Core Viewpoint - The biotechnology sector in the Hong Kong stock market has seen a surge in new listings, with several companies experiencing significant first-day gains, indicating a favorable environment for IPOs in this industry [2][12] Company Overview - Aikobio, established in 2013, focuses on discovering and developing therapies for respiratory and pediatric diseases, with six candidate drugs targeting various stages of these conditions [2][10] - The company has made multiple attempts to go public, with its latest effort being the third attempt to list on the Hong Kong Stock Exchange [2][6] Product Pipeline - Aikobio has developed six candidate drugs, including: - Qiruisuo (AK0529), a novel RSV treatment that has shown positive results in pivotal Phase III trials [7][8] - AK0610, a monoclonal antibody for RSV prevention currently in Phase II [3] - AK3280, targeting idiopathic pulmonary fibrosis, in the post-proof of concept clinical stage [3][9] - AK0901, an ADHD treatment in the NDA stage [3] - Additional candidates include AK0705 for COPD and AK0406 for influenza [4] Financial Backing - Aikobio has secured multiple rounds of financing from notable investors, achieving a post-money valuation of 4.69 billion yuan after its D round in June 2022 [6] Financial Performance - In 2023, Aikobio reported revenue of 6.701 million yuan, but projected zero revenue for 2024 and the first half of 2025 due to a paused collaboration on an HBV candidate drug [10][11] - The company has incurred losses of 270 million yuan in 2023, 197 million yuan in 2024, and 104 million yuan in the first half of 2025, highlighting its reliance on external financing [11] IPO Plans and Fund Utilization - If successful in its IPO, Aikobio plans to allocate funds towards: - R&D for core products Qiruisuo and AK3280 - Clinical research for other candidates including AK0610, AK0901, AK0705, and AK0406 - Milestone payments and potential licensing opportunities - Commercialization efforts in the Chinese market - General operational expenses [11]

Core Viewpoint - Shanghai Aikebaifa Biopharmaceutical Technology Co., Ltd. has submitted its IPO application to the Hong Kong Stock Exchange for the third time, following previous attempts in 2021 and 2023, with a focus on developing therapies for respiratory and pediatric diseases [1][2]. Group 1: Company Overview - Aikebaifa was established in 2013 and has developed six candidate drugs, including its core product, Qiruisuo Wei, aimed at treating respiratory syncytial virus (RSV) infections [2]. - The company employs a dual-track strategy for drug development, combining licensed high-potential candidates with internal research efforts [2]. Group 2: Financial Performance - The company reported net losses of RMB 270 million, RMB 197 million, and RMB 104 million for the years 2023, 2024, and the first half of 2025, respectively [6][8]. - In 2023, Aikebaifa achieved revenue of RMB 6.701 million, with no revenue projected for 2024 and the first half of 2025 [4][5]. Group 3: Research and Development Costs - Research and development costs for 2023, 2024, and the first half of 2025 were RMB 216 million, RMB 165 million, and RMB 86 million, respectively [3][5]. - The core products, Qiruisuo Wei and AK3280, accounted for 53.7%, 66.5%, and 44.1% of the total R&D costs in the respective years [3]. Group 4: Future Plans and Funding Needs - The funds raised from the IPO are intended for the development of core products, clinical trials for other candidates, and commercialization efforts in the Chinese market [3]. - The company anticipates significant increases in expenses due to ongoing clinical development activities and may require additional funding through various means to sustain operations [8][9].

Company Overview - Shanghai Aikebaifa Biopharmaceutical Technology Co., Ltd. (referred to as "Aikebaifa") has officially submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities and JPMorgan serving as joint sponsors [1] - Aikebaifa was established in 2013 and focuses on innovative therapies for respiratory and pediatric diseases, addressing unmet clinical needs in these areas [1] - The company has a product pipeline that includes candidates for treating diseases from acute to end-stage [1] Financial Performance - Aikebaifa is currently in a loss-making position, with losses recorded from 2020 to 2024 amounting to 214 million, 197 million, 104 million, 270 million, and 197 million yuan respectively [1] - In 2023, the company achieved revenue of 6.7 million yuan but has not generated further income since then [1] - For the first half of 2025, Aikebaifa has not realized commercial revenue, with R&D costs of approximately 86 million yuan, a year-on-year increase of 20.58%, and a net loss of 104 million yuan, an increase of 19.19% year-on-year [1] - Cash flow from operating activities for 2023, 2024, and the first half of 2025 was -232.8 million yuan, -188.7 million yuan, and -71.7 million yuan respectively, with cash and cash equivalents of 96.74 million yuan as of June 30, 2025 [1] R&D and Product Pipeline - The R&D team consists of over 60 members, accounting for about 70% of the total workforce, with more than half holding master's degrees or higher [2] - The core product, Qiruisuo Wei, is the world's first antiviral treatment for respiratory syncytial virus (RSV) infection currently in the New Drug Application (NDA) stage [2] - Another key candidate, AK0610, is a monoclonal antibody in Phase II for RSV prevention, while AK3280 is in the Phase II concept validation stage for treating idiopathic pulmonary fibrosis (IPF) [2] - The company anticipates that Qiruisuo Wei will receive NDA approval in 2026 and generate revenue between 2026 and 2027 [2] Shareholder Structure - Aikebaifa has a relatively dispersed shareholding structure with no controlling shareholder, with the founder and CEO, Dr. Wu Zheng, controlling approximately 25.2% of the shares through various entities [2] - Other significant shareholders include Qiming Venture Partners (10.66%), Hillhouse Capital's Yi Heng Investment (4.79%), and TPG Asia VII (4.79%) [2] - The company completed a D-round financing in June 2022, raising 190 million yuan, with a post-investment valuation of 4.69 billion yuan [2] Industry Outlook - According to a report by Zhi Shi Consulting, the global RSV treatment market is expected to grow from 30 million USD in 2024 to 819 million USD in 2026, reaching 8.6 billion USD by 2035, with a compound annual growth rate of 67.1% from 2024 to 2035 [3] - The market is anticipated to experience significant growth with the approval of innovative drugs specifically targeting RSV [3]

Core Insights - The Hong Kong stock market has become a significant financing hub for biopharmaceutical companies, with 13 mainland biotech firms successfully listing since 2025, surpassing the total from the previous year [1] - A surge in IPOs for biopharmaceutical companies occurred in September, highlighted by the successful listing of digital healthcare platform Health 160, which opened with a 154.84% increase [1] - Several innovative drug companies, including Hangzhou New Element Pharmaceuticals and Shanghai Aike Baifa, are accelerating their listing processes, focusing on innovative therapies in various disease areas [1][4] Financing Environment - Despite a recovery trend in the pharmaceutical market, the financing environment remains challenging for unprofitable innovative drug companies, which need to adopt diverse financing strategies to ensure ongoing R&D and long-term survival [2] - Pivotal's managing partner emphasized the importance of prioritizing business development collaborations for upfront payments and milestone funds, while being cautious with IPOs and refinancing [2] Market Dynamics - The biopharmaceutical industry is characterized by high investment, long cycles, and significant risks, with an average drug requiring 12.5 years and $2.3 billion for development, yet clinical success rates are below 10% [3] - The introduction of the 18A listing rule in 2018 has allowed unprofitable biotech companies to list on the Hong Kong Stock Exchange, creating a crucial financing channel [3] - The market is currently focused on R&D pipelines and technological capabilities, with companies that have breakthrough therapies or unique technologies more likely to attract investment [3] Company Profiles - Hangzhou New Element Pharmaceuticals, founded in 2012, focuses on metabolic, inflammatory, and cardiovascular disease therapies, with clinical-stage products currently in trials [4] - Shanghai Aike Baifa, established in 2013, specializes in respiratory and pediatric diseases, with its lead drug recognized as a breakthrough therapy [4] - Jinfang Pharmaceuticals, founded in 2017, is focused on oncology and autoimmune diseases, with its core product being the first KRAS G12C inhibitor in China [4] Financial Performance - Companies like New Element Pharmaceuticals and Aike Baifa have reported significant losses, with New Element's losses reaching approximately 97.42 million yuan in 2023 and 434 million yuan in 2024 [7] - Jinfang Pharmaceuticals has also not achieved profitability, with losses of 270 million yuan in 2023 and 197 million yuan in 2024 [7] Investment Trends - The current market environment has led to a selective approach towards high-quality biotech firms, with Jinfang Pharmaceuticals expected to raise approximately 1.444 billion HKD in its IPO, which will support future R&D investments [5] - The introduction of notable cornerstone investors has bolstered market confidence, indicating recognition of long-term value despite market volatility [5] Future Outlook - The ability of biotech companies to achieve sustainable growth will depend on the progress of clinical trials, regulatory approvals, and the execution capabilities of partners [9] - The Hong Kong market provides a global development platform for innovative drug companies, although uncertainties remain a critical consideration for investment decisions [9]

爱科百发已向港交所提交上市申请。摩根大通和中信证券为联席保荐人。 公司拥有六种候选药物的管线，包括核心产品齐瑞索韦(NDA阶段的RSV治疗药物)、AK0610(II期RSV 预防单克隆抗体)、AK3280(II期IPF药物)以及AK0901(NDA阶段的ADHD药物)。 公司成立于2013年，专注于发现和开发治疗呼吸系统和儿科疾病的疗法，其候选药物可应对目前缺乏有 效治疗的疾病。 其他候选药物还包括AK0705(治疗COPD)和AK0406(治疗流行性感冒)。 ...

Core Viewpoint - Shanghai Aikebaifa Biopharmaceutical Technology Co., Ltd. (Aikebaifa) has submitted its listing application to the Hong Kong Stock Exchange, with JPMorgan and CITIC Securities acting as joint sponsors [1]. Company Overview - Aikebaifa, established in 2013, focuses on discovering and developing therapies to address medical needs in respiratory and pediatric diseases. The company has developed a pipeline of six candidate drugs targeting various stages of respiratory and pediatric diseases, including its core product Qiruisuo Wei, which is in the New Drug Application (NDA) stage for treating respiratory syncytial virus (RSV) infections [4][5]. Product Pipeline - The candidate drugs include: - Qiruisuo Wei: First-in-class drug for RSV treatment in NDA stage - AK0610: Monoclonal antibody in Phase II for RSV prevention - AK3280: Drug for idiopathic pulmonary fibrosis (IPF) in Phase II clinical stage - AK0901: ADHD drug in NDA stage - AK0705: Drug for chronic obstructive pulmonary disease (COPD) - AK0406: Drug for influenza [4][5]. Competitive Advantages - Aikebaifa claims several competitive advantages: - Leading global innovation in RSV treatment and prevention - Potential best-in-class new generation IPF drug - New generation ADHD treatment filling a critical market gap in China - Dual drug development engine with mature global business development and multi-platform R&D capabilities - Strong research and development leadership supported by notable stakeholders [5]. Financial Performance - The company reported losses for the fiscal years ending June 30, 2023, and 2024, amounting to approximately RMB 270 million and RMB 197 million, respectively. The losses for the six months ending June 30, 2024, and 2025, were approximately RMB 87.5 million and RMB 104.3 million, respectively [5][6].

智通财经APP获悉，据港交所9月15日披露，上海爱科百发生物医药技术股份有限公司(简称：爱科百发)向港 交所主板提交上市申请书，摩根大通和中信证券为联席保荐人。 招股书显示，爱科百发是一家于2013年成立的生物制药公司，专注于发现和开发疗法，解决呼吸系统和儿科 疾病的医疗需求。公司的候选药物可应对目前缺乏有效治疗的急性、慢性和末期不同阶段的呼吸系统和儿科 疾病。 在创始人兼首席执行官邬博士和优秀的科学管理团队的领导下，公司已开发六种候选药物的管线，包括由核 心产品齐瑞索韦(全球首个新药申请("NDA")阶段的专门靶向呼吸道合胞病毒("RSV")感染的治疗药物)、 AK0610(用于预防RSV感染的II期单克隆抗体("mAb"))、处于II期概念验证("PoC")后临床阶段的核心产品特发 性肺纤维化("IPF")药物AK3280及NDA阶段的注意力不足过动症("ADHD")药物AK0901组成的RSV药物组 合。 公司还开发了其他相关疾病领域(包括用于治疗慢性阻塞性肺疾病("COPD")的AK0705及用于治疗流行性感冒 的AK0406)的候选药物。爱科百发于招股书中提示，公司可能无法成功开发：上市公司的管线产 ...