智通财经APP讯，迈威生物(688062.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的 《受理通知书》，9MW0813注射液的上市许可申请获得受理，用于糖尿病性黄斑水肿(DME)和新生血 管(湿性)年龄相关性黄斑变性(nAMD)。 据悉，9MW0813注射液是阿柏西普(艾力雅®)的生物类似药，为VEGFR-1和VEGFR-2胞外区结合域与人 免疫球蛋白Fc段重组形成的融合蛋白，可与VEGF-A和PlGF结合。 ...

Core Insights - The conference highlighted the growing global competitiveness of Chinese innovative drugs, particularly in areas like ADC and bispecific antibodies, while emphasizing the need for improvement in original innovation capabilities [1][5][6] - There is a consensus among industry leaders that "going global" is essential for the future of Chinese innovative drugs, with calls for more supportive policies to facilitate this process [1][7][9] Group 1: Current State of Chinese Innovative Drugs - Chinese innovative drugs have reached a global competitiveness level from "1 to 10," especially in engineering fields, but still need to enhance original innovation from "0 to 1" [1] - The quality of projects is crucial for international expansion, as highlighted by industry leaders who stress that strong data and comprehensive packages are essential for success [2][3] - The past decade has seen significant development in the Chinese innovative drug ecosystem, with a complete industrial chain now in place, particularly in cities like Shanghai [4] Group 2: Challenges and Opportunities - The domestic market's limitations are pushing companies to explore international markets, with a focus on countries involved in the Belt and Road Initiative [7] - There is a need for policy reforms regarding listing standards to support innovative drug companies that face long development cycles and high R&D costs [7][9] - The current pricing of innovative drugs in international markets is still influenced by domestic prices, which poses challenges for global competitiveness [9] Group 3: Future Directions and Innovations - The industry is witnessing a surge in various therapeutic areas, including small molecules, antibodies, peptides, RNA, and gene therapies, indicating a diverse landscape of innovation [10] - The potential for small nucleic acids and other novel therapies is recognized as a significant opportunity for Chinese companies to lead in the global market [10] - Industry leaders express confidence in the future of Chinese innovative drugs, anticipating that with time, more companies will emerge as global players [11]

作为科创板迈向"新高地"暨"硬科硬客"2025年会的重要内容之一，9月10日，君实生物（688180.SH）、 皓元医药（688131.SH）、药康生物（688046.SH）、美迪西（688202.SH）、迈威生物（688062.SH） 等科创板创新药领域龙头上市公司高管，逾50家机构投资者参与了创新药产业链的高层次闭门研讨会。 会议围绕中国创新药出海的核心能力、国际竞争力现状及未来发展方向进行深入研讨。 与会嘉宾认为，中国创新药已具备从"1到10"的全球竞争力，尤其在ADC、双抗等工程化领域国际领 先，但在"0到1"的原始创新方面仍需努力。出海，成为行业共识，企业呼吁政策进一步支持破解"出 海"难题。 "君实生物是最早把国际化当作自己重要战略的本土企业之一，特瑞普利单抗也是第一个获得美国FDA 批准上市的中国自研自产PD-1产品，目前已经在40个国家和地区获批。"李鑫坦言，产品出海是高成本 的事情，需要满足国际上未被满足的需求，同时要应对FDA等海外监管机构的严格审评，包括临床和生 产端。 皓元医药董事长兼总经理郑保富从产业链角度分析："创新药是我们CRO（定制研发机构）、CDMO （医药合同定制研发生产企 ...

Group 1 - Maiwei Biotech has signed exclusive licensing and preferred stock purchase agreements with Kalexo Bio, potentially receiving up to $1 billion in upfront and milestone payments, along with a significant stake in Kalexo's Series A financing [1] - The NewCo model, which involves granting overseas development and commercialization rights to a newly established company, is gaining traction among both large and small innovative pharmaceutical companies in China [1][2] - The NewCo approach is considered a smarter "going global" strategy compared to traditional licensing models, as it allows companies to benefit from both cash and equity in the new company [2] Group 2 - Maiwei Biotech's collaboration with Kalexo marks its first attempt at the NewCo model, which is backed by the Aditum Bio Fund [2] - Companies are now more rational in their "going global" strategies, considering not only economic returns but also the research capabilities and commercialization strengths of their partners [3] - The evolution of "going global" strategies reflects the accumulated experience of innovative pharmaceutical companies, leading to more sophisticated choices in partnership and negotiation [4] Group 3 - The market has seen the emergence of various NewCo models, including pure overseas NewCo and hybrid NewCo, with notable examples like BeiGene's royalty leasing model [5] - The relationship between multinational pharmaceutical companies and domestic innovative firms is characterized by a complementary dynamic, where each party leverages its strengths [5] - For small and medium-sized biotech companies in China, selling partial rights to early-stage projects can accelerate cash flow and support ongoing research and development efforts [5]

Summary of the Conference Call for Maiwei Bio Company Overview - **Company**: Maiwei Bio - **Industry**: Biopharmaceuticals, focusing on age-related diseases and chronic conditions Key Points and Arguments 1. **Collaboration Agreement**: Maiwei Bio has entered into a $1 billion collaboration agreement with Editum Bio, acquiring the RM7,141 project, which includes an upfront payment of $12 million, single-digit royalties, and double-digit Series A preferred equity in ClaxBio [2][3] 2. **Focus on Age-Related Diseases**: The company is concentrating on age-related diseases and chronic conditions, utilizing a dual-target small nucleic acid platform established over the past two to three years [2][4] 3. **ClaxBio's Role**: ClaxBio, established by Editum Bio, focuses on high-potential clinical pipeline projects and has successfully incubated companies like Bersani SpA, which was acquired by Eli Lilly for $1.9 billion [2][6] 4. **Research and Development Efficiency**: Maiwei Bio has approximately 400 R&D personnel, with over 100 dedicated to early-stage research, significantly enhancing R&D efficiency, allowing for candidate identification in just a few months [4][12][13] 5. **Patent Strategy**: The company has a comprehensive patent strategy for its siRNA delivery systems, including the dry lac delivery system and Link system, which have shown higher efficiency and lower costs in multiple models [4][18] 6. **Dual-Target Project**: The dual-target project primarily addresses cardiovascular diseases, aiming to achieve stronger synergistic effects through optimized combinations of different targets [10][23] 7. **Future Plans**: Maiwei plans to expand its dual-target approach and explore additional indications, including fat delivery systems, while maintaining a focus on cardiovascular diseases [11][15] 8. **Market Expectations**: Investors have high expectations for the siRNA molecules, as the recent business development validates the efficiency of the small nucleic acid drug development platform [14] 9. **Clinical Trial Timeline**: The project is currently in the early CMC stage, with plans to initiate clinical trials in the US and China in the second half of 2026 [16] 10. **Regulatory Progress**: The white介11 project for pathological scars is expected to receive approval by the end of this year, with initial efficacy data anticipated by mid-next year [25][27] Additional Important Information - **AI Integration**: Maiwei's technology platform is highly automated and AI-enabled, allowing for rapid screening and optimization of potential candidates, which can be replicated across other projects [19] - **Long-term Strategy**: The company emphasizes long-term value in its partnerships, focusing on the background and resource compatibility of potential collaborators [21][22] - **Competitive Advantage**: Maiwei's dual-target small nucleic acid molecules are designed to achieve significant synergistic effects, potentially outperforming existing products in the cardiovascular space [23][29] This summary encapsulates the essential insights from the conference call, highlighting Maiwei Bio's strategic initiatives, R&D capabilities, and market positioning within the biopharmaceutical industry.

Group 1 - The company announced a share buyback of 135,938 shares, which represents approximately 0.03% of its total share capital [1]

Core Viewpoint - Maiwei Biotech has signed exclusive licensing and preferred stock purchase agreements with Kalexo Bio, Inc. for the 2MW7141 project, which could yield up to $1 billion in upfront and milestone payments, along with low single-digit royalties [1][2]. Group 1: Company Overview - Maiwei Biotech's stock price increased by over 10% following the announcement, reaching a peak increase of 13.21% [1]. - The company is focused on developing dual-target small nucleic acid drugs, with 2MW7141 aimed at managing dyslipidemia and preventing high-risk cardiovascular events [2][5]. - The 2MW7141 project is currently in the CMC (Chemistry, Manufacturing, and Controls) development stage, and specific drug targets have not been disclosed due to confidentiality [1][5]. Group 2: Partnership Details - The agreement with Kalexo allows for exclusive global development, production, and commercialization rights for the 2MW7141 project [2]. - Kalexo, established in December 2023, is an innovative drug company created by AditumBio, which focuses on accelerating new drug development through capital and expertise [2][3]. - The potential total transaction value for the partnership is higher than previous collaborations, with Maiwei Biotech receiving an upfront payment of $12 million and milestone payments contributing to the total of up to $1 billion [3]. Group 3: Industry Context - The cardiovascular disease sector is highly competitive, with major pharmaceutical companies actively pursuing small nucleic acid therapies [5]. - Existing therapies, while effective, still leave room for improvement in reducing disease indicators, which the dual-target approach of 2MW7141 aims to address [5]. - Recent collaborations in the industry, such as the one between Boehringer Ingelheim and Novartis, highlight the trend of strategic partnerships focusing on early-stage projects in the small nucleic acid space [5][6].

Market Overview - The main funds in the Shanghai and Shenzhen markets experienced a net outflow of 108.41 billion yuan, with the Sci-Tech Innovation Board seeing a net outflow of 6.95 billion yuan [1] - A total of 222 stocks saw net inflows, while 366 stocks experienced net outflows [1] Sci-Tech Innovation Board Performance - On the Sci-Tech Innovation Board, 175 stocks rose, with two stocks, Dekoli and Huafeng Technology, hitting the daily limit, while 408 stocks declined [1] - The top three stocks with the highest net inflows were Huafeng Technology (337 million yuan), Maiwei Biology (298 million yuan), and Zhongwei Company (220 million yuan) [1][2] Continuous Fund Flow Analysis - There are 39 stocks that have seen continuous net inflows for more than three trading days, with Hanwujing leading at 22 consecutive days of inflow [2] - Conversely, 162 stocks have experienced continuous net outflows, with Naike Equipment leading at 15 consecutive days of outflow [2] Top Fund Inflows - The top stocks by net inflow include: - Huafeng Technology: 337.30 million yuan, with a 20% increase [2] - Maiwei Biology: 298.07 million yuan, with a 13.21% increase [2] - Zhongwei Company: 219.55 million yuan, with an 11.43% increase [2] Notable Outflows - The stocks with the highest net outflows included: - Haiguang Information: 1.17 billion yuan, with a 0.46% increase [1] - Dongxin Co. and SMIC: 819 million yuan and 731 million yuan outflows, respectively [1]

Group 1 - The chemical pharmaceutical sector increased by 0.47% on September 18, with Maiwei Biotech leading the gains [1] - The Shanghai Composite Index closed at 3831.66, down 1.15%, while the Shenzhen Component Index closed at 13075.66, down 1.06% [1] - Notable performers in the chemical pharmaceutical sector included Maiwei Biotech, which rose by 13.21% to a closing price of 54.75, and Xinnoway, which increased by 7.07% to 51.80 [1] Group 2 - The net inflow of main funds in the chemical pharmaceutical sector was 243 million yuan, while retail funds experienced a net outflow of 18.46 million yuan [2] - The top stocks by main fund inflow included Maiwei Biotech with 319 million yuan and Borui Pharmaceutical with 214 million yuan [3] - Retail investors showed significant outflows in several stocks, including Maiwei Biotech and Borui Pharmaceutical, indicating a shift in investor sentiment [3]

Group 1 - The company Maiwei Bio announced on September 18 that it repurchased approximately 140,000 shares through centralized bidding, accounting for about 0.03% of its total share capital of approximately 400 million shares [1] - The highest price for the repurchased shares was 58.02 RMB per share, while the lowest price was 52.79 RMB per share [1] - The total amount of funds used for the repurchase was approximately 7.36 million RMB [1]