Core Viewpoint - Maiwei Biotech has re-submitted its application for H-share issuance and listing on the Hong Kong Stock Exchange, marking its second attempt after an initial application in January 2025. The company is facing significant financial pressure due to ongoing losses and a governance crisis involving its chairman [2][10]. Company Overview - Founded in 2017, Maiwei Biotech specializes in the research, production, and sales of therapeutic biological products, primarily focusing on antibody and recombinant protein drugs. The company has 14 key products in various stages of clinical development, including 10 innovative drugs and 4 biosimilars, targeting cancer and age-related diseases [4][5]. Financial Performance - Since its listing on the Sci-Tech Innovation Board in early 2022, Maiwei Biotech has raised 3.3 billion yuan but has incurred cumulative losses exceeding 3.5 billion yuan. As of mid-2025, total losses since the company's inception have reached 6.27 billion yuan. The company's operating capital is heavily reliant on external financing, with a current debt level of 77% [4][5]. Research and Development Investment - The company has maintained high R&D expenditures, with investments of 759 million yuan, 836 million yuan, and 783 million yuan from 2022 to 2024, and 392 million yuan in the first half of 2025, representing a 21.72% increase year-on-year. R&D spending accounted for 387.57% of operating income, up 108.74 percentage points year-on-year [5]. Sales Performance - Despite having four products approved for commercialization, sales performance has been disappointing. For instance, sales of the core product Junmaikang (an adalimumab biosimilar) fell by 66.61% in 2024, generating only 31.6 million yuan. Other products like Mailishu and Maiweijian also reported low sales figures [6][8]. Governance Issues - The company is facing governance challenges, particularly following the investigation of its chairman, Liu Datao, for suspected insider trading. This situation raises concerns about the company's reputation and future development [8][10]. Financing Needs - Given the ongoing financial losses and governance issues, Maiwei Biotech views its Hong Kong listing as a critical opportunity to alleviate liquidity pressures. The company has re-applied for listing after its initial application expired due to regulatory delays [10]. Potential Breakthroughs - A key product for the company is the 9MW3811 injection, aimed at treating pathological scars and targeting anti-aging. The company is the first in China to develop an IL-11 antibody drug, with clinical trials expected to start by the end of the year. A licensing agreement with Calico, a leader in anti-aging research, has been established for this drug [11].

Company Overview - Maiwei Biotech (688062.SH) experienced a significant stock price increase, closing at a historical high of 57.60 yuan per share, with a market capitalization of 23.017 billion yuan [1] - The company has submitted a new application for an IPO in Hong Kong and received formal acceptance for its Phase II clinical trial of 9MW3811 injection for pathological scars, with plans to initiate patient enrollment by the end of this year [1][2] Product Development - 9MW3811 is a humanized monoclonal antibody targeting IL-11, which is closely related to aging-related diseases. The drug has shown potential in treating fibrosis-related diseases by inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway [2][3] - The drug has received approval for clinical studies in China, the United States, and Australia for advanced malignancies and idiopathic pulmonary fibrosis, with Phase I trials completed in Australia and China [2] Market Potential - The global incidence of pathological scars (HSK) is approximately 25 million, with around 7.4 million cases in China, projected to exceed 10 million by 2030 [3] - The aging intervention market has seen a surge in investment, with total financing in the sector reaching $8.49 billion in 2024, a 122% increase from $3.82 billion in 2023 [1][4] Strategic Partnerships - In June, Maiwei Biotech entered into an exclusive licensing agreement with Calico, a Google-affiliated anti-aging giant, for the development and commercialization of IL-11 targeted therapies outside of China, potentially yielding up to $571 million in milestone payments and royalties [4][7] Competitive Landscape - Maiwei Biotech is the first company in China to develop an IL-11 antibody drug, with 9MW3811 being the first to explore the pathological scar indication in clinical trials [3] - The competitive landscape includes similar drugs like BI 765423 from Boehringer Ingelheim, which has also entered Phase I clinical trials [2]

Market Overview - On September 1, the A-share market experienced fluctuations, with the Shanghai Composite Index rising by 0.12%, the Shenzhen Component Index by 0.11%, and the ChiNext Index by 0.55% [1][2] - The total trading volume for the market reached 1.85 trillion yuan, slightly lower than the previous day, with over 3,100 stocks rising [2] Precious Metals Sector - The precious metals sector saw significant gains, with gold, jewelry, cobalt, and small metal stocks becoming active [5][6] - Notable stocks that hit the daily limit included Haixing Co., Jintong Co., Shengda Resources, and Western Gold, among others [6] - The rise in precious metals was attributed to increased attractiveness due to expectations of a Federal Reserve rate cut, alongside geopolitical risks and trade tensions [7][8] Innovative Pharmaceuticals Sector - The innovative pharmaceutical sector was notably active, with stocks like Maiwei Biotech hitting the daily limit, alongside others such as Baihua Pharmaceutical and First Pharmaceutical [8][9] - Maiwei Biotech announced the approval of its two monoclonal antibody injection products in Pakistan, marking its first overseas registration [13] - The company also entered into a licensing agreement with CALICO LIFESCIENCES LLC, receiving an upfront payment of $25 million and potential milestone payments totaling up to $571 million [13] Stock Performance Highlights - Maiwei Biotech's stock price increased by 20% to 57.60 yuan, with a trading volume of 24.39 million shares [10][11] - Other notable performers in the pharmaceutical sector included Baijia Shenzhou and WuXi AppTec, both seeing significant gains [14]

Market Overview - On September 1, the A-share market experienced fluctuations, with the Shanghai Composite Index rising by 0.12%, the Shenzhen Component Index by 0.11%, and the ChiNext Index by 0.55% [1] - The total trading volume for the market reached 1.85 trillion yuan, slightly lower than the previous day, with over 3,100 stocks rising [1] Key Stocks and Sectors - The top trading stock was Cambrian (688256) with a trading volume of 18.6 billion yuan, followed by Xinyi (300502), Zhongji (300308), and Dongfang Caifu (300059), each exceeding 10 billion yuan in trading volume [1][2] - The precious metals, innovative pharmaceuticals, film and television, tourism, and storage chip sectors saw significant gains, while insurance, military equipment, securities, and airport shipping sectors experienced pullbacks [2] Precious Metals Sector - The precious metals sector surged, with stocks like Haixing (603115), Jintong (601958), and Shengda Resources (000603) hitting the daily limit, while Hunan Gold (002155) and Luoyang Molybdenum (603993) also saw gains [4] - The rise in precious metals is attributed to the recent increase in the U.S. core PCE index, which aligns with expectations for a Federal Reserve rate cut, enhancing the appeal of precious metals as safe-haven assets amid geopolitical risks and trade tensions [4][6] Innovative Pharmaceuticals Sector - The innovative pharmaceutical sector showed strong performance, with Maiwei Bio (688062) hitting the daily limit and other stocks like Baihua Pharmaceutical (600721) and First Pharmaceutical (600833) also experiencing significant gains [7][8] - Maiwei Bio announced the approval of its two biosimilar products in Pakistan, marking a significant milestone as the first biosimilar approved in the country, and has also entered a licensing agreement with Calico Life Sciences for global rights outside Greater China [9] - The recent adjustments in the national medical insurance catalog are expected to increase the attractiveness of innovative drugs, with a focus on new drugs and unique products [9]

【导读】贵金属、创新药引爆行情，迈威生物 20cm 封板 中国基金报记者 晨曦 大家好！ 9 月的第一个交易日，来一起关注上午的市场行情和最新资讯。 9 月 1 日上午， A 股市场反复震荡。截至午间收盘，上证指数涨 0.12% ，深证成指涨 0.11% ，创业板指涨 0.55% 。 | www.bounce 3862.65 | . | was were works 2906.03 | | --- | --- | --- | | 上证指数 +0.12% | 深证成指 +0.11% | 创业板指 +0.55% | 全市场半日成交额为 1.85 万亿元，较上日略有缩量，全市场超 3100 只个股上涨。 成交额方面，寒武纪成交额继续登顶，半日成交额达 186 亿元；新易盛、中际旭创、东方财 富等近期热门股成交额均超过 100 亿元。 | 序号 代码 | 名称 | 现价 涨跌 | 涨跌幅 | 成交额 ▼ | | --- | --- | --- | --- | --- | | = | 688256 寒武纪-U 1447.98 -44.51 | | -2.98% | 186.07亿 | | വ | 300502 新易盛 ...

Core Viewpoint - Maiwei (Shanghai) Biotechnology Co., Ltd. has received acceptance from the National Medical Products Administration (NMPA) for the clinical trial application of 9MW3811 injection for the treatment of pathological scars, marking a significant step in the drug's development process [1][2]. Drug Information - Drug Name: 9MW3811 Injection - Application: Clinical trial registration for domestic production - Acceptance Number: CXSL2500751 - Applicant: Maiwei (Shanghai) Biotechnology Co., Ltd. - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Mechanism and Efficacy - IL-11 is a cytokine that plays a crucial role in chronic inflammation and fibrosis-related diseases, significantly involved in the fibrotic processes of various organs [1]. - 9MW3811 effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, which is critical in the progression of fibrosis-related diseases [1]. - Preclinical studies have shown that 9MW3811 exhibits significant efficacy in models of pulmonary fibrosis and has potential applications in other fibrosis-related diseases [2]. Market Potential - The global patient population for pathological scars is approximately 25 million, with around 7.4 million in China, and the incidence is on the rise, expected to exceed 10 million in China by 2030 [2]. - Targeted therapy against IL-11 presents significant clinical value and market prospects [2]. Development Progress - The company has completed Phase I trials in Australia and China, demonstrating good safety and a half-life exceeding one month, positioning it as a leader in the global development of similar targeted therapies [2]. - The company plans to initiate Phase II clinical trials for pathological scars by the end of 2025, aiming to be among the first IL-11 targeted drugs in this indication [2]. Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC, granting CALICO global rights outside Greater China, with an upfront payment of $25 million and potential milestone payments up to $571 million [3]. - CALICO, a subsidiary of Alphabet, focuses on anti-aging therapies, indicating a broad application potential for 9MW3811 in various fibrotic diseases and aging-related conditions [3][4].

Core Viewpoint - Maiwei Biotech has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scars, marking a significant step in its development pipeline [1][2] Group 1: Product Development - 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, intervening in the pathological progression of fibrotic diseases [1] - Preclinical studies have shown significant efficacy of 9MW3811 in various models, including pulmonary fibrosis, and potential applications in fibrotic diseases such as hypertrophic scars and abnormal uterine bleeding [1] Group 2: Clinical Trials and Market Position - 9MW3811 has been approved globally for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis, with Phase I trials completed in Australia and China showing good safety and a half-life exceeding one month [2] - The company plans to initiate Phase II clinical trials for pathological scars by the end of 2025, positioning itself as one of the first IL-11 targeted drugs to enter clinical stages in this indication [2]

Core Viewpoint - Maiwei Biotech (688062.SH) has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scar indications [1] Company Summary - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, developed independently by Maiwei Biotech, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The mechanism of 9MW3811 involves high-affinity binding to IL-11, effectively inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway, thereby intervening in the pathological progression of fibrotic diseases [1] - Key advantages of 9MW3811 include higher target affinity and signaling blockade capability, as well as a half-life exceeding one month, making it suitable for the treatment of chronic diseases requiring long-term administration [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scar indications [1] Group 1: Product Information - 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 mechanism of 9MW3811 involves high-affinity binding to IL-11, effectively inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway, thereby intervening in the pathological progression of fibrotic diseases [1] Group 2: Competitive Advantages - The product boasts higher target affinity and signaling blockade capability [1] - It has a half-life of over one month, making it suitable for long-term administration in chronic disease treatment [1]

Core Viewpoint - The company, Maiwei Biotech, has received formal acceptance from the National Medical Products Administration for its clinical trial application of 9MW3811 injection for the indication of pathological scars [1] Group 1 - The clinical trial application for 9MW3811 has been officially accepted for Phase II trials [1] - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, developed independently by the company [1] - The product is classified as a Class 1 therapeutic biological product and holds independent intellectual property rights [1]