[14]. - The company aims for an early market launch of REC603 to meet the urgent global demand for the HPV 9-valent vaccine[14]. - REC610, a novel adjuvanted recombinant shingles vaccine, is currently in phase I/III clinical trials, with a vaccination rate of less than 1% in the Chinese market, indicating strong demand for domestically produced alternatives[15]. - ReCOV, a recombinant COVID-19 vaccine, has received emergency use authorization in Mongolia and is undergoing data analysis for a marketing application in China[17]. - The company aims to expedite the commercial application of its products and enhance core competitiveness in the second half of 2023[21]. - The company has developed a vaccine portfolio consisting of 12 candidates, including REC603, a recombinant HPV 9-valent vaccine currently in phase III clinical trials in China[33]. - The HPV vaccine manufacturing facility in Taizhou, Jiangsu province, has a designed capacity of 20 million doses of HPV 9-valent vaccines per year[31]. - The company has established an IPD System to advance the R&D of multiple vaccine candidates simultaneously[28]. - The vaccine pipeline includes a novel adjuvanted recombinant shingles vaccine currently under clinical research[33]. - The phase III clinical trial for REC603 involves a total of 16,050 subjects and includes primary efficacy, immuno-bridging in younger age groups, and immunogenicity comparison with Gardasil®9[43]. - An interim analysis will be conducted based on pathological endpoints, with plans to submit a BLA application to the NMPA in 2025[43]. - ReCOV, a COVID-19 vaccine, is undergoing international multi-centre Phase III trials in Russia and Nepal, and has received emergency use authorization in Mongolia[37]. - REC610, a novel adjuvanted recombinant shingles vaccine, is currently in phase I trials in the Philippines, with its clinical trial application accepted in China[37]. - The company has not encountered any material unexpected accidents or adverse changes related to REC603 since obtaining IND approval in China[43]. - REC603 achieved a favorable safety profile in the phase I clinical trial, with an adverse event rate of 53.75%, significantly lower than the 86.6% reported for Merck's Gardasil 9[48]. - The company is developing next-generation HPV quadrivalent and 9-valent vaccine candidates with a two-shot regimen, potentially offering superior efficacy compared to current three-shot regimens[58]. - The company is also developing REC602, a bivalent HPV vaccine targeting types 6 and 11, with phase I trials completed in late 2022[66]. - REC604a and REC604b are early-stage HPV vaccines formulated with a novel adjuvant, showing a 7.7 times increase in neutralizing antibodies compared to traditional aluminum adjuvants[69]. - The company has completed phase I clinical trials for its recombinant COVID-19 vaccine, ReCOV, in New Zealand and phase II studies in the Philippines and UAE, with positive results for neutralizing antibodies against the Omicron variant[74]. Financial Performance - The company reported a loss before tax of RMB 276,941,000 for the six months ended June 30, 2023, an improvement from a loss of RMB 357,117,000 in the same period of 2022[23]. - The loss attributable to owners of the parent for the period was RMB 272,549,000, compared to RMB 349,686,000 in the previous year[23]. - Total research and development costs for the six months ended June 30, 2023, amounted to RMB 248 million, with no costs capitalized during the same period[105][106]. - Research and development costs decreased by 30% from RMB 354 million for the six months ended June 30, 2022, to RMB 248 million for the same period in 2023[128][129]. - Clinical trial expenses decreased by RMB 74 million from RMB 179 million to RMB 105 million, mainly due to the progress of core product REC603 in phase III clinical trials[130]. - Total staff costs for the six months ended June 30, 2023, amounted to RMB 116 million, an increase of 14.85% from RMB 101 million for the same period in 2022[118][119]. - Other income and gains decreased by 24% from RMB 79 million for the six months ended June 30, 2022, to RMB 60 million for the six months ended June 30, 2023[124][127]. - Selling and distribution expenses increased from RMB 4 million for the six months ended June 30, 2022, to RMB 5 million for the same period in 2023, attributed to commercialization progress[125][128]. - Administrative expenses slightly increased from RMB 77 million for the six months ended June 30, 2022, to RMB 78 million for the same period in 2023[132]. - Financial costs rose from RMB 1 million to RMB 5 million, primarily due to additional debt financing for R&D projects[134]. - Property, plant, and equipment increased from RMB 559 million as of December 31, 2022, to RMB 618 million as of June 30, 2023, due to new machinery purchases and ongoing construction projects[135]. - Cash and bank balances decreased from RMB 1,325 million as of December 31, 2022, to RMB 1,099 million as of June 30, 2023, primarily due to expenditures on R&D services, raw materials, and administrative expenses[146]. - The current ratio decreased from 4.3 as of December 31, 2022, to 4.0 as of June 30, 2023, primarily due to a decrease in cash and cash equivalents[161]. - The gearing ratio increased to 40% as of June 30, 2023, compared to 28% as of December 31, 2022, due to significant loans taken for production and operations[161]. - Capital expenditure rose from RMB 84 million for the six months ended June 30, 2022, to RMB 102 million for the same period in 2023, mainly due to increased procurement of production equipment[165]. - Capital expenditure commitments increased from RMB 69 million as of December 31, 2022, to RMB 102 million as of June 30, 2023, attributed to progress in research and development projects[166]. Intellectual Property and Patents - The company has applied for a total of 15 invention patents for recombinant vaccines, including those against RSV and HSV, and 16 patents for novel adjuvants and their key materials[18]. - As of June 30, 2023, the company had registered 11 invention patents and filed 103 patent applications, including 100 Chinese and 3 PCT applications[115]. - The company has applied for a total of 15 invention patents related to antigens for various vaccine projects, including HSV and SARS-COV-2[115]. - The company has not been involved in any intellectual property infringement proceedings as of June 30, 2023[115]. Market and Competitive Landscape - The HPV vaccine market in China is significantly underserved, with an estimated 233.9 million females aged 9 to 45 unvaccinated by 2025, indicating a potential demand for 701.7 million doses[53]. - The first domestic HPV bivalent vaccine captured 66.7% of the market share in its first year, suggesting a strong potential for domestic HPV 9-valent vaccines to follow a similar trend[57]. - The company believes that the approval of more HPV 9-valent vaccines in China will lead to a larger market share for these products[52]. - The company is optimistic about the sales prospects of REC610 due to the largely untapped market in developing countries[15]. - The company anticipates benefiting from favorable government policies aimed at accelerating the approval process for domestic HPV vaccines[57]. Shareholder Structure - As of June 30, 2023, Taizhou Yuangong Technology holds 62,147,715 Domestic Shares, representing 17.16% of the company's total shares[183]. - Lianyungang Ruibaitai Medical Technology Partnership owns 8,076,923 Domestic Shares, accounting for 1.67% of the company's total shares[184]. - Beijing Junlian Shengyuan Equity Investment holds 7,084,855 Domestic Shares, which is 5.87% of the company's total shares[184]. - Shanghai Chaorui Medical Technology Partnership owns 29,912,024 H Shares, representing 6.19% of the company's total shares[188]. - YU Yue and LIU Hongyan together hold 7,734,298 Domestic Shares and 30,937,192 H Shares, accounting for 8.01% and 9.79% of the company's total shares respectively[188]. - ZHU Linan has an interest in 10,465,255 Domestic Shares and 37,317,145 H Shares, representing 9.89% and 11.80% of the company's total shares respectively[188]. - The company has a significant number of shares held by various substantial shareholders, indicating a diverse ownership structure[183]. - The report highlights the importance of controlled corporations in the ownership structure, with multiple shareholders having interests in these entities[186]. - The overall percentage of interest in the relevant class of shares shows a strong presence of institutional investors[184]. - The data reflects a stable shareholder base, which may contribute to the company's strategic decisions moving forward[187]. - The total number of H Shares held by various entities indicates a significant interest in the company, with multiple stakeholders holding over 4%[194]. - The company continues to attract investment from various funds and management entities, reflecting strong market confidence[194].
瑞科生物-B(02179) - 2023 - 中期财报