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轩竹生物-B再涨超9% 吡洛西利治疗乳腺癌相关临床数据于2025年ESMO公布
Zhi Tong Cai Jing· 2025-10-22 02:52
Core Viewpoint - Xuan Bamboo Biotech-B (02575) has seen its stock price increase by nearly 70% since its listing, with a recent rise of over 9% following the announcement of clinical trial results for its drug, Pyrocilin, in treating HR+/HER2- advanced breast cancer [1][2] Group 1: Stock Performance - As of the latest update, Xuan Bamboo Biotech-B's stock price is reported at 49.28 HKD, with a trading volume of 12.67 million HKD [1] - The stock has experienced a cumulative increase of approximately 70% since its initial public offering [1] Group 2: Clinical Trial Results - On October 22, 2025, Xuan Bamboo Biotech-B announced the presentation of mid-term analysis results from the Phase III clinical trial (BRIGHT-3) at the 2025 European Society for Medical Oncology (ESMO) [1] - The mid-term data from the BRIGHT-3 study has led to the acceptance of a new drug application by the National Medical Products Administration of China for Pyrocilin in combination with aromatase inhibitors for HR+/HER2- advanced breast cancer [1] Group 3: Drug Approval and Mechanism - Pyrocilin (brand name: Xuan Yuening) is a novel CDK2/4/6 inhibitor that exhibits a unique multi-target synergistic mechanism, effectively inhibiting tumor cell proliferation while significantly reducing common hematological toxicities associated with traditional CDK4/6 inhibitors [2] - On May 13, 2025, Pyrocilin received approval from the National Medical Products Administration of China for use in patients with disease progression after prior endocrine therapy, making it the first and only CDK4/6 inhibitor approved for single-agent indication in China [2]
港股异动 | 轩竹生物-B(02575)再涨超9% 吡洛西利治疗乳腺癌相关临床数据于2025年ESMO公布
Zhi Tong Cai Jing· 2025-10-22 02:06
Group 1 - Xuan Bamboo Biotech-B (02575) has seen its stock price increase by nearly 70% since its listing, with a recent rise of over 9% to HKD 49.28, and a trading volume of HKD 12.6681 million [1] - On October 22, 2025, Xuan Bamboo Biotech-B announced the presentation of mid-analysis results from the clinical III phase (BRIGHT-3) study on the combination of palbociclib with letrozole or anastrozole for HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) [1] - The China National Medical Products Administration accepted the new drug application for palbociclib combined with aromatase inhibitors (AI) for HR+/HER2- advanced breast cancer on May 14, 2025, based on the mid-term data from the BRIGHT-3 study [1] Group 2 - Palbociclib (brand name: Xuan Yue Ning) is a novel CDK2/4/6 inhibitor with a unique multi-target synergistic mechanism, effectively inhibiting tumor cell proliferation and significantly reducing the hematological toxicity commonly associated with traditional CDK4/6 inhibitors [2] - On May 13, 2025, palbociclib was approved by the China National Medical Products Administration for use in combination with fulvestrant for patients who have progressed after prior endocrine therapy, and as a monotherapy for patients who have progressed after receiving two or more endocrine therapies and one chemotherapy, making it the first and only CDK4/6 inhibitor approved for monotherapy indications in China [2]
轩竹生物-B: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
Zhi Tong Cai Jing· 2025-10-21 22:57
Core Viewpoint - Xuan Bamboo Biotech has presented interim analysis results of the BRIGHT-3 clinical trial at the 2025 ESMO, demonstrating the efficacy and safety of Pyrotinib combined with letrozole or anastrozole in treating HR+/HER2- advanced breast cancer [1][2] Group 1: Clinical Trial Overview - 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] - The trial aims to evaluate the effectiveness and safety of Pyrotinib in combination with letrozole or anastrozole as a first-line treatment [1] Group 2: Efficacy Results - As of January 10, 2025, with a median follow-up of 20.7 months, the mPFS for the Pyrotinib group has not yet been reached, while the control group reported mPFS of 18.43 months and 19.55 months [2] - The Pyrotinib regimen reduces the risk of disease progression or death by 47% compared to the placebo combined with endocrine therapy, with a notable 64% reduction in patients with liver metastases [2] - The overall response rate (ORR) in the intention-to-treat population for the Pyrotinib group is 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 are mostly grade 1-2, including diarrhea and neutropenia, which can be effectively managed through supportive care or dose adjustments [2] Group 4: Regulatory Status - 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, significantly reducing the hematological toxicity commonly associated with traditional CDK4/6 inhibitors [3] - It received approval from the National Medical Products Administration of China on May 13, 2025, for use in patients who have progressed after prior endocrine therapy, making it the first and only CDK4/6 inhibitor approved for monotherapy indications in China [3]
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 ...
四环医药:医美爆发+创新药兑现,估值洼地正在被填平
Zhi Tong Cai Jing· 2025-09-05 01:09
Core Viewpoint - The influx of southbound capital has turned Hong Kong stocks into a "reservoir" for Asian capital, with significant investments flowing into the healthcare sector, particularly in companies like Four Seasons Pharmaceutical [1][3]. Group 1: Capital Inflow and Market Performance - As of September 3, 2025, southbound funds through the Hong Kong Stock Connect have totaled approximately 935.997 billion RMB, with the Hang Seng healthcare sector seeing a net inflow of 163.683 billion RMB [1]. - Four Seasons Pharmaceutical has experienced a substantial increase in stock holdings by southbound funds, rising from 528 million shares at the beginning of the year to 1.321 billion shares by September 3, representing an increase in ownership from 8.83% to 14.15% of total shares [1]. - The stock price of Four Seasons Pharmaceutical has surged over 140% year-to-date, reflecting strong market confidence [3]. Group 2: Financial Performance and Business Segments - Four Seasons Pharmaceutical has entered a profit turnaround phase, achieving a total revenue of approximately 1.146 billion RMB in the first half of 2025, a year-on-year increase of 20.7%, and a net profit of approximately 103 million RMB [4]. - The company's gross margin improved to 66.1%, up from 64.2% in the same period last year, indicating effective cost control and product optimization [4]. - The medical aesthetics segment is the primary revenue driver, generating approximately 580 million RMB in revenue, a year-on-year increase of 81.3%, with segment profit soaring by 215.3% [4]. - The innovative drug segment also showed significant growth, with revenue reaching 58 million RMB, a year-on-year increase of 96.6%, primarily driven by the sales of diabetes medications [4]. Group 3: R&D and Product Development - Research and development expenditures decreased by 21.9% to 153 million RMB, reflecting a shift towards commercialization as core products enter the market [5]. - The company has established a comprehensive product line in the medical aesthetics sector, including various injectables and devices, with significant market penetration [7]. - Four Seasons Pharmaceutical is actively exploring AI applications in medical aesthetics, aiming to enhance product development and market competitiveness [7]. Group 4: Dividend Policy and Market Valuation - The company announced an interim cash dividend of 0.99 RMB per share, continuing its history of consistent dividends since its listing in 2010, which reflects management's confidence in future cash flows [6]. - As of September 3, 2025, the market capitalization of Four Seasons Pharmaceutical was 15.1 billion HKD, while the estimated valuation of its medical aesthetics business and cash reserves exceeds 17.3 billion HKD, indicating that the market has not assigned any value to its innovative drug segment [15][17]. - The management has demonstrated confidence in the company's future by executing 12 share buybacks in 2025, totaling approximately 94.867 million RMB [15].
四环医药(00460)发盈喜 预计中期净利润不低于5000万元
智通财经网· 2025-08-01 14:16
Core Insights - The company expects to achieve revenue of no less than RMB 1.1 billion and net profit of no less than RMB 50 million for the six months ending June 30, 2025 [1] - The financial performance during this period is influenced by several factors, including significant growth in the medical aesthetics business, the maturation of innovative drug operations, a narrowing decline in the generic drug sector, and a strong financial position with ample cash reserves [1] Group 1 - The medical aesthetics business is projected to grow at a rate of 50%-60% compared to the same period last year [1] - The innovative drug segment is entering a harvest phase, with reduced R&D expenses, a steady stream of new product approvals, and successful commercialization efforts [1] - The decline in the generic drug business is narrowing year by year [1] - The company maintains a robust financial status with substantial cash on hand [1] Group 2 - From January 2024 to July 2025, the company has received approvals for 41 new medical aesthetics and pharmaceutical products, including nine medical aesthetics products and 32 pharmaceutical products [2] - Key products include self-developed medical devices and innovative drugs, which are expected to drive future revenue and profit growth [2] - The company is confident about its future development prospects due to the simultaneous launch of numerous significant new products [2]
四环医药(00460.HK)盈喜:预期中期净利润不低于5000万元
Ge Long Hui· 2025-08-01 14:14
Group 1 - The company expects to achieve revenue of no less than RMB 1.1 billion and net profit of no less than RMB 50 million for the six months ending June 30, 2025 [1] - Key factors influencing the financial performance include a high growth rate in the medical aesthetics business, with an increase of 50%-60% compared to the same period last year [1] - The innovative drug business is entering a harvest period, with a gradual reduction in R&D expenses and a steady stream of new product approvals contributing to revenue growth [1] Group 2 - A total of 41 new medical aesthetics and pharmaceutical products have been approved for market launch from January 2024 to July 2025, including nine medical aesthetics products and 32 pharmaceutical products [2] - The launch of multiple heavyweight new products is expected to provide strong momentum for future revenue and profit growth, instilling confidence in the company's development prospects [2]
四环医药发盈喜 预计中期净利润不低于5000万元
Zhi Tong Cai Jing· 2025-08-01 14:13
Group 1 - The company expects to achieve revenue of no less than RMB 1.1 billion and net profit of no less than RMB 50 million for the six months ending June 30, 2025 [1] - Key factors influencing the financial performance include a high growth rate in the medical aesthetics business, with an expected increase of 50%-60% compared to the same period last year [1] - The innovative drug business is entering a harvest phase, with reduced R&D expenses and a steady stream of new product approvals contributing to revenue growth [1] - The decline in the generic drug business is narrowing year by year, indicating improved performance in this segment [1] - The company's financial position is robust, with ample cash reserves [1] Group 2 - From January 2024 to July 2025, the company has 41 new medical aesthetics and pharmaceutical products approved for launch, including nine medical aesthetics products and 32 pharmaceutical products [2] - Notable products include self-developed medical devices and innovative drugs, which are expected to drive significant future revenue and profit growth [2] - The company is confident about its future development prospects due to the simultaneous launch of multiple heavyweight new products [2]