来源：第一财经 迈威生物公告，公司近日收到合作客户The Searle Company Limited的通知，公司两款地舒单抗注射液 9MW0311和9MW0321（国内商品名：迈利舒®和迈卫健®）已获得巴基斯坦药品监管局的注册批准。 这是巴基斯坦药品监管局首次批准的地舒单抗生物类似药，也是公司首个获得海外注册批件的产品。 (本文来自第一财经) ...

Core Viewpoint - Maiwei Biotech (688062) has received regulatory approval for two biosimilar products in Pakistan, marking a significant milestone for the company and the biosimilar market in the region [1] Group 1: Regulatory Approvals - The Searle Company Limited has notified Maiwei Biotech that its two biosimilar injections, 9MW0311 and 9MW0321, have been approved by the Pakistan Drug Regulatory Authority [1] - This approval represents the first registration of a biosimilar drug for de-sulfanil in Pakistan [1] - The products are marketed under the names Mai Li Shu and Mai Wei Jian in China [1] Group 2: Clinical Trials - Maiwei Biotech has also received an acceptance notice from the National Medical Products Administration for the Phase II clinical trial application of 9MW3811 injection, which is intended for the treatment of pathological scars [1]

Core Viewpoint - The company has re-submitted its application for issuing H-shares and listing on the Hong Kong Stock Exchange on August 29, 2025, indicating a strategic move to access international capital markets [1] Group 1 - The application materials were prepared and published in accordance with the requirements of the Hong Kong Securities and Futures Commission and the Hong Kong Stock Exchange [1] - The submitted documents are in draft form and may be updated and revised as necessary [1] - If the issuance is implemented, the target investors will be limited to qualified foreign investors and domestic qualified investors who are authorized to conduct overseas securities investments under Chinese laws and regulations [1]

迈威生物公告，近日收到国家药品监督管理局签发的《受理通知书》，9MW3811注射液用于病理性瘢 痕适应症的II期临床试验申请已获正式受理。9MW3811是迈威生物自主研发的一款靶向人IL-11的人源 化单克隆抗体，拥有自主知识产权。临床前研究表明，9MW3811在肺纤维化等多种模型中展现出显著 疗效，并在瘢痕增生、子宫内膜异常出血等纤维化相关疾病中显示出潜在应用价值。公司计划于2025年 底启动其用于病理性瘢痕的II期临床试验，成为该适应症领域首批进入临床阶段的IL-11靶向药物。 ...

Core Viewpoint - The company has received regulatory approval for two biosimilar products in Pakistan, marking a significant milestone in its international expansion efforts [1] Group 1: Product Approval - The Searle Company Limited has notified the company that its two biosimilar injections, 9MW0311 and 9MW0321, have been approved by the Drug Regulatory Authority of Pakistan (DRAP) [1] - This approval represents the first registration of a biosimilar drug for denosumab by the DRAP [1] - The products are the company's first to receive overseas registration, indicating a successful entry into the international market [1] Group 2: Product Details - 9MW0311, marketed as "迈利舒" in China, is indicated for osteoporosis in postmenopausal women at high risk of fractures [1] - 9MW0321, marketed as "迈卫健" in China, is used for the treatment of giant cell tumor of bone (GCTB) that cannot be surgically removed or where surgery may lead to severe functional impairment [1]

Core Viewpoint - The financial performance of Maiwei Biotech (688062) for the first half of 2025 shows significant declines in revenue and net profit, indicating ongoing challenges in its business operations and financial health [1][5]. Financial Performance Summary - Total revenue for the first half of 2025 was 101 million yuan, a decrease of 12.43% year-on-year [1]. - Net profit attributable to shareholders was -551 million yuan, reflecting a 23.9% decline compared to the previous year [1]. - The gross margin decreased to 78.7%, down 16.86% year-on-year, while the net margin was -545.87%, a drop of 41.32% [1]. - Total expenses (selling, administrative, and financial) amounted to 254 million yuan, representing 250.6% of revenue, an increase of 22.08% year-on-year [1]. - Earnings per share were -1.38 yuan, a decrease of 24.32% year-on-year [1]. Cash Flow and Debt Analysis - The net cash flow from operating activities showed a significant improvement, increasing by 92.65% due to a large upfront payment received from Qilu Pharmaceutical [6]. - The company’s cash and cash equivalents decreased by 17.93% to 1.391 billion yuan [1]. - Interest-bearing liabilities increased by 19.34% to 2.237 billion yuan [1]. Investment and R&D Activities - Research and development expenses rose by 21.72%, indicating a continued focus on advancing clinical trials for various projects [6]. - The company has made significant investments in long-term equity, with a 97.73% increase attributed to new investments in Zhilian Health and Sinusai [3]. Business Model and Strategic Partnerships - The company relies heavily on a research-driven business model, necessitating careful examination of the underlying drivers of this approach [10]. - A strategic partnership with Calico Life Sciences has been established to advance the development of MW38, a monoclonal antibody targeting IL-11, aligning with the company's focus on age-related diseases [13][14]. Market Position and Fund Holdings - The largest fund holding in Maiwei Biotech is the Chuangjin Hexin Healthcare Stock A, with a current scale of 197 million yuan and a recent net value increase of 1.8% [12]. - The company has faced challenges in achieving positive returns on invested capital, with a historical median ROIC of -44.51% since its listing [9].

Core Viewpoint - Maiwei Biotech (688062.SH) reported a significant increase in revenue driven by drug sales, despite a substantial net loss for the period [1] Financial Performance - The company achieved operating revenue of 101.17 million yuan, primarily from drug sales amounting to 100.79 million yuan, representing a 53.50% increase compared to the same period last year [1] - The net profit attributable to shareholders was a loss of 551 million yuan [1] Research and Development - In the first half of 2025, the company's R&D investment reached 392.09 million yuan, which is a 21.72% increase compared to the first half of 2024 [1] - The high R&D expenses are attributed to the advancement of multiple clinical trials, particularly key registration clinical studies [1]

Core Viewpoint - Maiwei Biotech reported a decline in revenue and significant losses in the first half of 2025, despite a notable increase in stock price and market interest due to business development (BD) activities and the approval of its first self-developed innovative drug [1][2]. Financial Performance - The company achieved revenue of 101 million yuan in the first half of 2025, a year-on-year decrease of 12.43% [1]. - The net profit attributable to shareholders was -552 million yuan, indicating a larger loss compared to the previous year [1]. - The stock price reached a historical high of 50.36 yuan per share on August 29, 2025, with a year-to-date increase of over 137% [1]. Business Development Activities - Maiwei Biotech's first self-developed innovative drug, Mai Li Sheng (generic name: injection of Agrelistat α), was approved in May 2025, marking a shift from biosimilars to innovative drugs [2]. - The company entered into a BD collaboration with Qilu Pharmaceutical for the commercialization of Mai Li Sheng, potentially earning up to 500 million yuan in upfront and milestone payments [2]. - The company also licensed IL-11 targeted therapy rights to CALICO for regions outside China, with similar financial arrangements [2]. Product Pipeline and Challenges - The company has a total of 14 key products in various stages, including 10 innovative drugs and 4 biosimilars [5]. - The sales revenue of two biosimilars, including Dushuang (generic name: Dexamethasone), increased by 51.59% year-on-year, contributing significantly to the company's revenue [1]. - However, the company faces commercialization challenges, such as a 66.61% decrease in the shipment volume of Junmai Kang (generic name: Adalimumab) due to production capacity issues [2]. Research and Development Investment - The company reported R&D expenses of 392 million yuan in the first half of 2025, a year-on-year increase of 21.72%, accounting for 38% of its operating revenue [4]. - The increase in losses is attributed to substantial investments in clinical trials for multiple in-development products [4]. Market Position and Future Outlook - The ADC (antibody-drug conjugate) sector is a key focus for the company, with ongoing BD activities for three ADC drugs [5]. - The company plans to enhance its BD pipeline with new generation TCE (T-cell engager) platforms starting in 2026, indicating a strategic shift to maintain competitiveness in a crowded market [5].

Core Viewpoint - The company, Maiwei Biotech, reported a significant decline in revenue and an increase in net losses for the first half of 2025, while also achieving notable milestones in business development (BD) partnerships and product approvals [1][4][6]. Financial Performance - In the first half of 2025, the company achieved revenue of 101 million yuan, a year-on-year decrease of 12.43%, and a net profit attributable to shareholders of -552 million yuan, with losses widening compared to the same period last year [1]. - The company's stock price reached a historical high of 50.36 yuan per share on August 29, 2023, with a year-to-date increase of over 137% [2]. Product Development and Approvals - The company has maintained a rhythm of approving one product annually since its listing on the STAR Market in 2022, with three products approved from 2022 to 2024, all of which are biosimilars [3]. - The first self-developed innovative drug, Mai Li Sheng (generic name: injection of Agrelin α), was approved in May 2023, marking a key step in the company's transition from biosimilars to innovative drugs [4][5]. Business Development Partnerships - The company has entered into significant BD collaborations, including a partnership with Qilu Pharmaceutical for the commercialization of Mai Li Sheng, which could yield up to 500 million yuan in milestone payments [4]. - Additionally, a licensing agreement with Calico for the IL-11 targeted therapy could result in up to 571 million USD in milestone payments and royalties based on net sales [5]. Research and Development Focus - The company has reported a cumulative loss of over 5.72 billion yuan over the past eight years, with R&D expenses in the first half of 2025 reaching 392 million yuan, an increase of 21.72% year-on-year, accounting for 388% of its revenue [8]. - The company is advancing multiple BD initiatives, emphasizing that 2025 will be a critical year for its innovative drug BD business [6]. Market Challenges - The company faces commercialization challenges for its biosimilars, with significant declines in expected shipments due to production capacity issues and market competition [4]. - The ADC (antibody-drug conjugate) sector is becoming increasingly competitive, prompting the company to explore new pipeline developments to maintain its market position [10].

Core Viewpoint - Mabwell (Shanghai) Bioscience Co., Ltd. is a biotechnology company focused on innovative drug development, with significant ongoing research and development (R&D) investments, but it is currently not profitable and faces potential risks related to its financial sustainability and operational challenges [1][2][3]. Company Overview - Mabwell has 14 key products in various stages of development, including 10 innovative drugs and 4 biosimilars, primarily targeting oncology and age-related diseases [1]. - The company reported R&D expenditures of 392.09 million yuan in the first half of 2025, a 21.72% increase compared to the same period last year [1]. Financial Performance - For the first half of 2025, the company generated operating revenue of approximately 101.17 million yuan, a decrease of 12.43% from the previous year [9]. - The total profit for the period was a loss of approximately 552.18 million yuan, compared to a loss of 444.34 million yuan in the same period last year [9]. - The net assets attributable to shareholders decreased by 47.86% to approximately 818.07 million yuan compared to the end of the previous year [9]. Industry Context - The global pharmaceutical market is expected to grow significantly, driven by factors such as aging populations, rising chronic disease rates, and increased R&D spending [11]. - The Chinese pharmaceutical market is projected to expand from 1.63 trillion yuan in 2024 to 2.48 trillion yuan by 2032, with a compound annual growth rate (CAGR) of 7.3% [11]. - The oncology drug market is also experiencing rapid growth, with the global market expected to reach approximately 375.9 billion USD by 2028 [13][14]. Regulatory Environment - Recent reforms in China's drug approval processes are aimed at accelerating the development and approval of innovative drugs, which may benefit companies like Mabwell [11]. - The introduction of national centralized procurement for biosimilars may pose challenges to profitability but could also increase market share for these products in the long term [12].