本次获批的临床适应症为："本品配合饮食运动，用于单独使用盐酸二甲双胍血糖控制不佳的成人2型糖 尿病患者。"三药联合复方制剂药物作用机制互补，覆盖糖尿病的多重病理生理机制，可有效控制血 糖，且安全性和耐受性良好;同时可减少服药数量、简化降糖方案、提高患者治疗依从性，具有较高的 临床开发价值。该产品将为2型糖尿病患者提供新的治疗选择，并进一步丰富集团在代谢疾病领域的产 品线。 智通财经APP讯，石药集团(01093)发布公告，集团开发的普卢格列汀达格列净二甲双胍缓释片(该产品) 已获中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。 该产品为全球首款获批临床的由普卢格列汀、达格列净和盐酸二甲双胍组成的三药联合复方制剂。普卢 格列汀是一种二肽基肽酶-4(DPP-4)抑制剂，通过抑制DPP-4，使内源性活性胰高血糖素样肽-1(GLP-1) 水平升高，从而增强β细胞和α细胞对葡萄糖的敏感性，增加葡萄糖刺激的胰岛素分泌，并增强葡萄糖 对胰高血糖素分泌的抑制作用，进而改善高血糖。达格列净是一种钠—葡萄糖协同转运蛋白 2(「SGLT2」)抑制剂，通过抑制SGLT2，减少滤过葡萄糖的重吸收，从而促进尿糖排泄。二甲双胍 ...

格隆汇12月9日丨科源制药(301281.SZ)在互动平台表示，公司产品聚焦慢病领域，三高和心血管原料药 均有布局，目前降糖类主要原料药为格列齐特和盐酸二甲双胍，心血管类主要原料药为单硝酸异山梨 酯，目前公司暂未布局保健品原料药。 ...

Group 1: Termination of Restructuring - The termination of the restructuring project was primarily due to changes in the overall market environment, which affected the expectations of the parties involved in the transaction [2][3][6] - The company decided to terminate the restructuring to protect the long-term interests of all shareholders after thorough discussions and analyses with relevant parties [2][6][8] Group 2: Market Environment and Strategic Focus - Recent changes in centralized procurement policies have altered the supply-demand relationship for drugs, impacting the expectations for the restructuring project [3] - The company remains focused on drug research, production, and sales, with a strong emphasis on developing new products and expanding its product range, including categories such as hypoglycemic, anesthetic, cardiovascular, and psychiatric drugs [3][5][7] Group 3: Financial Performance - For the period from January to September 2025, the company achieved a revenue of ¥302,688,076.14 and a net profit attributable to shareholders of ¥31,261,045.17 [5] - The company plans to continue investing in core products to enhance market share and profitability, especially in light of the upcoming procurement agreements [5][7] Group 4: Future Plans and Collaborations - The company is committed to exploring new product introductions and market development strategies following the termination of the restructuring [7][8] - Collaborations with research institutions and industry partners are planned to enhance technological cooperation and joint research efforts [4][8] Group 5: Market Position and Competitive Advantage - The company has established a strong market position with key products such as Glimepiride and Metformin, supported by advanced technology and mature production processes [7][8] - The company holds 31 active pharmaceutical ingredient (API) registration numbers and 44 approved chemical drug formulations, with many products included in national medical insurance directories [8]

Core Insights - The "2025 China Listed Companies Excellence Demonstration Case Selection" results were announced, with Koyuan Pharmaceutical (301281.SZ) Secretary Li Chunhua awarded the "Outstanding Secretary" title [1] - The selection aims to promote high-quality development in China's capital market and advocates for value and long-term investment [1] Company Overview - Koyuan Pharmaceutical is a leading company in the domestic chemical raw materials drug sector, focusing on chronic disease areas such as diabetes, anesthesia, cardiovascular, and central nervous system disorders [1] - The company specializes in the R&D, production, and sales of chemical raw materials and formulations, with all products certified by national GMP and core products holding EU CEP certification [1] Product Development and Strategy - The company is enhancing its product development capabilities and expanding its product range, currently offering various categories of drugs including diabetes, anesthesia, cardiovascular, and psychiatric medications [1] - Key products include mature raw materials such as Glimepiride, Metformin Hydrochloride, Ropivacaine Hydrochloride, and Isosorbide Mononitrate, contributing to stable revenue and profit [1] Mergers and Acquisitions - Koyuan Pharmaceutical is actively pursuing an integrated development strategy of "raw materials + formulations" through the acquisition of Lino Pharmaceutical, which adds new growth potential [2] - The company has successfully passed anti-monopoly review for the acquisition of 99.42% equity in Shandong Hongjitang Pharmaceutical Group [2] Management Team - The management team consists of high-quality experts with multidisciplinary backgrounds and extensive experience in the chemical raw materials drug industry [2] - The team emphasizes sustainable long-term development and core competitiveness, implementing effective management systems across R&D, procurement, production, marketing, and human resources [2] Future Outlook - Koyuan Pharmaceutical will continue to adhere to its values of "long-termism, productism, and altruism," focusing on chronic disease areas and diversifying into other niche markets [2] - The company aims to enhance R&D capabilities and expand its core competitiveness through integrated raw material and formulation strategies [2]

Core Viewpoint - The company Fu Yuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for its product, Pioglitazone Metformin Tablets (15mg/850mg), allowing for its production [1] Group 1: Product Approval - The National Medical Products Administration has issued a drug registration certificate for Pioglitazone Metformin Tablets (15mg/850mg) [1] - The product is indicated for type 2 diabetes patients who have inadequate blood sugar control with Metformin alone or those currently using a combination of Pioglitazone and Metformin [1] Group 2: Market Context - The original manufacturer of the drug is Takeda Pharmaceutical Company, which received approval for the product in the United States in August 2005 [1] - The original manufacturer's version of Pioglitazone Metformin Tablets has not yet been launched in China [1]

Core Insights - Shandong Fukun Group's project on "Key Technologies and Industrialization of Crystalline Hydrochloride Metformin and Lazol Series Drugs" won the 2024 Shandong Provincial Science and Technology Progress Second Prize, achieving international advanced levels in high-quality drug crystal production [1] - The company has developed a complete industrial chain for Metformin, increasing its annual production capacity from 5,000 tons to 20,000 tons, capturing 70% of the domestic market and nearly one-third of the global market share [1][2] Group 1 - The project addresses common challenges in the production of crystalline Hydrochloride Metformin and Lazol series drugs through multi-scale research from molecular level to industrialization [1] - The fully automated production line at Shandong Fukun Group operates at a speed of 200 boxes per minute, showcasing advanced intelligent control systems monitoring the entire production process [1] - The transformation of limestone, costing 70 yuan per ton, into diabetes treatment drugs valued at 600,000 yuan per ton illustrates the company's innovative production capabilities [1] Group 2 - The company identified high-quality limestone from the Helan Mountain region as a stable raw material for producing Dicyandiamide, which constitutes over 60% of the production cost of Metformin [2] - In 2021, Shandong Fukun Group established the world's largest Dicyandiamide production base in Alxa League, Inner Mongolia, enhancing its upstream supply chain [2] - The company has formed a complete industrial chain that includes pharmaceutical intermediates, specialty raw materials, and finished formulations, with leading global production and sales in the raw material drug sector [2]

Investment Rating - The report maintains an "Accumulate" rating for the company [2][8]. Core Insights - The company reported a revenue of 228 million yuan for the first half of 2025, a year-on-year decrease of 3.91%. However, the net profit attributable to shareholders increased by 18.36% to 43 million yuan, and the net profit after deducting non-recurring gains and losses rose by 38.51% to 36 million yuan [3][8]. - In Q2 2025, the company achieved a revenue of 117 million yuan, reflecting a year-on-year growth of 28.39% and a quarter-on-quarter increase of 4.91%. The net profit for Q2 was 20 million yuan, up 34.96% year-on-year but down 15.10% quarter-on-quarter [8]. - The company focuses on chronic disease management and is expanding into other niche markets, emphasizing a diversified layout and integration of raw materials and formulations [8]. - The company is enhancing its R&D capabilities and has established a comprehensive technical innovation system, maintaining deep cooperation with downstream formulation clients [8]. - The company has a strong production advantage in raw materials and is actively developing new products, with a product portfolio that includes various categories such as hypoglycemic, anesthetic, cardiovascular, and psychiatric drugs [8]. - The company has a stable revenue and profit stream from its leading products, including Glimepiride and Metformin, and is pursuing an integrated development strategy of "raw materials + formulations" through acquisitions [8]. Financial Projections - The company is projected to achieve total revenue of 475 million yuan in 2025, with net profit expected to reach 71 million yuan, resulting in an EPS of 0.65 yuan. For 2026, revenue is forecasted at 489 million yuan, with net profit of 79 million yuan and an EPS of 0.73 yuan [9].

Core Insights - Shandong Keyuan Pharmaceutical Co., Ltd. reported a total revenue of 228 million yuan for the first half of 2025, a decrease of 3.91% compared to the same period last year [1] - The company achieved a net profit attributable to shareholders of 42.683 million yuan, an increase of 18.26%, indicating strong operational resilience [1] - The growth in net profit was primarily driven by increased market development efforts in the chemical drug formulation business, which led to a gross profit increase of 27.7036 million yuan, a growth rate of 28.58% [1] Business Performance - The formulation business showed strong growth, with revenue from chemical drug formulations reaching 102 million yuan, a year-on-year increase of 35.08%, and a gross margin of 79.91% [1] - Research and development investment was 19.3566 million yuan, reflecting a year-on-year increase of 20.35%, demonstrating the company's commitment to innovation and product upgrades [1] Product Development - The company has enhanced its product development capabilities, expanding its range of products to include various categories such as hypoglycemic, anesthetic, cardiovascular, and psychiatric drugs [2] - Key products include mature raw materials like Glimepiride, Metformin Hydrochloride, Ropivacaine Hydrochloride, and Isosorbide Mononitrate, which provide stable revenue and profit [2] - The acquisition of Shandong Linuo Pharmaceutical Co., Ltd. supports the integrated development strategy of "raw materials + formulations," adding new momentum for future growth [2]

Core Insights - The stock price of Koyuan Pharmaceutical reached 35.82 yuan, increasing by 1.65% compared to the previous trading day [1] - The company reported a half-year revenue of 228 million yuan and a net profit of 42.68 million yuan, marking a year-on-year growth of 18.26% [1] - The revenue from the formulation business was 102 million yuan, with a significant year-on-year increase of 35.08% and a gross margin of 79.91% [1] Financial Performance - Koyuan Pharmaceutical's R&D investment amounted to 19.36 million yuan, reflecting a year-on-year increase of 20.35% [1] - The company experienced a net outflow of 4.95 million yuan in main funds on August 15, with a cumulative net outflow of 15.27 million yuan over the past five days [1] Strategic Developments - The company announced plans to acquire 99.42% of Shandong Hongjitang Pharmaceutical Group to enhance its industry chain layout [1] - The fourth board meeting and the eighth supervisory board meeting were held on the same day to review and approve the half-year report and related proposals [1]

Core Viewpoint - The second largest shareholder of Koyuan Pharmaceutical plans to reduce its stake in the company, which has led to a significant drop in the company's stock price following the announcement [1][2]. Group 1: Shareholder Actions - Koyuan Pharmaceutical announced that its second largest shareholder, Wen Zehong, who holds 8.4 million shares (7.76% of total shares), intends to reduce his holdings by up to 3% of the total shares, equating to a maximum of 3.2487 million shares [1]. - The reduction is attributed to Wen Zehong's personal funding needs, with the shares being from his holdings prior to the company's initial public offering [1]. Group 2: Stock Performance - Following the announcement of the share reduction, Koyuan Pharmaceutical's stock price opened lower and fell by over 10% on May 26 [2]. - The company's stock had previously surged from 19.59 yuan per share on September 24, 2022, to a peak of 58.66 yuan per share by October 29, 2022, before experiencing a continuous decline [2]. Group 3: Financial Performance - Koyuan Pharmaceutical's main business involves the research, production, and sales of chemical raw materials and their formulations, covering key disease areas such as diabetes, anesthesia, cardiovascular, and mental health [2]. - In 2023, the company reported a revenue increase of 1.07% but a net profit decrease of 15.6%. For 2024, revenue is expected to grow by 3.6%, while net profit is projected to decline by 21.54%, indicating a trend of increasing revenue but decreasing profitability [2]. - The company's net profit margin has decreased from 20.61% in 2022 to 13% in 2024, highlighting significant challenges in profitability [2]. - The net cash flow from operating activities turned negative in 2024, recording -60.5158 million yuan, compared to a positive 37.031 million yuan in 2023 [2]. Group 4: M&A Activity - Koyuan Pharmaceutical is currently engaged in an acquisition transaction, planning to issue shares and pay cash to acquire 99.42% of Shandong Hongjitang Pharmaceutical Group [3]. - The transaction involves multiple related parties, including its controlling shareholder, Lino Investment, indicating that it constitutes a related party transaction [4].