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迈威生物-U(688062):BD持续兑现 创新管线快速推进
Xin Lang Cai Jing· 2025-11-01 00:38
Core Insights - The company reported a significant revenue increase of 301% year-on-year, reaching 566 million yuan, while the net profit attributable to shareholders was -598 million yuan [1] - The revenue growth was primarily driven by substantial income recognition from licensing agreements with Qilu Pharmaceutical and DISC MEDICINE, INC, along with increased drug sales compared to the previous year [1] Group 1: Licensing Agreements - The company granted Qilu Pharmaceutical rights for the development, production, and commercialization of the long-acting white blood cell booster injection, receiving an upfront payment of 380 million yuan [1] - An exclusive license for the IL-11 monoclonal antibody 9MW3811 was granted to CALICO LIFE SCIENCES LLC for all regions outside Greater China, with an upfront payment of 25 million USD [1] - The company also licensed the dual-target small nucleic acid drug 2MW7141 to Kalexo Bio, Inc. for global exclusive rights, receiving an upfront payment of 12 million USD [1] Group 2: Clinical Development Pipeline - The core product NECTIN-4 ADC 9MW2821 is currently undergoing three pivotal Phase 3 clinical trials in China, targeting various cancer treatments [2] - The ST2 monoclonal antibody 9MW1911 is advancing rapidly in Phase 2 clinical trials, with plans to initiate Phase 3 trials by the end of 2026 [2] - The TMPRSS6 monoclonal antibody 9MW3011 completed its first patient dosing in a Phase 2 clinical trial for PV patients in September 2025 [2] - The IL-11 monoclonal antibody 9MW3811 has had its Phase 2 clinical trial application accepted by the National Medical Products Administration, with a potential start by the end of 2025 [2] Group 3: Financial Projections - Revenue projections for the company are estimated at 886 million yuan, 1.145 billion yuan, and 2.285 billion yuan for 2025, 2026, and 2027 respectively [3] - Net profit projections are expected to be -676 million yuan, -618 million yuan, and -173 million yuan for the same years [3] - The company maintains a "Buy-A" investment rating, with a 6-month target price set at 54.40 yuan based on DCF modeling [3]
迈威生物(688062):BD持续兑现,创新管线快速推进
Guotou Securities· 2025-10-31 13:39
Investment Rating - The report maintains a "Buy-A" investment rating for the company, with a 6-month target price of 54.40 CNY [5][4]. Core Insights - The company reported a revenue of 566 million CNY for Q3 2025, representing a year-on-year growth of 301%. However, it recorded a net profit loss of 598 million CNY [1]. - The significant revenue growth is attributed to substantial income from licensing agreements with Qilu Pharmaceutical and DISC MEDICINE, INC, as well as increased drug sales compared to the previous year [1][2]. - The company has made progress in its innovative drug pipeline, with multiple products licensed and ongoing clinical trials for key products [2][3]. Financial Projections - Revenue projections for 2025, 2026, and 2027 are estimated at 886 million CNY, 1.145 billion CNY, and 2.285 billion CNY, respectively. Net profits are projected to be -676 million CNY, -618 million CNY, and -173 million CNY for the same years [4][11]. - The expected earnings per share (EPS) for 2025, 2026, and 2027 are -1.69 CNY, -1.55 CNY, and -0.43 CNY, respectively [4][11]. Clinical Development - The company is advancing its core product NECTIN-4 ADC (9MW2821) through three critical Phase III clinical trials in China and has initiated patient dosing in the U.S. for a clinical trial involving ADC in triple-negative breast cancer [3]. - Other products, such as ST2 monoclonal antibody (9MW1911) and IL-11 monoclonal antibody (9MW3811), are also progressing through clinical trials, with expectations for further advancements by the end of 2025 [3]. Market Performance - As of October 30, 2025, the company's stock price was 42.27 CNY, with a total market capitalization of approximately 16.89 billion CNY [5][6]. - The stock has shown a relative return of -15.4% over the past month, but a positive return of 63.5% over the past year [6].
首付款将达5亿元 迈威生物与齐鲁制药就注射用阿格司亭α达成合作
Quan Jing Wang· 2025-08-06 01:17
Core Viewpoint - The collaboration between Maiwei Biotech's subsidiary Taikang Biotech and Qilu Pharmaceutical has garnered significant attention, focusing on the licensing agreement for the injectable drug Agrelistat α (brand name: Maili Sheng®) [1] Group 1: Collaboration Details - The licensing agreement grants Maiwei Biotech exclusive rights for Qilu Pharmaceutical to develop, produce, improve, utilize, and commercialize the licensed product in Greater China, including mainland China, Hong Kong, Macau, and Taiwan [1] - Taikang Biotech is set to receive a total of up to 500 million RMB in upfront and milestone payments, along with royalties of up to double-digit percentages of net sales from the licensed product [1] Group 2: Product Information - Agrelistat α is a recombinant human serum albumin-granulocyte colony-stimulating factor (G-CSF) fusion protein, designed to reduce the incidence of infections in adult patients with non-myeloid malignancies undergoing chemotherapy that may cause febrile neutropenia [1] - This product represents a new generation of long-acting G-CSF with independent intellectual property rights, utilizing gene fusion technology to combine high-activity modified G-CSF with human serum albumin (HSA) [2] - The fusion with HSA increases molecular weight and significantly inhibits the clearance pathway mediated by G-CSF receptors, thereby extending the drug's half-life and reducing dosing frequency, which enhances treatment compliance [2] - HSA, being a natural component of human blood, provides a high level of safety as a carrier protein, and the product is produced using a Pichia pastoris expression system, simplifying the manufacturing process compared to chemically modified long-acting products [2]
迈威生物携手齐鲁制药,引领生物医药行业“研发+商业化”新趋势
Core Viewpoint - The collaboration between Maiwei Biopharma and Qilu Pharmaceutical reflects a new trend in the biopharmaceutical industry, where innovative drug companies focus on R&D while traditional pharmaceutical companies handle commercialization through technology licensing [1][2] Company Summary - Maiwei Biopharma has signed a technology licensing agreement with Qilu Pharmaceutical for the injectable drug Aggrastat α (trade name: Mai Li Sheng), granting exclusive rights for development, production, improvement, utilization, and commercialization in Greater China [1] - The agreement includes an upfront payment and milestone payments totaling up to 500 million RMB, along with royalties based on net sales of the licensed product [1] Product Summary - Aggrastat α is a recombinant human serum albumin-granulocyte colony-stimulating factor (G-CSF) fusion protein, designed to reduce the incidence of infections in adult patients undergoing chemotherapy that causes febrile neutropenia [1][2] - This product is the first approved drug in China utilizing albumin fusion technology, which enhances the drug's half-life and reduces dosing frequency, thereby improving patient compliance [2] - The production process utilizes a Pichia pastoris expression system, simplifying manufacturing and improving product uniformity compared to chemically modified long-acting products [2] Industry Trend - The partnership exemplifies a model that allows innovative drugs to reach patients more quickly and cost-effectively, contributing to a biopharmaceutical ecosystem characterized by specialized R&D, large-scale production, and refined commercialization [2]
交易总金额最高超47亿元,迈威生物官宣两项许可协议,均聚焦肿瘤领域药物
Mei Ri Jing Ji Xin Wen· 2025-06-27 15:06
Core Viewpoint - Recently, Maiwei Biotech announced two significant licensing agreements, potentially exceeding a total value of 4.7 billion RMB, which could enhance the company's operational strength and support its long-term development strategy [2][3][5]. Group 1: Licensing Agreements - Maiwei Biotech signed an exclusive licensing agreement with CALICO, a subsidiary of Alphabet, for the IL-11 targeted therapy, which includes the product 9MW3811. The agreement allows CALICO to develop, produce, and commercialize the product outside of China [3][4]. - The agreement with CALICO includes an upfront payment of 25 million USD (approximately 250 million RMB) and potential milestone payments totaling up to 571 million USD (approximately 4.095 billion RMB), along with royalties based on net sales [3][4]. - The second agreement with Qilu Pharmaceutical involves the product 8MW0511, which is an injectable drug for treating febrile neutropenia in cancer patients. This agreement includes an upfront payment of 3.8 billion RMB and potential sales milestone payments, as well as royalties based on net sales [4][6]. Group 2: Company Background and Financials - Founded in 2017, Maiwei Biotech focuses on the research, production, and sales of innovative drugs and biosimilars, primarily in oncology and other therapeutic areas [3][6]. - As of the end of 2024, the company has three products on the market but has not yet achieved profitability, with accumulated losses [3][6]. - In Q1 2025, the company reported revenue of 44.79 million RMB, a year-on-year decline of 33.7%, and a net loss of 292 million RMB, indicating an increase in losses due to high R&D expenditures [7]. - The company is preparing for an IPO on the Hong Kong Stock Exchange to alleviate financial pressures and enhance its international presence [7].
迈威生物: 迈威生物第二届董事会第十九次会议决议公告
Zheng Quan Zhi Xing· 2025-06-26 16:51
Group 1 - The board of directors of Maiwei (Shanghai) Biotechnology Co., Ltd. held its 19th meeting of the second session on June 26, 2025, with all 9 directors present, ensuring compliance with legal and regulatory requirements [1][2]. - The board approved a share repurchase plan via centralized bidding, aimed at enhancing investor confidence and promoting the stock price's return to its intrinsic value [1][2]. - The board also approved an exclusive licensing agreement with CALICO LIFE SCIENCES LLC, which aligns with the company's strategic development goals and is expected to positively impact its ongoing operations [2][3]. Group 2 - The board approved a technical licensing agreement for the new drug project involving injectable Agrestin α, which is expected to leverage mutual strengths and resources between the company and its partner, promoting long-term development [3]. - The board agreed to convene the company's first extraordinary general meeting of 2025 for further deliberation on the approved proposals [3].
迈威生物:与齐鲁制药就注射用阿格司亭α签署新药项目技术许可协议
news flash· 2025-06-26 13:29
Core Viewpoint - Maiwei Biotech has signed a new drug project technology licensing agreement with Qilu Pharmaceutical for the injectable drug Agresten α, which includes exclusive rights for development, production, improvement, utilization, and commercialization in Greater China [1] Group 1: Licensing Agreement Details - The agreement grants Maiwei Biotech exclusive licensing rights for Agresten α in Greater China, which encompasses mainland China, Hong Kong, Macau, and Taiwan [1] - The total payment and sales milestones can reach up to 500 million RMB, including a non-refundable upfront payment of 380 million RMB [1] - The licensing agreement also includes royalties based on net sales of the licensed product, which can reach a maximum of double-digit percentages [1] Group 2: Product Information - Agresten α, also known as Mai Li Sheng®, is a next-generation long-acting G-CSF (Granulocyte Colony-Stimulating Factor) developed by Maiwei Biotech [1] - The product utilizes gene fusion technology to combine high-activity modified G-CSF with human serum albumin (HSA) [1] - It is noted as the first drug in China approved for marketing that employs albumin long-acting fusion technology [1]
今年以来江苏获批7款国产1类创新药
Xin Hua Ri Bao· 2025-06-10 20:51
Core Viewpoint - The National Medical Products Administration has approved 11 innovative drugs for market launch, with 5 of them coming from Jiangsu province, indicating a strong focus on promoting local pharmaceutical innovation [1][2]. Group 1: Approved Innovative Drugs - Jiangsu province has received approval for 7 domestic Class 1 innovative drugs this year, with the latest batch including 5 drugs from Suzhou (3), Lianyungang (1), and Taizhou (1) [1]. - The approved drugs include: - Injection of Rukang Qumai (瑞康曲妥珠单抗) for treating HER2 mutated non-small cell lung cancer (NSCLC) patients [1]. - Hydrochloride of Jikaxitini tablets for patients with primary myelofibrosis and related conditions [1]. - Injection of Zenidatuzumab for HER2 high-expressing cholangiocarcinoma patients who have received prior systemic therapy [1]. - Malic acid of Famitinib capsules for recurrent or metastatic cervical cancer patients who failed platinum-based chemotherapy [2]. - Injection of Agrestin α for adult patients undergoing chemotherapy that may cause febrile neutropenia [2]. Group 2: Regulatory and Supportive Measures - The Jiangsu Provincial Drug Administration is implementing comprehensive reforms to enhance the pharmaceutical and medical device regulatory environment, aiming to create a high-quality development policy landscape [2][3]. - The administration has established a service mechanism to support innovative drug development, focusing on personalized guidance throughout the clinical trial and approval processes [2][3]. - Ongoing efforts include building a competitive strategic emerging industry cluster and promoting open innovation across the entire biopharmaceutical industry chain [3].
医药生物行业周报:创新药密集上市,关注后续医保谈判
Donghai Securities· 2025-06-03 09:43
Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [2][37]. Core Insights - The pharmaceutical and biotechnology sector saw an overall increase of 2.21% in the week from May 26 to May 30, ranking second among 31 industries in the Shenwan index and outperforming the CSI 300 index by 3.29 percentage points. Year-to-date, the sector has risen by 6.61%, ranking sixth among the 31 industries and outperforming the CSI 300 index by 9.02 percentage points [4][13][15]. - The current PE valuation for the pharmaceutical and biotechnology sector is 27.98 times, which is at the historical median level, with a valuation premium of 137% compared to the CSI 300 index. The top three sub-sectors in terms of growth are chemical pharmaceuticals, biological products, and medical services, with increases of 3.83%, 3.14%, and 2.46% respectively [4][22][15]. - A total of 373 stocks (77.9%) in the sector rose last week, while 97 stocks (20.3%) declined. The top five gainers were Shuyou Shen (60.41%), Huason Pharmaceutical (41.97%), Changshan Pharmaceutical (35.91%), Huana Pharmaceutical (32.62%), and Yifang Biological (30.51%) [4][27]. Market Performance - The pharmaceutical and biotechnology sector's performance is highlighted by the approval of 11 innovative drugs by the National Medical Products Administration (NMPA) on May 29, which enhances treatment options for patients and showcases the increasing innovation capability of China's pharmaceutical industry [5][29]. - The 2025 American Society of Clinical Oncology (ASCO) annual meeting showcased several domestic innovative drug projects, indicating that local companies are gaining international recognition for their innovative capabilities [5][32]. Investment Recommendations - The report suggests focusing on the innovative drug sector as it is the most certain and leading sub-sector within the pharmaceutical and biotechnology industry. Additionally, it recommends exploring investment opportunities in medical devices, traditional Chinese medicine, chain pharmacies, and medical services [6][35]. - Recommended stocks include Beida Pharmaceutical, Te Bao Biological, Qianhong Pharmaceutical, Ling Rui Pharmaceutical, and Lao Bai Xing. Stocks to watch include Kelong Pharmaceutical, Rongchang Biological, Kaili Medical, Huaxia Eye Hospital, and Baipu Sais [6][35].
多只银行股尾盘突然跳水,社保持仓医药股曝光(附股)
Market Overview - The last trading day before the Dragon Boat Festival saw a volume contraction in the two markets, with the pharmaceutical sector experiencing a broad rally, particularly in Alzheimer's, innovative drugs, and CROs [1] - Several stocks, including Ruizi Pharmaceutical, Wanbangde, and Hainan Haiyao, hit the daily limit up [1] - The pork and chicken sectors also saw a rise, while bank stocks remained active, with Hangzhou Bank and Chengdu Bank reaching new historical highs [1] Banking Sector - Despite the strong performance of bank stocks, a sell-off occurred in multiple bank stocks towards the end of the trading session, indicating a potential profit-taking behavior ahead of the holiday [8] - Regional banks like Hangzhou Bank and Chengdu Bank attracted end-of-day funds due to their earnings elasticity, but this was not enough to offset the selling pressure from larger state-owned banks [8] - The banking sector has been a focus for investors this year, driven by increasing risk aversion, and is expected to remain a key market theme post-holiday [8] Pharmaceutical Sector - On May 29, the National Medical Products Administration approved 11 innovative drugs for market entry, a notably rare occurrence [10] - Among these, five were from innovative companies listed on the Sci-Tech Innovation Board, indicating a supportive policy environment for the innovative drug sector [10] - The current valuation of the innovative drug industry stands at a price-to-earnings ratio (TTM) of 27.74, with a 150% premium over the CSI 300 index, suggesting a stable growth outlook despite recent net outflows from the sector [10] Social Security Fund Holdings - A summary of the latest holdings by the Social Security Fund highlights several pharmaceutical stocks, including Wo Wu Biological, Jiuzhou Pharmaceutical, and others, with varying market capitalizations and price-to-earnings ratios [12] - The data indicates a focus on companies with strong growth potential and established market positions within the pharmaceutical sector [12]