Core Viewpoint - Xuan Zhu Bio-B (02575) has seen a significant stock price increase, rising over 415% from its IPO price of 11.6 HKD to a peak of 59.85 HKD, reflecting strong market interest following the presentation of clinical trial results at the ESMO conference [1] Company Summary - Xuan Zhu Bio-B's stock price reached 59 HKD, with a trading volume of 183 million HKD, marking a 29.67% increase at the time of reporting [1] - The company presented the mid-analysis results of the BRIGHT-3 clinical trial, which evaluates the efficacy and safety of palbociclib combined with letrozole or anastrozole for first-line treatment of HR+/HER2- advanced breast cancer [1] - The BRIGHT-3 study is a randomized, double-blind Phase III clinical trial conducted at 58 centers in China [1] - Based on the mid-study data from BRIGHT-3, the National Medical Products Administration of China accepted the new drug application for palbociclib in combination with aromatase inhibitors for HR+/HER2- advanced breast cancer on May 14 [1]

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]

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]

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]

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].

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 ...

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]

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]

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]

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]