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。 （股份代號：2575） 自願性公告 NG-350A獲授美國FDA快速通道資格認定 軒 竹 生 物 科 技 股 份 有 限 公 司（「本公司」或「軒竹生物」，連 同 其 附 屬 公 司，統 稱 為 「本集團」）董 事 會（「董事會」）欣 然 宣 佈，本 集 團 從 臨 床 階 段 腫 瘤 公 司Akamis Bio Ltd.（「Akamis」）授 權 引 進 的 產 品NG-350A獲 得 美 國 食 品 藥 品 監 督 管 理 局（「FDA」） 授予快速通道資格(Fast Track designation)，用 於 治 療 錯 配 修 復 功 能 完 整(pMMR)的 局部晚期直腸癌(LARC)。本 集 團 擁 有NG-350A產 品 的 大 中 華 區 開 發、生 產 與 商 業 化 的 獨 家 權 利。有 關 與Akamis的授權協議及NG- ...

Core Viewpoint - Xuan Zhu Bio-B (02575.HK) has seen a significant increase in its stock price, rising over 5% to reach 62.65 HKD with a trading volume of 23.5573 million HKD [2] Company Summary - The stock price of Xuan Zhu Bio-B increased by 5.12% [2] - The current trading price is 62.65 HKD [2] - The total trading volume reported is 23.5573 million HKD [2]

Core Viewpoint - XuanZhu Biotech-B (02575) has seen a stock increase of over 5%, currently trading at 62.65 HKD with a transaction volume of 23.56 million HKD, following the announcement of positive interim results from the BRIGHT-3 clinical trial for its drug, Pyrotinib, in treating HR+/HER2- advanced breast cancer [1][1][1] Group 1 - XuanZhu Biotech presented interim analysis results of the Phase III BRIGHT-3 trial at the 2025 European Society for Medical Oncology (ESMO), showcasing the efficacy of Pyrotinib in combination with letrozole or anastrozole for first-line treatment of HR+/HER2- advanced breast cancer [1][1][1] - The China National Medical Products Administration officially accepted the new drug application for Pyrotinib combined with aromatase inhibitors (AI) for HR+/HER2- advanced breast cancer on May 14, 2025, based on the interim data from the BRIGHT-3 study [1][1][1] Group 2 - Pyrotinib is a novel CDK2/4/6 inhibitor with a multi-target synergistic mechanism that effectively suppresses tumor cell proliferation and significantly reduces common hematological toxicities associated with traditional CDK4/6 inhibitors [1][1][1] - In May 2023, Pyrotinib was approved in China for use in adult patients with HR+/HER2- advanced or metastatic breast cancer, either in combination with fulvestrant for patients with disease progression after prior endocrine therapy or as a monotherapy for patients who have experienced disease progression after two or more endocrine therapies and one chemotherapy [1][1][1]

Core Viewpoint - XuanZhu Biotech-B has seen a significant increase in its market capitalization, surpassing HKD 30 billion within a week of its Hong Kong listing, driven by positive clinical trial results for its drug, Pyrocilin, in breast cancer treatment [2][5][6]. Company Performance - On October 22, XuanZhu Biotech-B's stock price reached a high of HKD 61.500, doubling from its opening price on the first trading day, with a closing price of HKD 60.000, reflecting a 31% increase on that day and a 417% rise from the issue price [2][4]. - The company reported a trading volume of HKD 278 million on October 22, with a slight decline of 0.83% on October 23 [2]. Clinical Trial Results - XuanZhu Biotech presented interim analysis results of the BRIGHT-3 clinical trial at the 2025 European Society for Medical Oncology (ESMO), showcasing the potential of Pyrocilin in treating HR+/HER2- advanced breast cancer [2][5]. - The BRIGHT-3 trial involved 397 patients and indicated that the Pyrocilin group had a 63.5% objective response rate (ORR), significantly higher than the control group's 42.5% [6]. Market Context - The Hong Kong biotech sector is currently experiencing a correction, with the biotech index declining over the past three weeks, indicating a challenging environment for innovation drugs [7]. - Despite the overall market downturn, XuanZhu Biotech's stock performance stands out, alongside other companies like Yaojie Ankang and Boan Biotech, which also saw price increases [7]. Financial Health - XuanZhu Biotech reported revenues of HKD 17.893 million in the first half of the year, with a total loss of approximately HKD 111 million, highlighting the financial challenges faced by many biotech firms in the Hong Kong market [9].

Core Viewpoint - XuanZhu Bio (02575.HK) experienced a slight decline in stock price after its recent IPO, closing at 59.5 HKD per share, with a market capitalization of 30.8 billion HKD, despite a significant increase of approximately 417% from its initial offering price during its first six trading days [1][4]. Company Overview - Founded in 2018 and headquartered in Shijiazhuang, Hebei, XuanZhu Bio is an innovative pharmaceutical company focusing on major diseases such as digestive disorders, cancer, and non-alcoholic fatty liver disease [4]. - The company has developed a diverse product pipeline that includes small molecule drugs, large molecule biologics, and antibody-drug conjugates (ADCs), with three commercialized products and over ten projects in development [4]. IPO and Stock Performance - XuanZhu Bio officially listed on the Hong Kong Stock Exchange on October 15, 2023, with its stock price surging by 153.97% on the first day to close at 29.46 HKD per share [4]. - The stock price peaked at over 61 HKD per share on October 22, 2023, reflecting a market capitalization nearing 32 billion HKD [1][4]. Key Products and Clinical Data - The company's stock performance is linked to promising clinical data for its drug Pyrotinib, which was presented at the 2025 European Society for Medical Oncology (ESMO) conference, showing efficacy and safety in treating HR+/HER2- advanced breast cancer [5]. - Pyrotinib is a novel CDK2/4/6 inhibitor approved in May 2023 for specific breast cancer indications, while another core product, KBP-3571, is the first domestically developed proton pump inhibitor (PPI) targeting digestive diseases [6][7]. Financial Performance - Despite the stock price increase, XuanZhu Bio has not yet achieved profitability, reporting revenues of 40.92 million CNY, 37.74 million CNY, and 21.97 million CNY for 2023, 2024, and 2025 respectively, with net losses of 301 million CNY, 556 million CNY, and 111 million CNY during the same periods [8]. - The company attributes the increased losses to reduced revenue and rising research and development expenses [8]. Competitive Landscape - XuanZhu Bio faces significant competition for its core products, with KBP-3571 competing against seven similar products, five of which are generic drugs included in centralized procurement [8][9]. - Pyrotinib and XZP-3621 also encounter fierce competition, with multiple approved alternatives in the market and several others in the approval pipeline [9].

Summary of Key Points Group 1: 52-Week Highs - A total of 45 stocks reached their 52-week highs as of October 23, with notable performers including Base Champion Group (08460) at 234.56%, Tianjin Chuangye Environmental Protection Co., Ltd. (01065) at 136.88%, and Liji Engineering Holdings (01690) at 80.26% [1] - The closing prices and peak prices for the top three stocks are as follows: Base Champion Group closed at 0.250 with a peak of 0.455, Tianjin Chuangye at 4.880 with a peak of 10.020, and Liji Engineering at 0.105 with a peak of 0.137 [1] Group 2: 52-Week Lows - The report also highlighted stocks that reached their 52-week lows, with Huaxi Holdings (01689) showing a decline of 16.67%, China New Economy Equity (02958) down by 14.17%, and Agile Holdings (00186) down by 13.16% [2] - The closing prices and lowest prices for the top three declining stocks are: Huaxi Holdings at 0.400 with a low of 0.350, China New Economy at 0.123 with a low of 0.103, and Agile Holdings at 0.165 with a low of 0.165 [2]

Core Viewpoint - The ESMO annual meeting serves as a significant platform for innovative drug companies to disclose critical clinical data, which often catalyzes stock price increases for the companies involved [1] Group 1: Clinical Data and Market Reaction - XuanZhu Biotech presented promising Phase III clinical data for Pyrotinib at the ESMO conference, demonstrating efficacy and safety advantages [1] - Following the announcement, XuanZhu Biotech's stock surged by 31.87%, reaching a new high, reflecting market confidence in the clinical results and the company's future [1] Group 2: Clinical Trial Insights - The randomized double-blind trial involved 397 patients across 58 centers in China, showing that the combination of Pyrotinib with Letrozole or Anastrozole significantly outperformed the control group in terms of median progression-free survival (mPFS) and objective response rate (ORR) [2] - The mPFS was not reached at a median follow-up of 20.7 months, while the ORR was 63.5%, 21 percentage points higher than the control group [2] - The risk of disease progression or death was reduced by 47%, with a 64% reduction in liver metastasis patients, indicating clear therapeutic advantages [2] Group 3: Comprehensive Treatment Strategy - Pyrotinib's data represents a key component of its "full-cycle treatment strategy," having received approval for two indications earlier this year [3] - The drug is positioned to cover the entire treatment spectrum from late-line to first-line therapy, enhancing its market potential [3] Group 4: Competitive Advantages - Pyrotinib has established a unique competitive barrier through its efficacy, safety, and broad indications, outperforming competitors in key metrics [5] - The ORR of 63.5% for Pyrotinib in first-line treatment is significantly higher than that of similar products, indicating its long-term benefit potential [6] - Pyrotinib is the first and only CDK4/6 inhibitor approved for single-agent use in China, filling a critical gap in the treatment of difficult-to-treat breast cancer patients [6] Group 5: Market Potential and Evidence Support - The commercial potential of Pyrotinib is bolstered by strong clinical evidence and progress in reimbursement approval [8] - The drug has established a credible evidence base through publications in top journals and inclusion in clinical guidelines, enhancing trust among healthcare providers [9] - Pyrotinib has passed the initial review for inclusion in the national medical insurance directory, which is expected to significantly boost its sales [10] Group 6: Future Outlook - The successful approval of Pyrotinib for first-line treatment and its anticipated inclusion in the insurance directory could lead to substantial revenue growth for XuanZhu Biotech [10] - The product's comprehensive indication coverage and superior efficacy data position it well for market penetration, potentially replicating or exceeding the sales growth seen with similar products [10] - Pyrotinib's presence at ESMO symbolizes a shift for domestic innovative drugs from "catching up" to "leading," with its clinical advancements and reimbursement progress warranting ongoing investor attention [12]

Core Viewpoint - The stock price of Xuan Bamboo Biotech-B (02575.HK) surged significantly on its sixth trading day, reaching a market capitalization of over HKD 30 billion, driven by positive clinical data related to its drug, palbociclib, for breast cancer treatment [2][3]. Company Performance - On October 22, the company's stock opened strongly, peaking at HKD 61.50 per share, doubling from its initial listing price, and closing with a gain of over 31% at HKD 60 per share, representing an increase of approximately 417% from the issue price [2]. - The trading volume for the day was HKD 278 million, indicating strong investor interest [2]. Clinical Data Impact - The stock's rise is closely linked to the announcement of interim results from the BRIGHT-3 clinical trial, which evaluated palbociclib in combination with letrozole or anastrozole for HR+/HER2- advanced breast cancer [3][4]. - The BRIGHT-3 study involved 397 patients and showed that the palbociclib group had a significant reduction in the risk of disease progression or death by 47% compared to the control group, with a notable 64% reduction in patients with liver metastases [4]. Market Context - The Hong Kong biotech sector is currently experiencing a correction phase, with the innovation drug index having declined for three consecutive weeks, dropping from 1660.66 in mid-September to 1404.39 by October 22 [5][6]. - Despite the overall market downturn, Xuan Bamboo Biotech's stock managed to rise, contrasting with other companies in the sector that have seen declines despite positive news [5][6]. Financial Health - For the first half of the year, the company reported revenues of HKD 17.89 million and a total loss of approximately HKD 111 million, highlighting the challenges faced by biotech firms in achieving profitability [7]. - The competitive landscape for its pipeline products is intense, with multiple similar drugs already on the market or in development, posing risks to future revenue generation [7].

Key Points - As of October 22, 34 stocks reached their 52-week highs, with HaiNa Intelligent (01645), XuanZhu Bio-B (02575), and 1957 & CO. (08495) leading the high rate at 37.57%, 35.16%, and 28.57% respectively [1] - The highest closing prices among the top three stocks were 2.560, 60.000, and 0.360 [1] - Other notable stocks that reached new highs include FuTong Technology (00465) with a high rate of 26.19% and BiaoZhun Development Group (01867) at 17.31% [1] 52-Week Highs Summary - HaiNa Intelligent (01645) closed at 2.560 with a peak of 2.600, achieving a high rate of 37.57% [1] - XuanZhu Bio-B (02575) closed at 60.000 with a peak of 61.500, achieving a high rate of 35.16% [1] - 1957 & CO. (08495) closed at 0.360 with a peak of 0.360, achieving a high rate of 28.57% [1] 52-Week Lows Summary - Vietnam Manufacturing Processing Export (00422) reached a low rate of -19.44% with a closing price of 0.300 [2] - TianHuo Cultural Creativity (08500) had a low rate of -12.45% with a closing price of 0.234 [2] - ShanGao Holdings (00412) recorded a low rate of -10.28% with a closing price of 2.660 [2]

Core Viewpoint - XuanZhu Biotech-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 [1] Company Developments - XuanZhu Biotech announced the presentation of clinical III phase results for the BRIGHT-3 study at the 2025 European Society for Medical Oncology (ESMO) conference, focusing on the combination of palbociclib with letrozole or anastrozole for HR+/HER2- advanced breast cancer [1] - The BRIGHT-3 study is a randomized, double-blind clinical trial conducted at 58 centers in China, aimed at evaluating the efficacy and safety of palbociclib combined with aromatase inhibitors in first-line treatment for HR+/HER2- advanced breast cancer [1] - Based on the mid-term data from the BRIGHT-3 study, 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]