Workflow
XUANZHUBIO-B(02575)
icon
Search documents
轩竹生物-B(02575):吡洛西利一线治疗HR+/HER2-晚期乳腺癌临床III期研究数据于2025年ESMO公布
智通财经网· 2025-10-21 22:32
Core Viewpoint - Xuan Bamboo Biotech-B (02575) presented interim analysis results of the BRIGHT-3 clinical trial at the 2025 European Society for Medical Oncology (ESMO), demonstrating the efficacy and safety of Pyrotinib combined with Letrozole or Anastrozole for first-line treatment of HR+/HER2- advanced breast cancer [1][2]. Group 1: Clinical Trial Details - The BRIGHT-3 study is a randomized, double-blind Phase III clinical trial conducted at 58 centers in China, involving 397 HR+/HER2- advanced breast cancer patients [1]. - Among the intention-to-treat population, 55.7% of patients had visceral metastases, and 41.3% were newly diagnosed with advanced disease [1]. Group 2: Efficacy Results - The median follow-up time was 20.7 months as of January 10, 2025, with the mPFS for the Pyrotinib group not yet reached, while the control group reported mPFS of 18.43 months and 19.55 months [2]. - The Pyrotinib regimen reduced the risk of disease progression or death by 47% compared to the placebo combined with endocrine therapy, with a notable 64% risk reduction in patients with liver metastases [2]. - The overall response rate (ORR) for the Pyrotinib group was 63.5%, significantly higher than the control group's 42.5% [2]. Group 3: Safety Profile - Common adverse events associated with the Pyrotinib combination therapy were mostly grade 1-2, including diarrhea and neutropenia, which can be effectively managed through supportive care or dose adjustments [2]. - The overall safety profile of the Pyrotinib regimen is considered manageable [2]. Group 4: Regulatory Approval - Based on the interim data from the BRIGHT-3 study, the National Medical Products Administration of China accepted the new drug application for Pyrotinib combined with aromatase inhibitors for HR+/HER2- advanced breast cancer on May 14, 2025 [2]. Group 5: Product Information - Pyrotinib (brand name: XuanYueNing) is a novel CDK2/4/6 inhibitor with a unique multi-target synergistic mechanism, effectively inhibiting tumor cell proliferation while significantly reducing hematological toxicity compared to traditional CDK4/6 inhibitors [3]. - On May 13, 2025, Pyrotinib was approved for use in combination with Fulvestrant for patients who progressed after prior endocrine therapy, and as a monotherapy for patients who had previously received two or more endocrine therapies and one chemotherapy [3].
轩竹生物-B(02575) - 自愿公告吡洛西利一线治疗HR+/HER2-晚期乳腺癌临床III期研究...
2025-10-21 22:06
Xuanzhu Biopharmaceutical Co., Ltd. 軒竹生物科技股份有限公司 (一家於中華人民共和國註冊成立的股份有限公司) (股份代號:2575) 自願公告 吡洛西利一線治療HR+/HER2-晚期乳腺癌臨床III期研究數據 於2025年ESMO公佈 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之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致之任何損失承擔任何責任。 1 關於吡洛西利 吡洛西利片(商品名:軒悅寧)作為新型CDK2/4/6抑製劑,具有獨特的多靶點協 同作用機制,具有強效抑制腫瘤細胞增殖,顯著降低傳統CDK4/6抑製劑常見的血 液學毒性等優勢。吡洛西利已於2025年5月13日獲得中國國家藥品監督管理局批 准與氟維司群聯合用於既往接受內分泌治療後出現疾病進展的患者;單藥用於既 往轉移性階段接受過兩種及以上內分泌治療和一種化療後出現疾病進展的患者, 成為中國首個且唯一獲批單藥適應症的CDK4/6抑製劑。 關於軒竹生物 軒竹生物是四環醫藥控股集團有限公司(「四環醫藥」)旗下的創新藥子公司,是 ...
智通港股52周新高、新低统计|10月21日
智通财经网· 2025-10-21 08:45
Group 1 - As of October 21, 67 stocks reached their 52-week highs, with CMON (01792) leading at a high rate of 58.33% [1] - Other notable stocks include Hai Na Intelligent (01645) and Xuan Zhu Bio-B (02575), with high rates of 21.94% and 21.33% respectively [1] - The list of stocks reaching new highs includes Standard Development Group (01867) at 19.27% and XL Southern Hynix (07709) at 18.18% [1] Group 2 - The report also highlights stocks that reached their 52-week lows, with Jin Ye International Group (08549) showing a decline of 16.67% [2] - Other stocks experiencing significant declines include Ai Gao Group Equity (02952) at -12.00% and Fei Tian Yun Dong (06610) at -11.54% [2] - The lowest performing stock in this category is Shan Gao Holdings (00412), which decreased by 8.66% [2] Group 3 - The report includes various stocks with minor declines, such as Qu Zhi Group (00917) at -4.54% and Yun Kang Group (02325) at -4.46% [3] - Other stocks with slight decreases include XI Southern Samsung-U (09347) at -3.50% and Tian Hou Cultural Creation (08500) at -3.21% [3] - The overall trend indicates a mix of stocks reaching new highs and lows, reflecting market volatility [3]
轩竹生物-B(02575.HK)拉升逾14%
Mei Ri Jing Ji Xin Wen· 2025-10-21 05:56
Core Viewpoint - Xuan Zhu Bio-B (02575.HK) has seen a significant increase in its stock price, rising over 234% from its IPO price of 11.6 HKD to a peak of 38.8 HKD, indicating strong market interest and investor confidence [2] Summary by Category - **Stock Performance** - The stock rose more than 14% in the afternoon session, reaching a high of 38.8 HKD [2] - As of the report, the stock was up 12.12%, trading at 38.12 HKD with a transaction volume of 32.29 million HKD [2]
港股异动 | 轩竹生物-B(02575)拉升逾14% 较招股价已涨超2.3倍 公司今年迎来商业...
Xin Lang Cai Jing· 2025-10-21 05:54
Core Viewpoint - XuanZhu Biotech-B (02575) has seen a significant stock price increase of over 234% since its IPO, reflecting strong market interest and confidence in its drug development pipeline [1] Company Overview - XuanZhu Biotech is a spin-off from Hong Kong-listed company SiHuan Pharmaceutical (00460), representing a typical "H-share" structure [1] - The company is actively developing over ten drug assets targeting digestive system diseases, tumors, and non-alcoholic fatty liver disease (NASH) [1] Drug Development Pipeline - The company has three assets approved for New Drug Application (NDA), one drug project in the NDA registration stage, one in Phase III clinical trials, four in Phase I clinical trials, and five that have received Investigational New Drug (IND) approval [1] Commercialization Strategy - XuanZhu Biotech is expected to enter a commercialization explosion period by 2025, driven by dual support from digestive and tumor therapies [1] - The core tumor drugs, Pyrocilin and Delorac, are set to receive approvals, alongside the previously approved proton pump inhibitor, Annelazole Sodium, forming a "three-horse" product matrix that aligns innovation with commercialization [1]
港股异动 | 轩竹生物-B(02575)拉升逾14% 较招股价已涨超2.3倍 公司今年迎来商业化爆发期
智通财经网· 2025-10-21 05:48
Core Viewpoint - XuanZhu Bio-B (02575) has seen a significant stock price increase of over 234% since its IPO, reflecting strong market interest and confidence in its drug development pipeline [1] Company Overview - XuanZhu Bio-B is a spin-off from Hong Kong-listed company SiHuan Pharmaceutical (00460), representing a typical "H-share spin-off" [1] - The company is actively developing over ten drug assets targeting digestive system diseases, tumors, and non-alcoholic fatty liver disease (NASH) [1] Drug Development Pipeline - The company has three drug assets that have received New Drug Application (NDA) approval, one drug project is in the NDA registration stage, one is in Phase III clinical trials, four are in Phase I clinical trials, and five have received Investigational New Drug (IND) approval [1] - The dual focus on digestive and tumor treatments is expected to drive commercialization growth, with a projected peak in 2025 [1] Commercialization Strategy - The commercialization strategy is supported by three core products: Pyrocilin tablets, Dirocitin tablets, and the previously approved proton pump inhibitor Annelazole sodium, forming a "three-horse carriage" product matrix [1] - This strategy indicates a successful alignment of innovative drug development and commercialization efforts, gaining recognition from both the industry and the market [1]
轩竹生物-B拉升逾14% 较招股价已涨超2.3倍 公司今年迎来商业化爆发期
Zhi Tong Cai Jing· 2025-10-21 05:47
Core Viewpoint - XuanZhu Bio-B (02575) has seen a significant stock price increase of over 234% since its IPO, reflecting strong market interest and confidence in its drug development pipeline [1] Company Overview - XuanZhu Bio-B is a spin-off from the Hong Kong-listed company Sihuan Pharmaceutical (00460), representing a typical "H-share" structure [1] - The company is actively developing over ten drug assets targeting digestive system diseases, tumors, and non-alcoholic steatohepatitis (NASH) [1] Drug Development Pipeline - As of the latest actionable date, XuanZhu Bio-B has three NDA-approved assets, one drug project in the NDA registration stage, one in Phase III clinical trials, four in Phase I clinical trials, and five that have received IND approval [1] - The company is positioned for a commercial explosion by 2025, driven by dual support from its digestive and oncology drug portfolios [1] Commercialization Strategy - The core oncology drugs, Pirlosil and Diroac, are expected to receive approvals, alongside the previously approved proton pump inhibitor, Annelazole Sodium, forming a "three-horse" product matrix for commercialization [1] - This strategy indicates a successful alignment of innovative drug development with commercialization efforts, gaining recognition from both the industry and the market [1]
一周港股IPO:遇见小面、拉卡拉等9家递表;赛力斯、小马智行等5家通过聆讯
Cai Jing Wang· 2025-10-20 10:52
Core Viewpoint - The Hong Kong Stock Exchange reported that during the week from October 13 to October 19, 9 companies submitted listing applications, 5 companies passed the hearing, 4 companies launched their IPOs, and 2 new stocks were listed [1]. Group 1: Companies Submitted Listing Applications - Hantian Technology (Xiamen) Co., Ltd. is a leader in the global silicon carbide (SiC) epitaxy industry, focusing on the R&D, mass production, and sales of SiC epitaxy chips, with a projected market share of over 30% in 2024 [2]. - Impression Co., Ltd. is a state-owned cultural tourism service enterprise, ranking eighth in China's cultural tourism performance market in 2024, with revenues of approximately 63.04 million yuan in 2022 [3]. - Guangzhou Yujian Noodle Restaurant Co., Ltd. is the fourth largest operator of Chinese noodle restaurants in China, with a market share of 0.5% in 2024 [4]. - Baishan Cloud Holdings Ltd. is the second largest independent edge cloud service provider in China, with a market share of approximately 2.0% in 2024 [5][6]. - Shouchuang Securities Co., Ltd. is a financial service provider with a strong asset management capability, ranking fifth in revenue growth among 42 A-share listed securities companies from 2022 to 2024 [7]. - Chongqing Qianli Technology Co., Ltd. focuses on AI and mobility solutions, with stable growth in automotive products [8]. - Nanjing Qingtian All Tax Information Technology Co., Ltd. is a leading digital service provider for cross-border enterprises, ranking first in the smart tax solution market in China with a market share of 1.7% in 2024 [9]. - Lakala Payment Co., Ltd. is a leading digital payment provider in Asia, with a market share of 9.4% in 2024 [10]. - Sichuan Xin Hehua Traditional Chinese Medicine Co., Ltd. is one of the largest suppliers of traditional Chinese medicine products in China, ranking second in the market with a 0.4% market share in 2024 [12]. Group 2: Companies Passed Hearing - Seres Group Co., Ltd. focuses on the research, manufacturing, and sales of new energy vehicles, achieving revenues of approximately 340.56 billion yuan in 2022 [13]. - Minglue Technology is a leading data intelligence application software company in China, with revenues of approximately 12.69 billion yuan in 2022 [14]. - Pony AI Inc. specializes in autonomous driving services, with a total operational area exceeding 2000 square kilometers [15]. - Ningbo Joyson Electronic Corp. is a global leader in smart automotive technology solutions, ranking second in China and fourth globally in smart cockpit domain control systems [16][17]. - WeRide Inc. is a pioneer in L4 autonomous driving, with operations in over 30 cities across 11 countries [18]. Group 3: Companies Launched IPOs - Yunji Technology launched its IPO with a subscription that was oversubscribed by 5677 times, raising approximately 189.1 billion HKD [19]. - Haixi New Drug's IPO was delayed for regulatory approval, with a price range of 69.88-86.40 HKD per share [20]. - Jushuitan's IPO was set at 30.60 HKD per share, with a total of 681.66 million shares offered [21]. - Guanghetong's IPO was priced between 19.88-21.5 HKD per share, with a total of approximately 135 million shares offered [21]. Group 4: Newly Listed Stocks - Xuan Bamboo Biotechnology was listed on October 15, 2025, with a closing price of 26.30 HKD per share, reflecting a gain of 126.72% [22]. - Yunji was listed on October 16, 2025, with a closing price of 120.5 HKD per share, reflecting a gain of 26.05% [24].
港股午评|恒生指数早盘跌1.61% 燃气股逆市走高
智通财经网· 2025-10-17 04:10
Market Overview - The Hang Seng Index fell by 1.61%, down 415 points, closing at 25,472 points, while the Hang Seng Tech Index dropped by 2.81%. The early trading volume in the Hong Kong market was HKD 153.2 billion [1] Energy Sector - Gas stocks rose, with Zhongyu Energy (03633) increasing by over 10%. This surge is attributed to the early initiation of winter heating in Gansu and other regions due to continuous temperature drops, leading to increased natural gas demand [1] Biotechnology Sector - Newly listed stock Xuan Zhu Bio-B (02575) surged over 13%, reaching a new high, and is up more than 190% from its IPO price. Yimai Sunshine (02522) rose over 4% following the global launch of its medical imaging model product AIR. The performance of medical stocks varied, with Yaojie Ankang-B (02617.HK) up over 21%, Baize Medical (02609) up over 5%, while Kangfang Biotech (09926) fell by 2%. Kangning Jereh Pharma-B (09966) increased by over 13% after announcing a share buyback plan, with market attention on significant data from the ESMO conference [2] Precious Metals Sector - Laopu Gold (06181) rose over 4%, benefiting from increased channel expansion and upgrades, with institutions indicating that rising gold prices favor its high-end brand positioning [3] Hospitality Sector - Wanda Hotel Development (00169) increased by over 10% after completing a sale and announcing a special dividend of HKD 0.462 per share to be paid next month [4] Digital Assets Sector - Delin Holdings (01709) rose over 3% after entering a strategic cooperation agreement with Antalpha to promote business in the digital asset sector [5] Telecommunications Sector - Changfei Optical Fiber and Cable (06869) fell over 6%, having dropped 40% from its September peak due to declining fiber optic prices and shareholder sell-offs. Cryptocurrency-related stocks collectively declined, with Bitcoin experiencing significant volatility and a recent incident in the US stablecoin market. Mi Strategy (02440) fell by 4.36%, and OSL Group (00863) dropped by 3.99% [6] Semiconductor Sector - Chip stocks continued to decline, with SMIC (00981) down over 5% and Huahong (01347) down over 3%, as US export controls accelerate domestic semiconductor replacements [6]
轩竹生物-B再涨超11%
Mei Ri Jing Ji Xin Wen· 2025-10-17 03:16
Core Viewpoint - Xuan Zhu Bio-B (02575.HK) has seen a significant increase in stock price, rising over 190% from its IPO price of 11.6 HKD, reaching a new high of 33.96 HKD during trading [2] Summary by Category - **Stock Performance** - The stock price of Xuan Zhu Bio-B increased by over 11%, reaching 32.2 HKD at the time of reporting [2] - The trading volume was reported at 54.043 million HKD [2] - **Market Reaction** - The stock hit a new high of 33.96 HKD during the trading session, marking a significant milestone since its listing [2]