Group 1 - SystImmune, a subsidiary of BaiLi TianHeng, received a milestone payment of $250 million from Bristol-Myers Squibb, with potential future payments totaling up to $2.5 billion and additional payments of up to $7.1 billion based on specific development, registration, and sales milestones [1] - The milestone payment is expected to significantly enhance cash flow and support research and development efforts, serving as a benchmark case for domestic innovative drugs going global [1] Group 2 - Sanofi Biologics announced that two executives plan to reduce their holdings by up to 18,800 shares each, representing 0.012% of the company's total share capital, due to personal financial needs [2] - The combined share reduction is minimal and is not expected to have a significant direct impact on the market, reflecting a common phenomenon in the A-share market [2] Group 3 - Maiwei Biotech's innovative drug 9MW1911 has completed Phase IIa clinical trials in patients with moderate to severe chronic obstructive pulmonary disease (COPD), showing good safety and tolerability across all dosage groups [3] - The annual incidence of acute exacerbations of COPD decreased by over 30% compared to the placebo group at the recommended dose for Phase IIb studies, with a significant reduction in the proportion of patients experiencing severe exacerbations [3] - These results lay a solid foundation for the Phase IIb study, potentially providing new treatment options for the large COPD patient population and showcasing the R&D capabilities and market potential of domestic innovative drugs in respiratory diseases [3] Group 4 - Novartis announced that the FDA has approved Onasemnogene abeparvovec (Itvisma) for treating spinal muscular atrophy (SMA) in patients aged two and older with confirmed SMN1 gene mutations, making it the first and only gene therapy for this broad population [4] - The unique aspect of this drug is its one-time fixed-dose administration, which does not require adjustments based on age or weight, potentially changing the disease progression fundamentally and alleviating the burden of long-term medication [4] Group 5 - Novo Nordisk has submitted a supplemental new drug application to the FDA for a 7.2 mg dose of semaglutide injection, aimed at controlling long-term weight in obese adults in conjunction with a low-calorie diet and increased physical activity [5] - This move is expected to strengthen Novo Nordisk's leading position in the GLP-1 market and provide better treatment options for obese adults [5]

Core Viewpoint - The announcement details the progress of the clinical research for the innovative drug 9MW1911 developed by Maiwei Biotech, highlighting its safety, tolerability, and efficacy in patients with moderate to severe chronic obstructive pulmonary disease (COPD) [2][4]. Group 1: Drug Overview - 9MW1911 is an innovative monoclonal antibody developed using a high-efficiency B lymphocyte screening platform, targeting the ST2 receptor to block the IL33/ST2 signaling pathway [2]. - The drug has completed a Phase IIa clinical study involving 80 patients with moderate COPD, with a Phase IIb trial expected to start in July 2025 after enrolling at least 120 participants [2][3]. Group 2: Clinical Trial Results - The Phase IIa study (9MW1911-C03) was a randomized, double-blind, placebo-controlled trial assessing safety, tolerability, pharmacokinetics, and preliminary efficacy [3]. - Results indicated that all dosage groups of 9MW1911 showed good safety and tolerability compared to the placebo group, with an adverse event rate of 70% versus 85% for the placebo [4]. - The annualized rate of acute exacerbations in moderate COPD patients decreased by over 30% at the recommended Phase IIb dose compared to the placebo, and the rate of severe exacerbations decreased by over 40% [2][4].

Company Focus - Enjie Co., Ltd. plans to acquire 100% equity of Zhongke Hualian, leading to a stock suspension [2] - Canadian Solar Inc. and its controlling shareholder plan to establish a joint venture to adjust their U.S. market operations [3] - Jiarong Technology intends to acquire 100% of Hangzhou Lanan, with stock resuming trading [3] Equity Changes - ST Tianrui's controlling shareholder is planning a change in control, resulting in stock suspension [4] Shareholding Changes & Buybacks - Shanghai Chuangtou intends to reduce its stake in Zhongwei Company by no more than 1% [5] Operations & Performance - China Shenhua's subsidiary successfully completed a 168-hour trial run of its power generation unit, transitioning to commercial operation [6] - Baillie Tianheng received a milestone payment of $250 million from Bristol-Myers Squibb for the iza-bren project [7] - Jiangxi Copper is in the informal offer stage to acquire shares of SolGold Plc [8] - Aorede plans to sign a 635 million yuan computing power procurement agreement [9] - Maiwei Bio's clinical research for 9MW1911 shows significant reductions in acute exacerbation rates for COPD patients [10] - Huayang Co. has launched a high-performance carbon fiber project with an annual production capacity of 200 tons [10] Financing & Capital Increase - Ganfeng Lithium plans to issue $100 million in exchangeable notes to the China-Africa Development Fund [11] Stock Price Fluctuations - Tongyu Communications confirmed normal operations amid stock price fluctuations [12] - Rongji Software reported normal operations despite stock price declines [13] Other - Xianglou New Materials' application for a specific stock issuance has been accepted by the Shenzhen Stock Exchange [15] - JinkoSolar received a prepayment of 220 million yuan for a fire incident at its battery workshop [15] - Dameng Data's general manager has had his detention lifted [15] - Dongpeng Beverage has received approval from the CSRC for its overseas listing [16]

Core Viewpoint - Maiwei Biotech (688062) announced the completion of Phase IIa clinical study for its innovative drug 9MW1911 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) [1] Group 1: Clinical Study Results - The study involved 80 patients with moderate to severe COPD, with a control group of 20 patients receiving a placebo [1] - All dosage groups of 9MW1911 demonstrated good safety and tolerability compared to the placebo [1] - The annualized exacerbation rate of moderate COPD decreased by over 30% at the recommended Phase IIb dose (N=30) compared to the placebo group [1] - The annualized exacerbation rate for severe COPD decreased by over 40% compared to the placebo group [1] - The proportion of patients experiencing severe exacerbations was significantly lower in the treatment group (13.3% vs 35%) compared to the placebo group [1]

Core Viewpoint - Maiwei Biotech (688062.SH) announced the successful completion of Phase IIa clinical trials for its innovative drug 9MW1911 in patients with moderate to severe chronic obstructive pulmonary disease (COPD), demonstrating good safety and tolerability across all dosage groups [1] Group 1: Clinical Research Results - In the recommended dosage for Phase IIb studies, the annual incidence of acute exacerbations in moderate to severe COPD patients was reduced by over 30% compared to the placebo group [1] - The annual incidence of severe acute exacerbations decreased by over 40%, with a significant reduction in the proportion of patients experiencing severe acute exacerbations [1] - The company is actively advancing the Phase IIb clinical research for 9MW1911 in the COPD indication [1]

人民财讯11月30日电，11月30日，迈威生物宣布自主研发的抗ST2单抗创新药(研发代号：9MW1911)已 完成在中重度慢性阻塞性肺疾病(COPD)患者中的IIa期临床研究。研究结果显示，与安慰剂相比， 9MW1911所有剂量组均表现出良好的安全性与耐受性；总体的不良事件发生率与安慰剂组相似 (70%vs85%)；在IIb期研究推荐剂量(RP2D)下，中重度COPD急性加重年化发生率较安慰剂组降低超 30%，重度急性加重年化发生率较安慰剂组降低超40%。9MW1911是迈威生物基于高效B淋巴细胞筛选 平台自主研发的抗ST2单抗创新药，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。 ...

Core Viewpoint - Maiwei Biotech (688062.SH) has completed the Phase IIa clinical study of its innovative drug 9MW1911 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD), showing promising safety and efficacy results compared to placebo [1] Group 1: Clinical Study Results - The Phase IIa study involved 80 patients, with 20 in the placebo group [1] - All dosage groups of 9MW1911 demonstrated good safety and tolerability compared to the placebo [1] - The annualized rate of acute exacerbations of COPD decreased with increasing doses of 9MW1911 [1] Group 2: Efficacy Metrics - In the recommended Phase IIb dose (RP2D) study involving 30 patients, the annualized rate of acute exacerbations in moderate COPD patients was reduced by over 30% compared to the placebo group [1] - The annualized rate of severe acute exacerbations decreased by over 40% compared to the placebo group [1] - The proportion of patients experiencing severe acute exacerbations was significantly lower in the treatment group (13.3%) compared to the placebo group (35%) [1] Group 3: Future Developments - The company is actively advancing the Phase IIb clinical study of 9MW1911 for COPD indications [1]

证券代码：688062 证券简称：迈威生物 公告编号：2025-070 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW1911 临床研究进展的公告 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。 公司就 9MW1911 开展的 IIa 期临床研究（研究代号：9MW1911-C03）为一 项随机、双盲、安慰剂对照、多次给药、剂量递增研究，主要评价 9MW1911 在 既往吸烟的中重度 COPD 受试者中的安全性、耐受性及药代动力学特征，并初 步评价有效性及免疫原性。研究完成入组 80 例，受试者随机接受静脉输注的 9MW1911 注射液（100 mg、300 mg、600 mg、900 mg 四个剂量）或安慰剂，每 4 周给药一次。 结果显示，各组基线特征总体均衡，大多数受试者的基线血嗜酸性粒细胞计 数<300/μL。与安慰剂（N=20）相比，9MW1911 在各剂量组安全且耐受性良好， 总体的不良事件发生率与安慰剂组相似（70% vs 85%），所有受试者的免疫原性 均为阴性，且未发现新的安全性风险信号。药代动力学 ...

国泰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 开立、变更部分募集资金专用账户 并重新签订三方及四方监管协议事项的核查意见 国泰海通证券股份有限公司（以下简称"国泰海通证券"或"保荐机构"） 作为迈威（上海）生物科技股份有限公司（以下简称"迈威生物"或"公司"） 首次公开发行股票并上市持续督导保荐机构，根据《证券发行上市保荐业务管理 办法》《上市公司监管指引第 2 号——上市公司募集资金管理和使用的监管要求》 《上海证券交易所科创板股票上市规则》《上海证券交易所上市公司自律监管指 引第 11 号——持续督导》《上海证券交易所科创板上市公司自律监管指引第 1 号 ——规范运作》等有关规定，对迈威生物开立、变更部分募集资金专用账户并重 新签订三方及四方监管协议事项进行了核查，具体情况如下： 一、募集资金基本情况 根据中国证券监督管理委员会出具的《关于同意迈威（上海）生物科技股份 有限公司首次公开发行股票注册的批复》（证监许可〔2021〕3859 号），公司首 次向社会公开发行人民币普通股 99,900,000 股，每股发行价格为人民币 34.80 元， 募集资金总额为人民币 3,476,520,0 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-068 二、募集资金专用账户开立情况 迈威（上海）生物科技股份有限公司 关于开立、变更部分募集资金专用账户 并重新签订三方及四方监管协议的公告 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。 迈威（上海）生物科技股份有限公司（以下简称"公司"）于 2025 年 11 月 26 日召开第二届董事会第二十五次会议、第二届监事会第二十次会议，审议 通过了《关于开立、变更部分募集资金专用账户并重新签订三方及四方监管协议 的议案》，同意公司及全资子公司上海朗润迈威生物医药科技有限公司（以下简 称"朗润迈威"）和江苏泰康生物医药有限公司（以下简称"泰康生物"）本次 开立、变更部分募集资金专用账户并重新签订三方/四方监管协议，且授权公司 管理层办理此次募集资金专用账户开立、变更并重新签订三方/四方监管协议相 关事宜。保荐机构国泰海通证券股份有限公司（以下简称"国泰海通证券"或"保 荐机构"）对该事项出具了明确同意的核查意见。现将有关情况公告如下： 一、募集资金基本情况 1 ...