Recently, the National Drug Administration Drug Evaluation Center (CDE) announced that the clinical trial application (IND) for the mRNA vaccine YKYY025 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 been approved for clinical trials by the US FDA at the beginning of this year.

"Insight into and meeting clinical needs that have not yet been fully responded to have always been the core orientation and key path for our research and development work." Yu Weishi, chairman of Yuekang Pharmaceutical Group, said.

It is reported that in addition to RSV vaccines, Yuekang Pharmaceutical has obtained overseas clinical approval for a number of innovative drugs. On January 21, Yuekang Pharmaceutical's independently developed mRNA vaccine YKYY026 injection for the prevention of herpes zoster was officially accepted by CDE. Since it has been approved by the US FDA for clinical trials, this means that YKYY026 injection has also successfully completed dual reporting in China and the United States.

In addition, Yuekang Pharmaceutical's broad-spectrum anti-coronavirus peptide YKYY017 atomizer inhalation has obtained clinical approval in the United States and Australia; the ultra-long-acting lipid-lowering small nucleic acid drug YKYY015 injection has also been approved to enter the US clinical trial. It is worth mentioning that Yuekang Pharmaceutical's independently innovative nucleic acid delivery system has obtained patent authorizations from many countries such as the United States, Japan, and Israel, achieving unprecedented breakthroughs in this field.

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

It is understood that in the field of nucleic acid drug research and development, Yuekang Pharmaceutical has built a target discovery platform based on nucleic acid drugs, a high-throughput screening platform, an advanced process development and large-scale preparation platform, and a complete analytical quality control platform. It has made a systematic layout in the underlying key technologies of nucleic acid drugs such as AI target discovery, sequence optimization design, LNP delivery, GalNAc delivery, extrahepatic targeted delivery, nucleoside monomer modification, and co-capping, and has obtained patent authorization for a series of key technologies. It has the full-chain research and development capabilities from target screening and confirmation, sequence design, antigen design, drug efficacy evaluation, CMC small and pilot tests, clinical trials to registration and declaration.

At present, many innovative achievements of Yuekang Pharmaceutical have entered a period of intensive harvest. The listing applications of its three Class 1 innovative drugs, Hydroxysafflor Yellow A for Injection, Zihua Wenfei Zhisou Granules, and Tongluo Jiannao Tablets, have been accepted one after another; the peptide drug YKYY017 nebulizer inhalation has also entered Phase III clinical trials; the anti-liver cancer antisense nucleic acid (ASO) drug CT102 for injection is starting Phase III clinical trials. The research and development of these innovative drugs is not only expected to bring better treatment effects to patients, but will 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 a number of favorable policy supports, especially the implementation of policies to support the development of innovative drugs throughout the entire chain, which has accelerated the transformation of biomedical innovation results. Yuekang Pharmaceutical said that in the future, Yuekang Pharmaceutical will continue to move forward with all its strength towards the strategic goal of "building a leading biomedical enterprise in the entire pharmaceutical industry chain led by innovation", and empower the high-quality development of enterprises with new quality productivity.

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