Group 1 - The core viewpoint of the article highlights that Shijiazhuang Pharmaceutical Group (01093.HK) reported a decline in its mid-year performance for 2025, with revenue and net profit both decreasing significantly [1] Group 2 - The company reported a revenue of 13.27 billion RMB for the first half of 2025, representing a year-on-year decrease of 18.5% [1] - The net profit for the same period was 2.55 billion RMB, which is a year-on-year decrease of 15.6% [1]

Group 1 - The core viewpoint of the article is that the company reported a significant decline in revenue and profit for the first half of 2025, primarily due to the inclusion of two products in centralized procurement [1] - The company's total revenue for the first half of 2025 was RMB 13.273 billion, representing an 18.5% year-on-year decrease [1] - The reported profit attributable to shareholders was RMB 2.548 billion, a decrease of 15.6% compared to the previous year [1] Group 2 - The basic earnings per share were RMB 0.2229, and the board declared an interim dividend of HKD 0.14 per share for the 2025 fiscal year [1] - The revenue from the prescription drug business was RMB 10.248 billion, down 24.4% year-on-year [1] - Revenue from raw material products increased by 11.9% to RMB 2.075 billion, while revenue from functional foods and other businesses grew by 8.0% to RMB 0.951 billion [1]

| 其他信息 | | --- | | 其他信息 不適用 | | 發行人董事 | | 於 本 公 告 日 期 ，董 事 會 包 括 執 行 董 事 蔡 東 晨 先 生 、張 翠 龍 先 生 、王 振 國 先 生 、潘 衛 東 先生、王懷玉先生、李春雷 博士、姚兵博士、蔡鑫先生及陳衛平先生；及獨立非執行董事王波先生、CHEN Chuan先生、王宏廣教授、歐振國先生、羅卓堅先 | | 生及李泉女士。 | 第 2 頁 共 2 頁 v 1.1.1 第 1 頁 共 2 頁 v 1.1.1 EF001 EF001 免責聲明 | 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。 | 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 | | --- | --- | | 股票發行人現金股息公告 | | | 發行人名稱 | 石藥集團有限公司 | | 股份代號 | 01093 | | 多櫃檯股份代號及貨幣 | 不適用 | | 相關股份代號及名稱 | 不適用 | | 公告標題 | 截至二零二五年六月三十日止六個月之中期股息 | | ...

[Performance Summary](index=1&type=section&id=Performance%20Summary) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) In H1 2025, the Group's total revenue decreased by 18.5% to RMB 13.273 billion, mainly due to a decline in the finished drug business, while profit attributable to shareholders decreased by 15.6% to RMB 2.548 billion H1 2025 Financial Highlights (RMB '000) | Indicator | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | **13,273,416** | **16,284,282** | **-18.5%** | | Finished Drug Revenue | 10,247,652 | 13,549,079 | -24.4% | | Raw Material Product Revenue | 2,074,708 | 1,854,794 | +11.9% | | Functional Food & Other Revenue | 951,056 | 880,409 | +8.0% | | **Profit Attributable to Shareholders** | **2,547,851** | **3,020,374** | **-15.6%** | | **Basic Profit Attributable to Shareholders** | **2,319,521** | **3,216,870** | **-27.9%** | | Basic EPS (RMB cents) | 22.29 | 25.51 | -12.6% | | Interim Dividend per Share (HK cents) | 14.00 | 16.00 | -12.5% | - The Board declared an interim dividend of **HKD 14 cents per share** for 2025, a decrease from **HKD 16 cents** in the prior year period[6](index=6&type=chunk) - The company repurchased and cancelled **64.3 million shares** for **HKD 300 million** in H1 2025 to enhance EPS and shareholder returns[6](index=6&type=chunk) [Company and Business Overview](index=2&type=section&id=Company%20and%20Business%20Overview) [Company Overview](index=2&type=section&id=Company%20Overview) CSPC Pharmaceutical Group is an innovation-driven, integrated pharmaceutical enterprise pursuing a 'innovation + internationalization' dual-engine strategy with a global R&D team and extensive pipeline - The Group adheres to a 'innovation + internationalization' dual-engine strategy, continuously increasing R&D investment and strengthening team building[7](index=7&type=chunk) - The Group has an international R&D team of over **2,000 people** across multiple global centers, focusing on six core therapeutic areas including oncology, neuropsychiatry, and cardiovascular[8](index=8&type=chunk) - The Group has completed **4 out-licensing projects** year-to-date, with cumulative contract value reaching **USD 9.71 billion**, and a strategic R&D collaboration with AstraZeneca on an AI platform[10](index=10&type=chunk) - The Group has over **200 innovative drugs and formulations** in development, with over **160 clinical trials** underway, and expects to file for market approval for over **50 new drugs or indications** by the end of 2028[11](index=11&type=chunk) [Finished Drug Business](index=4&type=section&id=Finished%20Drug%20Business) In H1 2025, finished drug revenue decreased by 24.4% to RMB 10.248 billion, primarily due to centralized procurement impacting core products, while out-licensing revenue provided new growth Finished Drug Business Revenue by Therapeutic Area (RMB '000) | Therapeutic Area | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Neuroscience | 3,754,814 | 5,235,700 | -28.3% | | Oncology | 1,050,606 | 2,683,139 | -60.8% | | Anti-infectives | 1,656,912 | 2,307,375 | -28.2% | | Cardiovascular | 868,336 | 1,228,902 | -29.3% | | Respiratory System | 575,441 | 756,025 | -23.9% | | Digestive & Metabolic | 528,099 | 646,697 | -18.3% | | Other | 738,777 | 691,241 | +6.9% | | **Subtotal Sales of Goods** | **9,172,985** | **13,549,079** | **-32.3%** | | Licensing Fee Income | 1,074,667 | – | Not Applicable | | **Total Revenue** | **10,247,652** | **13,549,079** | **-24.4%** | - Core products like Duomeisu and Jinyouli faced significant price adjustments due to centralized procurement policies, leading to temporary pressure on finished drug business revenue[13](index=13&type=chunk) - In H1 2025, the Group's licensing income reached **RMB 1.075 billion**, becoming a new growth driver for the finished drug business, with plans to develop it into a core source of recurring revenue[15](index=15&type=chunk) [Neuroscience](index=5&type=section&id=Neuroscience) Neuroscience sales declined due to price reductions for NBP® and Shuanling® from national centralized procurement, but Mingfule® saw significant growth after entering the medical insurance catalog - NBP® sales revenue decreased due to national medical insurance negotiation price reductions, but improved product accessibility[22](index=22&type=chunk) - Shuanling® injection was included in the 10th batch of national centralized procurement, leading to a significant decrease in sales revenue[22](index=22&type=chunk) - Mingfule® sales revenue significantly increased year-on-year in H1 due to its new indication entering the medical insurance catalog[22](index=22&type=chunk) [Oncology](index=6&type=section&id=Oncology) Oncology sales significantly declined due to Duomeisu® inclusion in national centralized procurement and Jinyouli®'s expanded centralized procurement, while new products provided growth - Duomeisu®'s inclusion in the 10th batch of national centralized procurement led to a substantial reduction in sales price, being the primary reason for the decline in this segment's revenue[29](index=29&type=chunk) - Jinyouli® sales revenue significantly decreased due to the expansion of the '3+N' alliance centralized drug procurement policy in Beijing-Tianjin-Hebei[29](index=29&type=chunk) - Duoenyi® sales revenue significantly increased year-on-year, and newly launched product Enshuxing® also provided new growth momentum for the business[29](index=29&type=chunk) [Anti-infectives](index=7&type=section&id=Anti-infectives) Anti-infectives business saw reduced sales for key products like Anfulike®, Weihong®, and Nuomoling® in H1 2025 due to weakened market demand, with only Shuluoke® showing growth - Sales revenue for products such as Anfulike®, Weihong®, and Nuomoling® all decreased due to weakened market demand[31](index=31&type=chunk) [Cardiovascular](index=8&type=section&id=Cardiovascular) Cardiovascular sales declined as Xuanning® was impacted by centralized procurement volume-based tasks in public medical institutions, while only Daxinning® achieved steady growth - Xuanning® sales in public medical institutions were affected by the implementation of volume-based tasks for centralized procurement products, leading to a year-on-year revenue decrease[36](index=36&type=chunk) [Respiratory System](index=9&type=section&id=Respiratory%20System) Respiratory system sales decreased overall, as market impacts on Qixin®, Nuoyian®, and Qixiao® offset stable growth from Yiluoda® and new contributions from Ennitan® - Yiluoda® sales revenue achieved steady growth, and new product Ennitan® contributed new growth points to this segment[40](index=40&type=chunk) - Sales revenue for products such as Qixin®, Nuoyian®, and Qixiao® all decreased due to market impact, leading to an overall revenue reduction in this segment[40](index=40&type=chunk) [Digestive & Metabolic](index=9&type=section&id=Digestive%20%26%20Metabolic) Digestive and metabolic sales declined overall, as competitive market conditions and a pricing strategy adjustment for Debixin® led to a decrease in average selling price - Debixin®'s sales strategy adjustment led to a decrease in its unit price, which was the main reason for the overall decline in sales revenue for this segment[43](index=43&type=chunk) [Raw Material Product Business](index=10&type=section&id=Raw%20Material%20Product%20Business) In H1 2025, raw material product sales increased by 11.9% to RMB 2.075 billion, driven by a 21.6% rise in Vitamin C revenue from strong overseas demand, while antibiotic sales remained flat Raw Material Product Business Revenue (RMB Billion) | Product Category | H1 2025 Revenue | Year-on-Year Growth | | :--- | :--- | :--- | | **Total** | **2.075** | **+11.9%** | | Vitamin C | 1.196 | +21.6% | | Antibiotics | 0.879 | Flat | - Vitamin C product revenue growth was primarily driven by significantly increased overseas market demand[46](index=46&type=chunk) [Functional Food and Other Businesses](index=11&type=section&id=Functional%20Food%20and%20Other%20Businesses) In H1 2025, functional food and other businesses generated RMB 951.056 million in sales revenue, an 8.0% increase, primarily due to higher caffeine sales volume - Functional food and other businesses revenue was **RMB 951.056 million**, a year-on-year increase of **8.0%**, mainly due to increased caffeine sales volume[48](index=48&type=chunk) [R&D Progress](index=11&type=section&id=R%26D%20Progress) [R&D Investment and Pipeline Overview](index=11&type=section&id=R%26D%20Investment%20and%20Pipeline%20Overview) In H1 2025, R&D expenses increased by 5.5% to RMB 2.683 billion, representing 26.2% of finished drug revenue, with nearly 90 products in clinical stages and 12 submitted for market approval R&D Expenses | Indicator | Amount (RMB) | Year-on-Year Change | % of Finished Drug Revenue | | :--- | :--- | :--- | :--- | | R&D Expenses | 2.683 billion | +5.5% | 26.2% | - Currently, nearly **90 products** are in different stages of clinical trials, with **12 submitted for market approval** and over **30 key products** in registration clinical stages[49](index=49&type=chunk) [Registration and Approval Progress](index=11&type=section&id=Registration%20and%20Approval%20Progress) Year-to-date, the Group achieved significant regulatory milestones in China with 3 innovative product approvals and 5 marketing application acceptances, alongside 9 IND approvals and 1 Fast Track designation in North America - Year-to-date, the Group obtained approval for **3 innovative products** in China, accepted **5 marketing applications**, and received **4 breakthrough therapy designations**[50](index=50&type=chunk) Products Approved for Marketing in H1 2025 | Month | Drug Name | Indication | | :--- | :--- | :--- | | January 2025 | Sanzeping® (Pluoglitin Tablets) | Improving glycemic control in adults with type 2 diabetes | | February 2025 | Ennitan® (Omalizumab for Injection) | Treatment of moderate to severe persistent allergic asthma | | June 2025 | Meiluotai® (Meloxicam Injection (III)) | Moderate to severe pain in adults | Products with Marketing Applications Accepted in H1 2025 | Month | Investigational Drug | Indication | | :--- | :--- | :--- | | March 2025 | Aprepitant Injection | Prevention of postoperative nausea and vomiting | | March 2025 | Irinotecan Liposome Injection | First-line metastatic pancreatic cancer | | March 2025 | Paliperidone Palmitate Injection (1M) | Schizophrenia | | June 2025 | Pregabalin Extended-Release Tablets | Diabetic peripheral neuropathic pain and postherpetic neuralgia | | August 2025 | Semaglutide Injection | Glycemic control in adults with type 2 diabetes | [Key Clinical Research Progress](index=14&type=section&id=Key%20Clinical%20Research%20Progress) During the period, the Group initiated or completed first patient enrollment for multiple pivotal clinical trials across oncology, depression, and hypertension, with key studies reaching top-line results and findings published in international conferences - First patient enrollment achieved for Phase III clinical trials of multiple drugs including JSKN003, Amcitine Hydrochloride Enteric-coated Tablets, and SYS6010[60](index=60&type=chunk)[61](index=61&type=chunk) - TG103 Injection (GLP-1) Phase III clinical trial for the treatment of overweight and obesity completed its clinical study report[64](index=64&type=chunk) - Semaglutide Injection Phase III clinical trial for the treatment of type 2 diabetes completed its clinical study report[66](index=66&type=chunk) - Multiple research findings were presented as oral reports or posters at international conferences such as AACR, ASCO, and ESMO, gaining international recognition[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) [Clinical Pipeline Overview](index=20&type=section&id=Clinical%20Pipeline%20Overview) The Group maintains a robust clinical pipeline with multiple products submitted for market approval in China and the US, alongside dozens of ongoing pivotal clinical trials utilizing advanced technologies - Submitted marketing applications for **10 drugs** in China, including Semaglutide Injection (for type 2 diabetes) and Irinotecan Liposome Injection (for first-line pancreatic cancer)[70](index=70&type=chunk) - Submitted marketing applications for **2 drugs** in the United States, namely Amphotericin B Liposome for Injection and Irinotecan Hydrochloride Liposome Injection[70](index=70&type=chunk) - Over **20 pivotal clinical trials** are ongoing in China, covering high-demand therapeutic areas such as breast cancer, gastric cancer, obesity, diabetes, and depression[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) [Business Development and Financial Review](index=24&type=section&id=Business%20Development%20and%20Financial%20Review) [Business Development](index=24&type=section&id=Business%20Development) In H1 2025, the Group achieved significant business development breakthroughs through out-licensing, completing four major agreements with substantial potential transaction values, including a strategic AI platform collaboration with AstraZeneca - Reached an exclusive licensing agreement with Radiance Biopharma for ADC drug SYS6005, with a potential total value of up to **USD 1.24 billion**[76](index=76&type=chunk) - Reached an exclusive licensing agreement with Cipla USA for the commercialization rights of Irinotecan Liposome Injection in the US, with a potential total value of up to **USD 1.065 billion**[77](index=77&type=chunk) - Reached a strategic R&D collaboration with AstraZeneca on an AI drug discovery platform, with a potential total value of up to **USD 5.33 billion**[78](index=78&type=chunk) - Reached a global exclusive licensing agreement with Madrigal Pharmaceuticals for small molecule GLP-1 agonist SYH2086, with a potential total value of up to **USD 2.075 billion**[79](index=79&type=chunk) [Financial Review](index=25&type=section&id=Financial%20Review) In H1 2025, revenue decreased by 18.5% and gross margin by 6 percentage points to 65.6% due to centralized procurement, while operating expenses significantly decreased, and R&D investment continued to grow, maintaining a robust financial position - Revenue decreased by **18.5%** to **RMB 13.273 billion**, and gross margin decreased by **6.0 percentage points** to **65.6%**, primarily due to the inclusion of Duomeisu® and Jinyouli® in centralized procurement and a reduced proportion of finished drug business revenue[80](index=80&type=chunk) - Sales and distribution expenses decreased by **36.2%** year-on-year to **RMB 3.049 billion**, mainly due to significantly lower sales expenses for products winning centralized procurement bids[83](index=83&type=chunk) - R&D expenses increased by **5.5%** year-on-year to **RMB 2.683 billion**, primarily for ongoing and newly initiated clinical studies[84](index=84&type=chunk) - Cash inflow from operating activities was **RMB 3.187 billion**, significantly higher than **RMB 1.425 billion** in the prior year period[88](index=88&type=chunk) - As of June 30, 2025, the Group's bank deposits, balances, and cash reached **RMB 10.291 billion**, with a debt-to-asset ratio of only **0.7%**, indicating a robust financial position[89](index=89&type=chunk) [Condensed Consolidated Financial Statements](index=28&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Statement of Profit or Loss](index=28&type=section&id=Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss) For the six months ended June 30, 2025, the Group reported revenue of RMB 13.273 billion, a 18.5% decrease, and profit for the period of RMB 2.574 billion, a 15.6% decrease, despite reduced operating expenses Condensed Consolidated Statement of Profit or Loss (RMB '000) | Item | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Revenue | 13,273,416 | 16,284,282 | | Gross Profit | 8,710,192 | 11,654,547 | | Sales and Distribution Expenses | (3,049,160) | (4,777,410) | | R&D Expenses | (2,682,631) | (2,541,991) | | Profit Before Tax | 3,117,667 | 3,801,130 | | Profit for the Period | 2,574,050 | 3,051,466 | | Profit Attributable to Owners of the Company | 2,547,851 | 3,020,374 | [Condensed Consolidated Statement of Financial Position](index=30&type=section&id=Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, total assets were RMB 46.002 billion, total liabilities RMB 11.138 billion, and net assets RMB 34.864 billion, all showing slight increases from year-end 2024, with improved net current assets Condensed Consolidated Statement of Financial Position Summary (RMB '000) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **46,002,354** | **44,388,991** | | Non-current Assets | 23,392,266 | 22,500,847 | | Current Assets | 22,610,088 | 21,888,144 | | **Total Liabilities** | **11,138,478** | **10,522,701** | | Current Liabilities | 10,112,501 | 9,634,027 | | Non-current Liabilities | 1,025,977 | 888,674 | | **Net Assets/Total Equity** | **34,863,876** | **33,866,290** | [Other Information](index=40&type=section&id=Other%20Information) [Share Repurchase](index=40&type=section&id=Share%20Repurchase) As of June 30, 2025, the company repurchased and cancelled 64.3 million shares for approximately HKD 300 million, aiming to enhance earnings per share and shareholder value Share Repurchase Details | Month | Number of Shares Repurchased | Highest Price (HKD) | Lowest Price (HKD) | Total Consideration (HKD) | | :--- | :--- | :--- | :--- | :--- | | January | 38,850,000 | 4.72 | 4.38 | 176,597,000 | | March | 3,000,000 | 4.95 | 4.88 | 14,763,000 | | April | 22,450,000 | 4.95 | 4.66 | 108,155,000 | | **Total** | **64,300,000** | | | **299,515,000** |

Core Insights - The top three companies by Hong Kong Stock Connect holding ratios are China Telecom (00728) at 74.71%, Green Power Environmental (01330) at 69.95%, and China Shenhua (01088) at 68.06% [1] - The largest increases in holdings over the last five trading days were seen in the following companies: Yingfu Fund (02800) with an increase of 134.21 billion, Hang Seng China Enterprises (02828) with an increase of 66.24 billion, and Southern Hang Seng Technology (03033) with an increase of 51.77 billion [1] - The largest decreases in holdings over the last five trading days were recorded for Anta Sports (02020) with a decrease of 10.21 billion, Geely Automobile (00175) with a decrease of 7.70 billion, and HSBC Holdings (00005) with a decrease of 7.40 billion [2] Group 1: Hong Kong Stock Connect Holding Ratios - China Telecom (00728) has a holding of 10.368 billion shares, representing 74.71% [1] - Green Power Environmental (01330) has a holding of 0.283 billion shares, representing 69.95% [1] - China Shenhua (01088) has a holding of 2.299 billion shares, representing 68.06% [1] Group 2: Recent Increases in Holdings - Yingfu Fund (02800) saw an increase of 134.21 billion in holdings, with a change of 52.386 million shares [1] - Hang Seng China Enterprises (02828) experienced an increase of 66.24 billion, with a change of 7.216 million shares [1] - Southern Hang Seng Technology (03033) had an increase of 51.77 billion, with a change of 95.870 million shares [1] Group 3: Recent Decreases in Holdings - Anta Sports (02020) had a decrease of 10.21 billion in holdings, with a change of -10.268 million shares [2] - Geely Automobile (00175) experienced a decrease of 7.70 billion, with a change of -38.819 million shares [2] - HSBC Holdings (00005) saw a decrease of 7.40 billion, with a change of -7.332 million shares [2]

Major Events - CSPC Pharmaceutical Group (01093) received clinical trial approval for Dupilumab injection in China [1] - Rongchang Biopharmaceutical (09995) was granted breakthrough therapy designation for RC148 for non-small cell lung cancer by the National Medical Products Administration [1] - China Biologic Products (01177) included LM-302 "CLDN18.2 ADC" in the breakthrough therapy program [1] - Sunshine Oilsands (02012) plans to acquire 51% stake in Noble Technology Limited for HKD 50.91945 million [1] - Galenica Pharmaceutical-B (01672) plans to issue shares at a discount of approximately 9.9%, raising HKD 468 million [1] Financial Performance - Xiaomi Group-W (01810) reported record high revenue and profit for Q2, with attributable profit of HKD 11.904 billion, up 133.51% year-on-year [1] - Pop Mart (09992) announced a mid-term profit of HKD 4.574 billion, a year-on-year increase of 396.5% [1] - Fuyao Glass (03606) reported a half-year net profit of approximately HKD 4.805 billion, up 37.33% year-on-year [1] - China Resources Beer (00291) announced a mid-term profit of HKD 5.789 billion, an increase of 23.04% year-on-year [1] - Kunlun Energy (00135) reported a mid-term profit of HKD 3.161 billion, down 4.36% year-on-year, with a dividend of HKD 0.166 per share [1] - WuXi Biologics (02269) reported a mid-term profit of approximately HKD 2.339 billion, up 56% year-on-year [1] - Sunny Optical Technology (02382) announced a mid-term profit of HKD 1.646 billion, an increase of 52.56% year-on-year [1] - Yixin Group (02858) reported an adjusted net profit of HKD 648 million, up 28% year-on-year [1] - Kangchen Pharmaceutical (01681) reported a mid-term profit of HKD 498 million, up 24.6% year-on-year, maintaining market leadership with its flagship product [1] - Ping An Good Doctor (01833) reported a mid-term profit of HKD 134 million, a year-on-year increase of 136.84% [1] - China Communication Services (02342) reported a mid-term profit of HKD 61.781 million, returning to profitability [1] - XPeng Motors-W (09868) achieved record levels in core business and financial metrics for Q2, with a net loss of HKD 480 million, narrowing by 62.8% year-on-year [1] - Guochuang Tongqiao (02190) reported a mid-term profit of HKD 121 million, up 76% year-on-year [1] - Yanda Pharmaceutical (00512) reported record revenue of HKD 6.107 billion [1] - Jinli Permanent Magnet (06680) reported a mid-term profit of approximately HKD 305 million, up 154.81% year-on-year [1] - Zhaogang Group-W (06676) issued a profit warning, expecting a mid-term profit of approximately HKD 140 million to HKD 180 million, returning to profitability [1] - Longyuan Power (00916) reported a mid-term profit of HKD 3.519 billion, down 14.4% year-on-year [1] - Yancoal Australia (03668) reported a mid-term profit of AUD 16.3 million, down 61.19% year-on-year [1] - SF Holding (06936) reported total revenue of HKD 24.847 billion for July in logistics, supply chain, and international business, up 9.95% year-on-year [1] - Chow Sang Sang (00116) expects a mid-term profit from continuing operations of approximately HKD 900 million to HKD 920 million [1]

石药集团(01093)发布公告，本集团开发的度普利尤单抗注射液(该产品)已获中国国家药品监督管理局批 准，可在中国开展临床试验。 该产品是一种靶向IL-4Rα的重组全人源单克隆抗体药物，为达必妥的生物类似药，按照治疗用生物制品 3.3类申报，适用于治疗成人中重度特应性皮炎。 该产品的研发遵循生物类似药相关研究指南。药学及非临床研究结果显示，该产品与原研参照药在质 量、安全性和有效性方面高度相似，支持开展后续临床研究。 ...

Core Viewpoint - The announcement indicates that CSPC Pharmaceutical Group (01093.HK) has received approval from the National Medical Products Administration of China to conduct clinical trials for Dupilumab Injection, a biosimilar to Dupixent, targeting moderate to severe atopic dermatitis in adults [1] Group 1: Product Development - The product is a recombinant fully human monoclonal antibody drug targeting IL-4Rα, classified as a biosimilar to Dupixent [1] - The application was submitted under the category of biological products for therapeutic use, specifically Class 3.3 [1] - The research results from pharmaceutical and non-clinical studies demonstrate high similarity in quality, safety, and efficacy compared to the reference drug, supporting the initiation of subsequent clinical studies [1]

Group 1 - The core point of the article is that CSPC Pharmaceutical Group (01093) has received approval from the National Medical Products Administration of China to conduct clinical trials for its drug Dupilumab Injection [1] - The product is a recombinant fully human monoclonal antibody targeting IL-4Rα and is a biosimilar to Dupixent, classified under Category 3.3 for therapeutic biological products [1] - The drug is intended for the treatment of moderate to severe atopic dermatitis in adults [1] Group 2 - The development of the product follows the relevant research guidelines for biosimilars [1] - Pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the initiation of subsequent clinical studies [1]

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的任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 石 藥 集 團 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 」）欣 然 宣 布，本集團開發的度普利尤單抗注射液（「該產品」）已獲中華人民共和國國家藥品監督管理 局批准，可在中國開展臨床試驗。 該產品是一種靶向IL -4Rα的重組全人源單克隆抗體藥物，為達必妥®的生物類似藥，按照 治療用生物製品3.3類申報，適用於治療成人中重度特應性皮炎。 該產品的研發遵循生物類似藥相關研究指南。藥學及非臨床研究結果顯示，該產品與原研 參照藥在質量、安全性和有效性方面高度相似，支持開展後續臨床研究。 代表董事會 石藥集團有限公司 主席 蔡東晨 香港，2025年8月19日 於 本 公 告 日 期 ， 董 事 會 包 括 執 行 董 事 蔡 東 晨 先 ...