证券代码:300199 证券简称:翰宇药业 深圳翰宇药业股份有限公司 投资者关系活动记录表 编号:2016-002 | --- | --- | --- | --- | |-------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------|-------| | | 团特定对象调研 | | | | 投资者关系 | 口媒体采访 | □分析师会议 □业绩说明会 | | | 活动类别 | □新闻发布会 | □路演活动 | | | | □现场参观 | | | | | 口其他:投资者恳谈会 | | | | 参与单位名称 及人员姓名 | 国泰君安 赵旭照,国泰君安 马铮,顺鑫置业 杨云峰, 裕晋投资 石宁,裕晋投资 吴柠彬 | | | | | | | | | 时间 | 2016年1月15日下午 15:30-16:30 | | | | 地点 | 公司五楼办公室 ...

Group 1: Market Potential and Product Overview - The new product Carboprost has a significant market potential, with an estimated market size of 2 billion to 4 billion RMB, driven by approximately 2.5 million new births annually in China, especially with the full implementation of the two-child policy [2][3] - Carboprost is a long-acting oxytocin analog that enhances uterine contractions, making it a critical drug for preventing postpartum hemorrhage, with a clinical application that is both safe and effective [2] Group 2: Company Performance and Integration - The acquisition of Chengji Pharmaceutical was completed in February 2015, allowing for the integration of management structures and production systems, which has laid a solid foundation for achieving annual operational goals [3] - The company has successfully upgraded Chengji Pharmaceutical's production capacity and is leveraging its advantages to expand market scale and enhance overall profitability [3] Group 3: Regulatory and International Market Developments - The company’s Acetate Glatiramer has received DMF registration from the FDA, paving the way for future generic drug approvals [3] - The international application for the peptide formulation has passed document review, and the raw material production facility has successfully undergone FDA inspection, indicating steady progress in international market expansion [3] Group 4: Future Prospects and R&D - The company is positioned to benefit from the expiration of patents for Liraglutide in August 2017, which is expected to lead to increased demand for raw materials and a surge in sales [3] - Ongoing R&D efforts for Liraglutide formulations are progressing, with plans to enter the formulation certification phase upon completion [4]

Group 1: Company Overview and Performance - Shenzhen Hanyu Pharmaceutical Co., Ltd. completed the acquisition of Chengji Pharmaceutical in February 2015, enhancing its management and operational capabilities [2] - The company successfully upgraded Chengji Pharmaceutical's production capacity in Q4 2015, laying a solid foundation for achieving annual operational goals [2] - Hanyu aims to leverage Chengji's production scale and cost advantages to establish a nationwide production base [2] Group 2: Product Portfolio - Chengji Pharmaceutical's main products are categorized into three types: clinical injections, solid preparations, and medical devices [3] - Key products include the injection of Acyclovir, exclusive pediatric acetaminophen tablets, and the patented "Hanneng" automatic injection pen [3] - "Hanneng" meets the safety and efficiency needs of healthcare professionals, while "Hanquan" is a state-of-the-art automatic injection technology with significant market potential [3] Group 3: Internationalization and Future Plans - The company is actively expanding its international presence, seeking collaborations for its mature peptide products and progressing with the registration of generic drugs abroad [3] - Hanyu is focusing on maintaining its existing raw material market while exploring international pathways for its formulation products [4] - The company is preparing for a surge in demand for raw materials following the expiration of patents in August 2017, which is expected to boost sales significantly [3]

Product Overview - Cabergoline is a synthetic long-acting oxytocin analog approved for market in February 2016, aimed at preventing postpartum hemorrhage and enhancing uterine contractions [2] - The product's launch enriches the company's core product line and is expected to significantly boost company performance [2] Sales Performance - Terlipressin, a synthetic vasopressin analog, generated sales revenue of ¥68,370,177.72 in the first half of 2016, marking a 35.08% increase compared to the same period last year [3] - The company aims for a 50% revenue growth for Terlipressin by the end of the year through enhanced academic promotion and sales efforts [3] International Market Strategy - The company has a strong R&D capability in peptide drugs and aims to expand its international market presence, including in developed regions like the US, Europe, Japan, and South Korea, as well as emerging markets like India [3] - Plans include increasing overseas registration and market expansion efforts for peptide drugs and raw materials [3] Competitive Advantages - The company has invested 10 years in the R&D of Glatiramer and 7 years in Liraglutide, establishing a competitive edge in the international raw material drug market [4] - The company is recognized as a preferred supplier for major pharmaceutical companies, enhancing its market share and brand recognition [4] Recent Acquisitions and Growth - Following the acquisition of Chengji Pharmaceutical, the company has integrated its management and production systems, leading to significant revenue growth in combination packaging products (¥39,859,100, up 320.49%) and medical devices (¥53,301,000, up 259.29%) in the first half of 2016 [4] - Future plans include leveraging Chengji's production scale and cost advantages to expand sales and improve overall profitability [4]

Group 1: Financial Performance - In the first three quarters of 2016, the raw material drug business achieved revenue of approximately 110 million CNY, with a year-on-year growth exceeding 500% [2] - The peptide business generated nearly 90 million CNY in revenue, reflecting a year-on-year increase of about 8% [2] - The market for carboprost, a synthetic long-acting oxytocin analog, is projected to reach 2 to 4 billion CNY due to an estimated annual increase of 2.5 million newborns following the full implementation of the two-child policy [4] Group 2: Market Expansion and Product Development - The company has established stable partnerships with several major pharmaceutical companies abroad, enhancing its competitiveness in the international raw material drug market [2] - The company has invested 10 years and 7 years in the R&D of the raw materials for liraglutide and glatiramer, respectively, leading to recognized production processes and competitive quality [2] - The non-invasive continuous blood glucose monitoring wristband project is actively progressing with clinical trials in Europe, aimed at improving the quality of life for diabetes patients [3] Group 3: Regulatory and Strategic Adjustments - The company terminated its third employee stock ownership plan due to significant changes in regulatory policies and market conditions, with plans to initiate a new stock ownership plan when conditions are favorable [5] - The company is actively researching national policies and market trends to adjust its marketing strategies and optimize product structure in response to domestic market challenges [4]

Group 1: Product Overview - Carboprost is a synthetic long-acting oxytocin analog used to enhance uterine contractions during cesarean sections, preventing uterine atony and postpartum hemorrhage [2] - In China, approximately 16.5 million newborns are born annually, with an expected increase of 2.5 million newborns per year after the full implementation of the two-child policy [2] - The cesarean section rate is around 45%, indicating a market potential of 2-4 billion RMB for Carboprost, as each cesarean section patient may require 1-2 doses [2] Group 2: Market Impact - The approval of Carboprost and its injection formulation by the National Medical Products Administration in February 2016 has diversified the company's core product offerings [2] - The introduction of Carboprost is expected to significantly enhance the company's performance and optimize its product structure [2] Group 3: Collaboration and Development - The non-invasive continuous glucose monitoring wristband project, in collaboration with Pudi Medical, utilizes near-infrared and bio-resistance signals to provide real-time glucose data, improving the quality of life for diabetes patients [3] - Clinical trials for the glucose monitoring wristband are actively progressing in Europe, with ongoing optimizations based on trial feedback [3] Group 4: Production Expansion - The biopharmaceutical production base in Wuhan has commenced construction, covering an area of 342 acres with a planned building area of 250,000 square meters [3] - The project includes a peptide raw material production base, a high-end solid preparation production base, a national-level biopharmaceutical R&D production base, and an administrative service center [3]

Company Overview - Shenzhen Hanyu Pharmaceutical Co., Ltd. was established in 2003, focusing on the research, production, and sales of peptide drugs, recognized as a national high-tech enterprise [2] - The company has established multiple subsidiaries and research centers, including a national peptide drug public laboratory and a production base for peptide drugs [2] Financial Performance - In the first three quarters of 2016, the raw material drug business achieved revenue of approximately CNY 110 million, a year-on-year increase of over 500% [3] - The peptide business generated nearly CNY 90 million in revenue, with a growth rate of about 8% [3] - The revenue from Terlipressin reached CNY 119,401,132.91, reflecting a year-on-year growth of 38.61% [4] Research and Development - Over 30% of the company's employees are involved in R&D, with R&D investment consistently exceeding 10% of sales revenue [3] - The company has applied for over 300 invention patents and has received nearly 200 authorized patents [3] - Hanyu Pharmaceutical has participated in several national-level major scientific projects and has been recognized with various awards for innovation and quality [3] Market Strategy - The company has secured exclusive agency rights for the non-invasive continuous glucose monitoring device GlucoPred in the Chinese market [2] - A strategic partnership with Tencent was established to enhance the management of chronic diseases through mobile internet technology [3] - The company aims to expand its international market presence, particularly in the raw material drug sector, leveraging its R&D and technical advantages [4]

Group 1: Product Overview - Acetate Glatiramer is a key product for the company, with a global market annual sales exceeding $4 billion [2] - The product has received high recognition in the industry after years of R&D investment and technological breakthroughs [2] - The active pharmaceutical ingredient (API) received a DMF number in 2015 and completed DMF file updates by the end of 2016 [2] Group 2: Market Potential and Strategic Position - The company is actively promoting the ANDA application for Acetate Glatiramer injection in collaboration with Akorn, which is expected to positively impact future operating performance [2] - The product's successful FDA registration will significantly enhance the company's overseas market performance and improve its international sales system [2] Group 3: Liraglutide Development and Market Advantages - Liraglutide has been approved for treating type II diabetes and obesity, showing significant cardiovascular risk reduction in a large clinical trial [3] - The company has developed proprietary processes and technology for Liraglutide, achieving high product purity and quality recognized by industry experts [3] - With the expiration of the original Liraglutide patent, demand for the API is expected to grow, further boosting the company's export scale and market share in the international API market [3]

Group 1: Product Overview - Terlipressin is a synthetic vasopressin analog initially developed in the early 1980s, primarily used for treating variceal bleeding due to liver cirrhosis [2] - It is widely applied in clinical settings for conditions such as hepatorenal syndrome, ascites due to cirrhosis, septic shock, burns, acute liver failure, and cardiac arrest [2] - Terlipressin is the only known drug that can improve survival rates in patients with liver cirrhosis-related complications, making it significant in treatment guidelines [2] Group 2: Market Position and Competition - The domestic market for injectable terlipressin is currently dominated by two companies: the original manufacturer, Ferring, and Hanyu Pharmaceutical [3] - Prior to 2009, the terlipressin market in China was monopolized by imported drugs until Hanyu launched its generic version, breaking the monopoly and filling a market gap [3] - Hanyu's terlipressin has shown rapid growth in sales, achieving a leading position in the domestic market [3] Group 3: Marketing Strategies - The marketing strategy for terlipressin combines academic promotion with expert education, focusing on various academic activities to enhance physician awareness [3] - The drug has gained recognition among experts, doctors, and patients due to its clinical efficacy and extensive market cultivation [3] - After being included in the national medical insurance directory, Hanyu plans to intensify academic and sales promotions to solidify and expand its competitive advantage in the market [3]

Group 1: Employee Stock Ownership Plan - The third employee stock ownership plan was terminated due to significant changes in regulatory policies and market conditions, despite attempts to adjust it according to new regulations [2] - The company plans to consider launching a new employee stock ownership plan or other equity incentive methods in the future when conditions are favorable [2] Group 2: Impact of Liraglutide Generic Drug - The global market sales for Liraglutide reached $2.7 billion in 2015 and are expected to grow to $3 billion this year, indicating a positive market outlook [3] - The company is actively pursuing ANDA applications for Liraglutide, which is expected to increase demand and enhance its competitive advantage as a preferred supplier of raw materials [3] Group 3: Future Growth Points - The company anticipates growth in the international market, particularly for Liraglutide and Glatiramer, with ongoing international registration efforts [3] - The company is also targeting both regulated and unregulated markets to expand its market share [3] Group 4: National Medical Insurance Inclusion - The company’s products, Terlipressin and Eptifibatide, are considered popular candidates for inclusion in the national medical insurance directory [4] - The relationship between drug inclusion in insurance and price reduction is not direct and depends on market competition [4] Group 5: Market Outlook for Older Products - The sales of older products like Thymopentin are affected by national policies, but they still maintain a strong market presence due to their widespread clinical applications [4] - The company aims to sustain the market scale of older products while seeking continuous growth in its main business [4]