的申請版本 香港聯合交易所有限公司及證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整 性亦不發表任何意見，並明確表示概不就因本申請版本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。 Shanghai Ark Biopharmaceutical Co., Ltd. 上海愛科百發生物醫藥技術股份有限公司 （「本公司」） （於中華人民共和國註冊成立的股份有限公司） (a) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的。投資者不應根據本 文件中的資料作出任何投資決定； (b) 在聯交所網站登載本文件或其補充、修訂或更換附頁，並不引起本公司、本公司的任何聯席 保薦人、整體協調人、顧問或包銷團成員在香港或任何其他司法權區必須進行發售活動的責 任。本公司最終會否進行發售仍屬未知之數； (c) 本文件或其補充、修訂或更換附頁的內容可能會亦可能不會在最後正式的上市文件內全部或 部分轉載； (d) 本文件並非最終的上市文件，本公司可能不時根據《香港聯合交易所有限公司證券上市規則》 作出更新或修訂； (e) 本文件並不構成向任何司法權區的公眾提呈出售任何證券的招股章程 ...

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. No offer or invitation will be made to the public in Hong Kong until after a prospectus of the Company has been registered with the Regi ...

Core Insights - The U.S. FDA has cleared ArkBio's IND application for AK3280, allowing the initiation of a Phase 2 proof-of-concept clinical trial for idiopathic pulmonary fibrosis (IPF) [1] - The Phase 2 trial is designed to evaluate the efficacy, safety, and pharmacokinetics of AK3280, which is an optimized, small-molecule anti-fibrotic agent [1] - Current IPF therapies have limited clinical benefits and are often associated with gastrointestinal side effects, highlighting the unmet need for better treatment options [1] Company Overview - ArkBio is a commercial-stage biotechnology company focused on innovative therapeutics for respiratory and pediatric diseases, founded in 2014 [1] - The company has developed proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations [1] - Key pipeline assets include Ziresovir (AK0529), AK3280, and AK0901, with strategic partnerships established with multinational pharmaceutical companies and leading academic institutions [1] Clinical Development - The Phase 2 trial for AK3280 is a multi-center, randomized, partially double-blind, placebo- and active-controlled study [1] - Previous Phase 2 results in China showed AK3280's significant clinical activity, including a dose-dependent increase in forced vital capacity (FVC) at Week 24 [1] - AK3280 demonstrated a favorable safety profile with no significant gastrointestinal adverse effects, differentiating it from existing IPF therapies [1] Market Potential - The FDA clearance for the IND is a significant milestone for ArkBio, paving the way for future regulatory submissions and potential commercialization in major markets [1] - There is a substantial unmet need for therapies that offer improved efficacy and safety for patients with IPF, which AK3280 aims to address [1]

Group 1 - The pharmaceutical industry in A-shares is showing a recovery trend, with some companies exceeding performance expectations for 2025 [1][14] - WuXi AppTec expects revenue of approximately 45.456 billion yuan for 2025, a year-on-year increase of about 15.84%, and a net profit of approximately 19.151 billion yuan, a year-on-year increase of about 102.65% [1][15] - WuXi AppTec's performance is driven by stable growth in its main business and the sale of equity in three companies, generating nearly 5.6 billion yuan in revenue [1][15] Group 2 - WoHua Pharmaceutical anticipates a net profit between 80 million and 115 million yuan for 2025, representing a year-on-year increase of 119.76% to 215.90% [2][16] - The growth in WoHua's performance is attributed to the price-volume trade-off trend after the entry of its product into centralized procurement and the extension to outpatient markets [3][17] Group 3 - Kangchen Pharmaceutical expects a net profit between 14.5 million and 17.5 million yuan for 2025, a year-on-year increase of 243% to 315% [4][19] - The company attributes its performance to the absence of goodwill impairment provisions for 2025, following a decline in revenue from a previously acquired business [5][19] Group 4 - Baiaosaitu is projected to achieve a net profit growth of 249.5% in 2025, with expected revenue of 1.31 billion yuan, a year-on-year increase of 37.75% [6][20] - The company began to achieve commercial profitability in 2024, successfully turning around its financial performance [6][20] Group 5 - The Chinese pharmaceutical market is expected to see significant developments in 2026, with a focus on innovative drug research and business development (BD) [7][21] - China has become the second-largest market for innovative drug launches globally, with leading pharmaceutical companies showing R&D intensities close to global averages [7][21] Group 6 - The total value of innovative drug licensing transactions from China is expected to exceed 130 billion USD in 2025, indicating strong recognition of Chinese pipelines by overseas buyers [9][23] - The CXO service industry is recovering, with predictions that the market size will approach 100 billion USD in 2026, driven by increased demand from innovative drug development [9][23] Group 7 - The AI pharmaceutical sector is becoming increasingly active, with significant transactions and the listing of AI companies on stock exchanges [11][25] - The global market for AI solutions in healthcare is projected to grow from 13.7 billion USD in 2022 to 155.3 billion USD by 2030, highlighting the potential for companies in this space [13][27]

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested additional information from Aikobai regarding its compliance with stock incentive plans and reasons for not completing its overseas listing after previous approvals [1][2][3] Group 1: Regulatory Requirements - Aikobai is required to clarify the actual operations of its medical device production and business, including whether it has obtained the necessary qualifications and if its business scope involves areas listed in the "Negative List for Foreign Investment Access (2024 Edition)" [1] - The company must provide details on the regulatory procedures for overseas investments and foreign exchange management related to its overseas subsidiaries, along with a conclusive opinion on compliance [1] - Aikobai is also asked to explain the compliance of its implemented stock incentive plan, including the composition of participants, any relationships with other shareholders, and the legality and fairness of the plan [1] Group 2: Listing Status and Plans - The company needs to explain the reasons for not completing its overseas listing after previous approvals [3] - Aikobai is required to detail its prior A-share listing guidance and the reasons for withdrawing its application to the Shanghai Stock Exchange's Sci-Tech Innovation Board, including whether it plans to continue pursuing A-share listing and any potential impacts on the current listing [3] Group 3: Company Overview - Aikobai, established in 2013, is a biopharmaceutical company focused on discovering and developing therapies for respiratory and pediatric diseases [3] - The company has developed a pipeline of six candidate drugs, including its core product Qiruisuo Wei, which targets respiratory syncytial virus (RSV) infections, and other drugs in various clinical stages for conditions such as idiopathic pulmonary fibrosis (IPF) and attention deficit hyperactivity disorder (ADHD) [3]

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested Aikobai's supplementary explanations regarding compliance of its implemented equity incentive plan and reasons for not completing its overseas listing after previous approval [1][2][3] Group 1: Regulatory Requirements - Aikobai is required to clarify the actual operations of its medical device production and business, including whether it has obtained the necessary qualifications and if its business scope involves areas listed in the "Negative List for Foreign Investment Access (2024 Edition)" [1] - The company must provide details on the regulatory procedures for overseas investments and foreign exchange management related to its overseas subsidiaries, along with a conclusive opinion on compliance [1] - Aikobai needs to explain the compliance of its implemented equity incentive plan, including the composition of participants, their relationships with other stakeholders, and the fairness of pricing and decision-making processes [1] Group 2: Listing Status - The company must explain the reasons for not completing its overseas listing after previous approval [3] - Aikobai is also required to provide details on its prior A-share listing guidance and the reasons for withdrawal, including whether it plans to continue pursuing A-share listing and any potential impacts on the current issuance [3] Group 3: Company Overview - Aikobai, established in 2013, is a biopharmaceutical company focused on discovering and developing therapies for respiratory and pediatric diseases [3] - The company has developed a pipeline of six candidate drugs, including its core product Qiruisuo Wei, which targets respiratory syncytial virus (RSV) infections, and other drugs in various clinical stages for conditions such as idiopathic pulmonary fibrosis (IPF) and attention deficit hyperactivity disorder (ADHD) [3]

Core Viewpoint - The innovative pharmaceutical company Aikobai has submitted a new IPO application to the Hong Kong Stock Exchange, marking its second attempt in five years, following previous rejections and withdrawals from both the Hong Kong and STAR Market listings [1][3]. Financial Summary - As of mid-2023, Aikobai reported cash and cash equivalents of less than 100 million RMB, while its R&D costs and administrative expenses were 86.138 million RMB and 19.434 million RMB, respectively, leading to a loss exceeding 100 million RMB for the period [3][4]. - The company has experienced significant losses, with a pre-tax loss of 269.799 million RMB for the year ending December 31, 2023, and a projected loss of 197.419 million RMB for the year ending December 31, 2024 [4][12]. Product Development and Market Position - Aikobai is focusing on the development of Qiruisuo Wei (齐瑞索韦), a treatment for Respiratory Syncytial Virus (RSV), which is nearing market approval after submitting a new drug application to the National Medical Products Administration [5][8]. - The global market for RSV treatments is limited, with only three approved drugs for prevention, highlighting the potential market opportunity for Qiruisuo Wei as it is the only product close to approval in this category [8][9]. Industry Context - The company’s reliance on the licensing-in model for drug development is increasingly seen as outdated, especially as domestic innovation capabilities grow [10][11]. - The overall market for RSV treatments is expected to evolve, with new vaccines being approved, which may impact the commercial prospects for Aikobai's products [8][9][13]. - The challenges faced by Aikobai reflect broader issues within the biotech sector, particularly for companies that depend heavily on licensing models and have not yet achieved profitability [13].

Core Insights - A large number of medical companies, including Aikobio, are applying for listings on the Hong Kong Stock Exchange, indicating a trend in the healthcare sector [1] - Aikobio has previously attempted to list on the Hong Kong Stock Exchange and has shifted its focus to the A-share market, but later withdrew its application due to strategic considerations [2][3] - The company has a dual-track drug development strategy, combining both in-house research and external collaborations [8] Company Overview - Aikobio was founded in August 2013 and became a joint-stock company in March 2021, headquartered in Shanghai [5] - The company has received multiple rounds of investment from notable investors such as Hillhouse Capital and Qiming Venture Partners [5] - As of June 2025, the founder, Dr. Wu Zheng, controls 25.17% of the company and has a strong background in pharmaceutical research [6] Product Pipeline - Aikobio has developed six candidate drugs, including AK0529, which targets respiratory syncytial virus (RSV) and is in the NDA stage [10] - The company’s core product, AK0529, is the first RSV-specific antiviral drug to show positive results in pivotal Phase III trials [18] - Another key product, AK3280, is in Phase II and targets idiopathic pulmonary fibrosis (IPF), with a significant market potential projected to grow from $6.9 billion in 2024 to $22.2 billion by 2035 [23] Financial Performance - Aikobio has not yet commercialized any products and reported cumulative losses of 570 million RMB over two and a half years [28] - The company’s revenue primarily comes from a collaboration on a hepatitis B virus candidate drug, but this project has been paused [28] - As of December 2025, the company had approximately 96.73 million RMB in cash and cash equivalents, which is expected to sustain its operations for about 16 months at the current burn rate [30]

Core Viewpoint - Aikobio has submitted its prospectus for a third attempt to go public on the Hong Kong Stock Exchange after previous unsuccessful attempts in 2021 and 2023, with a post-investment valuation of 4.69 billion yuan and no commercialized products or profitability to date [1][2][18]. Company Overview - Aikobio, established in 2013, focuses on discovering and developing therapies for respiratory and pediatric diseases, with six candidate drugs in its pipeline, including the core product Qiruisuo Wei, which targets respiratory syncytial virus (RSV) [6][8]. - The company has developed a partnership with Roche for Qiruisuo Wei, granting Aikobio exclusive rights for global development and commercialization [9]. Financial Performance - Aikobio reported revenues of 6.7 million yuan in 2023, with losses of approximately 270 million yuan, 197 million yuan, and 104 million yuan for the years 2023, 2024, and the first half of 2025, respectively, indicating a lack of profitability [11][12][13]. - As of June 30, 2025, Aikobio held cash and cash equivalents of 96.74 million yuan, which may not be sufficient to sustain a year of research and development operations given its current expenditure rate [14]. Shareholder Structure - The actual controller of Aikobio is Jim Zhen Wu, who holds approximately 25.17% of the company's shares through various entities [16]. - Aikobio has received multiple rounds of financing, with its latest round in June 2022 raising 190 million yuan, supported by notable investors such as Qiming Venture Partners and Hillhouse Capital [18].

Core Viewpoint - Aikobio has submitted its prospectus for a third attempt to list on the Hong Kong Stock Exchange after previous unsuccessful attempts in 2021 and 2023, with a post-investment valuation of 4.69 billion yuan and no commercialized products or profitability [1][2]. Company Overview - Aikobio, founded in 2013, is a biopharmaceutical company focused on discovering and developing therapies for respiratory and pediatric diseases [2][3]. - The company has developed six candidate drugs, including its core product Qiruisuo Wei, which is the first drug in the NDA stage targeting respiratory syncytial virus (RSV) infection [3][4]. Financial Performance - Aikobio reported revenues of 6.7 million yuan in 2023, with losses of approximately 270 million yuan, 197 million yuan, and 104 million yuan for the years 2023, 2024, and the first half of 2025, respectively [4][5]. - The company has not yet achieved profitability and has incurred significant research and development costs, totaling approximately 216 million yuan, 165 million yuan, and 86.14 million yuan during the same period [5]. Ownership and Management - The actual controller of Aikobio is Jim Zhen Wu, who holds approximately 25.17% of the company's shares [6][7]. - Jim Zhen Wu has over 30 years of experience in drug development and has held various senior positions in prominent pharmaceutical companies before founding Aikobio [7]. Investment and Valuation - Aikobio has received multiple rounds of financing, with the latest round in June 2022 raising 190 million yuan, leading to a post-investment valuation of 4.69 billion yuan [7][8]. - Notable investors include Qiming Venture Partners, Hillhouse Capital, and TF Capital, among others [8].