Core Viewpoint - Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the Phase II clinical trial of its drug 9MW3811, aimed at treating pathological scars [1] Company Summary - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The drug effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, which is crucial in the progression of fibrotic diseases [1] - Key advantages of 9MW3811 include higher target affinity and signaling blockade capability, as well as a long half-life of over one month, making it suitable for chronic disease treatment requiring long-term administration [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the clinical trial of its drug 9MW3811, targeting pathological scars in a Phase II study [1] Company Summary - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The drug effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, which is crucial in the progression of fibrotic diseases [1] - Key advantages of 9MW3811 include higher target affinity and signaling blockade capability, along with a long half-life of over one month, making it suitable for chronic disease treatment requiring long-term administration [1]

Group 1 - The core point of the news is that Maiwei Biotech's stock price has dropped by 5.01%, currently trading at 42.24 CNY per share, with a total market capitalization of 16.879 billion CNY [1] - Maiwei Biotech, established on May 12, 2017, and listed on January 18, 2022, focuses on the research, production, and sales of therapeutic biological products, with 99.91% of its revenue coming from product sales [1] - The trading volume for Maiwei Biotech reached 256 million CNY, with a turnover rate of 2.90% [1] Group 2 - Southern Fund's Southern CSI 1000 ETF (512100) has entered the top ten circulating shareholders of Maiwei Biotech, holding 2.1906 million shares, which is 1.07% of the circulating shares [2] - The estimated floating loss for the Southern CSI 1000 ETF today is approximately 4.885 million CNY [2] - The Southern CSI 1000 ETF was established on September 29, 2016, with a current scale of 76.63 billion CNY and has achieved a year-to-date return of 28.25% [2] Group 3 - The fund manager of Southern CSI 1000 ETF is Cui Lei, who has been in the position for 7 years and 2 days, managing a total asset scale of 122.76 billion CNY [3] - During Cui Lei's tenure, the best fund return was 176.39%, while the worst return was -15.93% [3]

Group 1 - The core viewpoint of the news is that Maiwei Biotech has shown significant financial activity, with a notable increase in revenue and changes in shareholder structure [1][2]. Group 2 - As of November 6, 2023, Maiwei Biotech's stock price increased by 0.50%, with a trading volume of 304 million yuan. The financing buy-in amount was 22.19 million yuan, while the financing repayment was 30.38 million yuan, resulting in a net financing buy of -8.19 million yuan [1]. - The total margin balance for Maiwei Biotech reached 613 million yuan, with the financing balance accounting for 6.74% of the circulating market value, indicating a high level compared to the past year [1]. - The company has not engaged in any short selling on November 6, 2023, with a short selling balance of 93.38 million yuan, also reflecting a high level compared to the past year [1]. Group 3 - For the period from January to September 2025, Maiwei Biotech reported a revenue of 566 million yuan, representing a year-on-year growth of 301.03%. However, the net profit attributable to the parent company was -598 million yuan, showing a year-on-year increase of 13.89% [2]. - As of September 30, 2025, the number of shareholders for Maiwei Biotech reached 19,600, an increase of 9.15% from the previous period. The average circulating shares per person decreased by 8.38% to 10,425 shares [2]. - Among the top ten circulating shareholders, E Fund Medical Healthcare Industry Mixed A ranked as the fourth largest shareholder with 3.17 million shares, while Hong Kong Central Clearing Limited ranked sixth with 2.87 million shares, showing a decrease of 1.87 million shares from the previous period [2].

Summary of the Conference Call for Maiwei Biotech Company Overview - **Company**: Maiwei Biotech - **Date**: November 4, 2025 Key Points Financial Performance - As of September 30, the company reported cash and cash equivalents of 1.439 billion RMB, an increase of over 200 million RMB compared to the end of last year [5] - Revenue for the first three quarters reached 566 million RMB, a year-on-year increase of 300%, driven by growth in technical service fees and a 70% increase in the sales of Dizu monoclonal antibody [5] - The loss for the third quarter significantly reduced to 49 million RMB, a year-on-year decrease of 200 million RMB, marking the first substantial reduction in losses [5] Business Development (BD) Achievements - The company achieved multiple breakthroughs in BD, including collaborations on Bai Jie 11, small nucleic acids, and long-acting Shengmai injections, resulting in over 800 million RMB in cash inflow [6][7] - Several BD pipelines are in progress, including 94 ADR BTC, CDED, and STE U monoclonal antibodies, with expectations for more results in the future [7] Core Projects and Pipeline Progress - The core pipeline includes 9KT 4 ADC, B713 ADC, and CD17 ADC, with multiple products expected to be approved and initiate patient enrollment in both China and the U.S. [8] - The SE2 monoclonal antibody for COPD has completed enrollment of 80 patients in the EB27 clinical trial, with expectations to complete follow-up by the end of the year [3] - The company is also advancing the CDH17 ADC project, which has received overseas authorization with a total amount exceeding 1 billion USD for liver delivery exploration [3][4] Market Expansion and Product Launches - Dizu monoclonal antibody sales approached 100 million RMB in the first half of the year, ranking first among domestic products [16] - The company has signed agreements with over 10 countries to expand biosimilars into emerging markets, with the first launch in Pakistan in August [16] - A supplemental application for bone metastasis indications is expected to be approved in the first half of next year, which could significantly increase revenue [16] Future Development Plans - The company is focusing on four key platforms: antibody discovery, ADC, TCE, and small nucleic acids, with plans to launch more TCE products into clinical trials next year [8] - The company is also developing treatments for age-related diseases, such as the SE2 monoclonal antibody for COPD, with plans for larger sample size trials [8] Clinical Trials and Regulatory Approvals - The company is actively communicating with the FDA regarding clinical trial designs and endpoints, particularly for the Bai Jie 11 project targeting pathological scars [9][28] - The 2,821 project is expected to focus on single endpoint PFS (Progression-Free Survival) to shorten clinical cycles and sample sizes [18][25] Innovations in Drug Development - The siRNA platform has been authorized to Editas, with ongoing development of dual-target siRNA and exploration of liver and CNS delivery systems [12][33] - The company is also developing a new oral small molecule drug for osteoarthritis, which is currently advancing to phase II clinical trials [14] Market Outlook - The company anticipates significant revenue growth from traditional products like Dizu and Adalimumab, with a complete transition to Maiwei's invoicing by 2026 [22] - The aging population in China is expected to drive demand for ophthalmic preparations, particularly for age-related macular degeneration [38] Conclusion - Maiwei Biotech is positioned for growth with a robust pipeline, significant financial improvements, and strategic collaborations, aiming to expand its market presence and enhance its product offerings in the coming years [39]

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of 56.44 CNY, indicating a potential upside from the current price of 47.48 CNY [3][6]. Core Insights - The company has shown significant revenue growth, with a 301.0% increase in revenue for the first three quarters of 2025, amounting to 5.66 billion CNY. The net profit attributable to the parent company was -5.98 billion CNY, reflecting a 13.9% year-on-year improvement [10]. - The report highlights successful clinical advancements and commercialization efforts, with multiple new clinical trials set to commence and ongoing collaborations expected to enhance revenue streams [10]. - The financial forecasts have been adjusted, with a downward revision for 2025 revenue and R&D expenses, while 2026 revenue and management expenses have been increased. The projected net profits for 2025-2027 are -7.35 billion CNY, -6.55 billion CNY, and -2.91 billion CNY respectively [3][10]. Financial Summary - Revenue projections for 2025 are set at 747 million CNY, with a year-on-year growth of 274.1%. By 2026, revenue is expected to reach 1.066 billion CNY, growing at 42.6% [5]. - The company is expected to incur a net loss of 735 million CNY in 2025, improving to a loss of 655 million CNY in 2026, and further narrowing to 291 million CNY by 2027 [5]. - The gross margin is projected to be 93.5% in 2025, with a net margin of -98.4% [5]. - The company’s market capitalization is estimated at 225.55 billion CNY based on discounted cash flow valuation [11].

Core Insights - Maiwei Biotech (688062.SH) has repurchased a total of 437,474 shares, representing 0.11% of the company's total share capital [1] - The highest repurchase price was RMB 58.02 per share, while the lowest was RMB 40.61 per share [1] - The total amount spent on the repurchase was RMB 20.695 million, excluding transaction fees such as stamp duty and commissions [1]

Company Summary - Maiwei Bio announced on November 3 that as of October 31, 2025, it has repurchased approximately 440,000 shares, accounting for 0.11% of the company's total share capital [1] - The highest repurchase price was RMB 58.02 per share, while the lowest was RMB 40.61 per share [1] - The total amount spent on the share repurchase was RMB 20.695 million [1]

证券代码：688062 证券简称：迈威生物 公告编号：2025-065 公司于 2025 年 8 月 5 日召开第二届董事会第二十次会议，审议通过了《关于 调整回购股份价格上限的议案》，同意将回购股份价格上限由人民币 35.00 元/股（含） 调整为人民币 48.00 元/股（含）。具体内容详见公司于 2025 年 8 月 6 日在上海证 券交易所网站（www.sse.com.cn）上披露的《关于调整回购股份价格上限的公告》 （公告编号：2025-041）。除上述调整外，回购股份方案的其他内容不变。 公司于 2025 年 9 月 17 日召开第二届董事会第二十二次会议，审议通过了《关 于调整回购股份价格上限的议案》，同意将回购股份价格上限由人民币 48.00 元/股 （含）调整为人民币 66.46 元/股（含）。具体内容详见公司于 2025 年 9 月 18 日在 上海证券交易所网站（www.sse.com.cn）上披露的《关于调整回购股份价格上限的 公告》（公告编号：2025-053）。除上述调整外，回购股份方案的其他内容不变。 二、 回购股份的进展情况 根据《上市公司股份回购规则》《上海证券交易所上市公司 ...

Core Insights - The company reported a significant revenue increase of 301% year-on-year, reaching 566 million yuan, while the net profit attributable to shareholders was -598 million yuan [1] - The revenue growth was primarily driven by substantial income recognition from licensing agreements with Qilu Pharmaceutical and DISC MEDICINE, INC, along with increased drug sales compared to the previous year [1] Group 1: Licensing Agreements - The company granted Qilu Pharmaceutical rights for the development, production, and commercialization of the long-acting white blood cell booster injection, receiving an upfront payment of 380 million yuan [1] - An exclusive license for the IL-11 monoclonal antibody 9MW3811 was granted to CALICO LIFE SCIENCES LLC for all regions outside Greater China, with an upfront payment of 25 million USD [1] - The company also licensed the dual-target small nucleic acid drug 2MW7141 to Kalexo Bio, Inc. for global exclusive rights, receiving an upfront payment of 12 million USD [1] Group 2: Clinical Development Pipeline - The core product NECTIN-4 ADC 9MW2821 is currently undergoing three pivotal Phase 3 clinical trials in China, targeting various cancer treatments [2] - The ST2 monoclonal antibody 9MW1911 is advancing rapidly in Phase 2 clinical trials, with plans to initiate Phase 3 trials by the end of 2026 [2] - The TMPRSS6 monoclonal antibody 9MW3011 completed its first patient dosing in a Phase 2 clinical trial for PV patients in September 2025 [2] - The IL-11 monoclonal antibody 9MW3811 has had its Phase 2 clinical trial application accepted by the National Medical Products Administration, with a potential start by the end of 2025 [2] Group 3: Financial Projections - Revenue projections for the company are estimated at 886 million yuan, 1.145 billion yuan, and 2.285 billion yuan for 2025, 2026, and 2027 respectively [3] - Net profit projections are expected to be -676 million yuan, -618 million yuan, and -173 million yuan for the same years [3] - The company maintains a "Buy-A" investment rating, with a 6-month target price set at 54.40 yuan based on DCF modeling [3]