Group 1 - The stock price of China Biologic Products Holdings has dropped by 11%, reaching 7.75 HKD [1] - The trading volume for the stock was 233 million HKD [1] - The total market capitalization of the company is 145.4 billion HKD [1]

Investment Rating - The report maintains an "Outperform" rating for Sino Biopharmaceutical with a target price of HKD 10.87, reflecting a positive outlook on the company's performance [2][7]. Core Insights - Sino Biopharmaceutical achieved revenue of CNY 17.6 billion in 1H25, representing an 11% year-on-year increase, with a gross profit margin of 82.5% [3][12]. - The company's innovative drug sales reached CNY 7.8 billion, growing by 27% year-on-year, while generic drug revenue was CNY 9.8 billion, showing slight growth [4][13]. - The report highlights the strong growth drivers in oncology and surgery/analgesia segments, with oncology revenue at CNY 6.7 billion (+25% YoY) and surgery/analgesia revenue at CNY 3.1 billion (+20% YoY) [19]. Financial Performance - Revenue forecasts for 2025 and 2026 have been raised to CNY 33.4 billion and CNY 37.6 billion, respectively, due to expected growth in out-licensing revenue [17]. - Net profit attributable to parent shareholders is adjusted to CNY 4.8 billion and CNY 5.1 billion for FY25E and FY26E, respectively [17]. - The report indicates a projected diluted EPS of CNY 0.27 for 2025 and CNY 0.28 for 2026, with a gross profit margin expected to remain stable at 82.5% [10][17]. Clinical Pipeline and Growth Potential - The respiratory portfolio includes multiple candidates in clinical stages, with significant progress in PDE3/4 inhibitors for COPD and TSLP monoclonal antibodies for asthma [4][14]. - Six innovative products are expected to launch in 2025, including key products like TQB3616 (CDK2/4/6 inhibitor) and HER2 inhibitors [15][16]. - The report emphasizes the potential for out-licensing several innovative products in oncology and respiratory pipelines, which could enhance revenue streams [16].

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 ...

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]

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]

Core Insights - China National Pharmaceutical Group's subsidiary, Chengdu Tianqing Pharmaceutical, has successfully completed the first shipment of innovative anti-cancer drugs to the Hong Kong-based Greater China Cancer Foundation, marking a significant step in their collaboration [1][2] - The shipment includes innovative anti-cancer drugs Anlotinib and Bemarituzumab, providing new treatment options for cancer patients in Hong Kong with urgent medical needs [1][2] - The Named Patient Program (NPP) allows doctors to provide unregistered drugs to patients in need, aligning with the Hong Kong government's 2023 policy report aimed at improving drug accessibility [1][2] Company Collaboration - The partnership agreement between Chengdu Tianqing and the Greater China Cancer Foundation was signed in March, focusing on providing innovative cancer treatment solutions to patients with significant unmet medical needs in Hong Kong [2] - The efficient completion of compliance reviews and cross-border logistics demonstrates the effectiveness of the NPP model in enhancing drug accessibility [2] - The president of Chengdu Tianqing emphasized the commitment to advancing China's pharmaceutical development and ensuring that innovative products reach Hong Kong patients [2] Social Responsibility - China National Pharmaceutical Group integrates corporate social responsibility into its development strategy, actively participating in charitable initiatives [3] - The successful shipment enhances treatment options for cancer patients in Hong Kong and reflects the deepening and innovative collaboration between mainland China and Hong Kong in the healthcare sector [3]

Core Viewpoint - The company reported strong financial performance in the first half of 2025, with significant growth in both revenue and net profit, driven by innovative products and a solid position in key therapeutic areas [1][2]. Financial Performance - In H1 2025, the company achieved revenue of 17.57 billion (CNY) (+10.7%) and a net profit attributable to shareholders of 3.39 billion (CNY) (+140.2%) [1]. - Adjusted net profit (non-HKFRS) reached 3.09 billion (CNY) (+101.1%), indicating a substantial increase in profitability [1]. Innovation and Product Development - The company launched two innovative products approved by NMPA in H1 2025, contributing to a revenue of 7.8 billion (CNY) from innovative products (+27.2%), which now account for 44.4% of total revenue (+5.8 percentage points) [1]. - The company has a broad pipeline of nearly 20 innovative products expected to be approved between 2025 and 2027, with over half projected to have peak sales exceeding 2 billion (CNY) [2]. Business Segments - The oncology segment generated revenue of 6.694 billion (CNY) (+24.9%), while the surgical/pain management segment achieved revenue of 3.105 billion (CNY) (+20.2%) in H1 2025 [1]. Future Outlook - The company anticipates that the proportion of revenue from innovative products will increase to 50% in 2025, 55% in 2026, and 60% in 2027, positioning innovation as the core driver of revenue growth [2]. - The acquisition of Lixin Pharmaceutical is expected to enhance the company's innovation pipeline and strengthen its core technology capabilities [2]. Profit Forecast - Revenue projections for 2025-2027 are 32.78 billion (CNY), 36.87 billion (CNY), and 41.14 billion (CNY), with year-on-year growth rates of 13.6%, 12.5%, and 11.6% respectively [3]. - Net profit forecasts for the same period are 4.81 billion (CNY), 4.88 billion (CNY), and 5.12 billion (CNY), with growth rates of 37.5%, 1.5%, and 4.8% respectively [3].