倍诺达®
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港股公告掘金 | 京东物流拟2.7亿美元收购京东集团本地即时配送服务业务 加强“最后一公里”配送能力
Zhi Tong Cai Jing· 2025-10-09 15:11
Major Events - MIRXES-B (02629) received approval from the National Medical Products Administration of China for the GASTROClear™ IVD registration certificate for gastric cancer screening [1] - JD Logistics (02618) plans to acquire JD Group's local instant delivery service business for $270 million to enhance "last mile" delivery capabilities [1] - HSBC Holdings (00005) intends to privatize Hang Seng Bank (00011) [1] - Fuhong Hanlin (02696) reported that the phase III clinical study of Hansu® (sulizumab injection) in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer achieved its primary endpoint [1] - WuXi AppTec (02126) announced that the National Medical Products Administration officially accepted the supplementary application for the post-marketing use of Benodda® with a domestic viral vector [1] - Sunny Optical (02382) plans to transfer approximately 1.903 billion yuan to Shanghai Aolai and invest in GoerTek to jointly develop AI/AR optical business [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval for SYH2070 injection (double-stranded small interfering RNA drug) in the United States [1] - Yanda Pharmaceutical (00512) completed patient enrollment for the registration clinical study of a globally innovative temperature-sensitive embolic agent in China [1] - CloudWalk Technology (09678) successfully won bids for multiple intelligent agent projects, including the AI capability platform for Beijing Friendship Hospital [1] - Huakang Biomedical (08622) received a cash offer from Anselme Limited to acquire 27.71% of its shares at a discount of approximately 68.10%, with resumption of trading on October 10 [1] Operating Performance - Baolong Properties (01238) reported a total contracted sales of approximately 5.431 billion yuan in the first nine months, a year-on-year decrease of 43.64% [2] - Fast Retailing (06288) released its annual performance, with a net profit attributable to shareholders of 433.009 billion yen, a year-on-year increase of 16.4%, with trading resuming on October 10 [2] - Jingrui Holdings (01862) reported a contracted sales amount of 740 million yuan in the first nine months, a year-on-year decrease of 49.52% [2] - Dongfeng Motor Group (00489) recorded cumulative automobile sales of 1.3168 million units in the first nine months, a year-on-year decline of approximately 3.6% [2] - Yaoshi Bang (09885) reported a total transaction volume of approximately 658.4 million yuan for its brand promotion business in the third quarter, a year-on-year increase of 163% [2]
药明巨诺-B(02126.HK):中国国家药监局正式受理倍诺达®使用国产病毒载体的上市后补充申请
Ge Long Hui· 2025-10-09 09:03
Core Insights - WuXi AppTec's subsidiary, WuXi Biologics, has received formal acceptance from the National Medical Products Administration (NMPA) for its supplemental application for the post-marketing use of its domestically produced viral vector, JWLV011, for the production of its CAR-T therapy, Ruili Kelong [1][2] Group 1: Product Development - The application is based on a Phase II single-arm study aimed at evaluating the comparability of Ruili Kelong produced with the new viral vector JWLV011 against that produced with existing viral vectors [2] - The study has completed at least three months of follow-up, showing an objective response rate (ORR) of 66.67% and a complete response (CR) rate of 41.67% [2] Group 2: Safety and Efficacy - The most common severe adverse event reported was cytopenia, with CAR-T related toxicities such as cytokine release syndrome (CRS) primarily at grade 1, and no occurrences of grade 3 or higher CRS or any grade of immune effector cell-associated neurotoxicity syndrome (ICANS) [2] - Clinical data indicates that the Ruili Kelong produced with the domestically sourced JWLV011 is clinically comparable to that produced with existing viral vectors [2] Group 3: Strategic Importance - The chairman and CEO of WuXi AppTec emphasized that the domestically produced viral vector is not only a crucial raw material for cell therapy products but also the most expensive, making its domestic substitution strategically significant for the company [2] - Successful completion of the viral vector substitution is expected to stabilize supply for commercial products and clinical development while significantly reducing costs, enhancing the company's competitive position in commercialization and insurance negotiations [2]
药明巨诺-B(02126.HK):中期收入达到1.06亿元 同比增加22.5%
Ge Long Hui· 2025-08-27 11:43
Core Viewpoint - WuXi AppTec's revenue for the six months ending June 30, 2025, reached RMB 106.3 million, representing a year-on-year increase of 22.5% driven by sales of its commercialized product, Benauda®, and a non-exclusive license granted to Juno for JW sLVV production technology and related patents [1] Financial Performance - Revenue for the period was RMB 106.3 million, up 22.5% year-on-year [1] - Gross profit increased by 48.9% to RMB 65.1 million, primarily due to incremental contributions from the sLVV licensing [1] - The gross margin from product sales improved from 50.4% for the six months ending June 30, 2024, to 51.1% for the current period [1] Operational Efficiency - The company is focused on enhancing production operational efficiency, exploring new technologies for process improvement, and implementing cost reduction plans [1]
药明巨诺-B(02126)发布中期业绩 毛利6511.7万元 同比增加48.86%
智通财经网· 2025-08-27 11:34
Group 1 - The company reported a revenue of 106 million RMB for the six months ending June 30, 2025, representing a year-on-year increase of 22.5% [1] - Gross profit reached 65.12 million RMB, showing a year-on-year increase of 48.86% [1] - Research and development expenses amounted to 92.04 million RMB, indicating a focus on innovation and product development [1] Group 2 - The leading product, Benaoda®, has made continuous progress in commercialization [2] - The company completed patient enrollment for a clinical trial of Benaoda® as a second-line treatment for relapsed or refractory large B-cell lymphoma (LBCL) patients [2] - The National Medical Products Administration granted Benaoda® "Breakthrough Therapy Designation" in January 2025, and a supplemental new drug application (sNDA) was submitted in May 2025 [2] - The company developed its own platform technology and successfully produced lentiviral vectors for Benaoda®, reducing product costs [2] - Clinical studies have shown comparable results to existing lentiviral vectors, and patient enrollment for the investigational new drug application (IND) has been completed [2] - Significant progress has been made in developing innovative products with global commercialization potential [2]
药明巨诺-B(02126)发布年度业绩,收入1.58亿元 预计下一期间倍诺达®的销售收入会再次增加
智通财经网· 2025-03-27 10:40
Group 1 - The company reported a revenue of RMB 158 million for the year ending December 31, 2024, representing a 9% decrease year-on-year [1] - The net loss for the year was RMB 591 million, a reduction of 23.1% compared to the previous year [1] - Research and development expenses amounted to RMB 283 million, down 31.58% year-on-year [1] - The loss per share was RMB 1.43 [1] Group 2 - The company achieved significant progress in developing, producing, and commercializing cell immunotherapy products, with operational efficiency improvements such as stable gross margins and reduced cash outflows [2] - The leading product, Benauda®, continued to make progress in commercialization, with approvals from the National Medical Products Administration (NMPA) for clinical trials in specific patient groups [2] - Benauda® became the first cell therapy product approved in China for treating r/r Mantle Cell Lymphoma (MCL) patients [2] - The company has established a strong commercial team responsible for the commercialization of Benauda® in China, enhancing its sales, marketing, and market access capabilities [2]