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之內容概不負責，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分內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 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，本集團開發的普盧格列汀達格列淨二甲雙胍緩釋片（「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。 該產品為全球首款獲批臨床的由普盧格列汀、達格列淨和鹽酸二甲雙胍組成的三藥聯合複 方製劑。普盧格列汀是一種二肽基肽酶-4（「DPP -4」）抑制劑，通過抑制DPP -4，使內源性活 性胰高血糖素樣肽-1 (GLP -1)水平升高，從而增強β細胞和α細胞對葡萄糖的敏感性，增加 葡 萄 糖 刺 激 的 胰 島 素 分 泌 ， 並 增 強 葡 萄 糖 對 胰 高 血 糖 素 分 泌 的 抑 制 作 用 ， 進 而 改 善 高 血 糖。達格列淨是一種鈉—葡萄糖協同轉運蛋 ...

Core Viewpoint - The announcement by Zhifei Biological indicates a significant breakthrough in the treatment of metabolic diseases, specifically with the completion of Phase III clinical trials for the CA508 insulin injection, which lays the groundwork for future market approval [1] Group 1: Clinical Trial Results - The CA508 injection, developed by the subsidiary Chuanan Biological, has completed Phase III clinical trials and received a summary report, marking a key milestone for the company in the diabetes treatment sector [1] - The clinical trial was led by Peking University People's Hospital and involved 40 domestic research centers, focusing on Type 2 diabetes patients with inadequate insulin treatment [1] - Results show that CA508 injection is comparable in efficacy and safety to the original drug (NovoRapid®), meeting relevant guidelines and providing core evidence for registration [1] Group 2: Product Details - CA508 injection is a new generation of basal-bolus insulin formulation, combining degludec insulin and aspart insulin, which allows for dual control of basal and postprandial blood glucose levels [1] - The formulation is a clear solution that requires 1-2 daily injections without the need for mixing, enhancing patient compliance [1] Group 3: Market Implications - Currently, there is only one other similar product approved in the domestic market aside from the original drug, indicating a potential competitive advantage for CA508 if approved [1] - The successful launch of CA508 injection would further solidify the company's integrated "prevention & treatment" strategy, strengthening its market position and industry competitiveness [1]

Core Viewpoint - The global first dual receptor agonist for glucagon (GCG) and glucagon-like peptide-1 (GLP-1), Masitide Injection, developed by Innovent Biologics, has shown promising results in two Phase III clinical studies for type 2 diabetes patients in China, published in the prestigious journal Nature [1][2]. Group 1: Clinical Research Results - The DREAMS-1 and DREAMS-2 studies demonstrated that Masitide is superior to placebo and dulaglutide (1.5mg) in controlling blood sugar and weight loss, while also improving various cardiovascular, liver, and kidney-related indicators [2]. - The results of the weight loss Phase III study (GLORY-1) for Masitide were published in the New England Journal of Medicine (NEJM) in May [1]. Group 2: Future Developments - The DREAMS-3 trial, set to reach its primary endpoint in October 2025, will be the first global Phase III clinical trial comparing Masitide directly with semaglutide in diabetes treatment [2]. - Masitide has been approved in China for both diabetes and weight loss indications and has initiated seven Phase III studies covering diabetes, obesity, and related complications [3]. Group 3: Target Population - The ongoing Phase I clinical study for adolescent obesity has achieved its primary endpoint, indicating that Masitide can provide weight loss and multiple metabolic benefits for adolescents [3]. - A Phase III registration study for adolescent obesity will soon commence, marking the first such trial in China targeting weight loss in this demographic [3].

Core Viewpoint - The inclusion of the innovative long-acting human GLP-1 receptor agonist, Icosapent Ethyl (brand name: Yinuo Qing), in the 2025 National Medical Insurance Drug List marks a significant step towards making diabetes treatment more accessible in China, aligning with the "Healthy China 2030" initiative [1] Group 1: Company Developments - Silver诺医药-B (02591) saw its stock price increase by 3.43%, reaching HKD 32, with a trading volume of HKD 20.74 million [1] - The company’s drug, Icosapent Ethyl, is now officially recognized for the treatment of blood sugar control in adult patients with type 2 diabetes, effective from January 1, 2026 [1] Group 2: Industry Impact - The inclusion of Icosapent Ethyl in the National Medical Insurance Drug List is a crucial advancement for the accessibility of innovative diabetes treatments in China [1] - The "National Guidelines for Diabetes Prevention and Management (2025)" lists Icosapent Ethyl as a key injectable GLP-1RA, providing policy and regulatory support for its use in primary healthcare settings [1] - The guidelines emphasize the importance of GLP-1RA for adult type 2 diabetes patients with comorbidities such as atherosclerotic cardiovascular disease (ASCVD), heart failure, chronic kidney disease (CKD), and those needing weight management [1]

Core Insights - A recent study by the Chinese Center for Disease Control and Prevention highlights the alarming economic burden of diabetes in China, projecting that by 2030, costs related to diabetes could reach $460 billion, accounting for one-third of the national public health expenditure in 2024 [1] - The study indicates that the direct medical costs associated with diabetes are only a fraction of the total burden, with complications leading to increased hospitalization, productivity loss, and indirect costs [1] Group 1: Treatment Paradigm Evolution - Over the past 30 years, the treatment philosophy and technology for diabetes in China have undergone significant changes due to the growing patient population and disease burden [2] - The evolution of diabetes medications has transitioned from traditional drugs to insulin therapies and newer glucose-lowering agents, with a focus on addressing complex pathophysiological mechanisms [2] - Recent advancements include SGLT2 inhibitors and GLP-1 receptor agonists, which not only lower blood sugar but also show potential cardiovascular protection and reduced kidney disease risk [2] Group 2: Shift Towards Personalized Treatment - There is a growing recognition among endocrinologists that solely targeting blood sugar levels is insufficient for addressing metabolic disorders in patients [3] - The focus of diabetes management is shifting towards metabolic syndrome management through precision medicine and multi-target drug development [3] - The demand for more convenient and quality-of-life-enhancing administration methods is increasing, leading to a trend towards oral medications [3] Group 3: Breakthroughs in Oral Drug Delivery - Oral medications are preferred for their ease of use, but the delivery of large-molecule drugs has been challenging due to their physicochemical properties [4] - Innovations in drug delivery systems, such as Emisphere's Eligen technology and MYCAPSSA, aim to overcome barriers to oral absorption of large molecules [4] - Novo Nordisk's development of SNAC as an absorption enhancer for oral semaglutide represents a significant breakthrough in the field [5][6] Group 4: Comprehensive Metabolic Benefits - GLP-1 receptor agonists provide multiple therapeutic benefits beyond glucose control, including weight loss, improved lipid profiles, and cardiovascular and renal protection [7][8] - Clinical trials have demonstrated that oral semaglutide significantly reduces HbA1c levels and body weight while also lowering blood pressure and improving lipid levels [8] - The recent SOUL trial results indicate that oral semaglutide reduces the risk of major adverse cardiovascular events (MACE) by 14%, with even higher reductions in specific populations [8] Group 5: Innovative Payment Models - The introduction of innovative payment systems is essential for improving access to oral glucose-lowering medications and reducing the economic burden on patients and society [10] - The "Xinxiang Care" patient support program aims to alleviate medication costs and enhance treatment accessibility for type 2 diabetes patients [10] Group 6: Future of Diabetes Treatment - The emergence of oral GLP-1 receptor agonists marks a new era in diabetes treatment, integrating treatment into daily life and enhancing patient experience [11] - Oral semaglutide is the first and currently the only oral GLP-1 receptor agonist proven to have cardiovascular benefits, indicating a shift in chronic disease management [12]

Summary of Hualing Pharmaceutical Conference Call Company Overview - **Company**: Hualing Pharmaceutical - **Product**: Dapagliflozin (多格列艾汀), a GKA (glucokinase activator) for diabetes treatment Key Points Industry and Market Potential - Dapagliflozin sales are projected to grow steadily, with expected revenues of CNY 750 million in 2025, reaching CNY 1.85 billion by 2028, and potentially CNY 2 billion without price reductions. By 2030, sales could approach CNY 3 billion, and by 2032-2033, exceed CNY 4 billion [2][3][22] - The domestic market peak for the first-generation GKA product is estimated at CNY 4-5 billion, while the overseas market could reach USD 7-8 billion, with potential to exceed USD 10 billion [3][16][17] Product Differentiation and Clinical Efficacy - Dapagliflozin is noted for its unique mechanism targeting the root cause of diabetes, protecting pancreatic beta-cell function, and demonstrating superior safety compared to other diabetes medications [2][7][19] - The DRIVE study showed a 52-week drug withdrawal relief rate of 65.2%, indicating its potential for early diabetes patients to manage their condition without long-term medication [2][9][10] Sales and Marketing Strategy - The sales team is expected to double from 100 to over 200 representatives by Q1 2026, with plans to expand to 400-500 by 2028 [2][4][8] - The company aims to submit an IND application for a combination product of Dapagliflozin and Metformin by the end of the year, targeting first-line treatment for severe cases [2][13][14] Research and Development - Ongoing clinical trials are progressing well, with plans for a larger-scale drug withdrawal study expected to yield results in H1 2027 [5][9] - The company is exploring new indications, including diabetes-related cognitive impairment and prevention, with collaborations underway for cystic fibrosis-related diabetes research [5][21] Financial Projections and Cost Management - Sales targets for the next three years are set at CNY 900 million for 2026, CNY 1.35 billion for 2027, and CNY 1.85 billion for 2028, factoring in potential price negotiations [3][22] - The sales expense ratio is projected to decrease from 40% this year to around 35% by 2027, with long-term stabilization between 25-30% [8][19] Competitive Landscape - Dapagliflozin's unique characteristics and strong clinical backing provide a competitive edge in a challenging market environment, supported by favorable national policies [19][20] - The product is positioned to complement GLP-1RA drugs, expanding its applicability beyond just obese patients [18][19] Future Outlook - The company expresses confidence in achieving significant sales growth and enhancing market value through strategic partnerships and product development [6][22] - The second-generation GKA product is anticipated to launch overseas around 2032-2033, with improvements tailored for Western populations [15][16] Conclusion - Hualing Pharmaceutical is strategically positioned in the diabetes treatment market with a robust pipeline, strong sales growth expectations, and a commitment to innovation and collaboration, aiming to enhance its market presence and shareholder value [22]

Core Insights - Hualing Pharmaceutical-B (02552) saw a significant stock increase, closing up over 4% and reaching a trading volume of 16.7041 million HKD [1] - The company’s core product, Dapagliflozin, is the first glucose kinase activator (GKA) approved globally in 2022, with rapid sales growth expected after regaining commercialization rights in 2025 [1] - The company reported a 110% year-on-year revenue increase in the first half of the year, driven by deferred income from Bayer, leading to profitability [1] - Hualing Pharmaceutical-B is developing a second-generation GKA using sustained-release technology and has submitted a clinical application to the FDA, indicating a focus on international expansion [1] - The GKA market is evolving with the first drug commercialized and second-generation products advancing, positioning Hualing Pharmaceutical-B as a key player in this sector with no other listed companies currently advancing similar core pipelines [1] Research and Development - A real-world study involving 2,000 type 2 diabetes patients across 80 centers in China confirmed the broad applicability and safety of Dapagliflozin [2] - New research findings on diabetes remission and cognitive improvement further solidify Hualing Pharmaceutical-B's global leadership in GKA research and treatment [2]

Core Insights - Diabetes, especially type 2 diabetes, is not an abrupt disease but rather a long and hidden process, with early warning signs that should not be ignored [1] Group 1: Symptoms and Early Warning Signs - Common symptoms indicating potential diabetes include fatigue, excessive thirst, frequent urination, blurred vision, skin issues, and slow wound healing [6][7] - Individuals with a history of giving birth to large babies are at a higher risk of developing diabetes [6] Group 2: Prevention and Management Strategies - For high-risk individuals, preventing obesity and regular check-ups are crucial [7] - For diagnosed patients, managing diet and exercise under medical guidance can help maintain a quality of life similar to that of healthy individuals [7] Group 3: Dietary Recommendations - A balanced diet should include a variety of food groups such as grains, fruits, vegetables, and proteins [8] - It is advised to reduce intake of fatty meats and processed foods while opting for high-fiber and low-GI foods [9] Group 4: Eating Habits - Slowing down the eating pace can lower the risk of diabetes, with recommendations to take 15-20 minutes for breakfast and about 30 minutes for lunch and dinner [10] - A suggested eating order is vegetables, followed by protein, and then carbohydrates [10] Group 5: Lifestyle Modifications - Adequate sleep of 7-8 hours is recommended to maintain hormonal balance and prevent blood sugar fluctuations [13] - Regular physical activity is essential, with a target of at least 150 minutes of aerobic exercise per week, along with resistance training [14]

Core Viewpoint - Gan & Lee Pharmaceuticals has received a positive opinion from the European Medicines Agency (EMA) for its insulin glargine injection (brand name: Ondibta), recommending it as a biosimilar to Lantus SoloStar for diabetes treatment in adults, adolescents, and children aged 2 and above [2]. Drug Basic Information - Drug Name: Ondibta - Generic Name: Insulin Glargine - Indication: Diabetes - Dosage Form: Injection - Specification: 3ml: 100 units/ml (pre-filled pen) - Applicant: Gan & Lee Pharmaceuticals Europe GmbH [3]. Market Context - According to the International Diabetes Federation (IDF), there are approximately 588.7 million diabetes patients aged 20-79 globally in 2024, with Europe accounting for 65.6 million, representing 11.1% of the global patient population [3]. - The total medical expenditure due to diabetes is estimated at $193 billion globally, with an average annual expenditure of $2,951 per patient [3]. - The diabetes prevalence among the adult population in Europe is 9.8% [3]. Competitive Landscape - As of the announcement date, Sanofi is the main supplier of insulin glargine in Europe, with projected global sales of €2.855 billion (approximately $2.989 billion) for 2024, including €819 million (approximately $857 million) in Europe [3][4]. - Gan & Lee Pharmaceuticals has invested a total of 936 million RMB in research and development for the insulin glargine project as of September 30, 2025 [4].

Core Viewpoint - Tonghua Dongbao Pharmaceutical Co., Ltd. has received a drug registration certificate for its Aspart Insulin Injection from the Ministry of Public Health and Social Welfare of the Dominican Republic, indicating a significant opportunity to expand its market presence in the region [1][3]. Group 1: Product Registration Details - Product Name: Aspart Insulin Injection [1] - Dosage Form: Injection [1] - Specification: 3ml:300IU (100 units per ml) in a pre-filled pen [1] - Indication: Diabetes [1] - Registration Number: RM2025-1863 [1] - Manufacturer: Tonghua Dongbao Pharmaceutical Co., Ltd. [1] Group 2: Market Context - The Dominican Republic is the largest economy in the Caribbean and one of the fastest-growing in Latin America, with a population of approximately 10.76 million as of 2024 [2]. - The demand for medical services in the Dominican Republic has been increasing, with an estimated 1.2037 million diabetes patients aged 20-79 in 2024, representing a prevalence rate of 16.6% [2]. - A significant portion of diabetes patients (42.8%) remain undiagnosed, highlighting a substantial unmet medical need [2]. - The average annual expenditure per diabetes patient is approximately $1,353.9 [2]. Group 3: Impact on the Company - The approval of Aspart Insulin Injection allows Tonghua Dongbao to sell the product in the Dominican Republic, enhancing its international product line and brand image [3]. - This development is expected to accelerate the company's expansion into emerging markets and improve its competitiveness in the international market [3].