“YX2401K” has been included in the key variety service list
Recently, Beletalent (ZHUHAI) Pharmaceutical Co., Ltd. received a notice from the Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection of NMPA(hereinafter referred to as GBACDEI). After review, it was decided to include YX2401K in the key variety service list of GBACDEI(Key variety number:ZDPZ20250024)
In June 2024, the GBACDEI Review and Inspection issued the "Announcement on Key Varieties in the Service Area of the GBACDEI Review and Inspection", which evaluates key varieties by comprehensively considering factors such as the clinical value of varieties, regional industrial development needs, and drug accessibility. According to the “key varieties” policy, after YX2401K is included in the key varieties list, the company can, based on the communication needs at each research and development stage, submit applications for communication guidance,file – setting guidance and other services in accordance with the current working procedures of the sub – center. The sub – center will receive these applications, set up a separate service sequence, prioritize arrangements, and provide dedicated personnel services, offering pre – and in – process communication and guidance services for problems encountered by the company during the research and development and declaration stages.
The successful inclusion of YX2401K this time not only represents a high recognition of Bailing Yuxiu’s R&D achievements and innovation capabilities, but also helps improve the efficiency and quality of drug R&D and registration. It has greatly enhanced the company’s confidence in the smooth progress of R&D work, promoted the transformation of innovative achievements, and further accelerated the launch pace of the YX2401K new drug.
The core mechanism of action of YX2401K lies in inhibiting the activity of RNA virus-dependent RNA polymerase (RdRp), thereby interfering with viral genome replication to achieve antiviral effects. In the follow-up, Beletalent will take this inclusion as an opportunity to actively advance the research progress of YX2401K, further accelerate its new drug launch process, and strive to benefit more patients at an early date. At the same time, the company will continue to adhere to the innovation-driven development strategy, commit to cultivating more varieties with independent intellectual property advantages and innovative edges, and promote the company’s high-quality development to a new level with firmer confidence and more powerful actions.