Core Viewpoint - The acceptance of Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd.'s IPO application under the fifth set of standards for the Sci-Tech Innovation Board marks a significant milestone after a two-year hiatus for similar projects [1][9]. Financial Performance - Tainuo Maibo's revenue from 2022 to 2024 was 4.34 million yuan, 0 yuan, and 15.06 million yuan, respectively, while net losses during the same period were 429 million yuan, 446 million yuan, and 515 million yuan, totaling over 1.4 billion yuan [2]. - The company plans to raise 1.5 billion yuan through the IPO to fund new drug development, expand antibody production facilities, and supplement working capital [6]. Product Pipeline - Tainuo Maibo's core products include the recombinant anti-tetanus toxin monoclonal antibody, "Xintuituo" (new tetanus antibody), which has been approved for market, and TNM001, which is currently in Phase III clinical trials [3][15]. - "Xintuituo" is the first recombinant anti-tetanus toxin monoclonal antibody globally, aimed at reducing reliance on human blood-derived products for passive immunity [11][12]. Market Challenges - The competitive landscape for "Xintuituo" is challenging, with similar products priced below 200 yuan, leading to a price drop of over 50% compared to pre-collection prices [5][13]. - The terminal market price for "Xintuituo" is set at 798 yuan per injection, while competing products have significantly lower prices due to recent price reductions in the market [13]. Competitive Landscape - TNM001 targets respiratory syncytial virus (RSV) and is facing competition from established products like Synagis and Clesrovimab, which are already available in the market [15][17]. - The global market for RSV treatments is projected to reach $12.8 billion by 2030, indicating significant commercial potential for TNM001 [15]. Strategic Implications - The progress of Tainuo Maibo's core products exceeds the requirements for the fifth set of IPO standards, suggesting a more certain commercial outlook [18]. - The acceptance of Tainuo Maibo's IPO application may serve as a reference for other companies considering similar paths in the future [18].

Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. successfully passed the IPO review by the Shanghai Stock Exchange on July 1, marking a significant case of implementing the China Securities Regulatory Commission's policy to enhance the inclusiveness of the Sci-Tech Innovation Board for unprofitable companies [1]. Group 1: Company Overview - Heyuan Biotechnology is an innovative biopharmaceutical company with a leading global plant bioreactor technology platform, focusing on the production of pharmaceuticals, pharmaceutical excipients, and research reagents [4]. - The company was established in November 2006 and transformed into a joint-stock company in December 2014, with a total share capital of 268.048646 million shares before the issuance [4]. Group 2: Financial Performance - The company's revenue for the reporting period was 13.3997 million yuan, 24.2641 million yuan, and 25.2161 million yuan, while the net profit attributable to the parent company was -148.6051 million yuan, -200.9395 million yuan, and -166.7474 million yuan [6]. Group 3: Major Shareholder Information - Yang Daichang is the largest shareholder, holding 15.03% of the shares directly and controlling a total of 29.25% of the voting rights through various agreements and entities [5]. Group 4: Key Questions from the Listing Committee - The listing committee inquired about the advanced nature of the core technologies related to the recombinant protein expression and purification platforms, as well as the reliability of specific performance indicators [7]. - Questions were raised regarding the market potential of the drug HY1001 compared to its competitors, including efficacy, indications, market acceptance, pricing, and cost [7]. - The committee also sought clarification on the operational standards for the production of medicinal rice, including breeding, planting, harvesting, storage, transportation, processing, and waste disposal, to ensure compliance and safety [8].

Group 1 - The first company to be reviewed under the restarted fifth set of standards for the Sci-Tech Innovation Board is Wuhan Heyuan Biotechnology Co., Ltd. (Heyuan Bio) [1][3] - Heyuan Bio is an innovative biopharmaceutical company known for its "rice-derived blood" technology and has established a unique plant expression system and two technical platforms [3][4] - The company has adjusted its fundraising target down by approximately 1.1 billion yuan, from an initial 3.502 billion yuan to 2.4 billion yuan, due to steady progress in R&D and business operations [5][6] Group 2 - Heyuan Bio's asset-liability ratio is projected to increase significantly in 2024, with ratios of 18.81%, 23.96%, and 43.37% for the years 2022 to 2024 respectively [6][7] - The company has not yet achieved profitability, with reported revenues of approximately 13.4 million yuan, 24.3 million yuan, and 25.2 million yuan for the years 2022 to 2024, and net losses of approximately 144 million yuan, 187 million yuan, and 151 million yuan for the same period [7] - Heyuan Bio's core product, HY1001, is expected to be approved for market launch soon, having completed its Phase III clinical trials with promising results [7][8] Group 3 - The recent policy changes by the China Securities Regulatory Commission aim to enhance the inclusivity and adaptability of the Sci-Tech Innovation Board, facilitating the listing of unprofitable companies [4] - Other companies currently in the review process under the fifth set of standards include Beixin Life, Hengrun Da, Sizherui, and Bibete, with some making faster progress than others [8][9]

Core Viewpoint - Wu Yuan Bio is the first company to be reviewed under the newly established fifth set of standards for the Sci-Tech Innovation Board, following the announcement of support for unprofitable companies to list [1][7]. Company Overview - Wu Yuan Bio, established in 2006, focuses on innovative drug research and development, with its core product HY1001 (recombinant human albumin injection) having completed Phase III clinical trials and included in the priority review process by the National Medical Products Administration [3][4]. - The company has not yet generated revenue from its core innovative drug products, with current income primarily from pharmaceutical excipients and research reagents [3][6]. - Cumulative R&D investment from 2022 to 2024 is projected to reach 386 million yuan, with a workforce of 178 employees, 122 of whom are dedicated to R&D, indicating a strong focus on innovation [3][6]. Product Development - HY1001 aims to supplement or enhance the levels of human serum albumin in the blood, potentially replacing plasma-derived human serum albumin, which is currently the most widely used blood product in clinical settings [3][4]. - The company has achieved breakthroughs in increasing the expression and purity of recombinant human albumin, reducing production costs, and enhancing clinical safety, earning a second-class National Technology Invention Award for its related technology [4]. Industry Context - As of 2024, 20 companies have been listed under the fifth set of standards, primarily consisting of innovative biopharmaceutical firms, with a combined revenue exceeding 14 billion yuan, reflecting a growth of over 40% from 2023 [6][7]. - In the first quarter of 2025, these companies collectively achieved a revenue of 3.78 billion yuan, marking a year-on-year growth of 29.27% [7]. - The fifth set of standards has facilitated the listing of 17 first-class new drugs, accounting for approximately 12% of the total number of domestically approved innovative drugs from 2018 to the first quarter of 2025, establishing itself as a backbone of China's pharmaceutical innovation [7].

Core Viewpoint - The article discusses the first successful case of a company, Wuhan Heyuan Biotechnology Co., Ltd. (Heyuan Bio), applying for listing on the Sci-Tech Innovation Board under the fifth set of standards, highlighting the challenges and adjustments in their IPO fundraising amount [1]. Group 1: IPO Details - Heyuan Bio's IPO fundraising amount has been reduced from 3.5 billion yuan to 2.4 billion yuan, a decrease of over 30% [1]. - The reduction in fundraising is primarily due to a significant cut in the "supplementary working capital" project, which was lowered from 800 million yuan to 100 million yuan [1]. - Other companies currently under review for the fifth set of standards include Shenzhen Beixin Life Technology Co., Ltd., Shanghai Hengrun Da Biological Technology Co., Ltd., Harbin Sizhe Rui Intelligent Medical Equipment Co., Ltd., and Guangzhou Bibete Pharmaceutical Co., Ltd. [1]. Group 2: Product and Market Potential - Heyuan Bio's core product, HY1001, is a plant-derived recombinant human serum albumin injection, which has received acceptance for its drug registration application for "hypoalbuminemia" by the drug regulatory authority [4][7]. - Currently, there are no similar products approved for sale in China, indicating a unique market position for HY1001 [6]. - The product is expected to be approved for sale in 2025, with large-scale sales anticipated in 2026, potentially becoming the first recombinant albumin product approved in the country [7]. Group 3: Industry Context - The successful listing of Heyuan Bio may provide confidence to other companies in the same sector, such as Tonghua Anruite Biological Pharmaceutical Co., Ltd., which is also focused on recombinant albumin but uses a yeast expression system [8]. - Anruite's recombinant albumin product has already been launched in Russia and has completed phase III clinical trials in China, but it is still in the IPO guidance stage [9].

Group 1 - The core viewpoint of the article is that the China Securities Regulatory Commission (CSRC) has implemented new guidelines to allow unprofitable companies to list on the STAR Market under the fifth set of standards, while ensuring that there will not be a large-scale expansion of IPOs [1] Group 2 - The reform aims to enhance the inclusiveness and adaptability of the STAR Market by creating a dedicated tier for growth-oriented companies [1] - The CSRC emphasizes maintaining strict entry standards for IPOs and managing the issuance process to avoid excessive market expansion [1]