GYBYS(600332)
Search documents
预计全生命周期订单总金额约150亿元!387亿机器人概念股获两家头部品牌主机厂客户项目定点|盘后公告集锦
Xin Lang Cai Jing· 2025-09-15 12:01
Company Announcements - Junsheng Electronics' subsidiary has recently secured a global automotive intelligence project with a total order value of approximately 15 billion yuan, expected to start mass production in 2027 [1] - Shangluo Electronics plans to acquire 88.79% of Ligon Technology for 700 million yuan, focusing on authorized distribution of storage chips and various IC products [2][3] - Xinda Zheng intends to purchase at least 51% of Jiaxin Liheng Facility Management (Shanghai) Co., Ltd., with the stock currently suspended [1] - Dingtong Technology plans to invest up to 15 million USD to establish a wholly-owned subsidiary in Vietnam for R&D and production of optical module liquid cooling products [1][3] - Kexing Pharmaceutical's shareholders are inquiring about transferring shares at an initial price of 30.88 yuan per share, which is a 28% discount compared to the closing price [4] - Zhongtai Automobile has been ordered to pay 29.5 million yuan plus overdue interest due to a court ruling, which may significantly impact its current or future performance [5] - Shoukai Co., Ltd. has seen a significant increase in shareholder numbers and some institutional shareholders have reduced their holdings [5] Investment and Contracts - Laofengxiang plans to jointly invest in establishing Laofengxiang Precision Materials Company to build a modern refining and testing laboratory [8] - Longci Technology intends to invest 210 million yuan in the second phase of its Vietnam project to localize the supply of permanent magnet ferrite raw materials [9] - Sileck has signed a 230 million yuan investment cooperation agreement for a new energy precision structural components project [10] Shareholding Changes - Jingchen Co. plans to acquire 316 million yuan for 100% of Chip Micro Semiconductor [6] - Beijing Junzheng has seen a reduction of 4.8254 million shares by its shareholder Beijing Yitang Shengxin [5] - Green Harmony's actual controllers have completed a reduction of 2.99% of their shares [7] - Hangke Technology's actual controller plans to transfer 3% of the total share capital [7] Stock Price Movements - Nanfeng Co. has reported that its 3D printing service project has not yet materialized, which may affect its current year's revenue and profit [3] Other Developments - Borui Pharmaceutical's BGM0504 tablets have been approved for clinical trials in overweight/obese adults, with no similar oral formulations approved globally [4] - Southwest Securities' subsidiary will lose its listing status on September 29 due to failure to meet resumption guidelines [20]
白云山:选择性RET小分子抑制剂BYS10片进入关键性临床试验
Zhi Tong Cai Jing· 2025-09-15 11:16
Core Viewpoint - Baiyunshan Pharmaceutical Group Co., Ltd. has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor BYS10 tablets, indicating progress in the clinical evaluation of the drug for treating advanced solid tumors with RET gene fusions or mutations [1] Group 1: Clinical Research Details - The clinical study is an open-label, multi-center Phase I/II trial aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of BYS10 tablets in patients with advanced solid tumors harboring RET gene fusions or mutations [1]
白云山(600332.SH):选择性RET小分子抑制剂BYS10片进入关键性临床试验
智通财经网· 2025-09-15 11:16
Core Viewpoint - Baiyunshan Pharmaceutical Group's subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor, BYS10 tablets, which are undergoing clinical trials for treating advanced solid tumors with RET gene fusions or mutations [1] Group 1 - The clinical study is an open-label, multi-center Phase I/II trial aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of BYS10 tablets [1] - The trial specifically targets advanced solid tumors associated with RET gene fusions or mutations [1]
白云山(00874.HK):分公司药物BYS10片进入关键性临床试验
Ge Long Hui· 2025-09-15 11:09
Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor BYS10 tablets, which are currently undergoing clinical trials for treating advanced solid tumors with RET gene fusions or mutations [1] Clinical Trial Information - The clinical trial registration number is CTR20220752, and the trial protocol number is BYS10-001 [1] - The trial aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of BYS10 tablets in treating advanced solid tumors with RET gene fusions or mutations [1] - This is an open-label, multi-center Phase I/II clinical study [1] Product Overview - BYS10 tablets are developed by Baiyunshan Pharmaceutical's manufacturing plant and are selective RET small molecule inhibitors [1] - The formulation specifications are 25mg and 100mg, with indications for non-small cell lung cancer and medullary thyroid carcinoma among other advanced solid tumors [1] - As of August 2025, the project has incurred research and development expenses amounting to RMB 146 million [1]
白云山:CDE同意BYS10 片未来采用Ⅱ期单臂临床试验申请上市
Zhi Tong Cai Jing· 2025-09-15 11:04
Core Viewpoint - Baiyunshan Pharmaceutical's selective RET small molecule inhibitor BYS10 has received feedback from the National Medical Products Administration (NMPA) for its clinical trial application, indicating progress towards potential market approval [1] Group 1: Company Developments - Baiyunshan Pharmaceutical's subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., has developed BYS10, which is indicated for advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1] - The clinical trial for BYS10 began with approval from the NMPA in January 2022, and the first patient signed the informed consent in January 2023 [1] - Phase I clinical trial results show that BYS10 exhibits strong and durable anti-tumor activity in patients with RET gene mutations, demonstrating good clinical efficacy and tolerability [1] Group 2: Industry Context - Currently, only two RET inhibitors, Pralsetinib (BLU-667) and Selpercatinib (LOXO-292), have been approved for sale in China, with sales projected at RMB 154.91 million and RMB 65.45 million respectively for 2024 [2] - There are no other drugs with a similar structure to BYS10 that have been registered or approved in the domestic or international markets [2]
白云山(600332) - 广州白云山医药集团股份有限公司关于分公司药物进入关键性临床试验的公告

2025-09-15 11:01
证券代码:600332 证券简称:白云山 公告编号:2025-070 广州白云山医药集团股份有限公司 关于分公司药物进入关键性临床试验的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗 漏,并对其内容的真实性、准确性和完整性承担法律责任。 广州白云山医药集团股份有限公司(以下简称"公司")分公司 广州白云山医药集团股份有限公司白云山制药总厂(以下简称"白云 山制药总厂")研发的选择性RET小分子抑制剂BYS10片于近日收到国 家药品监督管理局药品审评中心(以下简称"CDE")的反馈意见, 现将相关情况公告如下: 一、临床试验相关情况 试验登记号:CTR20220752 试验方案编号:BYS10-001 试验专业题目:评价BYS10片治疗RET基因融合或突变的晚期实体 瘤的安全性、耐受性、药代动力学特征及有效性的开放、多中心Ⅰ/ Ⅱ期临床研究 试验通俗题目:BYS10片治疗RET基因融合或突变的晚期实体瘤的 Ⅰ/Ⅱ期临床研究 二、BYS10片主要情况介绍 BYS10片是白云山制药总厂研发的选择性RET小分子抑制剂,制剂 规格25mg、100mg,适应症为非小细胞肺癌、甲状腺髓样 ...
白云山(00874) - 海外监管公告

2025-09-15 10:53
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完 整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 茲刊載廣州白雲山醫藥集團股份有限公司(「本公司」)在上海證券交易所網站(www.sse.com.cn)刊登的 本公司關於分公司藥物進入關鍵性臨床試驗的公告之中文全文,僅供參考。 廣州白雲山醫藥集團股份有限公司 董事會 中國廣州,2025年9月15日 於本公告日,本公司董事會成員包括執行董事李小軍先生、程寧女士、程洪進先生、唐和平先生與 黎洪先生,及獨立非執行董事陳亞進先生、黃民先生、黃龍德先生與孫寶清女士。 证券代码:600332 证券简称:白云山 公告编号:2025-070 广州白云山医药集团股份有限公司 关于分公司药物进入关键性临床试验的公告 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出的。 二、BYS10片主要情况介绍 BYS10片是白云山制药总厂研发的选择性RET小分子抑制剂,制剂 规格25mg、100mg,适应症为非小细胞肺癌、甲状腺髓样癌等晚期实 本公司 ...
白云山:分公司药物BYS10片进入关键性临床试验
Mei Ri Jing Ji Xin Wen· 2025-09-15 10:47
Core Viewpoint - Baiyunshan (600332.SH) announced that its subsidiary Baiyunshan Pharmaceutical Factory received feedback from the National Medical Products Administration, allowing the application for a Phase II single-arm clinical trial for the selective RET small molecule inhibitor BYS10 tablets, which are intended for the treatment of advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1] Company Summary - BYS10 tablets are currently the only drug of its kind in development in China, with no similar drugs registered or approved domestically or internationally [1] - As of August 2025, the project has incurred research and development expenses amounting to RMB 146.0935 million [1] - The company acknowledges the inherent uncertainties in innovative drug development, indicating that future R&D expenses are expected to increase, but these will not significantly impact the company's financial status and operating results in the short term [1]
白云山:分公司药物进入关键性临床试验
Xin Lang Cai Jing· 2025-09-15 10:40
Core Viewpoint - Baiyunshan's subsidiary, Baiyunshan Pharmaceutical Factory, has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor, BYS10 tablets, which are intended for the treatment of advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1] Summary by Categories Product Development - BYS10 tablets have undergone research and development with an investment of RMB 146 million [1] - The NMPA has agreed to allow BYS10 tablets to apply for market approval through a Phase II single-arm clinical trial [1] Market Context - Currently, only two RET inhibitors, Pralsetinib (BLU-667) and Selpercatinib (LOXO-292), have been approved for market release globally [1]
“宫崎骏电影世界”登陆广州塔:IP经济再掀消费热潮
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-14 06:03
Core Insights - The project "Ghibli Studio's Magical Journey" will open at Guangzhou Tower on December 25, 2025, and will run until October 8, 2026, offering an immersive experience of Studio Ghibli's iconic films [1][2] - The project aims to enhance the cultural tourism industry in Guangzhou by integrating new business models and consumer experiences [1][3] Group 1 - The project will cover nearly 3,000 square meters, featuring multimedia interactive designs and three-dimensional scenes from Ghibli films, providing a unique immersive experience for visitors [1][2] - Studio Ghibli, founded in 1985 by Hayao Miyazaki, Isao Takahata, and Toshio Suzuki, is renowned for its high-quality animated films, and this year marks its 40th anniversary [1][2] - The project is officially authorized by Studio Ghibli and has been developed over nearly a year in collaboration with a team experienced in creating attractions for top global theme parks [2] Group 2 - Guangzhou Tower is transforming into a comprehensive cultural tourism enterprise, integrating sightseeing, dining, entertainment, exhibitions, performances, and cultural creativity under the "Guangzhou Tower+" strategy [2] - The opening of the Guangzhou Tower Theater aligns with Guangzhou's strategy to become an international performing arts capital and a world-class tourism destination [3] - The project will leverage cultural and technological empowerment to create a highly anticipated IP entertainment experience in the Greater Bay Area by 2026 [3]