Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the clinical trial application (IND) for the mRNA vaccine YKKYY025 injection for the prevention of respiratory syncytial virus (RSV) submitted by Hangzhou Tianlong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuekang Pharmaceutical, has been accepted. Prior to this, this vaccine had obtained clinical trial approval from the US FDA earlier this year.

Understanding and meeting unmet clinical needs has always been the core direction and critical path of our research and development work, "said Yu Weishi, Chairman of Yuekang Pharmaceutical Group.

It is reported that in addition to RSV vaccine, Yuekang Pharmaceutical has obtained overseas clinical approvals for multiple innovative drugs. On January 21st, the clinical trial application for YKY026 injection, an mRNA vaccine independently developed by Yuekang Pharmaceutical for the prevention of herpes zoster, was officially accepted by CDE. Due to its previous clinical trial approval by the US FDA, this means that YKY026 injection has also successfully completed the US China dual reporting.

In addition, Yuekang Pharmaceutical's broad-spectrum anti coronavirus peptide YKKYY017 nebulized inhaler has obtained clinical approval in the United States and Australia; The ultra long acting lipid-lowering small nucleic acid drug YKY015 injection has also been approved for clinical trials in the United States. It is worth mentioning that Yuekang Pharmaceutical's independently innovated nucleic acid delivery system has obtained patent authorizations from multiple countries such as the United States, Japan, and Israel, achieving unprecedented breakthroughs in this field.

Song Gengshen, director of Yuekang Pharmaceutical and director of the Drug Research Institute, stated that Yuekang Pharmaceutical has established a unique mRNA technology ecosystem, which greatly shortens the research and development cycle of different varieties through the reuse of core delivery system technology. This dual independent intellectual property architecture of "delivery system+sequence design" has enabled China to form a complete closed-loop capability in the global mRNA vaccine patent field.

It is reported that in the field of nucleic acid drug research and development, Yuekang Pharmaceutical has built a target discovery platform, high-throughput screening platform, advanced process development and large-scale preparation platform, and a complete analysis and quality control platform based on nucleic acid drugs. It has systematically laid out key technologies at the bottom layer of nucleic acid drugs, such as AI target discovery, sequence optimization design, LNP delivery, GalNAc delivery, extrahepatic targeted delivery, nucleoside monomer modification, co capping, etc. It has obtained a series of patent authorizations for key technologies and has the full chain research and development capabilities from target screening and confirmation, sequence design, antigen design, efficacy evaluation, CMC small and pilot trials, clinical trials to registration and application.

At present, multiple innovative achievements of Yuekang Pharmaceutical have entered a period of intensive harvest. The marketing applications for three Class 1 innovative drugs, namely hydroxysafflower yellow pigment A for injection, Zihua Wenfei Zhishou granules, and Tongluo Jiannao tablets, have been accepted successively; Peptide drug YKY017 nebulized inhaler has also entered phase III clinical trials; The phase III clinical trial of CT102 for injection of anti liver cancer antisense nucleic acid (ASO) drug is underway. The development of these innovative drugs is not only expected to bring better therapeutic effects to patients, but also inject new impetus into the development of Yuekang Pharmaceutical in the field of biomedicine.

In recent years, the development of the domestic innovative drug industry has received multiple favorable policy supports, especially the implementation of policies that support the development of innovative drugs throughout the entire chain, which has accelerated the transformation of innovative achievements in biomedicine. Yuekang Pharmaceutical stated that it will continue to strive towards the strategic goal of "building an innovative leading biopharmaceutical leader in the entire pharmaceutical industry chain" and empower the company with high-quality development through new quality productivity.