Core Viewpoint - China Biopharmaceutical (01177) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, intended for the treatment of type 2 diabetes [1][2] Company Summary - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway, effectively promoting insulin secretion while reducing β-inhibitory protein recruitment and receptor internalization, thereby extending the duration of drug efficacy [1] - Preclinical studies indicate that TQF3250 significantly improves glucose tolerance in mouse models at doses as low as 1 mg/kg, showing comparable activity to the similar drug Orforglipron, demonstrating high efficacy in glucose reduction [1] - In monkey models, the no-observed-adverse-effect level (NOAEL) for TQF3250 reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Industry Summary - Third-party statistics show that the global market for GLP-1 receptor agonists is expected to exceed $50 billion in 2024 and is projected to surpass $150 billion by 2031 [1] - The current GLP-1 receptor agonist market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule formulation, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stable storage, with the formulation showing stability for 24 months at 25°C 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] - Currently, there is only one approved oral GLP-1 receptor agonist globally, and the company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for type 2 diabetes patients [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 TQF3250膠囊「GLP-1受體激動劑」臨床試驗申請獲NMPA受理 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，本集團自 主研發的國家1類創新藥TQF3250膠囊「GLP-1受體激動劑(GLP-1RA)」的新藥臨床試驗申請(IND)已獲 得中國國家藥品監督管理局(NMPA)受理，擬用於治療2型糖尿病。 TQF3250是一款口服小分子偏向型GLP-1RA，通過選擇性激活cAMP偏向的GLP-1R信號通路，高效 促進胰島素分泌，同時減少β－抑制蛋白募集和受體內吞，從而延長藥效持續時間。 臨床前研究顯示，在小鼠模型中，TQF3250在低至1 mg/kg的劑量下即可顯著改善糖耐量，其活性 與同類藥物Orforglipron相當，展現出高效降糖作用。在 ...

Core Viewpoint - Daiwa maintains a "Buy" rating for China Biologic Products (01177) and raises the target price from HKD 5.6 to HKD 10, reflecting an upward revision in revenue and earnings forecasts due to improved sales of innovative drugs and expected dividend income from Sinovac Biotech [1] Group 1: Financial Projections - Revenue forecasts for China Biologic Products for 2025 to 2027 have been adjusted upward by 1% to 6% [1] - Earnings per share estimates have been increased by 56% to 106% [1] Group 2: Product Development - The sales of innovative drugs are progressing as expected, with a 27% year-on-year increase in revenue for innovative drug products, reaching RMB 7.8 billion in the first half of the year [1] - The company anticipates launching a total of 21, 26, and over 35 innovative products in 2025, 2026, and 2027, respectively [1] Group 3: New Drug Launches - The report highlights three new drugs expected to be launched by 2027: TQC3721 (PDE3/4), LM-302 (Claudin18.2 ADC), and TQC2731 (TSLP mAb) [1] - The authorization deal for TQC3721 (PDE3/4 inhibitor) is expected to be completed within 2025, as the company is revising terms with potential partners [1]

港股创新药概念股震荡下挫，中国生物制药、维亚生物、复星医药跌超4%，君实生物、荣昌生物、信 达生物多股跌超3%。 ...

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]