Core Viewpoint - Maiwei Biotech (688062) has received FDA approval for its clinical trial application for 9MW1911 injection, allowing the company to proceed with a Phase IIa clinical study to evaluate the pharmacokinetics, safety, tolerability, and preliminary efficacy of 9MW1911 in participants with moderate to severe chronic obstructive pulmonary disease (COPD) [1] Group 1 - The FDA issued a "Notice of Continuation of Clinical Research" for Maiwei Biotech on December 23 [1] - The clinical study will be randomized, double-blind, and placebo-controlled [1] - The focus of the study is on participants with moderate to severe COPD [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received a Study May Proceed Notification from the FDA, allowing the clinical trial application for 9MW1911 to proceed [1] Group 1: Company Information - 9MW1911 is an innovative monoclonal antibody developed based on a high-efficiency B lymphocyte screening platform [1] - The product is classified as a Class 1 therapeutic biological product [1] - 9MW1911 has a high affinity for the ST2 receptor, which blocks the IL33/ST2 signaling pathway [1]

9MW1911为一款基于高效B淋巴细胞筛选平台自主研发的创新单克隆抗体，属于治疗用生物制品1类， 可高亲和力结合ST2受体，从而阻断IL33/ST2 信号通路。 智通财经APP讯，迈威生物(688062.SH)发布公告，近日，公司收到美国食品药品监督管理局(FDA)签发 的《临床研究继续进行通知书》(Study May Proceed Notification)，9MW1911注射液临床试验申请正式获 得FDA许可。 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-077 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW1911 注射液临床试验申请 获得 FDA 许可的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 近日，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"）收到美国食品药品监督管理局（FDA）签发的《临床研究继续进行通知书》 （Study May Proceed Notification），9MW1911 注射液临床试验申请正式获得 FDA 许可。由于药品的研发周期长、审批环节多，容易受到一些不确定性因素的影响， 敬请广大投资者谨慎决策，注意防范投资风险。现将相关情况公告如下： 一、药品基本情况 药品名称：9MW1911 注射液 申请号：IND 177824 申请人：迈威（上海）生物科技股份有限公司 审批结论：FDA 已完成对本次申请的安全性评估，同意本品按照拟定的临床 研究计划开展，即"以评估 9MW1911 在中重度慢性阻塞性肺疾病（COPD）参与 者中的药 ...

2024年1至12月份，迈威生物的营业收入构成为：医药制造行业占比99.92%，其他业务占比0.08%。 每经AI快讯，迈威生物（SH 688062，收盘价：39.45元）12月23日晚间发布公告称，2025年12月23日， 公司完成回购，已实际回购公司股份约119万股，占公司总股本的比例为0.3%，回购最高价格为58.02 元/股，回购最低价格为37.48元/股，回购均价为41.93元/股，支付的资金总额为人民币4999.45万元。 每经头条（nbdtoutiao）——地产"优等生"受困20亿元到期债务，首次债务展期仍在博弈，明年还有超 百亿元公开债到期 （记者 王晓波） 截至发稿，迈威生物市值为158亿元。 ...

迈威（上海）生物科技股份有限公司 关于股份回购实施结果的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 证券代码：688062 证券简称：迈威生物 公告编号：2025-078 重要内容提示： | 回购方案首次披露日 | 2025/6/27 | | | | --- | --- | --- | --- | | 回购方案实施期限 | 2025 年 6 月 26 日~2026 6 月 | 年 | 25 日 | | 预计回购金额 | 2,500万元~5,000万元 | | | | 回购价格上限 | 66.46元/股 | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | | | □用于转换公司可转债 | | | | | □为维护公司价值及股东权益 | | | | 实际回购股数 | 119.24万股 | | | | 实际回购股数占总股本比例 | 0.30% | | | | 实际回购金额 | 4,999.45万元 | | | | 实际回购价格区间 | 37.48元/股~58.02元/股 | | | 一、 ...

迈威生物公告，近日，公司收到美国食品药品监督管理局（FDA）签发的《临床研究继续进行通知书》 （Study May Proceed Notification），9MW1911注射液临床试验申请正式获得FDA许可。 ...

Group 1 - The central economic work conference emphasized that the long-term supportive conditions and basic trends of China's economy remain unchanged, urging confidence and the need to leverage advantages while addressing challenges to maintain economic stability and growth [2] - The pharmaceutical industry is highlighted as a key area for innovation, with a significant increase in the approval of innovative drugs, reaching 48 new class 1 innovative drugs in 2024, which is over five times the number approved in 2018 [2] - The biopharmaceutical sector is recognized as a long-term supported industry with characteristics such as long R&D cycles and high investment, and it has been designated as a key development area during the 14th Five-Year Plan [2] Group 2 - Liu Dato, Chairman and CEO of Maiwei Biotech, noted that the focus on new productive forces in the 14th Five-Year Plan and the recent conference's emphasis on innovation-driven growth have elevated the strategic importance of innovation, boosting industry confidence [3] - Source innovation is identified as the core competitiveness of biopharmaceutical companies, with Maiwei Biotech having developed several globally competitive innovative products [3] - The company aims to establish sustainable innovation capabilities by enhancing its technology platform and integrating AI technology into its R&D processes, which is expected to expand into more fields with technological advancements [3] Group 3 - The domestic biopharmaceutical industry has made significant progress over the past decade due to continuous innovation, although there is still room for improvement in basic research compared to developed countries [4] - Maiwei Biotech plans to continue focusing on source innovation and enhancing its capabilities in target innovation and technology innovation, aiming to promote the transformation of innovative results and improve global competitiveness [4]

Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]

Core Viewpoint - Maiwei Biotech, a company listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board in 2022, has grown into a billion-dollar enterprise with 15 key products in various stages of clinical development and a research team of nearly 400 people [1] Group 1: Company Overview - Maiwei Biotech has developed two first-in-class drugs, positioning itself among the top tier of the global biopharmaceutical industry [1] - The company has not yet achieved profitability but has effectively addressed critical pain points in research and development [1] Group 2: Industry Context - A total of 22 biopharmaceutical companies, including Maiwei Biotech, have adopted the fifth set of listing standards on the Sci-Tech Innovation Board, with cumulative R&D investments exceeding 70 billion yuan over the past three years [1] - The Sci-Tech Innovation Board is facilitating significant R&D investments from innovative drug companies, which are substantially higher than the average level in the sector [1] - Through institutional innovation, capital injection, and supportive measures, the Sci-Tech Innovation Board is helping biopharmaceutical companies overcome challenges related to long R&D cycles, high investment costs, and slow profitability, enabling a leap from R&D to commercialization and from local to global markets [1]