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 LM-2417「NaPi2b/4-1BB雙特異性抗體」完成中國I期臨床首例患者入組 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，本公 司全資附屬公司禮新醫藥科技（上海）有限公司（「禮新醫藥」）自主研發的國家1類創新藥LM-2417 「NaPi2b/4-1BB雙特異性抗體」在中國開展的I期臨床試驗已順利完成首例患者入組，標誌著這一創新 療法正式進入臨床開發階段。 NaPi2b由SLC34A2基因編碼，屬於II型鈉依賴性磷酸鹽轉運蛋白SLC34家族成員之一，在機體磷酸鹽 穩態調控中發揮重要作用。NaPi2b在高級別漿液性卵巢癌、輸卵管癌、原發性腹膜癌，以及甲狀腺 癌、乳腺癌和非鱗狀非小細胞肺癌等多種惡性腫瘤中呈高表達，而在正常組織中分佈有限，因此被 ...

Group 1 - The Hong Kong stock market for innovative drugs is experiencing a correction, with the Hong Kong Stock Connect Innovative Drug ETF (520880) opening high but closing down 1.74%, with a trading volume exceeding 1.4 billion yuan [1] - Major constituent stocks are declining, with Yimeng Biotech-B down over 7%, China National Pharmaceutical Group down over 4%, and CSPC Pharmaceutical Group down over 3% [1] Group 2 - The Chief Executive of the Hong Kong SAR proposed the establishment of a "Greater Bay Area Clinical Trial Collaboration Platform" and a "Real-World Research and Application Center" to accelerate the approval and commercialization of innovative drugs [3] - The National Medical Products Administration announced an optimized clinical trial review and approval process, with eligible applications to be completed within 30 working days [3] Group 3 - Despite short-term market fluctuations, the long-term logic of the innovative drug industry remains strong, transitioning from quantity to quality, with a focus on profitable products and companies by 2025 [4] - The industry is witnessing a recovery in demand, continuous supply-side clearing, and a trend towards domestic substitution, with mergers and acquisitions helping companies grow stronger [4] - The innovative drug sector's sustainability is supported by ongoing trends of "innovation + internationalization," enhancing China's global competitiveness in innovative drugs [4] Group 4 - The Hong Kong Stock Connect Innovative Drug ETF (520880) is the first ETF tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, focusing 100% on innovative drug research and development [5]

Core Insights - China Biopharmaceutical's self-developed innovative drug TQF3250, a GLP-1 receptor agonist, has received acceptance for clinical trial application from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1][2] - TQF3250 is an oral small molecule GLP-1RA 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 at doses as low as 1 mg/kg in mouse models, showing comparable efficacy to the similar drug Orforglipron [1] - In monkey models, TQF3250's no-observed-adverse-effect level (NOAEL) reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Market Potential - Third-party statistics show that the global GLP-1RA market is expected to exceed $50 billion in 2024 and surpass $150 billion by 2031 [1] - The current GLP-1RA market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stability in storage, with the formulation showing stability for 24 months at 25ºC 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] Development Strategy - The company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for patients with type 2 diabetes [2]

Core Viewpoint - China National Pharmaceutical Group (01177.HK) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1]. Group 1 - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway [1]. - The drug effectively promotes insulin secretion while reducing the recruitment of β-inhibitory proteins and receptor internalization, thereby extending the duration of its efficacy [1].

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].