股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 中國生物製藥有限公司 呈交日期: 2025年9月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01177 | 說明 | - | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 30,000,000,000 | HKD | | 0.025 | HKD | | 750,000,000 | | 增加 / 減少 (-) | | | 0 | | | | HKD | | 0 | | 本月底結存 | | | 30,000,000,000 | HKD | | 0.025 | HKD | | 750,000,000 ...

Core Viewpoint - The performance of innovative pharmaceutical companies in China for the first half of 2025 is impressive, with significant revenue and profit growth driven by innovative drug sales, indicating a potential recovery in the pharmaceutical industry [1][3][10]. Summary by Sections Company Performance - Heng Rui Pharmaceutical achieved a revenue of 15.761 billion yuan, a year-on-year increase of 15.88%, and a net profit of 4.450 billion yuan, up 29.67%. Innovative drug sales accounted for 60.66% of total revenue [3][12]. - Bai Jie Shen Zhou reported total revenue of 17.518 billion yuan, a 46.0% increase, with a net profit of 450 million yuan, marking a turnaround from losses. The sales of its key products, including the BTK inhibitor and PD-1 inhibitor, significantly contributed to this growth [3][7]. - Xin Da Biotech achieved revenue of 5.953 billion yuan, a 50.6% increase, and a net profit of 1.213 billion yuan, compared to a loss in the previous year, driven by strong sales of its PD-1 inhibitor and new weight-loss drug [8]. - Xian Sheng Pharmaceutical reported a revenue increase of 15.1% to 3.585 billion yuan, with innovative drug revenue reaching 2.776 billion yuan, accounting for 77.4% of total revenue [9]. Market Trends - The rising proportion of innovative drug revenue among multiple pharmaceutical companies suggests a shift towards innovation-driven strategies, with increasing market demand for innovative products supported by healthcare policies [10][20]. - Business Development (BD) activities are becoming crucial for growth, with significant deals indicating a robust international presence for Chinese innovative drug companies [12][13]. Challenges and Outlook - Despite the positive trends, companies face challenges such as intense market competition, high project uncertainty, and increasing accounts receivable [18]. - Some companies, like Bai Li Tian Heng and Bei Da Pharmaceutical, reported declines in net profit due to high R&D costs and overdue payments to partners, highlighting the risks associated with innovation investments [18][19]. - Overall, the industry is transitioning from a low point to a recovery phase, with expectations for sustained growth in the innovative drug sector driven by efficiency and cost advantages [20].

Group 1 - The core point of the article is the approval of the oral HER2 tyrosine kinase inhibitor, Saint Heru (Zong Aitini), for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 activation mutations in mainland China [1] - Saint Heru is the first and currently the only approved oral HER2 tyrosine kinase inhibitor in the industry, addressing a significant unmet medical need in lung cancer treatment [1] - The approval reflects the high recognition of the clinical value of this innovative drug by the National Medical Products Administration, as it received "breakthrough therapy designation" and "priority review" status, leading to accelerated approval [1] Group 2 - The strategic partnership between Boehringer Ingelheim and China National Pharmaceutical Group aims to bring innovative oncology therapies to the mainland Chinese market [2] - The collaboration will focus on multiple innovative oncology products from Boehringer Ingelheim that are in late-stage clinical development, enhancing the treatment options available for cancer patients in China [2]

Performance Summary - China Railway Construction (01186.HK) reported a revenue of 489.2 billion yuan, a decrease of 5.2% year-on-year, with a net profit of approximately 10.7 billion yuan, down 10.1% [2] - Industrial and Commercial Bank of China (01398.HK) achieved a revenue of 409.1 billion yuan, an increase of 1.8% year-on-year, while net profit fell by 1.4% to 168.1 billion yuan [2] - Agricultural Bank of China (01288.HK) recorded a revenue of 369.79 billion yuan, up 0.7% year-on-year, and a net profit of 139.51 billion yuan, an increase of 2.66% [2] - China Construction Bank (00939.HK) reported a revenue of 385.91 billion yuan, a 3% increase year-on-year, with net profit around 162.08 billion yuan, down 1.4% [2] - Bank of China (03988.HK) had a revenue of 329.42 billion yuan, up 3.61% year-on-year, while net profit decreased by 0.85% to 117.59 billion yuan [2] - Postal Savings Bank of China (01658.HK) reported a revenue of 179.53 billion yuan, a 1.5% increase year-on-year, with net profit of 49.23 billion yuan, up 0.85% [2] - China Merchants Bank (03968.HK) achieved a revenue of 169.92 billion yuan, down 1.7% year-on-year, while net profit increased by 0.3% to 74.93 billion yuan [2] - Bank of Communications (03328.HK) reported a revenue of 133.50 billion yuan, up 0.7% year-on-year, with net profit of 46.02 billion yuan, an increase of 1.6% [2] - Minsheng Bank (01988.HK) had a revenue of 70.70 billion yuan, up 7.8% year-on-year, while net profit decreased by 4.9% to 21.38 billion yuan [2] - China Everbright Bank (06818.HK) reported a revenue of 65.95 billion yuan, down 5.6% year-on-year, with net profit of 24.62 billion yuan, an increase of 0.55% [2] - BYD Company (01211.HK) achieved a revenue of 371.28 billion yuan, up 23.3% year-on-year, with net profit of 15.51 billion yuan, an increase of 13.8% [2] - China Communications Construction Company (01800.HK) reported a revenue of 335.45 billion yuan, down 5.8% year-on-year, with net profit of 9.99 billion yuan, down 16.9% [2] - Lenovo Holdings (03396.HK) achieved a revenue of 281.59 billion yuan, up 21% year-on-year, with net profit of 699 million yuan, an increase of 144% [2] - Great Wall Motors (02333.HK) reported a revenue of 92.34 billion yuan, up 1% year-on-year, with net profit of 6.34 billion yuan, down 10.2% [2] - BYD Electronics (00285.HK) achieved a revenue of 80.61 billion yuan, up 2.6% year-on-year, with net profit of 1.73 billion yuan, an increase of 14% [2] - Country Garden (02007.HK) reported a revenue of 72.57 billion yuan, with a net loss of 19.078 billion yuan [2] - China Reinsurance (01508.HK) achieved a revenue of 61.03 billion yuan, up 0.6% year-on-year, with net profit of 6.244 billion yuan, an increase of 9.03% [2] - Yanzhou Coal Mining Company (01171.HK) reported a revenue of 53.966 billion yuan, down 13.17% year-on-year, with net profit of 4.731 billion yuan, down 38.7% [2] - Jitu Express (01519.HK) achieved a revenue of 5.499 billion USD, up 13.1% year-on-year, with net profit of 156 million USD, an increase of 147.1% [2] - AVIC Industry (02357.HK) reported a revenue of 37.465 billion yuan, up 11.43% year-on-year, with net profit of 1.03 billion yuan, down 17.67% [2] - CITIC Financial Assets (02799.HK) achieved a revenue of 31.136 billion yuan, up 2.9% year-on-year, with net profit of 6.168 billion yuan, an increase of 15.7% [2] - Bank of China Hong Kong (02388.HK) reported a net interest income of 25.06 billion HKD, down 3.5% year-on-year, with net profit of 22.12 billion HKD, an increase of 10.54% [2] - Zoomlion Heavy Industry (01157.HK) achieved a revenue of 24.855 billion yuan, up 1.3% year-on-year, with net profit of 2.765 billion yuan, an increase of 20.84% [2] - New Town Development (01030.HK) reported a revenue of 22.1 billion yuan, down 34.82% year-on-year, with net profit of 895 million yuan, down 32.11% [2] - Huatai Securities (06886.HK) achieved a revenue of approximately 20.98 billion yuan, up 5.86% year-on-year, with net profit of 7.549 billion yuan, an increase of 42.16% [2] - China Sanjiang Chemical (02198.HK) reported a revenue of 9.106 billion yuan, down 1.5% year-on-year, with net profit of 301 million yuan, an increase of 95.5% [2] - Tianjin Bank (01578.HK) achieved a revenue of 8.828 billion yuan, up 0.8% year-on-year, with net profit of 1.988 billion yuan, an increase of 1.1% [2] - Harbin Bank (06138.HK) reported a revenue of 7.386 billion yuan, up 2.6% year-on-year, with net profit of 915 million yuan, an increase of 20% [2] - Qingjian International (01240.HK) achieved a revenue of approximately 4.404 billion HKD, down 9.8% year-on-year, with net profit of 2.992 million HKD, an increase of 25.6% [2] - Xingye Alloy (00505.HK) reported a revenue of 4.389 billion yuan, up 22.1% year-on-year, with net profit of 106 million yuan, down 24.7% [2] - 3SBio (01530.HK) achieved a revenue of 4.355 billion yuan, down 0.8% year-on-year, with net profit of 1.358 billion yuan, an increase of 24.6% [2] - Huya Technology (01860.HK) reported a revenue of 938 million USD, up 47% year-on-year, with adjusted EBITDA of 88.681 million USD, an increase of 41% [2] - Haitong Securities (01905.HK) achieved a revenue of 3.521 billion yuan, down 12.6% year-on-year, with net profit of 785 million yuan, down 3.4% [2] - Dazhong Public Utilities (01635.HK) reported a revenue of approximately 3.449 billion yuan, down 5.8% year-on-year, with net profit of approximately 333 million yuan, an increase of 172.6% [2] Company News - China Biologic Products (01177.HK) received approval for the launch of Zongaitini tablets for the treatment of HER2-mutant non-small cell lung cancer [3] - Shandong High-Speed New Energy (01250.HK) reported a total operating power generation of approximately 3.6744 million MWh, an increase of approximately 6.9% year-on-year [3] - Fosun International (00656.HK) reached a settlement with Cainiao regarding a share buyback involving 350 million USD [3] Buyback Activities - Tencent Holdings (00700.HK) repurchased approximately 55 million HKD worth of shares, buying back 919,000 shares at prices ranging from 594.5 to 605 HKD [3] - China Hongqiao (01378.HK) repurchased approximately 22.7 million HKD worth of shares, buying back 8.9235 million shares at a price of 25.44 HKD [3] - HSBC Holdings (00005.HK) repurchased approximately 15.3 million HKD worth of shares, buying back 1.5276 million shares at prices ranging from 99.8 to 100.7 HKD [3] - Hang Seng Bank (00011.HK) repurchased approximately 2.3517 million HKD worth of shares, buying back 210,000 shares at prices ranging from 111.5 to 112.5 HKD [3] - MGM China (02282.HK) repurchased approximately 1.60602 million HKD worth of shares, buying back 1 million shares at prices ranging from 15.92 to 16.27 HKD [3] - Sinopec Engineering (02386.HK) canceled 136,500 shares that had been repurchased [3]

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 3.62% on August 29, with a trading volume of 2.004 billion yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of August 28, 2024, the fund's latest share count was 6.619 billion, with a total size of 6.126 billion yuan, reflecting an increase of 1574.08% in shares and 1521.35% in size year-to-date [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 85.10% during the tenure [2] - The top holdings of the fund include Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant weightings such as 9.52% for Innovent Biologics and 9.47% for WuXi Biologics [2] - The fund's recent trading activity shows a cumulative trading amount of 34.226 billion yuan over the last 20 trading days, averaging 1.711 billion yuan per day [1]

Core Viewpoint - China National Medical Products Administration has approved the listing of Zongaitini tablets (brand name: Shenghetu®) for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have received at least one prior systemic therapy [1] Group 1: Product Approval - Zongaitini tablets are the first and currently the only approved oral HER2 tyrosine kinase inhibitor globally [1] - The conditional approval in China is based on positive results from the Beamion-LUNG1 study, which evaluated the efficacy and safety of Zongaitini in patients with advanced NSCLC harboring HER2 (ERBB2) mutations [1] Group 2: Clinical Data - In the treated cohort of previously treated patients (N=75), the objective response rate (ORR) reached 71% (95% CI: 60-80), with 7% achieving complete response [1] - The disease control rate (DCR) was as high as 96%, with a median duration of response (DoR) of 14.1 months and a median progression-free survival (PFS) of 12.4 months [1] - The safety profile of Zongaitini is manageable, with a treatment interruption rate of only 2.9% during the study [1] Group 3: Future Research - Additional research data for TQC3721 (PDE3/4 inhibitor), TQC2731 (TSLP monoclonal antibody), and TQC3403 (Umeclidinium/Vilanterol inhalation powder) will be presented at the ERS 2025 conference [2]

Group 1 - China National Medical Products Administration has approved the listing of Zongaitini tablets (brand name: Shenghetu) for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy [1] - Shenghetu is the world's first and currently the only approved oral HER2 tyrosine kinase inhibitor, receiving conditional approval in China based on positive results from the Beamion-LUNG1 study, which evaluated the efficacy and safety of Zongaitini in patients with advanced NSCLC with HER2 (ERBB2) mutations [1] - In the treated cohort of previously treated patients (N=75), the objective response rate (ORR) reached 71% (95% CI: 60-80), with 7% achieving complete response, and the disease control rate (DCR) was as high as 96% [1] Group 2 - Lung cancer remains the leading cancer type globally and in China, with significant unmet clinical needs [2] - The approval of Shenghetu in China will provide a more effective and compliant treatment option for many HER2-mutated non-small cell lung cancer patients, further enriching the company's product line in the oncology field [2] - The company aims to bring therapeutic benefits to more patients with the motto "Health technology, warming more lives" [2]

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的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 宗艾替尼片獲批上市 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團與 勃林格殷格翰在中國大陸聯合推廣的宗艾替尼片（商品名：聖赫途® ）已獲得中國國家藥品監督管理局 的上市批准，用於治療存在HER2（ERBB2）激活突變且既往接受過至少一種系統治療的不可切除的局 部晚期或轉移性非小細胞肺癌（NSCLC）成人患者。 1 肺癌無論在全球還是中國，均為第一大癌種，臨床仍存在巨大的未滿足治療需求。聖赫途®在中國獲 批，將為國內眾多HER2突變非小細胞肺癌患者帶來更高效、依從性更佳的治療選擇，也將進一步豐 富本集團在腫瘤領域的產品線，爭取為更多患者帶來治療獲益，用『健康科技，溫暖更多生命』。 [1] Heymach, J. et al. Zongert ...

Core Insights - The approval of Zongertinib (圣赫途) by the National Medical Products Administration of China marks a significant advancement in the treatment of HER2-mutated non-small cell lung cancer (NSCLC) [1][2] - Zongertinib is the first and only oral HER2 tyrosine kinase inhibitor approved globally, providing a new treatment option for patients with advanced NSCLC who have previously received systemic therapy [1] Company Developments - Boehringer Ingelheim and China National Pharmaceutical Group (China Biopharmaceutical) announced their collaboration to promote Zongertinib in mainland China [1] - The drug's conditional approval is based on positive results from the Beamion-LUNG1 study, which demonstrated an objective response rate (ORR) of 71% and a disease control rate (DCR) of 96% among treated patients [1] - The median duration of response (DoR) was reported at 14.1 months, and the median progression-free survival (PFS) was 12.4 months, indicating strong efficacy [1] Industry Impact - The approval of Zongertinib addresses a critical challenge in NSCLC treatment, as there has been a lack of effective oral medications targeting HER2 with good tolerability [2] - The introduction of this innovative drug is expected to set a new benchmark for treating patients with HER2-mutated advanced NSCLC, significantly improving treatment options for a patient group with poor prognosis [2] - The drug's design allows for high selectivity, minimizing severe adverse reactions commonly associated with traditional treatments, thus enhancing patient quality of life [2]

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed down 1.26% on August 28, with a trading volume of 2.227 billion yuan [1] - The fund was established on January 3, 2024, with a management fee of 0.50% per year and a custody fee of 0.10% per year [1] - As of August 27, 2024, the fund's latest share count was 6.506 billion shares, with a total size of 6.134 billion yuan, reflecting a year-to-date increase of 1545.50% in shares and 1523.46% in size compared to December 31, 2023 [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 88.56% during the tenure [2] - The top holdings of the fund include Innovent Biologics (9.52%), WuXi Biologics (9.47%), BeiGene (8.73%), and others, with their respective market values and share counts detailed [2] - The fund's liquidity is strong, with a cumulative trading amount of 35.359 billion yuan over the last 20 trading days, averaging 1.768 billion yuan per day [1][2]