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乳腺癌治疗新突破,恒瑞医药瑞康曲妥珠单抗新适应证申报上市丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-09-17 23:15
Group 1 - Heng Rui Medicine's subsidiary received a notice from the National Medical Products Administration for the marketing application of SHR-A1811, which is suitable for treating locally advanced or metastatic HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies [1] - The approval process for SHR-A1811 has been prioritized, indicating its potential significance in the breast cancer treatment market, particularly for HER2-positive patients [1] - The unique design of SHR-A1811 and its previous success in lung cancer treatment may provide new options for breast cancer patients and enhance the development of breast cancer therapies [1] Group 2 - Maiwei Biotech signed an exclusive licensing agreement with Kalexo for the 2MW7141 project, which includes potential upfront and milestone payments of up to $1 billion, along with low single-digit royalties [2] - The collaboration is significant as the 2MW7141 project has broad prospects and could fill a market gap, providing new therapies for patients if successful [2] - This partnership is expected to enhance Maiwei Biotech's profitability and international influence, although the high risks associated with biopharmaceutical development and the uncertainty of the $1 billion payment should be noted [2] Group 3 - Kangfang Biotech's AK138D1, a novel antibody-drug conjugate targeting HER3, has received clinical trial approval in China, marking the company's first ADC drug to enter clinical stages [3] - HER3 is a popular target in tumor drug development, with expression or overexpression in various malignancies, including breast, ovarian, lung, colorectal, melanoma, head and neck, cervical, and prostate cancers [3] - The unique design of AK138D1 and its progress in early clinical trials may offer new hope for patients with advanced malignancies and enhance Kangfang Biotech's competitiveness [3] Group 4 - Aikobio has submitted its listing application to the Hong Kong Stock Exchange, with J.P. Morgan and CITIC Securities as joint sponsors, focusing on therapies for respiratory and pediatric diseases [4] - The company has developed a pipeline of six candidate drugs, indicating good progress in its research and development efforts [4] - Although Aikobio has not yet achieved profitability and faces significant R&D costs, a successful listing could provide funding to support commercialization and enhance competitiveness in a competitive market [4]
迈威(上海)生物科技股份有限公司关于与Kalexo签署独家许可协议的公告
Group 1 - The company signed an exclusive licensing agreement with Kalexo Bio, Inc. for the 2MW7141 project, which includes a total potential payment of up to $1 billion, consisting of upfront and milestone payments, as well as low single-digit royalties [2][5][11] - The agreement is expected to positively impact the company's future performance and enhance its profitability [3][11] - The 2MW7141 project is a dual-target small nucleic acid drug in the preclinical stage, aimed at regulating blood lipids and preventing high-risk cardiovascular events [6][7] Group 2 - The licensing agreement allows Kalexo exclusive rights for the global development, production, and commercialization of the licensed product [8] - The agreement includes a one-time, non-refundable upfront payment of $12 million in cash, and the company will also receive a total of double-digit A-round preferred shares from Kalexo under certain conditions [2][8] - The agreement is governed by New York law and interpreted according to California law [9] Group 3 - The company aims to leverage the collaboration with Kalexo to provide innovative treatment options for global patients, enhancing its brand value and international influence [11] - The agreement will not change the company's main business or operational scope and will not affect its independence [11]
最高可获10亿美元,迈威生物签独家许可协议;11连板天普股份明日复牌丨公告精选
迈威生物公告称,公司与Kalexo Bio,Inc.就2MW7141项目相关签署《独家许可协议》及《优先股股权购 买协议》。根据许可协议,迈威生物许可Kalexo在全球范围独家开发、生产和商业化以及其他方式开发 许可产品的权利。交易金额方面,迈威生物将从Kalexo获得最高可达10亿美元的预付款和里程碑付款, 以及低个位数的特许权使用费,其中包括一次性、不可返还的首付款及近端付款1,200万美元现金。作 为对价的一部分,迈威生物将在符合约定条件下另外获得Kalexo总计双位数的A轮优先股。此次交易预 计将对公司未来业绩产生积极影响,有利于提升公司的盈利能力。2MW7141是公司自主研发的一款处 于临床前阶段的双靶点小核酸药物,主要针对血脂异常人群的血脂调控以及高危心血管事件的预防。 恒瑞医药:注射用瑞康曲妥珠单抗新适应症上市申请获受理并纳入优先审评 恒瑞医药公告称,公司子公司苏州盛迪亚生物医药有限公司收到国家药监局下发的《受理通知书》,公 司注射用瑞康曲妥珠单抗(SHR—A1811)用于治疗既往接受过一种或一种以上抗HER2药物治疗的局 部晚期或转移性HER2阳性成人乳腺癌患者的新适应症上市许可申请获国家药监 ...
迈威生物:关于2025年度开展外汇衍生品交易业务的公告
Zheng Quan Ri Bao· 2025-09-17 14:09
Core Viewpoint - The company, Maiwei Biotech, announced plans to engage in foreign exchange derivative trading to mitigate risks associated with foreign exchange market fluctuations, with a total trading limit of up to $50 million or equivalent in other currencies [2] Group 1: Trading Strategy - The company and its subsidiaries intend to use self-owned funds for foreign exchange derivative trading, which includes but is not limited to foreign exchange forwards, swaps, options, and structured forwards [2] - The trading counterparties will be large domestic banks and financial institutions that are approved by regulatory authorities and have a solid credit rating [2] Group 2: Trading Limit and Duration - The total trading limit for foreign exchange derivatives is set at a maximum of $50 million [2] - The validity period for the authorized trading limit is 12 months from the date of approval by the company's board of directors, and the limit can be used in a rolling manner within this timeframe [2]
9月17日重要资讯一览
Group 1: Fiscal Revenue and Budget - In the first eight months of 2025, the national general public budget revenue reached 148198 billion yuan, showing a year-on-year growth of 0.3% [1] - Tax revenue amounted to 121085 billion yuan, with a slight increase of 0.02% year-on-year, while non-tax revenue was 27113 billion yuan, growing by 1.5% [1] - Central government budget revenue was 64268 billion yuan, reflecting a year-on-year decline of 1.7%, whereas local government budget revenue was 83930 billion yuan, increasing by 1.8% [1] Group 2: Smart Connected Vehicles - The Ministry of Industry and Information Technology is soliciting public opinions on mandatory national standards for smart connected vehicle combination driving assistance systems [2] - The proposed standards aim to establish a safety baseline for smart connected vehicle products, requiring systems to activate only under designed operating conditions [2] - The standards include comprehensive safety technical requirements covering human-machine interaction, functional safety, information security, and data recording, creating a "triple safety guarantee" [2] Group 3: Service Consumption Policies - The Ministry of Commerce plans to introduce a series of specialized documents to promote high-quality development in the accommodation industry and the integration of railways and tourism [3] - Over 30 policies have already been implemented to establish a "1+N" policy system for service consumption [3] Group 4: Financial Support for Consumption - The People's Bank of China is actively supporting qualified financial institutions to issue financial bonds and credit asset-backed securities to enhance consumer credit supply capacity [4] - From January to July this year, automotive financial companies issued financial bonds totaling 215 billion yuan and credit asset-backed securities amounting to 484 billion yuan [4] Group 5: Corporate News - Shanghai Construction Group reported that its gold business revenue constitutes a low proportion of total operating income [6] - NIO received an investment of 1.16 billion USD [6] - New materials company plans to reduce its stake by no more than 2% [6] - Huazhu Group intends to invest up to 10 billion yuan in financial products [6] - Several companies, including Maimai Bio and Xinyuan Technology, are involved in significant partnerships and developments [6]
迈威生物:关于与Kalexo签署独家许可协议的公告
Zheng Quan Ri Bao· 2025-09-17 13:36
证券日报网讯 9月17日晚间,迈威生物发布公告称,公司与KalexoBio,Inc.公司(简称"Kalexo")就 2MW7141项目相关(简称"许可产品")签署《独家许可协议》(简称"许可协议")及《优先股股权购 买协议》(简称"股权购买协议")。根据许可协议和股权购买协议,迈威生物许可Kalexo就2MW7141 项目相关在全球范围的独家开发、生产和商业化以及其他方式开发许可产品的权利。交易金额:迈威生 物将从Kalexo获得最高可达10亿美元的预付款和里程碑付款,以及低个位数的特许权使用费,其中包括 一次性、不可返还的首付款及近端付款1,200万美元现金,作为对价的一部分,迈威生物将在符合约定 条件下另外获得Kalexo总计双位数的A轮优先股。根据有关规定,公司本次交易事项已经第二届董事会 第二十二次会议审议通过,无需提交股东大会审议。 (文章来源:证券日报) ...
迈威生物与Kalexo签署独家许可协议 最高可获10亿美元预付款和里程碑付款
Zhi Tong Cai Jing· 2025-09-17 12:56
迈威生物(688062.SH)发布公告,公司与Kalexo Bio,Inc.公司(以下简称"Kalexo")就2MW7141项目相关(以 下简称"许可产品")签署《独家许可协议》(以下简称"许可协议")及《优先股股权购买协议》。 根据许可协议和股权购买协议,迈威生物许可Kalexo就2MW7141项目相关在全球范围的独家开发、生 产和商业化以及其他方式开发许可产品的权利。交易金额:迈威生物将从Kalexo获得最高可达10亿美元 的预付款和里程碑付款,以及低个位数的特许权使用费,其中包括一次性、不可返还的首付款及近端付 款1,200万美元现金,作为对价的一部分,迈威生物将在符合约定条件下另外获得Kalexo总计双位数的A 轮优先股。 ...
迈威生物(688062.SH)与Kalexo签署独家许可协议 最高可获10亿美元预付款和里程碑付款
智通财经网· 2025-09-17 12:55
根据许可协议和股权购买协议,迈威生物许可Kalexo就2MW7141项目相关在全球范围的独家开发、生 产和商业化以及其他方式开发许可产品的权利。交易金额:迈威生物将从Kalexo获得最高可达10亿美元 的预付款和里程碑付款,以及低个位数的特许权使用费,其中包括一次性、不可返还的首付款及近端付 款 1,200 万美元现金,作为对价的一部分,迈威生物将在符合约定条件下另外获得 Kalexo 总计双位数 的A轮优先股。 智通财经APP讯,迈威生物(688062.SH)发布公告,公司与Kalexo Bio, Inc.公司(以下简称"Kalexo")就 2MW7141项目相关(以下简称"许可产品")签署《独家许可协议》(以下简称"许可协议")及《优先股股权 购买协议》。 ...
迈威生物与Kalexo就2MW7141项目签署独家许可协议
Bei Jing Shang Bao· 2025-09-17 11:57
公告显示,根据许可协议和股权购买协议,迈威生物许可Kalexo就2MW7141项目相关在全球范围的独 家开发、生产和商业化以及其他方式开发许可产品的权利。迈威生物将从Kalexo获得最高可达10亿美元 的预付款和里程碑付款,以及低个位数的特许权使用费,其中包括一次性、不可返还的首付款及近端付 款1200万美元现金,作为对价的一部分,迈威生物将在符合约定条件下另外获得Kalexo总计双位数的A 轮优先股。 北京商报讯(记者 丁宁)9月17日晚间,迈威生物(688062)发布公告称,公司与Kalexo Bio, Inc.公司 (以下简称"Kalexo")就2MW7141项目相关签署《独家许可协议》及《优先股股权购买协议》。 ...
A股公告精选 | 超10亿美元!迈威生物(688062.SH)心血管领域创新药出海
智通财经网· 2025-09-17 11:56
Group 1 - Ping An Insurance has completed the purchase of 74.615 million H-shares through the secondary market as part of its 2025 long-term service plan, accounting for 0.412% of the total share capital, with a total transaction amount of 3.875 billion yuan and an average transaction price of approximately 51.87 yuan per share [1] - The plan involves 83,024 core talents voluntarily participating, with board members, supervisors, and senior management holding 2.52% of the shares, while other employees hold 97.48% [1] Group 2 - Maiwei Biotech has signed an exclusive licensing agreement with Kalexo for the 2MW7141 project, which could yield up to 1 billion USD in upfront and milestone payments, along with low single-digit royalties [2] - The agreement includes a non-refundable upfront payment of 12 million USD and potential equity in Kalexo, with the 2MW7141 drug targeting lipid regulation and prevention of high-risk cardiovascular events [2] Group 3 - Pingzhi Information has been selected as a candidate for a 169.92 million yuan AI computing power technology service project, currently in the candidate public announcement period [3] - The company has disclosed four instances of bidding or pre-bidding for computing power projects in 2025, totaling 362 million yuan in signed contracts [3] Group 4 - Tianpu Co. announced that its stock will resume trading on September 18, 2025, after a period of significant price increase, with uncertainties regarding the change in control of the company [4] - The company has not identified any need for corrections or supplements to previously disclosed information [4] Group 5 - Haoshi Electromechanical announced that director Xiao Yonglin plans to reduce his holdings by up to 290,000 shares, representing 0.09% of the total share capital, for personal financial arrangements [5] - The reduction will be conducted through centralized bidding or block trading, with the price determined by market conditions [5] Group 6 - Xingye Technology has signed a strategic cooperation agreement with Suzhou Nengda to jointly develop flexible electronic skin based on natural leather and bio-based materials [6][7] - The collaboration aims to combine sensor technology with natural and environmentally friendly materials for applications in various emerging industries [6][7] Group 7 - Zhiming Technology is planning a change in control, leading to a temporary suspension of its stock trading starting September 18, 2025, to ensure fair information disclosure [8] - The suspension is expected to last no more than two trading days [8] Group 8 - Zhifei Biological has received approval to conduct clinical trials for its CA111 injection in overweight or obese adults, which is a dual agonist targeting GIP and GLP-1 receptors [9] - The drug has significant market potential in diabetes and weight management [9] Group 9 - Huahai Pharmaceutical's subsidiary has received FDA approval to conduct Phase I clinical trials for HB0043, a bispecific antibody for treating autoimmune diseases [10] - The drug represents a breakthrough in targeting IL-17A and IL-36R, with significant investment already made in its development [10] Group 10 - Top Group's actual controllers have terminated their share reduction plan early, having collectively reduced 3.4936 million shares, or 0.2010% of total shares [11] - The reduction was primarily due to personal funding needs being met [11] Group 11 - Heng Rui Pharmaceutical's injection for breast cancer treatment has had its new indication application accepted and prioritized for review by the National Medical Products Administration [12] - The drug is already approved for use in other cancer treatments, indicating its expanding therapeutic applications [12] Group 12 - China Resources Sanjiu plans to invest up to 10 billion yuan of its own funds in bank wealth management products, with funds being available for rolling use [13] Group 13 - Anke Biotechnology's affiliate has received approval for a key Phase II clinical trial for PA3-17 injection, the first CAR-T cell therapy targeting CD7 to gain such approval [14] - This product is aimed at treating adult relapsed and refractory CD7-positive hematological malignancies [14] Group 14 - Xinhang New Materials' controlling shareholder plans to reduce holdings by up to 2% of the company's shares, totaling approximately 3.4976 million shares [15] Group 15 - Changchun High-tech has reached a cooperation agreement with Denmark's ALK-Abelló A/S for the development and commercialization of allergen-specific immunotherapy products in China [16][17] - The collaboration includes exclusive rights to three products developed by ALK, enhancing the company's portfolio in allergy treatment [16][17]