Hunan Jiudian Pharmaceutical Co., Ltd.

Hunan Jiudian Pharmaceutical Co., Ltd. is a modern pharmaceutical enterprise listed on the ChiNext board of the Shenzhen Stock Exchange since 2017. The company integrates research and development, production, sales, and CXO services, focusing on various pharmaceutical sectors, including chemical drug preparations, active pharmaceutical ingredients (APIs), pharmaceutical excipients, traditional Chinese medicine, and health and wellness products. The company's main business lines encompass a range of pharmaceutical preparations, including Loxoprofen Sodium Gel Patch, Pantoprazole Sodium Enteric-Coated Tablets, and Rosuvastatin Calcium Tablets, among others. Additionally, Hunan Jiudian specializes in the production of key APIs such as Oseltamivir Phosphate and Peramivir, as well as pharmaceutical excipients for biopharmaceuticals and vaccines. With a strong emphasis on research and development, the company has established a robust technical team and various research centers, positioning itself as a significant player in the pharmaceutical manufacturing industry.

(I) R&D Advantages The company has always attached great importance to product R&D and technological reserve since its establishment. At present, the company's leading products and main varieties are all independently developed and successfully industrialized, becoming the driving force for the company's development. The company's R&D strength and industrialization ability have been reliably verified. Mr. Zhu Zhonghong, the actual controller and chairman of the company, has been the R&D leader since the establishment of the company. In the long-term R&D process, the company has cultivated and led a large number of research and development forces and established a research and development technical team of more than 400 people, mainly composed of doctors, masters, and overseas returnees. The company is a national enterprise technology center, a national high-tech industrialization demonstration enterprise, a national torch plan key high-tech enterprise, and a high-tech enterprise in Hunan Province. The company has established a Pharmaceutical Research Institute, which has been recognized as Hunan Provincial Enterprise Technology Center. The company has also set up a postdoctoral scientific research workstation, a new type of gel paste preparation Hunan Provincial Engineering Research Center, and a Hunan Provincial Respiratory Drug Engineering Technology Research Center. Gel patch is a complex local transdermal drug delivery system, which evolved from poultices and has been widely used and introduced into the Chinese and Western markets with the development of high molecular materials and industrial level. According to the characteristics and advantages of the gel patch formulation and the technical development situation, its development trend is mainly divided into three major directions: 1) transforming traditional external ointments into gel patches; 2) transforming traditional oral and injectable drugs into gel patches; 3) using new drug formulation technologies to improve the performance of existing gel patches. Currently, the company has 2 drug registration certificates for gel patch products, more than 15 research and development external drug products, of which 7 have been applied for production. The company is also committed to the development of new functional materials for transdermal drug delivery, overcoming key technological bottlenecks in transdermal drug delivery development, and achieving the development and industrialization of new materials; and establishing a transdermal drug delivery formulation and evaluation system to support the development and marketing of transdermal drug delivery products. The company's Loxoprofen Sodium Gel Patch is a unique national medical insurance formulation, mainly used for bone and joint diseases, muscle pain, and swelling and pain caused by trauma. In 2023, the company obtained approval for Ketorolac Gel Patch, which is a unique formulation, mainly used for symptom relief in osteoarthritis. The approval of Loxoprofen Gel Patch further validates the company's Gel Patch platform technology and solidifies its industry position in this field. Compared with oral formulations, Gel Patches can avoid the first-pass effect caused by oral administration, as well as the stimulation and damage to the gastrointestinal mucosa, cardiovascular system, and liver caused by oral non-steroidal anti-inflammatory analgesics, making them more suitable for patients who have difficulty taking oral medication for various reasons; compared with traditional plasters, Gel Patches have obvious advantages such as good breathability, strong penetration, rapid transdermal absorption, no residual paste on the skin, no staining of clothing, high safety, etc. Loxoprofen Sodium Gel Patch and Ketorolac Gel Patch, as local external application patches, have a large accommodating drug amount and accurate dosage, high permeability, and can ensure excellent efficacy and strength. They are comfortable to apply, have good skin compatibility, high safety, and have obvious clinical advantages and broad market prospects. At the same time, the company has formed a high product technology barrier through continuous R&D and process optimization. The company has always adhered to the product strategy of "high technology, new products, patent drugs" and has obtained approvals for 118 formulations and completed registration for 83 API and 86 pharmaceutical excipient varieties, forming a comprehensive development layout of "pharmaceutical preparations + APIs + pharmaceutical excipients". The company's leading products are all independently developed, and nearly 100 research and development products and applications are pending, which will greatly enrich the company's product pipeline. The company has formed a rich product reserve in the treatment fields of anti-inflammatory and analgesic, digestive system, and anti-infection, including Loxoprofen Sodium Gel Patch, Ketorolac Gel Patch, Loxoprofen Sodium Tablets in the anti-inflammatory and analgesic field; Pantoprazole Sodium Enteric-coated Tablets, Rabeprazole Sodium Enteric-coated Tablets, Shenling Oral Liquid, Colloidal Bovine Gelatin Dry Powder Suspension, and Aluminum Hydroxide Chewable Tablets in the digestive system field; and Oxazolidinone Dispersible Tablets and Deryngestamycin Enteric-coated Tablets in the anti-infection field. The company has rich experience in research and development and production of API, with a modern R&D laboratory, an excellent R&D team, and has formed a complete industrial platform from small-scale to pilot to large-scale production. The production lines have advanced production equipment and complete inspection facilities, with standardized management and stable quality. The company has always paid attention to process optimization and equipment improvement of API, and has formed a unique API production technology and fine management mode of production, thus ensuring quality while creating a low-cost advantage for API. The domestic market share of erythromycin and levo-propiracetam API is high, and it has a strong advantage in the international market; oxidine, and levocetirizine hydrochloride etc. API cover the main domestic market. The company has developed 83 API varieties, with the characteristics of many products and a complete series. By the end of the report period, the company has successfully developed and produced 86 pharmaceutical excipients, such as phosphate series (potassium dihydrogen phosphate, potassium dihydrogen phosphate, sodium dihydrogen phosphate and different crystalline water of dihydrogen phosphate), microcrystalline cellulose, lactose, maltodextrin, sodium octanoate, ammonium sulfate, anhydrous calcium phosphate, sucrose for injection, etc. The competitive advantage of pharmaceutical excipients has become prominent. The company's main formulation products are produced using self-produced API, pharmaceutical excipients, with some API and excipients currently under development. This ensures a high standard and consistency in the quality of the formulations from the source, while also ensuring stable API supply and independence from upstream API manufacturers, preventing the situation where the company's formulation products are dominated by other companies in terms of API supply. Furthermore, self-production of API and excipients gives the company's formulation products a clear cost advantage compared to similar products in the domestic market.