Recently, Suzhou Jingye Medicine & Chemical (Jingye) successfully obtained the "Notice of Approval for Chemical Active Pharmaceutical Ingredient (API) Marketing Application" issued by the National Medical Products Administration (NMPA) for its raw material of Clomipramine hydrochloride.
This significant achievement not only affirms Jingye's profound capabilities in the research and development of APIs, but also recognizes its rigorous production processes and quality management system, which strive for excellence. Meanwhile, as a partner of Jingye, Medicilon has provided services such as API process development and solvent substitution. This also demonstrates Medicilon's professionalism and reliability in the field of API services. Following Jingye's successful transformation and the achievement of its first API going to market, Medicilon has specially invited Mr. Weidong Yuan, the responsible person from Jingye, to provide an in-depth analysis and share the story behind this significant milestone.
Weidong Yuan, President and Head Senior Engineer of Suzhou Jingye Medicine & Chemical, has been deeply involved in the field of APIs for over twenty years. He possesses extensive professional expertise and experience in research and development management. He has held key positions at Jiangsu Wuzhong Medical Company, Suzhou Pharmaceutical Factory, and Suzhou Changzheng-Xinkai (formerly Suzhou Changzheng Pharmaceutical Factory), spanning across research and development, production, management, procurement, and marketing, demonstrating outstanding industry insights and leadership.
With forward-looking strategic vision and technical strength, Weidong Yuan is leading Suzhou Jingye Medicine & Chemical into the CDMO (Contract Development and Manufacturing Organization) field. He is dedicated to advancing diversification and continuous production within the industrial chain. Under his leadership, the company's research and development capabilities continue to strengthen. Several competitively positioned APIs currently in development have achieved significant breakthroughs. Simultaneously, there is active expansion into the solid preparation form sector, facilitating the company's advancement into broader business domains.
Mr. Yuan: Suzhou Jingye Medicine & Chemical was originally a production enterprise mainly focusing on pharmaceutical intermediates. In 2018, the company received approval for a transformation and upgrade project from Suzhou High-tech Zone Economic Development Bureau. Hydrochloride quetiapine is the first API that the company has applied for. The approval of this variety signifies that the transformation and upgrade of the company have begun to show results, strengthening the company's confidence in continuing to develop along the path of APIs!
Mr. Yuan: Jingye has over 20 years of experience in commercial production, process development, and optimization. The company offers comprehensive services from small-scale trials to pilot-scale and commercial-scale production. Hydrogenation reaction is a distinctive capability of the company, with hydrogenation reactor capacities ranging from 50L to 3000L and a maximum hydrogenation pressure of 12 MPa. The company utilizes DCS automatic control systems and SISA safety instrument systems to ensure production safety. The company has engaged in deep collaboration with large well-known pharmaceutical enterprises both domestically and internationally such as AstraZeneca from the UK, Sanofi from France, Novartis from Switzerland, Sumitomo Chemical from Japan since its early years. This collaboration involves providing customized research and development as well as production of pharmaceutical intermediates.
Mr. Yuan: Jingye's current layout in API focuses primarily on APIs for psychiatric disorders and chronic diseases. In the second half of this year, the company is set to obtain its second API registration approval and has 3-4 APIs under research and development. Additionally, in the second half of 2023, the company has initiated a second transformation and upgrade project in Suzhou High-tech Zone, converting a synthesis workshop into a precision drying and packaging workshop to further expand the scope and capacity of API production. Simultaneously, the company plans to construct a new integrated solid dosage form building to gradually enter the field of solid preparation. Furthermore, Jingye's holding company, Jiangsu Jiye Medicine & Chemical. (Huai'an Industrial Park), is also planning a transformation and upgrade to focus on API production.
Mr. Yuan: In the future, we hope to evolve into a comprehensive pharmaceutical group integrating research, production, and sales of pharmaceutical intermediates, APIs, and solid preparation.
In the era following centralized procurement, as the value of generic drugs gradually returns, the quality standards of APIs are also significantly improving. Medicilon, as one of the few comprehensive biopharmaceutical preclinical R&D service platforms in China, specializes in the field of APIs. It currently possesses cGMP-compliant API production lines that meet IND requirements for both China and the United States. Medicilon provides end-to-end services from small-scale synthesis and process development in preclinical stages to commercial production. Medicilon is capable of accommodating diverse production needs ranging from milligrams to kilograms.
At the same time, Medicilon's analytical and quality inspection teams also provide comprehensive analysis and research services. These include developing and validating analysis methods, process validation, impurity identification and separation, quality research of APIs and intermediates, as well as stability testing of APIs. In addition, Medicilon's process department not only offers services such as research and development, analytical testing, and stability studies for generic drugs, but also meets the research, production, analytical testing, and stability study needs of Phase I and Phase II clinical trials for innovative drugs.
Medicilon congratulates Jingye on the official approval and market launch of hydrochloride quetiapine! Looking forward to the future, Medicilon will continue to leverage over twenty years of accumulated experience in empowering global innovation and generic drug research and development. We aim to provide comprehensive customized R&D services to pharmaceutical companies worldwide, accelerating the drug development process and facilitating higher-quality medications to reach clinical trials and enter the market earlier.
About Suzhou Jingye Medicine & Chemical
Suzhou Jingye Medicine & Chemical was established in 1998 in the Suzhou High-tech Zone Incubator. The company primarily focuses on the production of APIs, pharmaceutical intermediates, and CDMO project services. The company covers an area of nearly 80 acres, with a current workforce of 282 employees. It operates 9 commercial production workshops, including 3 GMP-compliant workshops and 1 CDMO workshop. The main products include intermediates for Pregabalin, Quetiapine Hydrochloride, Quetiapine Fumarate, Paroxetine Hydrochloride, and Sitagliptin. In 2008, the company achieved simultaneous certification for ISO 9001 Quality Management System, ISO 14001 Environmental Management System, and ISO 18001 Occupational Health and Safety Management System. In 2014, it obtained Level II Safety Standardization Certification in Jiangsu Province. Furthermore, in 2021, the company obtained its Drug Production License. So far, the company has developed 36 high-tech products and applied for 25 invention patents, out of which 15 have been granted. In 2023, Jingye achieved a production value of RMB 230 million.
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