Core Viewpoint - The approval of the new indication for Pyrotinib (brand name: XuanYueNing) for first-line treatment of HR+/HER2- advanced breast cancer significantly enhances its clinical value and accessibility, supporting future sales growth for the company [1]. Company Summary - Four Seasons Pharmaceutical (00460) announced that its subsidiary, XuanZhu Biotechnology Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the new indication of Pyrotinib in combination with aromatase inhibitors for first-line treatment of HR+/HER2- advanced breast cancer [1]. - This marks the third approved indication for Pyrotinib in China, making it the first and only drug in the country to cover the entire treatment course for HR+/HER2- advanced breast cancer across first, second, and later lines [1]. Industry Summary - Breast cancer is the most commonly diagnosed malignant tumor among women globally, with new cases in China projected to rise from 322,200 in 2018 to 374,700 in 2024, and expected to reach 435,000 by 2032 [2]. - HR+/HER2- breast cancer is the most prevalent subtype in China, accounting for approximately 75% of total cases, with about 30% of these patients diagnosed with advanced breast cancer [2]. - The market for CDK4/6 inhibitors combined with endocrine therapy for HR+/HER2- advanced breast cancer in China is expected to reach RMB 13 billion by 2032 [2]. Clinical Research Summary - The approval of the new indication is based on data from the BRIGHT-3 study (NCT05257395), a randomized, double-blind Phase III clinical trial conducted at 58 centers in China [3]. - The study aimed to evaluate the efficacy and safety of Pyrotinib in combination with Letrozole or Anastrozole for first-line treatment of HR+/HER2- advanced breast cancer [3]. - Results indicated that the median progression-free survival (mPFS) for the Pyrotinib group has not yet been reached, while the control group reported mPFS of 18.43 months and 19.55 months, suggesting a durable efficacy advantage for Pyrotinib [3]. - 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% reduction in patients with liver metastases [3]. - The overall response rate (ORR) in the intention-to-treat population for the Pyrotinib group was 63.5%, significantly higher than the control group's 42.5% [3]. - Common adverse events associated with the Pyrotinib regimen were mostly grade 1-2 and manageable through supportive care or dose adjustments, indicating an overall controllable safety profile [3].

本次新适应症的获批主要基于BRIGHT-3研究(NCT05257395)的数据结果。BRIGHT-3研究是一项在中国 58家中心开展的随机、双盲的III期临床试验，旨在评估吡洛西利联合来曲唑或阿那曲唑一线治疗 HR+/HER2-晚期乳腺癌的有效性和安全性。此前，BRIGHT-3的研究成果在2025年欧洲肿瘤内科学会 (2025年ESMO)首次发表。结果显示，在疗效方面，吡洛西利组由研究者和独立评审委员会评估的mPFS 均暂未达到，对照组分别为18.43个月和19.55个月。mPFS尚未达到，提示吡洛西利组有更多患者仍未发 生疾病进展，反映出其持久的疗效优势。与安慰剂联合内分泌治疗相比，吡洛西利方案可降低47%的疾 病进展或死亡风险，且尤其在预后较差的肝转移患者中，疾病进展或死亡风险大幅降低64%，显示出其 在难治人群中的突出潜力。在意向治疗人群中，吡洛西利组的ORR达63.5%，显著优于对照组的42.5%; 安全性方面，吡洛西利联合方案常见不良事件(如腹泻、中性粒细胞减少等)多为1–2级，可通过支持治 疗或剂量调整得以有效管理，整体安全性可控。 乳腺癌是全球女性最常见被诊断出的恶性肿瘤，灼识咨询报告显示，中国 ...

本次新适应症的获批主要基于BRIGHT-3研究(NCT05257395)的数据结果。BRIGHT-3研究是一项在中国 58家中心开展的随机、双盲的III期临床试验，旨在评估吡洛西利联合来曲唑或阿那曲唑一线治疗 HR+/HER2-晚期乳腺癌的有效性和安全性。此前，BRIGHT-3的研究成果在2025年欧洲肿瘤内科学会 (2025年ESMO)首次发表。结果显示，在疗效方面，吡洛西利组由研究者和独立评审委员会评估的mPFS 均暂未达到，对照组分别为18.43个月和19.55个月。mPFS尚未达到，提示吡洛西利组有更多患者仍未发 生疾病进展，反映出其持久的疗效优势。与安慰剂联合内分泌治疗相比，吡洛西利方案可降低47%的疾 病进展或死亡风险，且尤其在预后较差的肝转移患者中，疾病进展或死亡风险大幅降低64%，显示出其 在难治人群中的突出潜力。在意向治疗人群中，吡洛西利组的ORR达63.5%，显著优于对照组的42.5%; 安全性方面，吡洛西利联合方案常见不良事件(如腹泻、中性粒细胞减少等)多为1–2级，可通过支持治 疗或剂量调整得以有效管理，整体安全性可控。 四环医药(00460)发布公告，集团旗下非全资附属公司轩竹生物科 ...

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。 Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 （於百慕達註冊成立的有限公司） （股份代號：0460） 自願公告 軒悅寧® （吡 洛 西 利 片）第 三 個 適 應 症 上 市 申 請 獲 得NMPA批 准 用於一線治療HR+/HER2-晚期乳腺癌 吡 洛 西 利 片（商 品 名：軒 悅 寧®）作 為 國 內 首 個 獲 批 的CDK2/4/6抑 制 劑，其 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 制 劑 常 見 的 血 液 學 毒 性 等 優 勢。吡 洛 西 利 已 於 二 零 二 五 年 五 月 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 ...

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。 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 軒悅寧® （吡 洛 西 利 片）第 三 個 適 應 症 上 市 申 請 獲 得NMPA批 准， 用於一線治療HR+╱HER2-晚期乳腺癌 本次新適應症的獲批主要基於BRIGHT-3研究(NCT05257395)的數據結果。BRIGHT-3 研究是一項在中國58家 中 心 開 展 的 隨 機、雙 盲 的III期 臨 床 試 驗，旨 在 評 估 吡 洛 西利聯合來曲唑或阿那曲唑一線治療HR+╱HER2-晚期乳腺癌的有效性和安全 性。此 前，BRIGHT-3的研究成果在2025年 歐 洲 腫 瘤 內 科 學 會（「2025年ESMO」）首 次 發 表。結 果 顯 示，在 療 效 ...

Group 1 - The core point of the article is that XuanZhu Bio-B (02575) saw its stock price rise over 5%, reaching a high of 71.9 HKD, approaching its historical peak of 72 HKD, following the inclusion of its innovative drug, Pyrocilin, in the national basic medical insurance drug list [1] - The inclusion of Pyrocilin in the insurance list is expected to enhance its affordability and accessibility for patients, thereby promoting the drug's market penetration and sales growth, which will positively impact the long-term operational development of XuanZhu Bio [1] - Pyrocilin, a new CDK2/4/6 inhibitor, has shown strong efficacy in inhibiting tumor cell proliferation and was approved by the National Medical Products Administration of China for specific types of advanced or metastatic breast cancer patients in May 2025 [1] Group 2 - Both approved indications for Pyrocilin have been included in the 2025 national basic medical insurance directory, and an application for its use in first-line treatment in combination with aromatase inhibitors is currently under review [1]

Core Viewpoint - Xuan Bamboo Biotech-B (02575) shares rose nearly 3%, currently up 1.98% at HKD 66.95, with a trading volume of HKD 15.1953 million following the announcement of its innovative drug, Pirlosil, being included in the 2025 National Basic Medical Insurance Directory [1] Group 1 - The innovative drug Pirlosil (brand name: Xuan Yue Ning) has been included in the 2025 National Basic Medical Insurance Directory, which will be implemented on January 1, 2026 [1] - The inclusion in the insurance directory is expected to enhance the affordability and accessibility of Xuan Yue Ning for patients, thereby promoting market expansion and increasing sales scale [1] - The company plans to actively support the implementation of the insurance policy, continue to advance hospital access, expand core markets, and increase market coverage to improve patient access to medication [1]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The development of trispecific antibodies (TsAbs) is accelerating, with a focus on companies such as Zai Lab and Sanofi [18]. - The report highlights the performance of various sub-sectors within the industry, ranking them as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [12][13]. Summary by Sections Industry Performance - The A-share pharmaceutical index has increased by 1.3% this week and 2.5% year-to-date, outperforming the CSI 300 by 0.2% and 3.6% respectively [11]. - The H-share biotechnology index has shown a 0.3% increase this week and a 27.8% increase year-to-date, outperforming the Hang Seng Technology Index by -1.7% and 9.6% respectively [11]. Specific Company Recommendations - From a growth perspective, the report recommends focusing on innovative drug companies such as Zai Lab, Sanofi, and others [13]. - For undervalued stocks, it suggests looking into traditional Chinese medicine companies like Zai Lab and Dong-E E-Jiao [13]. - High dividend yield stocks are recommended from the traditional Chinese medicine sector, including Jiangzhong Pharmaceutical and Yunnan Baiyao [13]. Trispecific Antibodies Development - TsAbs are engineered antibodies capable of binding to three different antigen targets, offering enhanced therapeutic potential in cancer immunotherapy [18]. - Currently, no TsAbs have been approved for market, but several companies, including Zai Lab and Sanofi, are actively developing these therapies [18][32]. Clinical Progress - The report outlines the clinical stages of various TsAbs, noting that Zai Lab's ZG006 is among the leading candidates in clinical trials [32]. - Other notable candidates include those from companies like Sanofi and IBI3003 from Innovent Biologics, which are also in advanced clinical stages [32].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The development of trispecific antibodies (TsAbs) is accelerating, with a focus on companies such as Zai Lab and Sanofi [18]. - The report highlights the performance of various sub-sectors within the industry, ranking them as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [12][13]. - Specific stock selection strategies are recommended based on growth potential, valuation, dividend yield, and left-side investment opportunities [13]. Summary by Sections Industry Performance - The A-share pharmaceutical index has increased by 1.3% this week and 2.5% year-to-date, outperforming the CSI 300 by 0.2% and 3.6% respectively [11]. - The H-share biotechnology index has shown a 0.3% increase this week and a 27.8% increase year-to-date, outperforming the Hang Seng Technology Index by -1.7% and 9.6% respectively [11]. Trispecific Antibodies - TsAbs are engineered antibodies capable of binding to three different antigen targets, offering enhanced therapeutic potential in cancer immunotherapy [18]. - Currently, no TsAbs have been approved for market, but several companies, including Zai Lab and Sanofi, are actively developing these therapies [18][32]. Stock Recommendations - Growth-oriented stock picks focus on innovative drug companies such as Zai Lab, Sanofi, and others [13]. - For undervalued stocks, the report recommends traditional Chinese medicine companies like Zai Lab and Dong-E E-Jiao [13]. - High-dividend stocks are primarily found in the traditional Chinese medicine sector, with companies like Jiangzhong Pharmaceutical and Yunnan Baiyao highlighted [13]. Clinical Development - The report outlines the clinical stages of various trispecific antibody drugs, noting that the fastest progress is seen in Merck's Restoret, currently in phase 2b/3 trials [31]. - Domestic companies are also advancing in this area, with Zai Lab's ZG006 and others in clinical stages [32].