北京植德（上海）律师事务所 关于迈威（上海）生物科技股份有限公司 2024 年第三次临时股东大会的 法律意见书 植德沪(会)字[2024]0041 号 致：迈威（上海）生物科技股份有限公司（迈威生物/贵公司） 北京植德（上海）律师事务所（以下简称"本所"）接受贵公司的委托，指 派律师出席并见证贵公司 2024 年第三次临时股东大会（以下简称"本次会议"）。 二〇二四年九月 上海市徐汇区虹桥路 183 号徐家汇中心三期 A 座办公楼 27 层（THREE itc） 邮编：200030 27 th Floor Tower A, THREE itc, No.183 Hongqiao Road, Xuhui District, Shanghai 200030 P.R.C 电话(Tel)：021-52533500 传真(Fax)：021-52533599 www.meritsandtree.com 北京植德（上海）律师事务所 关于迈威（上海）生物科技股份有限公司 2024 年第三次临时股东大会的法律意见书 植德沪（会）字[2024]0041 号 本所律师参加本次会议进行见证，并根据《中华人民共和国公司法》（以下 简称" ...

Investment Rating - The investment rating for the company is "Outperform the Market" [1][3][11] Core Insights - The core product 9MW2821, a Nectin-4 ADC, is rapidly advancing in clinical trials for multiple indications, including entering Phase 3 registration trials for urothelial carcinoma (UC) and cervical cancer (CC) [1][11] - The company is also progressing with its pipeline products, including ST2 monoclonal antibody 9MW1911 in Phase 2 trials for COPD, and other ADCs in early clinical stages [1][11] - The commercialization of biosimilars is proceeding smoothly, with a reported sales increase of 28.4% in the first half of the year, driven by a significant rise in drug sales revenue [1][5] Financial Forecast and Metrics - Revenue projections for 2024-2026 are estimated at 4.17 billion, 8.87 billion, and 14.31 billion yuan, representing year-on-year growth rates of 226%, 113%, and 61% respectively [1][13] - The net profit forecast for the same period is expected to be -749 million, -516 million, and -126 million yuan [1][13] - The company reported a net loss of 4.45 billion yuan in the first half of the year, with R&D expenses of 3.22 billion yuan [1][5][13]

Investment Rating - Maintains "Outperform" rating [1][3] Core Views - The core product 9MW2821, a Nectin-4 ADC, is advancing rapidly in multiple indications, including urothelial carcinoma (UC) and cervical cancer (CC), with Phase 3 registration trials underway [1] - 9MW2821 is also being tested in esophageal cancer (EC) and breast cancer (BC), with clinical data disclosed for CC, EC, and TNBC, aiming to compete with PADCEV through differentiated indications [1] - The company plans to conduct overseas clinical trials for 9MW2821, leveraging comprehensive domestic clinical data to potentially expand into international markets through licensing [1] - The ST2 monoclonal antibody 9MW1911 is in Phase 2 trials for COPD, leading among domestic companies [1] - Other pipeline products, including 7MW3711 (B7-H3 ADC) and 9MW2921 (TROP2 ADC), are in Phase 1/2 trials, while 8MW0511 (long-acting leukocyte booster) has had its marketing application accepted [1] - The company has demonstrated strong commercialization capabilities, with further product approvals and clinical progress expected to drive sales growth [1] Financial Performance - H1 sales reached RMB 116 million (+28.4%), driven by drug sales of RMB 66 million (+371.9%) and significant technology licensing income from the 9MW3011 project [5] - H1 net loss was RMB 445 million (+7.6%), with R&D expenses of RMB 322 million (-5.4%), sales expenses of RMB 113 million (+29.8%), and administrative expenses of RMB 112 million (+18.3%) [5] - Shipments of Maikang exceeded 20,000 units, while Maikang and Maijian completed commercial shipments [5] Revenue and Profit Forecast - Revenue for 2024-26 is projected to be RMB 417 million, RMB 887 million, and RMB 1.431 billion, representing year-on-year growth of 226%, 113%, and 61%, respectively [1] - Net profit attributable to shareholders for 2024-26 is forecasted to be RMB -749 million, RMB -516 million, and RMB -126 million, respectively [1] Pipeline Progress - 9MW1911 (ST2 monoclonal antibody) is in Phase 2 trials for COPD [1] - 7MW3711 (B7-H3 ADC) and 9MW2921 (TROP2 ADC) are in Phase 1/2 trials [1] - 8MW0511 (long-acting leukocyte booster) has had its marketing application accepted [1] Commercialization - The company has shown strong commercialization capabilities, with further product approvals and clinical progress expected to drive sales growth [1]

海通证券股份有限公司 关于迈威（上海）生物科技股份有限公司 2024 年度持续督导半年度跟踪报告 | 保荐机构名称：海通证券股份有限公司 | 被保荐公司简称：迈威生物 | | --- | --- | | 保荐代表人姓名：王永杰、陈新军 | 被保荐公司代码：688062 | 重大事项提示 截至 2024 年 6 月末，尽管公司已有三款产品陆续获批上市并推进至商业化 阶段，但公司尚未盈利且存在累计未弥补亏损，主要原因是君迈康®、迈利舒®、 迈卫健®上市时间较短，且公司作为一家创新型生物医药企业，成立以来一直保 持较高的研发投入。截至本报告披露日，公司拥有 15 个处于临床或上市阶段的 关键品种，包括 11 个创新药，4 个生物类似药，覆盖肿瘤、免疫、骨疾病、眼 科、血液等多个重大疾病治疗领域。其中，已上市品种 3 个，处于上市许可审评 阶段品种 1 个，处于 III 期关键注册临床阶段品种 3 个，处于其他不同临床阶段 品种 8 个。2024 年 1-6 月，公司研发投入为 32,212.49 万元。 公司未来几年将存在累计未弥补亏损及持续亏损，并将面临如下潜在风险： 公司虽有药品获批上市，但销售收入可能无法弥补 ...

Investment Rating - The report maintains an "Accumulate" rating for the company with a target price of 30.27 CNY, reflecting a potential upside from the current price of 23.1 CNY [3][5]. Core Insights - The company's sales revenue has significantly increased, achieving 116 million CNY in the first half of 2024, a year-on-year growth of 28.42%. The pharmaceutical sales revenue reached 65.67 million CNY, a remarkable increase of 371.85% due to the shipment of 116,994 units of the drug Mai Li Shu and the addition of 487 new hospitals [1][2]. - The Nectin-4 ADC clinical trials are progressing rapidly across multiple indications, with several Phase III trials initiated for various cancers, including urothelial carcinoma and cervical cancer, marking significant advancements in the company's pipeline [1][2]. - The company is actively introducing new products and has established a multi-tier pipeline, including a long-acting G-CSF that has submitted an NDA and is expected to be approved in 2025, and a biosimilar of Abicipar that has completed Phase III trials [1][2]. Financial Summary - The company reported a net profit attributable to the parent company of -444.5 million CNY for the first half of 2024, a decrease of 7.61% year-on-year. The forecast for net profit for 2024-2026 has been adjusted to -1.138 billion CNY, -918 million CNY, and -559 million CNY respectively [1][2]. - The projected revenue for 2024 is 310 million CNY, with a year-on-year growth of 142.8%, and is expected to reach 1.576 billion CNY by 2026 [2][8]. - The company's reasonable market value is estimated at 12.094 billion CNY, corresponding to a target price of 30.27 CNY per share [6][7].

迈利舒放量显著，Nectin-4 ADC 进展迅速 ——迈威生物 2024 年中报点评 核心观点 ⚫ 迈利舒迅速放量，药品销售收入大幅增长。公司发布 24 年中报，实现营业收入 1.16 亿元（同比+28.42%），归母净利润-4.45 亿元（同比-7.61%），扣非归母净 利润-4.61 亿元（同比-10.88%）。其中药品销售收入 6,566.50 万元（同比 +371.85%），主要系迈利舒新增发货 116,994 支，新增准入医院 487 家，上半年销 售已超 23 年全年。 ⚫ Nectin-4 ADC 临床进展迅速，多适应症全面铺开。公司 Nectin-4 ADC 今年以来披 露了多个适应症的积极数据，24 年上半年已在多瘤种中迅速推进多项临床试验： 1）尿路上皮癌：启动联用 PD-1 抑制剂一线治疗的 III 期临床试验；2）宫颈癌：启 动单药二/三线治疗的 III 期临床试验（全球首个在该适应症进入 III 期的同靶点药 物），联用 PD-1 抑制剂一线治疗的 IND 获受理；3）三阴性乳腺癌：启动联用 PD1 抑制剂一线治疗或单药二线治疗的 II 期临床试验；4）食管癌：联用 PD-1 抑制 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [4] Core Insights - The company reported a revenue of 116 million yuan for the first half of 2024, representing a year-over-year increase of 28.42%. However, the net profit attributable to shareholders was -445 million yuan, and the net profit after deducting non-recurring items was -461 million yuan [2][6] - The development of ADC (Antibody-Drug Conjugate) is progressing steadily, with multiple Phase III clinical trials initiated for the drug 9MW2821, which has received several FDA designations, including orphan drug status for esophageal cancer and fast track designation for cervical cancer and triple-negative breast cancer [6] - Sales are increasing significantly, with G-CSF expected to be approved for market by 2025. In the first half of 2024, drug sales revenue reached 65.67 million yuan, a year-over-year increase of 371.85% [6] Financial Performance and Projections - The company expects revenues for 2024, 2025, and 2026 to be 714 million yuan, 1.704 billion yuan, and 2.967 billion yuan, respectively, with year-over-year growth rates of 458.42%, 138.64%, and 74.14% [6] - The projected net profits for the same years are -1.025 billion yuan, -888 million yuan, and -539 million yuan, with growth rates of 2.70%, 13.38%, and 39.33% respectively [6] - The earnings per share (EPS) are forecasted to be -2.57 yuan, -2.22 yuan, and -1.35 yuan for 2024, 2025, and 2026 [6] Market Position and Valuation - The current price of the stock is 22.19 yuan, with a market capitalization of approximately 4.53 billion yuan [4] - The company has a total share capital of 399.60 million shares, with 204.17 million shares in circulation [4] - The price-to-earnings (P/E) ratio is projected to be -8.7 for 2024, -10.0 for 2025, and -16.5 for 2026, indicating a negative earnings outlook [6]

Investment Rating - The investment rating for the company is "Buy - A" with a target price of 37.87 CNY for the next six months [3][5]. Core Insights - The company reported a revenue of 116 million CNY for the first half of 2024, representing a year-on-year growth of 28.42%. However, it incurred a net loss of 445 million CNY during the same period [1]. - The NECTIN-4 ADC clinical program is progressing rapidly, with three Phase 3 clinical trials currently underway, targeting various types of cancer [1]. - The long-acting white blood cell enhancer is expected to be approved for market launch in 2025, with the company having submitted its application in December 2023 [1]. - The company has a robust pipeline of innovative drugs, including B7H3 ADC and TROP2 ADC, which are advancing through clinical trials [1]. Financial Projections - Revenue projections for the company are estimated at 300 million CNY in 2024, 1.11 billion CNY in 2025, and 2.01 billion CNY in 2026, with net losses expected to decrease from 920 million CNY in 2024 to 87 million CNY in 2026 [2][6]. - The company anticipates significant revenue growth driven by the launch of its existing and upcoming products [2][6]. Market Performance - The company's stock price as of August 30, 2024, was 22.19 CNY, with a market capitalization of approximately 8.87 billion CNY [3]. - The stock has shown a 12-month price range between 20.0 CNY and 36.5 CNY [3]. Clinical Development - The NECTIN-4 ADC has received multiple designations from the FDA, including Fast Track Designation and Orphan Drug Designation, indicating its potential in treating specific cancer types [1]. - The company is leveraging its next-generation ADC technology, which is expected to enhance the efficacy and safety of its drug candidates [1].

Research and Development - The company invested significant funds in R&D, with expenses of CNY 622.51 million in 2021, CNY 758.61 million in 2022, CNY 835.78 million in 2023, and CNY 322.12 million in the first half of 2024[2]. - The company has 12 core products in the pipeline, requiring ongoing substantial R&D investment for preclinical research, clinical trials, and new drug market preparation[2]. - The R&D of innovative drugs is characterized by long cycles and high costs, with a typical new drug taking around ten years from development to approval[5]. - The company emphasizes the importance of risk-benefit assessment throughout the drug lifecycle, as outlined in recent regulatory guidelines[6]. - The company's R&D expenditure accounted for 278.83% of operating revenue, a decrease of 99.59 percentage points compared to the previous year[23]. - The company has established four technology platforms for drug discovery and development, resulting in 15 new varieties, 3 domestic marketing approvals, and 30 clinical trial approvals since its inception[42]. - The company has filed 47 new invention patent applications from January 1, 2024, to June 30, 2024, bringing the total to 434 applications and 76 granted patents[42]. - The company has completed clinical trial sample preparation for 9 research products and commercial production for 2 products, with a total of 102 batches of raw liquid produced[44]. - The company is committed to driving new product development through innovative technology platforms and exploring drug mechanisms[51]. - The company has established a comprehensive quality management system based on Chinese GMP, US FDA cGMP, and EU EMA GMP standards, covering the entire product lifecycle[101]. Financial Performance - The company's revenue for the first half of 2024 was approximately ¥115.53 million, representing a 28.42% increase compared to ¥89.96 million in the same period last year[22]. - The net profit attributable to shareholders of the listed company was a loss of ¥444.98 million, compared to a loss of ¥413.53 million in the previous year[22]. - The net cash flow from operating activities was a negative ¥461.62 million, compared to a negative ¥321.35 million in the same period last year[22]. - The net assets attributable to shareholders of the listed company decreased by 16.09% to ¥2.17 billion from ¥2.58 billion at the end of the previous year[22]. - Total assets increased by 2.39% to ¥4.56 billion from ¥4.45 billion at the end of the previous year[22]. - The company's operating revenue for the reporting period increased by 25.57 million yuan, a year-on-year growth of 28.42%, primarily driven by pharmaceutical sales revenue of 65.67 million yuan, which grew by 371.85% compared to 13.92 million yuan in the same period last year[23]. - The net loss attributable to shareholders increased by 31.46 million yuan compared to the same period last year, mainly due to significant investments in clinical trials for ongoing projects and increased commercialization-related expenses[24]. - The net cash outflow from operating activities increased by 140.28 million yuan compared to the same period last year, primarily due to the refund of research settlement funds to Shengsen Bio[25]. - The company reported a total R&D investment of ¥322,124,870.91, a decrease of 5.38% compared to the previous year[129]. - The company reported a net loss attributable to shareholders of 444.98 million yuan, with a net loss of 460.73 million yuan after excluding non-recurring gains and losses, primarily due to increased expenditures for clinical trials and commercialization efforts[156]. Market and Product Development - The company is focusing on the development of innovative drugs guided by clinical value, aligning with national policies to enhance the biopharmaceutical industry[28]. - The company is actively involved in the development of antibody-drug conjugates, with products like 9MW2821 and 9MW2921 targeting Nectin-4 and Trop-2, respectively[13]. - The company has developed multiple monoclonal antibody injection products, including 9MW0113, a fully human anti-TNF-α monoclonal antibody injection, and 9MW0311, a fully human anti-RANKL monoclonal antibody injection[13]. - The company is exploring market expansion opportunities through strategic partnerships and collaborations with other biotech firms[12]. - The company has confirmed significant technical authorization income from the 9MW3011 project under a licensing agreement with DISC MEDICINE, INC.[23]. - The company is actively pursuing additional indications for 9MW0321 and has established partnerships for its commercialization in multiple countries[61]. - The company has signed formal cooperation agreements for the product 9MW0311 with a Brazilian pharmaceutical company, which will be responsible for product registration and commercialization in Brazil[143]. - The company aims to leverage its existing business network in emerging markets to achieve rapid product launches, particularly in countries along the "Belt and Road" initiative[51]. - The company is committed to accelerating the overseas business expansion and registration process, utilizing its extensive commercial resources and international registration capabilities[144]. - The company has established a strong overseas business development capability and rich registration experience, focusing on emerging markets along the "Belt and Road" initiative[143]. Regulatory and Compliance - The domestic production registration application for the self-developed product 8MW0511 was accepted by the National Medical Products Administration in December 2023, with potential impacts on sales revenue if it fails to pass approval[3]. - The company is committed to adhering to Current Good Manufacturing Practice (cGMP) standards to ensure quality in production processes[13]. - The company has established a drug safety committee to manage major risks and drug safety events[124]. - The company has implemented a drug safety quality management system to ensure compliance with relevant laws and regulations[124]. - The company has set up multiple channels to collect adverse drug reaction reports from healthcare professionals and patients[124]. Market Trends and Competitive Landscape - The Chinese pharmaceutical market is projected to reach 1.828 trillion yuan in 2024, with a compound annual growth rate of approximately 6.0% from 2025 to 2030[27]. - The biopharmaceutical market in China is expected to grow to 587.1 billion yuan in 2024 and 1.1491 trillion yuan by 2030, with a compound annual growth rate of about 11.2% from 2025 to 2030[27]. - Recent government policies aim to improve the payment environment for innovative drugs, which is expected to stabilize market expectations and support long-term growth in the biopharmaceutical sector[29]. - The global market for long-acting G-CSF is projected to reach ¥10.27 billion by 2025 and ¥13.54 billion by 2030, indicating a positive market outlook[31]. - The global autoimmune disease drug market is expected to reach $141.9 billion by 2024, with a compound annual growth rate (CAGR) of 3.68% from 2023 to 2030[32]. - The Chinese autoimmune disease drug market is projected to grow to $6.1 billion by 2024, with a CAGR of 27.3% from 2021 to 2025[32]. - The company’s adalimumab biosimilars are gaining market share due to their price advantages, with a projected market share increase[34]. - The company is focusing on addressing the increasing osteoporosis prevalence due to aging demographics in China[36]. - The company is enhancing its marketing system to address the low usage rates of biopharmaceuticals in various treatment areas, amidst increasing competition from domestic innovative drug companies[46]. Production and Operational Capacity - The company has established a production capacity of 8,000L for antibody drugs and 4,000L for recombinant protein drugs at its Taizhou production base, with a total of 102 batches of raw material production completed[137]. - The Shanghai Jinshan production base is advancing a project for an annual production capacity of 1,000kg of antibodies, with 50,637 square meters of construction completed[137]. - The ADC pilot industrialization project has completed the construction of the first phase, with 4 batches of ADC raw material production and 5 batches of formulation production successfully prepared[138]. - The Taizhou production base has completed trial production of ADC drugs, producing 4 batches of ADC raw liquid and 5 batches of formulations, all of which passed quality inspection, marking a key step in the full industrial chain layout for ADC drugs[45]. - The company has completed the installation and validation of two raw material production lines and one vial formulation production line at the Shanghai Jinshan production base, with trial production underway[123]. Environmental and Social Responsibility - The company invested 586,600 CNY in environmental protection during the reporting period[194]. - The total wastewater discharge during the reporting period was 6,073 tons, with all monitoring indicators within normal ranges and below regulatory limits[198]. - The total air emissions during the reporting period reached 13.5 million cubic meters, all meeting the required standards[198]. - The company processed 34.0 tons of hazardous solid waste and 3.4 tons of waste liquid during the reporting period[198]. - The company has established a dedicated environmental health and safety management department to oversee pollution control and compliance with regulations[199].

迈威（上海）生物科技股份有限公司 2024年度"提质增效重回报"行动方案 迈威（上海）生物科技股份有限公司（以下简称"迈威生物"或"公司"） 为秉持"投资者至上"的发展宗旨，维护全体股东利益，推动企业不断优化运营 管理、规范公司治理，并致力于为投资者创造价值，全面提升公司质量，基于对 公司未来发展的坚定信念、对公司价值的充分认可，以及认真履行社会责任的承 诺，特制定 2024 年度"提质增效重回报"行动方案。具体方案如下： 量的 9MW1911 后，安全且耐受性良好。目前正在开展慢性阻塞性肺疾病（COPD） 适应症 Ib/IIa 期临床试验。另一款靶向人白介素-11（IL-11）的单抗（9MW3811） 全球进展处于第一梯队，也是国内首个进入临床的药物，主要应用于肺纤维化疾 病（IPF）等领域，市场前景广阔，现已在中国、澳大利亚和美国获批进入临床阶 段，目前已完成中澳 I期临床研究。此外，靶向 TMPRSS6单抗（9MW3011）研发 进展亦处于全球第一梯队，针对 β-地中海贫血、真性红细胞增多症等与铁稳态相 关的疾病，展现出较大治疗潜力，已先后获得美国食品药品监督管理局的快速通 道认定（FTD）和孤儿药认定 ...