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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]
一颗“新药”引爆板块!港股创新药主题ETF“蹦极”
Di Yi Cai Jing· 2025-09-17 11:49
Core Viewpoint - The recent volatility in the Hong Kong innovative drug sector, particularly the dramatic price fluctuations of药捷安康, has sparked widespread debate regarding the legitimacy of its rapid inclusion in major indices despite lacking financial performance support [1][7]. Group 1: Stock Performance and Market Reaction -药捷安康's stock price surged over 550% within six days, reaching a market capitalization of 164.7 billion HKD, entering the "billion-dollar club" [4][5]. - On September 16, the stock experienced extreme volatility, with a price increase of over 63% in the morning, followed by a drop of 5.73% by the end of the day, resulting in a total intraday fluctuation of nearly 124% [3][4]. - Following the stock's volatility, several innovative drug ETFs saw significant declines, with the银华国证港股通创新药ETF dropping 2.98% and other related ETFs also experiencing declines exceeding 1% [3][4]. Group 2: Inclusion in Indices and Controversy - The core controversy revolves around the inclusion of药捷安康 in the国证港股通创新药指数, despite the company being listed for less than three months and having no revenue, with a reported pre-tax loss of 123 million HKD for the first half of the year [7][8]. - The index's criteria for inclusion require companies to have no significant violations or financial issues, raising questions about the appropriateness of药捷安康's inclusion given its lack of operational history and financial performance [7][8]. - The rapid inclusion of新股 in indices has led to concerns about the impact on passive investment products, as these products must track indices and thus are subject to the volatility of newly included stocks [9]. Group 3: Trading Volume and Investor Behavior - The trading volume of药捷安康 surged dramatically, with daily trading volume increasing from 0.13 million HKD to 45.43 billion HKD, indicating a significant influx of capital [5][6]. - Southbound capital has been a crucial support factor, with continuous accumulation of药捷安康 shares, reaching a holding value of 789 million HKD by September 16 [6]. - The market's speculative behavior surrounding药捷安康 reflects broader trends in the innovative drug sector, where high volatility is characteristic, particularly for newly listed companies [9].
安科生物(300009.SZ):参股公司PA3-17注射液获准进入关键性II期临床试验
Ge Long Hui A P P· 2025-09-17 11:48
Core Viewpoint - Anke Biotech (300009.SZ) announced that its affiliated companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the key Phase II clinical trial of PA3-17 injection, a targeted CAR-T cell therapy for adult relapsed and refractory CD7-positive hematological malignancies [1] Group 1 - The PA3-17 injection is the world's first targeted CD7 autologous CAR-T cell therapy product to receive clinical trial approval [1] - The product utilizes advanced genetic engineering technology to modify the patient's own T cells, enabling them to specifically recognize and kill CD7-positive tumor cells [1] - The approval marks a significant milestone for Boshengji Anke in the development of innovative cancer therapies [1]
智飞生物CA111注射液临床试验获批
Bei Jing Shang Bao· 2025-09-17 11:44
Core Viewpoint - Zhifei Biological (300122) announced that its subsidiary, Chongqing Chen'an Biological Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of CA111 injection in overweight or obese adults [1] Group 1: Company Developments - The CA111 injection developed by Chen'an Biological is designed to reduce side effects compared to similar single-target drugs due to its dual agonist synergistic effect [1]
昊海生科实控人蒋伟因涉嫌内幕交易遭证监会处罚
Cai Jing Wang· 2025-09-17 11:29
Core Viewpoint - The core issue revolves around Jiang Wei, a significant shareholder and actual controller of Hyaluronic Acid giant Haohai Biological Technology, receiving a notice of administrative penalty from the China Securities Regulatory Commission for suspected insider trading. The company asserts that the matter is unrelated to its operations and is solely a personal issue concerning Jiang Wei [1]. Company Summary - Haohai Biological Technology announced that Jiang Wei, one of its major shareholders and actual controllers, has been penalized by the China Securities Regulatory Commission for alleged insider trading [1]. - The company emphasized that the penalty pertains to Jiang Wei as an individual and does not involve the company itself [1]. - Although Jiang Wei founded Haohai Biological Technology, he has largely remained behind the scenes and does not actively participate in the company's operations [1]. - Jiang Wei has established a shareholding structure that allows him to maintain control over Haohai Biological Technology, and he has received over 250 million yuan in dividends from the company during its six years as a publicly listed entity [1]. Industry Context - The incident highlights the ongoing scrutiny of insider trading practices within the biotechnology sector in China, particularly among companies with significant market presence like Haohai Biological Technology [1]. - The company's chairman, Hou Yongtai, previously stated that Jiang Wei is primarily an investor who enjoys trading stocks, but he does not engage in trading Haohai Biological Technology's shares [1].
塞力医疗:拟4274万元增资武汉华纪元 推进疗性降血压疫苗(HJY-ATRQβ-001)项目各期临床试验
Mei Ri Jing Ji Xin Wen· 2025-09-17 11:11
Core Viewpoint - The company, Celery Medical (603716.SH), plans to increase its investment in its subsidiary, Wuhan Huajiyuan Biotechnology Development Co., Ltd., by 42.74 million yuan, which will raise its ownership stake to 41% [1] Group 1: Investment Details - The actual controller, Wen Wei, intends to acquire a 10% stake from shareholder Sun Danping for 27.2 million yuan, based on a post-investment valuation of 272 million yuan [1] - The total investment from the company and Wen Wei will amount to 69.94 million yuan [1] Group 2: Future Plans - The target company is expected to be included in the company's consolidated financial statements as a controlled subsidiary by 2026 [1] - All parties have agreed to actively promote the clinical trials for the therapeutic antihypertensive vaccine (HJY-ATRQβ-001) project, aiming to complete Phase I and Phase IIa clinical trials within two years, followed by the implementation of Phase IIb clinical trials [1]
安科生物:参股公司PA3-17注射液获准进入关键性II期临床试验 为全球首款获得新药临床试验批准的靶向CD7的自体CAR-T细胞治疗产品
Mei Ri Jing Ji Xin Wen· 2025-09-17 10:57
Core Viewpoint - Anke Biotech (300009.SZ) announced that its affiliated companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd., received approval from the National Medical Products Administration for the key Phase II clinical trial of PA3-17 injection, a targeted CAR-T cell therapy product for treating adult relapsed and refractory CD7-positive hematological malignancies [1]. Group 1 - Anke Biotech's affiliated companies have received a communication meeting minutes from the National Medical Products Administration regarding the PA3-17 injection [1]. - PA3-17 injection is the world's first targeted CD7 autologous CAR-T cell therapy product that has received approval for clinical trials [1]. - The product is specifically designed for the treatment of adult patients with relapsed and refractory CD7-positive hematological malignancies [1].
安科生物:参股公司PA3-17注射液获准进入关键性II期临床试验
Xin Lang Cai Jing· 2025-09-17 10:54
Core Viewpoint - The announcement highlights that the affiliated companies of Anke Bio, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd., have received approval from the National Medical Products Administration (NMPA) for the key Phase II clinical trial of PA3-17 injection, a targeted CAR-T cell therapy product for treating adult relapsed and refractory CD7-positive hematological malignancies [1]. Group 1 - The PA3-17 injection is the world's first CAR-T cell therapy product targeting CD7 that has received clinical trial approval [1]. - The approval allows the applicant to proceed with critical Phase II clinical trials [1]. - The product is specifically designed for adult patients with relapsed and refractory CD7-positive hematological malignancies [1].
腾盛博药-B(02137)因受限制股份单位获归属发行15.99万股
智通财经网· 2025-09-17 10:15
Group 1 - The company, Tengsheng Bo Pharmaceutical-B (02137), announced the issuance of a total of 159,900 shares due to the allocation of restricted stock units from September 1 to September 17, 2025 [1]