自主研发筑基，BD 合源，双轮驱动创新价值高效兑现 ——迈威生物深度报告 迈威生物-U（688062.SH） 化学制药 证券研究报告/公司深度报告 2026 年 02 月 25 日 | 公司盈利预测及估值 | | | | | | | --- | --- | --- | --- | --- | --- | | 指标 | 2023A | 2024A | 2025E | 2026E | 2027E | | 营业收入（百万元） | 128 | 200 | 674 | 1,163 | 1,273 | | 增长率 yoy% | 361% | 56% | 238% | 72% | 10% | | 归母净利润（百万元） | -1,053 | -1,044 | -922 | -661 | -355 | | 增长率 yoy% | -10% | 1% | 12% | 28% | 46% | | 每股收益（元） | -2.64 | -2.61 | -2.31 | -1.65 | -0.89 | | 每股现金流量 | -1.96 | -2.39 | -1.81 | -1.29 | 0.17 | | 净资产收益率 | -40% | -6 ...

自主研发筑基，BD 合源，双轮驱动创新价值高效兑现 ——迈威生物深度报告 迈威生物-U（688062.SH） 化学制药 证券研究报告/公司深度报告 2026 年 02 月 25 日 | 公司盈利预测及估值 | | | | | | | --- | --- | --- | --- | --- | --- | | 指标 | 2023A | 2024A | 2025E | 2026E | 2027E | | 营业收入（百万元） | 128 | 200 | 674 | 1,163 | 1,273 | | 增长率 yoy% | 361% | 56% | 238% | 72% | 10% | | 归母净利润（百万元） | -1,053 | -1,044 | -922 | -661 | -355 | | 增长率 yoy% | -10% | 1% | 12% | 28% | 46% | | 每股收益（元） | -2.64 | -2.61 | -2.31 | -1.65 | -0.89 | | 每股现金流量 | -1.96 | -2.39 | -1.81 | -1.29 | 0.17 | | 净资产收益率 | -40% | -6 ...

Core Insights - The Chinese innovative pharmaceutical industry is undergoing a historic transformation, shifting from "fast followers" to "original creators" supported by solid data and market performance [1] - By 2025, the total value of innovative drug licensing transactions in China is expected to exceed $130 billion, with over 150 transactions, marking a historical high [1] - Shanghai's Pudong district is becoming a key hub for the global market, with significant achievements in CAR-T products and first-class new drugs [1] Industry Overview - China's pharmaceutical industry ranks second globally, with approximately 30% of innovative drugs in development worldwide [1] - The industry is entering a critical phase characterized by "innovation realization + global layout" [1] Company Developments - Chinese innovative drug companies are leveraging speed and cost-effectiveness to gain a competitive edge in the global market [3] - Companies like Maiwei Biotech and Jinsai Pharmaceutical are forming significant overseas business development (BD) partnerships, enhancing China's global competitiveness [3][4] - Maiwei Biotech has accelerated its BD efforts, securing exclusive licensing agreements for innovative therapies, including a $1 billion potential deal with Aditum Bio [4][5] Market Trends - By 2025, Pudong is expected to have approved four CAR-T products, accounting for 30% of the global total, and seven first-class new drugs, representing 14% of the national total [1] - The commercial sales of innovative drugs in Pudong are projected to exceed 11.6 billion yuan in 2024, with several new drugs achieving over 1 billion yuan in annual sales [10] Strategic Initiatives - Companies are focusing on building comprehensive global capabilities covering research, registration, and sales to transition from "licensing out" to "commercialization abroad" [10] - Jinsai Pharmaceutical has established local teams in the U.S. and Europe to manage clinical trials and seek collaboration opportunities [8] Innovation and Collaboration - The future of innovative drugs lies in international markets, with companies emphasizing deep understanding of disease biology as a core competitive advantage [5] - Companies are forming cooperative committees with BD partners to ensure project progress through information sharing and resource collaboration [5] Ecosystem Support - The rise of China's innovative drug industry is attributed to years of policy guidance, technological accumulation, and capital cultivation [23] - The unique industrial atmosphere, talent pool, and complete industrial chain in Zhangjiang are seen as core advantages for local companies [23][24] - Pudong's talent policies and supportive platforms are facilitating the rapid gathering of global talent resources [23] Future Outlook - The next 3-5 years are expected to see continued emphasis on internationalization and globalization among Chinese biopharmaceutical companies [14] - Companies are increasingly focusing on source innovation and high-quality BD potential to meet global market demands and achieve high valuations [17]

Core Viewpoint - The Chinese innovative pharmaceutical industry is undergoing a historic transformation, shifting from "fast followers" to "original creators," supported by solid data and market performance [1]. Group 1: Industry Overview - China's pharmaceutical industry is the second largest globally, with innovative drugs accounting for approximately 30% of global research [1]. - By 2025, the total value of innovative drug licensing transactions in China is expected to exceed $130 billion, with over 150 transactions, marking historical highs [1]. - The increase in competitiveness and cost-effectiveness of Chinese pharmaceutical assets is driving the industry into a critical phase of "innovation realization + global layout" [1]. Group 2: Regional Development - Shanghai's Pudong district is becoming a core hub for the global market connection of China's biopharmaceutical industry, with significant achievements in innovative drug approvals and business development transactions [1]. - By 2025, Pudong has approved 4 CAR-T products (30% of the global total) and 7 Class 1 new drugs (14% of the national total), with business development transaction amounts reaching $20.4 billion (14% of the global total) [1]. Group 3: Competitive Advantages - Chinese innovative pharmaceutical companies are gaining a competitive edge in the global market due to their speed and cost-effectiveness, being able to advance drug discovery 2-3 times faster and recruit clinical trial patients 2-5 times faster than international counterparts [3]. - The cost per patient for clinical trials in China is only half that of Europe and the US [3]. Group 4: Business Development Collaborations - Companies like Maiwei Biopharma and Jinsai Pharmaceutical are forming significant overseas business development collaborations, enhancing China's global competitiveness in innovative drugs [3][5]. - Maiwei Biopharma has accelerated its business development efforts, securing exclusive licensing agreements for innovative therapies within months of initial meetings [3][4]. Group 5: Full-Chain Layout - A number of innovative pharmaceutical companies are rapidly constructing comprehensive overseas layouts covering research, registration, and sales, transitioning from "licensing out" to "commercialization abroad" [9]. - By 2024, Pudong is expected to have over 20 innovative drugs achieving commercial sales, with total sales exceeding 11.6 billion yuan [9]. Group 6: Source Innovation - The market consensus is that only companies with source innovation capabilities, quality business development potential, and global layout abilities can effectively meet global market demands and achieve high valuations [16]. - Companies like Jinfang Pharmaceutical are focusing on unique therapeutic areas and avoiding following trends, which positions them favorably in the global market [17]. Group 7: Industry Ecosystem - The rise of China's innovative pharmaceutical industry is attributed to years of policy guidance, technological accumulation, and capital cultivation, leading to a critical growth inflection point [21]. - The unique industrial atmosphere, quality talent pool, and complete industrial chain in Zhangjiang are considered core advantages for companies operating in the region [21][22]. Group 8: Future Outlook - The Pudong district is set to enhance its support for the biopharmaceutical industry, aiming to become a global hub for innovative drug launches and scientific entrepreneurship [23]. - The ongoing development of a differentiated industrial linkage pattern is expected to further support the growth of the life sciences industry in the region [23]. Group 9: Conclusion - The path of globalization for Chinese innovative drugs is deepening, supported by core industrial hubs like Pudong and the continuous upgrading of companies' innovation and internationalization capabilities [24].

Market Overview - The A-share pharmaceutical and biotechnology index fell by 1.17%, underperforming the CSI 300 index by 2.44 percentage points and the ChiNext index by 1.89 percentage points, ranking 17th among 31 sub-industries [4] - The H-share Hang Seng Healthcare Index also declined by 0.71%, lagging behind the Hang Seng Index by 1.45 percentage points [4] R&D Progress - Recent IND applications include Yifang Biotech's D-0502 tablets and Hengrui Medicine's HRS-6257 tablets; clinical applications include BeiGene's BG-C137 injection and Hengrui's HRS-4642 [5] - Shijiazhuang Pharmaceutical's SYS6002 and Zai Lab's Epcoritamab are in Phase III clinical trials; Maiwei Biotech's 9MW3811 is in Phase II; and 3SBio's SSGJ-709 is in Phase I [5] Policy and Market Developments - On December 7, the National Healthcare Security Administration released the new National Basic Medical Insurance Drug Directory and the Commercial Health Insurance Innovative Drug Directory for 2025, with 127 products participating in negotiations, of which 114 were successfully included, achieving a success rate of 88%, the highest in seven years [6] - The first commercial insurance directory included 24 drugs, with 19 successfully negotiated, including CAR-T therapies and treatments for rare diseases such as neuroblastoma and Gaucher disease, as well as Alzheimer's disease [6] - The implementation of the commercial insurance innovative drug directory is expected to open broader market opportunities for innovative drugs in the context of a growing number of "global new" drugs emerging in China [6] Investment Strategy - The investment strategy for the pharmaceutical sector is shifting towards emphasizing the clinical value of drugs, addressing clinical needs of patients, influenced by domestic healthcare policies and global expansion [7] - The focus is on the innovative drug supply chain and innovative medical devices, reflecting a clinical value-based investment approach [7]

Core Insights - Maiwei Biotech has received approval from the National Medical Products Administration (NMPA) for its IL-11 monoclonal antibody 9MW3811 to enter Phase II clinical trials for pathological scars, marking it as the first drug targeting this indication in clinical exploration [1] - The company has established an exclusive licensing agreement with CALICO Life Sciences, which includes an upfront payment of $25 million and potential milestone payments totaling up to $571 million, along with tiered royalties based on net sales [1][2] - Maiwei Biotech reported a significant revenue increase of 301.03% year-on-year, reaching 566 million yuan in the first three quarters of 2025, driven primarily by income from innovative product collaborations [2] Group 1: Clinical Development and Partnerships - The company has a comprehensive pipeline with 15 core products at various stages, including 11 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases [2] - The Phase II clinical trial for the anti-TMPRSS6 monoclonal antibody 9MW3011 has commenced, with the first patient dosed in the U.S., marking a significant milestone in its collaboration with DISC Medicine [3] - Maiwei Biotech has entered into a partnership with Qilu Pharmaceutical for long-acting white blood cell-boosting drugs, with a contract value of up to 500 million yuan, including a non-refundable upfront payment of 380 million yuan [4] Group 2: Financial Performance - The substantial increase in technical service revenue is attributed to the licensing agreements with CALICO, Qilu, and DISC, indicating the successful commercialization of innovative research [4] - The company’s revenue from technical services reached 407 million yuan, a year-on-year increase of 715.52%, while drug sales contributed 156 million yuan, reflecting a 72.10% increase [2] - Maiwei Biotech's ongoing clinical trials for its core pipeline products, including 9MW2821 and JS207, show promising efficacy signals in treating triple-negative breast cancer [5]

Policy Developments - Jiangxi Province is promoting the development of brain-computer interface medical devices, emphasizing the need for regulatory compliance and collaboration among industry players to seize opportunities in emerging technologies [1] - The market for brain-computer interface medical devices is noted to have significant potential, with a strong development momentum in Jiangxi Province [1] Medical Device Approvals - In October, the National Medical Products Administration approved 204 medical device products, including 173 domestic Class III devices, 10 imported Class III devices, and 21 imported Class II devices [2] Pharmaceutical Logistics - The Shanghai Municipal Drug Administration encourages the development of modern pharmaceutical logistics, advocating for improved storage and management systems to enhance operational efficiency and reduce costs [3] Drug Approvals - Fangsheng Pharmaceutical announced that its Indobufen tablets received a drug registration certificate from the National Medical Products Administration, allowing for production [4] - Saito Bio's application for the chemical raw material drug Mometasone Furoate has been approved, indicating its use in treating asthma and skin conditions [5] - Tianyao Pharmaceutical received a drug registration certificate for Metoclopramide injection, which is used for treating nausea and vomiting [6] Capital Market Activities - Yingsi Intelligent submitted a listing application to the Hong Kong Stock Exchange, aiming to raise funds for its AI-driven drug development initiatives [7][8] - Rejuve Bio plans to repurchase shares worth between 100 million and 200 million yuan to support employee stock ownership plans [9] Industry Developments - AstraZeneca's Baxdrostat demonstrated significant reductions in 24-hour average systolic blood pressure in treatment-resistant hypertension patients during the Bax24 Phase III trial, achieving a reduction of 14.0 mmHg compared to placebo [10][11] - The drug showed good overall tolerability and consistent safety profiles, with a notable percentage of patients achieving target blood pressure levels [11] - Maiwei Bio's IL-11 monoclonal antibody 9MW3811 received approval for Phase II clinical trials targeting pathological scars, marking it as the first IL-11 targeted drug to enter clinical trials for this indication [12] - Aiwei Technology's subsidiary obtained a medical institution practice license, enabling it to provide third-party medical testing services [13] - Anke Bio signed an exclusive agency framework agreement with Boshengji for the PA3-17 injection product, aimed at enhancing its product portfolio in the innovative drug market [14][15]

Core Insights - Wuhan Heyuan Biotechnology Co., Ltd. is set to become the first incremental enterprise in the Sci-Tech Innovation Board's growth layer, focusing on innovative drug development, particularly the "rice blood" technology [1] - The Sci-Tech Innovation Board has supported 13 innovative drug companies with a total market capitalization of nearly 500 billion, leading to the approval of 25 new drugs since its inception [1][4] - The introduction of the fifth set of listing standards has allowed unprofitable companies to access capital markets, significantly boosting the innovative drug sector in China [2] Industry Development - Since 2019, China's innovative drug industry has raised over 1 trillion in financing across primary and secondary markets, leading to unprecedented activity in drug research and development [2] - China's innovative drug R&D pipeline accounts for approximately 25% of the global total, surpassing the number of active innovative drugs in the U.S. [2] - The establishment of the "growth layer" in the Sci-Tech Innovation Board aims to enhance support for technology innovation and has been pivotal for companies like Suzhou Zelgen Biopharmaceuticals, which has successfully launched three new drugs since listing [2] R&D Investment and Performance - High R&D investment is a key reason for the lack of profitability among companies in the growth layer, but it is also a critical driver for future innovation [3] - BeiGene, a leading innovative drug company, is projected to invest 14.1 billion in R&D in 2024, maintaining its position as the top R&D spender on the Sci-Tech Innovation Board [3] - BeiGene's drug, Zebrutinib, has achieved significant global sales, generating 1.3 billion in revenue in the first half of the year, with a year-on-year growth of over 56% [3] Financial Performance - The innovative drug companies in the growth layer are transitioning from R&D investment to commercialization, with a combined revenue of 31.9 billion expected in 2024, reflecting a year-on-year growth rate of 54.39% [5] - The annual compound growth rate of these companies' revenue since 2019 is 52.33%, significantly outpacing the growth rate of other sectors [5][6] - Innovent Biologics reported a net profit of 3.7 billion after its IPO, driven by a strategic partnership with Bristol-Myers Squibb, which included an upfront payment of 800 million [4] International Collaboration and Market Recognition - The innovative drug companies have engaged in international collaborations, with potential transaction values nearing 5 billion, indicating strong global market recognition [7] - Companies like Innovent Biologics and Nocera have secured licensing agreements with international firms, further validating the strength of China's innovative drug sector [7]

Core Insights - He Yuan Bio, the world's first company to innovate "rice hematopoiesis," will debut on the Sci-Tech Innovation Board, becoming the first incremental enterprise in the Sci-Tech Growth Layer [1] - The Sci-Tech Growth Layer currently has 13 innovative pharmaceutical companies with a total market value of nearly 500 billion, having facilitated the approval of 25 new drugs since their listing [1] Group 1: Institutional Reform and Investment Trends - The establishment of the fifth set of listing standards on the Sci-Tech Innovation Board has allowed unprofitable companies to go public, significantly aiding innovative pharmaceutical companies in overcoming funding bottlenecks and accelerating drug development [2] - Since 2019, the cumulative financing scale of China's innovative pharmaceutical industry in both primary and secondary markets has exceeded 1 trillion [2] - The R&D pipeline of China's innovative drugs accounts for approximately 25% of the global total [2] Group 2: R&D and Commercialization Acceleration - High R&D investment is the main reason for the current unprofitability of companies in the Sci-Tech Growth Layer, but it is also the key driver for future innovation development [3] - In 2024, the total revenue of these innovative pharmaceutical companies is expected to reach 31.9 billion, with a year-on-year growth rate of 54.39% [3] - These companies have successfully launched 20 new drugs with "global new" attributes and achieved "breakthrough therapy" designation for 10 innovative drugs across 17 indications [3] Group 3: Leading Companies and Market Performance - Innovative pharmaceutical leader BeiGene has achieved a "qualitative leap" through a combination of "hardcore technology and commercialization breakthroughs," with R&D investment reaching 14.1 billion in 2024 [4] - BeiGene's core product, Zebrutinib, has been approved in over 70 countries and regions, benefiting 180,000 patients, with a half-year sales revenue of 1.3 billion, a year-on-year increase of over 56% [4] - BeiGene expects to exceed 35 billion in total revenue by 2025, entering a positive cycle of "R&D breakthroughs—product volume—profit realization" [4] Group 4: International Market Engagement - Several companies in the Sci-Tech Growth Layer have actively pursued international transactions this year, with a potential total transaction amount of nearly 5 billion [5] - For instance, Maiwei Bio has reached an exclusive licensing agreement with Calico, including a potential transaction total of 596 million [5] - Nocera Jianhua has announced a licensing agreement with Zenas BioPharma, expecting a total transaction amount exceeding 2 billion [5]

Core Viewpoint - He Yuan Bio, a pioneer in "rice hematopoiesis" innovative drugs, will debut on the Sci-Tech Innovation Board, marking it as the first incremental enterprise in the Sci-Tech Growth Layer [1] Group 1: Institutional Reform and Investment Trends - The fifth set of listing standards on the Sci-Tech Innovation Board has enabled companies without revenue or profits to go public, facilitating funding for innovative drug companies and spurring an investment boom in the sector [3] - Since 2019, the cumulative financing scale of China's innovative drug industry in both primary and secondary markets has exceeded 1 trillion yuan, leading to a surge in R&D activities [3] - The establishment of the "Sci-Tech Growth Layer" aims to enhance the adaptability and inclusiveness of the Sci-Tech Innovation Board, supporting the development of new productive forces and technological innovation [3] Group 2: R&D Investment and Commercialization - High R&D investment is the main reason for the current lack of profitability among innovative drug companies in the Sci-Tech Growth Layer, but it is also the key driver for future acceleration in innovation [5] - In 2024, the total revenue of these companies is expected to reach 31.9 billion yuan, with a year-on-year growth rate of 54.39%, significantly outpacing the average compound growth rate of the sector [5] - These companies have successfully launched 20 new national Class 1 drugs with "global new" attributes and achieved breakthrough therapy designations for 10 innovative drugs across 17 indications [5] Group 3: Market Recognition and Future Prospects - Innovative drug leaders like BeiGene have achieved significant milestones, including a projected revenue of over 35 billion yuan in 2025 and a positive operating profit, entering a virtuous cycle of R&D breakthroughs and product commercialization [6] - Several companies in the Sci-Tech Growth Layer have engaged in international transactions, with potential total transaction amounts nearing 5 billion dollars, indicating strong international market recognition [6] - Notable agreements include a licensing deal between Maiwei Bio and Calico, with a potential total of 596 million dollars, and a partnership between Nuocheng Jianhua and Zenas BioPharma, expected to yield over 2 billion dollars [6]