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复宏汉霖(02696):美国食品药品管理局批准HLX14(地舒单抗,美国商品名:BILDYOS®以及BILPREVDA®)两个产品用于特定人群骨质疏松症治疗等8项适应症
智通财经网· 2025-09-01 11:29
智通财经APP讯,复宏汉霖(02696)发布公告,近日,集团收到美国食品药品管理局(FDA)的批准函, BILDYOS以及BILPREVDA两个产品的生物制品许可申请(BLA)获FDA批准,该等商品名由N.V. Organon于美国注册商标。获批适应症具体包括: 此次FDA的批准主要是基于对HLX14(地舒单抗)(HLX14)与其参照药 (Prolia)一系列比对研究数据的全面 审查,包括分析相似性研究及临床比对研究。这些研究数据充分证明了HLX14与其参照药在质量、安 全性和有效性方面的高度相似。根据FDA发布的行业指南《证明与参照药生物相似性方面的科学考 虑》,HLX14获准用于参照药Prolia 和XGEVA在美国已获批的所有适应症。同时,集团HLX14相关生 产场地和设施亦接受了FDA的批准前检查(Pre-License Inspection, PLI),该等生产场地和设施均符合FDA 的cGMP 要求。 产品一: BILDYOS(60 mg/mL):(1)骨折高风险的绝经后妇女的骨质疏松症治疗;(2)骨折高风险的男性 骨质疏松症的增加骨量治疗;(3)糖皮质激素引起的骨折高风险的男性与女性骨质疏松症的 ...
腾讯、抖音、快手、B站、DeepSeek等平台官宣:上线AI标识功能
Xin Lang Cai Jing· 2025-09-01 11:28
Core Points - The "Measures for Identifying AI-Generated Synthetic Content" officially implemented on September 1 mandates that all AI-generated content must be clearly identified [1] - Major platforms like Tencent, Douyin, Kuaishou, Bilibili, and DeepSeek have begun to refine their regulations in response to the new measures [1][2] Group 1: Implementation of Identification Measures - The measures require explicit and implicit identification of AI-generated content, including text, images, audio, and video [1] - Douyin has launched two core features: an AI content identification function and an AI content metadata identification function to assist creators in labeling AI-generated content [1][2] - Tencent announced enhancements to its content recognition capabilities to ensure transparency and credibility for users accessing AI-generated content [2] Group 2: Compliance and User Responsibilities - Users are prohibited from deleting, altering, or concealing AI identification labels when publishing or disseminating AI-generated content [2][4] - Platforms will impose penalties for violations of laws and regulations, as well as for any malicious actions regarding AI content labeling [2][4] - DeepSeek has also implemented identification measures and provided a model principle and training method explanation to enhance user understanding of AI technology [5] Group 3: Platform-Specific Actions - Bilibili has introduced an option for creators to declare AI-generated content during submission, ensuring compliance with the new regulations [3] - Kuaishou has implemented both explicit and implicit labeling for AI-generated content and will provide prominent notifications for such content [3][4]
高盛:升澳博控股(00880)目标价至3.1港元 维持“中性”评级
智通财经网· 2025-09-01 11:26
高盛发布研报称,澳博控股(00880)次季EBITDA大幅下降,按季下跌28%至6.88亿港元,主要因VIP赢 率降至2.4%。若调整至理论赢率3.3%,则EBITDA按季跌幅收窄至13%,为8.02亿港元,与预行预期相 符,但仍显著低于市场预期的8亿至10.5亿港元。该行对澳博2025至27年EBITDA预测下调12%至上调 2%不等。目标价由2.7港元升至3.1港元,维持"中性"评级。 ...
上半年全球创作者AI创作收益飙升159% AI、小游戏等成快手变现“新富矿”?
Mei Ri Jing Ji Xin Wen· 2025-09-01 11:23
Core Insights - The rise of ordinary creators on platforms like Kuaishou reflects a broader trend of increased visibility and commercial opportunities in content creation [1][3] - Kuaishou's annual creator conference highlights the platform's growth and the challenges of content differentiation in a competitive landscape [1][4] Group 1: Creator Growth and Engagement - Kuaishou reported a 100% year-on-year increase in submissions from creators with over 10,000 followers, with 26 million creators earning income on the platform [1][4] - The creator An Wan experienced significant growth, increasing his followers from 380,000 to 2.87 million after integrating short videos into his content strategy [3][4] Group 2: Business Model and Revenue Generation - Kuaishou's "short video and live streaming integration" strategy has proven effective, with creators using this model achieving 4 to 10 times more traffic efficiency compared to those using a single content format [4][5] - The platform's total revenue reached 35 billion yuan in Q2, marking a 13.1% year-on-year increase, with adjusted net profit growing by 20.1% to 5.6 billion yuan [5][6] Group 3: Emerging Opportunities - The gaming and short drama sectors are emerging as new revenue streams for creators, with potential earnings of 100,000 yuan for short drama creators and 10,000 yuan for game creators over six months [6] - AI-generated content has seen a 321% increase in viewership, with AI content creators experiencing a 159% rise in earnings from January to June [6]
复宏汉霖(02696.HK):美国食品药品管理局(FDA)批准HLX14(地舒单抗,美国商品名:BILDYOS以及BILPREVDA)两个产品用于特定人群骨质疏松症治疗等8项适应症
Ge Long Hui· 2025-09-01 11:22
格隆汇9月1日丨复宏汉霖(02696.HK)公告,近日,集团收到美国食品药品管理局(FDA)的批准函, BILDYOS以及BILPREVDA两个产品的生物制品许可申请(BLA)获FDA批准,该等商品名由N.V. Organon于美国注册商标。 此次FDA的批准主要是基于对HLX14(地舒单抗)(HLX14)与其参照药(Prolia)一系列比对研究数据 的全面审查,包括分析相似性研究及临床比对研究。这些研究数据充分证明了HLX14与其参照药在质 量、安全性和有效性方面的高度相似。根据FDA发布的行业指南《证明与参照药生物相似性方面的科学 考虑》,HLX14获准用于参照药Prolia和XGEVA在美国已获批的所有适应症。同时,集团HLX14相关生 产场地和设施亦接受了FDA的批准前检查(Pre-License Inspection, PLI),该等生产场地和设施均符合FDA 的cGMP要求。 获批适应症具体包括:产品一: BILDYOS(60 mg/mL):(1)骨折高风险的绝经后妇女的骨质疏松症治 疗;(2)骨折高风险的男性骨质疏松症的增加骨量治疗;(3)糖皮质激素引起的骨折高风险的男性与女性 骨质疏松症的治疗 ...
中仑新材(301565.SZ):Strait拟减持不超1%股份
智通财经网· 2025-09-01 11:21
智通财经APP讯,中仑新材(301565.SZ)发布公告,持股10.750%的股东Strait Co,Ltd.(简称"Strait"),计划 自公告发布之日起15个交易日后的3个月内拟通过大宗交易方式减持公司股份合计不超过公司总股本的 1%,即不超过400.01万股。 ...
快讯|“80后”林祝波接棒永升服务总裁 周洪斌升任副董事长
Mei Ri Jing Ji Xin Wen· 2025-09-01 11:20
Group 1 - The core point of the article is the leadership transition at Yongsheng Services, with Zhou Hongbin being promoted to Vice Chairman and Lin Zhubo taking over as President and Executive Director starting September 1, 2025 [2] Group 2 - Zhou Hongbin joined Yongsheng Services in 2017 and played a key role in its successful listing on the Hong Kong Stock Exchange in 2018, proposing a "platform + ecosystem" development strategy and establishing a five-year development path [6] - Under Zhou's leadership, Yongsheng Services has transformed from a residential management service company to a smart city service brand, with the managed contract area increasing from 33.34 million square meters in 2017 to 355 million square meters by mid-2025 [6] - Lin Zhubo, born in the 1980s, joined Xuhui Group in 2014 and was appointed as a non-executive director of Yongsheng Services in June this year, having previously worked at China State Construction Engineering and Vanke [6]
悟喜生活:黎碧芝获委任为独立非执行董事
Zhi Tong Cai Jing· 2025-09-01 11:20
Group 1 - The company announced that Ms. Lin Wanwen has resigned as an independent non-executive director and member of the audit, nomination, and remuneration committees effective September 1, 2025, to dedicate more time to other business commitments [1] - Ms. Li Bihua has been appointed as an independent non-executive director and member of the board's audit, nomination, and remuneration committees [1]
腾讯控股9月1日斥资5.5亿港元回购91万股
Zhi Tong Cai Jing· 2025-09-01 11:20
腾讯控股(00700)发布公告,于2025年9月1日斥资5.5亿港元回购股份91万股,每股回购价格为601.5- 609.5港元。 ...
蔚来8月交付新车31305台 乐道L90上市首月交付破万
Feng Huang Wang· 2025-09-01 11:19
Group 1 - NIO delivered 31,305 vehicles in August, a year-on-year increase of 55.2%, marking a historical high and a 49% increase from the previous month [1] - The breakdown of deliveries includes 10,525 vehicles from the NIO brand, 16,434 from the Ladao brand, and 4,346 from the Firefly brand [1] - Cumulatively, NIO has delivered 838,036 vehicles, with 748,448 from the NIO brand, 75,033 from the Ladao brand, and 14,555 from the Firefly brand [1] - The Ladao L90 achieved 10,575 deliveries in its first month, making it the fastest model in NIO's history to surpass 10,000 units [1] Group 2 - The new ES8 was pre-sold on August 21, with a starting price of 416,800 yuan, utilizing a BaaS battery rental model with a lower starting price of 308,800 yuan [1] - The G318 Tibet charging route was officially completed on August 16, spanning 2,950 kilometers with 15 battery swap stations along the way [1] - From August 29 to October 12, the G318 route offers unlimited free battery swap services for all NIO and Ladao users, excluding operational vehicles [1] Group 3 - NIO Day 2025 is scheduled for late September in Hangzhou, with the theme "Grow with the Light," where the new ES8 will be officially launched [2]