In the wave of pharmaceutical innovation, every groundbreaking achievement carries the mission of safeguarding life and health. Recently, Yichang Tianrui Biomedical Co., Ltd. (hereinafter referred to as "Yichang Tianrui"), a wholly-owned subsidiary of Yichang Humanwell Pharmaceutical Co., Ltd., has brought exciting news: its core product, Osimertinib Mesylate, has successfully obtained the "Breakthrough Therapy Drug" designation (marked with "I") from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. Yichang Tianrui has become one of only two enterprises in China to receive this approval. This milestone progress not only highlights the clinical value of Osimertinib Mesylate, but also confirms Yichang Tianrui's strong strength in the field of high-end pharmaceutical active pharmaceutical ingredients (APIs).

As a clinically significant API related to targeted therapy, the quality and safety of Osimertinib Mesylate are directly related to the efficacy of downstream preparations and the medication safety of patients. 

The successful approval and high-quality performance of Osimertinib Mesylate are inseparable from Yichang Tianrui's profound corporate accumulation and forward-looking industrial layout. As a core platform focusing on high-end pharmaceutical APIs under Yichang Humanwell Pharmaceutical Co., Ltd., Yichang Tianrui has been aiming to "become a world-class supplier of pharmaceutical APIs" since its establishment in November 2022. Rooted in Baiyang Biomedical Industrial Park, Yichang High-Tech Development Zone, Hubei Province, the company has a total investment of 2 billion yuan and plans to build 13 modern GMP workshops in line with international cGMP standards on a 330-mu industrial land. At present, the Phase I project has completed an investment of 800 million yuan, with 2 commercial production workshops and 9 professional production lines put into operation smoothly, providing a solid hardware guarantee for the stable supply of high-quality APIs.

Relying on Yichang Humanwell's global leading advantages in the field of anesthetic and analgesic drugs, Yichang Tianrui has built an industrial system covering the entire industrial chain of R&D, production and sales. Equipped with core technology platforms such as high-pressure hydrogenation, freeze-drying and spray drying, the company's main business covers high-end APIs (such as Samidorphan Malate, Maribavir, Letermovir, Lumateperone Tosylate), key pharmaceutical intermediates (such as 2-(2-Amino-5-bromo-benzoyl)pyridine, 7-ANCA) and veterinary APIs (such as Tiletamine Hydrochloride, Atipamezole Hydrochloride, Alfaxalone). At the same time, the company also provides customized development and production services (CDMO/CMO) for highly active APIs and special-process APIs, comprehensively meeting the diversified needs of customers. The approval of Osimertinib Mesylate as a CDE "Breakthrough Therapy Drug" is a vivid practice of the company's development philosophy of "taking technology as the core and quality as the lifeblood".

During the critical period when China's pharmaceutical industry is transforming towards high quality and innovation, the "Breakthrough Therapy Drug" designation by CDE not only opens a "green channel" for the R&D and industrialization of Osimertinib Mesylate, but also marks the important value of this product in meeting unmet clinical needs. As one of only two approved enterprises in China, Yichang Tianrui will take this opportunity to continuously give play to its technical advantages and quality control capabilities in the field of high-end APIs, accelerate the industrialization process of Osimertinib Mesylate, provide stable and high-quality API guarantees for downstream preparation enterprises, and ultimately benefit more patients.

From the construction of core technology platforms to the improvement of international production systems, from the quality control of individual products to the coordinated development of the entire industrial chain, Yichang Tianrui is moving forward steadily in the field of high-end pharmaceutical APIs with firm steps. In the future, the company will continue to rely on the strong support of Yichang Humanwell, take innovation as the driving force and quality as the core, and continuously launch more high-end pharmaceutical API products that meet international standards, contributing "Tianrui Strength" to the innovative development of China's pharmaceutical industry and writing a more brilliant chapter in safeguarding human life and health.