健友股份（603707.SH）12月5日在投资者互动平台表示，门冬胰岛素已经提交申请，若获批公司会第 一时间发布公告。赖脯胰岛素预计在2027年提交申请，甘精胰岛素预计在2026年提交申请，前述期限均 为预估期限，请您关注公司后续发布的公告，以公告内容为准。 每经AI快讯，有投资者在投资者互动平台提问：请问公司与通化东宝合作的三款胰岛素（甘精胰岛 素、门冬胰岛素、赖脯胰岛素）产品，是否已经提交FDA审批，预计获批时间？能对该三款产品在美国 销售预期做展望吗？ （记者 王晓波） ...

Core Insights - The company reported significant growth in its Q3 2025 financial results, with a revenue of 806 million yuan, a year-on-year increase of 13.90%, and a net profit of 984 million yuan, surging by 499.86% [1] - The substantial increase in net profit is attributed to strategic investment adjustments, including the transfer of shares in Xiamen Te Bao Biological Engineering Co., which enhanced short-term profits and supported long-term innovation [1] Financial Performance - In the first three quarters, the company achieved a revenue of 2.18 billion yuan, reflecting a year-on-year growth of 50.55%, and a net profit of 1.20 billion yuan, marking a turnaround from losses [1] - The non-recurring net profit reached 321 million yuan, up 137.92%, indicating improved profit quality [1] Product Development - The company's third-generation insulin products have become the largest revenue contributor, with sales increasing by approximately 50% year-on-year, surpassing second-generation insulin [2] - This shift in product structure signifies a strategic breakthrough in the insulin market, particularly following the implementation of the second insulin procurement policy [2] International Expansion - The company has accelerated its internationalization efforts, obtaining approvals for insulin formulations in four countries, including Uzbekistan, Nicaragua, Myanmar, and Indonesia [3] - The company is also progressing in the U.S. market, with the acceptance of its BLA for insulin aspart by the FDA and plans for further submissions [3] Shareholder Engagement - The company has introduced an employee stock ownership plan, aiming to transfer up to 11.08 million shares, which represents 0.566% of the total share capital, to enhance employee engagement and company competitiveness [4] - Additionally, a share repurchase plan has been announced, with intentions to buy back shares worth 20 to 40 million yuan to support the employee stock ownership plan and/or equity incentives [4] Future Strategy - The company aims to drive growth through "innovation + internationalization," focusing on expanding its presence in the diabetes treatment sector and increasing market share in both domestic and international markets [5]

Investment Rating - The report maintains a "Positive" investment rating for the insulin industry [10] Core Insights - The insulin market is stabilizing post-collection procurement, with companies focusing on innovation and steady progress in R&D pipelines, creating a closed-loop advantage in insulin, diabetes, endocrine, and metabolism sectors [3][9] - The progress of insulin exports is promising, expected to contribute to new growth [8] - The cash flow of companies is gradually stabilizing, and the valuation of innovative pipelines is likely to be reshaped [9] Summary by Sections Domestic Insulin Collection Procurement - The domestic insulin market is broad, with insulin analogs becoming the main driving force. In 2021, there were approximately 14.1 million diabetes patients in China, with an expected increase to 29.3 million by 2030. The market size for insulin in China is projected to be 22.3 billion yuan in 2024, reflecting a year-on-year decrease of 14.23% [20] - The first round of national collection procurement was moderate, ensuring basic procurement volume and expanding external market channels. Nearly 50% of the insulin market share was not included in the procurement, allowing leading companies to significantly increase sales volume [27][20] - The second round of procurement renewal has seen price increases for some companies, reflecting a balanced approach by the National Medical Insurance Administration [30][27] Insulin Export Progress - Companies like Ganli Pharmaceutical and Tonghua Dongbao are making significant progress in exporting insulin to developed regions like Europe and the US, where the insulin market is valued at $13.2 billion. The market in developing regions such as Asia, Africa, and Latin America is estimated to be between $4.3 billion and $6.5 billion [8][20] Innovative Drug Pipeline - The innovative drug pipeline is gradually yielding results, with a focus on GLP-1 research and development. Insulin companies are expected to leverage their advantages in sales terminals, process development, and production capacity in the GLP-1 sector [9][8] - The management teams and innovation systems of these companies are undergoing significant changes, which may lead to a reshaping of their valuations [9]

Core Viewpoint - The global insulin raw material market is projected to reach USD 3.76 billion by 2031, with a compound annual growth rate (CAGR) of 4.1% in the coming years [1][6]. Market Overview - Insulin raw materials are active pharmaceutical ingredients used in the production of various insulin formulations, crucial for diabetes management [1]. - The market is dominated by major players such as Novo Nordisk, Sanofi-Aventis, and Eli Lilly, with the top five companies holding approximately 88.0% of the market share in 2024 [6][16]. Product Segmentation - Insulin analogs represent the largest segment, accounting for about 82.0% of the market share [8]. - Rapid-acting insulin is the primary demand source, making up approximately 34.9% of the market [10]. Market Drivers - The increasing prevalence of diabetes, especially in developing countries and aging populations, is driving demand for insulin formulations, thereby expanding the upstream raw material market [13]. - Advances in biotechnology and production processes, including recombinant DNA technology, have made insulin production more efficient and cost-competitive [13]. - Countries are promoting generic drug policies to encourage local production of insulin raw materials, which supports the growth of domestic industries [13]. Challenges - The market faces high technical barriers, making it difficult for small and medium enterprises to enter and achieve stable production [14]. - The international market is highly concentrated, with major multinational companies dominating, posing challenges for new entrants in customer acquisition and product recognition [14]. - Stricter regulatory requirements, including GMP compliance and data integrity, are critical for market entry, necessitating continuous investment from companies [14]. - Fluctuations in raw material prices, stringent environmental policies, and geopolitical factors may disrupt the stability of raw material production and exports [14].

Group 1 - The company is actively expanding its international market presence, particularly in the U.S. insulin market through strategic partnerships and ongoing clinical trials for three types of insulin [1] - The company has achieved sales of approximately 200,000 units of liraglutide injection in Q1 2025, with a strong foundation for annual sales growth due to successful procurement results [2] - The company is focusing on the sales of insulin analog products and expanding its market presence for GLP-1 receptor agonists and SGLT-2 inhibitors to meet diverse patient needs [2] Group 2 - The company has received approvals for insulin products in several developing countries, including Nicaragua and Uzbekistan, and is working on expanding registrations for insulin products in these markets [1] - The company is advancing its clinical trials for new products, including THDBH120 for weight loss, which has completed its Phase II clinical trial [2][3] - The company is not currently developing oral insulin products due to technical challenges but will monitor industry advancements for potential future adjustments in R&D strategy [3] Group 3 - The company’s parent group, Dongbao Group, is working to reduce its share pledge ratio, which is currently high due to long project cycles and financial pressures [3] - The long-term outlook for Dongbao Group is positive, with ongoing projects and products expected to enter a recovery phase, improving operational capabilities [4]

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for its stock performance [5][7]. Core Views - The company is positioned as a leading player in the heparin raw material market, with a strong potential for growth in its API business due to improving market conditions [3][4]. - The company is focusing on its sterile injection formulations, which are experiencing rapid growth in overseas markets, supported by a robust product matrix and strategic acquisitions [4][61]. - The global biosimilar market is expected to expand significantly, and the company is well-positioned to capitalize on this trend through both self-developed products and strategic partnerships [5][67]. Summary by Sections 1. Company Overview - The company has transitioned from a traditional heparin raw material supplier to a high-end injection formulation and biosimilar provider, covering multiple therapeutic areas [13][16]. 2. Heparin API Market Improvement - The heparin raw material market is showing signs of recovery, with expectations for price stabilization and potential revenue growth for the company [3][31]. - The company has a strong production and sales level in its heparin API business, which is crucial for funding its injection formulation expansion [36][37]. 3. Focus on Sterile Injection Formulations - The company's injection business has seen significant revenue growth, with a 12.8% increase in 2023 and a compound annual growth rate (CAGR) of 47.4% from 2018 to 2023 [41][46]. - The company has a diverse product line in the injection segment, including low molecular weight heparin and anti-tumor agents, with a strong competitive position in the domestic market [47][55]. 4. Biosimilar Drug Development - The global biosimilar market is projected to grow rapidly, with the company actively developing multiple biosimilar products and securing market entry through strategic acquisitions [67][72]. - The company has made significant progress in obtaining FDA approvals for its biosimilar products, positioning itself as a key player in the U.S. market [72][73]. 5. Financial Projections - The company is expected to achieve substantial profit growth, with projected net profits of 9.0 billion, 11.9 billion, and 15.4 billion yuan for 2024, 2025, and 2026, respectively [5][6].