Given that the coronavirus is not expected to disappear completely in the short term, it is highly likely to coexist with humans for a long time and gradually become seasonal, similar to the flu. It is also constantly mutating, and may continue to produce variants that have stronger abilities to escape, spread faster, and have higher potential for pathogenicity, which poses a far greater threat to human health than common colds and flu. Therefore, it is still crucial to develop broad-spectrum and effective drugs against the coronavirus. Youcare Pharmaceutical Group's peptide drug YKYY017 nebulized inhalation solution for preventing and treating new coronavirus infections has made significant progress, which is of great significance to the pharmaceutical industry.
Another breakthrough in the development of new coronavirus drugs.
Recently, Youcare Pharmaceutical Group and the Institute of Pathogen Biology, Chinese Academy of Medical Sciences held the DMC midterm analysis meeting, phase II summary meeting and phase III plan drafting meeting for YKYY017 nebulized inhalation solution clinical research in Beijing. The highly anticipated YKYY017 nebulized inhalation solution has made significant progress in the clinical research of treating coronavirus: Phase II clinical research has been successfully completed and Phase III development is about to begin. Many top experts and scholars from the industry gathered at the meeting, including Wang Chen, academician of the Chinese Academy of Engineering, Cao Bin, professor at the China-Japan Friendship Hospital, researchers from clinical research representative units and the Chinese Academy of Sciences, Wang Fusheng, academician, and Li Taisheng, professor at Peking Hospital and DMC chairman. In addition, representatives of researchers from more than 20 other participating research centers and clinical departments and clinical institutions, as well as the guest of honor, He Ruyi, chief scientist of the National Drug Evaluation Center of the China National Medical Products Administration and the executive team of Youcare Pharmaceutical Group, attended this grand event together.
At the meeting, many top experts and scholars from the industry gathered, including Wang Chen, academician of the Chinese Academy of Engineering, Cao Bin, professor at the China-Japan Friendship Hospital, researchers from clinical research representative units and the Chinese Academy of Sciences, Wang Fusheng, academician, and Li Taisheng, professor at Peking Hospital and DMC chairman. They discussed the future direction of drug development. In addition, representatives of researchers from more than 20 other participating research centers and clinical departments and clinical institutions, as well as the guest of honor, He Ruyi, chief scientist of the National Drug Evaluation Center of the China National Medical Products Administration and the executive team of Youcare Pharmaceutical Group, attended the event.
DMC midterm analysis meeting, phase II summary meeting and phase III plan drafting meeting for YKYY017 nebulized inhalation solution clinical research.
What is the "magic" of this in-development drug that has won the recognition of academician experts? The answer is about to be revealed in the passionate discussions. This not only points the way for the next stage of new drug development at Youcare Pharmaceutical Group, but also inspires the industry's infinite expectations for future treatment options.
01 Breaking the "blankness" of similar research.
For a long time, a key issue in the industry has been whether the development of anti-coronavirus polypeptide drug YKYY017 nebulized inhalation solution was too late amidst a variety of new coronavirus products.
To answer this question, there is no escaping the current environment of new coronavirus drug development.
After analyzing the current market, there are mainly two technological paths for new coronavirus-specific drugs: one is biologically active macromolecules with antibodies as the core, and the other is small molecule compound drugs targeting key steps such as virus invasion and replication. However, the limitations of antibody-based biologically active macromolecule drugs have gradually emerged. These drugs mainly function by specifically binding to the RBD region of the S protein of the novel coronavirus, thereby blocking the infection process of the virus and the host cell. However, the problem is that the RBD region is precisely the part where the new coronavirus is most prone to mutation. This has resulted in many antibody drugs losing their effectiveness when facing mutant strains such as omicron, or even becoming completely ineffective.
On the other hand, small molecule compound drugs function by inhibiting viral replication and are currently the main means of clinical treatment for new coronavirus.
A typical example is that 3CL protease inhibitors and RdRp inhibitors have shown unique advantages in antiviral treatment. However, when the 3CL protease inhibitor is used in conjunction with ritonavir to reduce drug metabolism, drug interaction has become a significant problem, causing considerable challenges in clinical practice when multiple drugs are used in combination. The RdRp inhibitor not only inhibits the RdRp activity of the virus, but also affects the RNA polymerase of the host cell, thus affecting DNA replication and repair of host cells. This effect may lead to adverse reactions such as DNA damage, cell apoptosis, and mutations, which is known as genetic toxicity.
Therefore, Wang Chen, academician of the Chinese Academy of Engineering and president of the Chinese Academy of Medical Sciences, emphasized in his speech at the meeting that the continuous search for effective breakthroughs in coronavirus drugs is crucial.
In view of the continuous mutation of the virus and the long-term existence of the epidemic, even with a variety of new coronavirus products emerging, YKYY017 nebulized inhalation solution, with its unique mechanism of action and broad-spectrum characteristics, still stands out and has outstanding advantages when facing new mutant strains.
Main researchers and academics, Wang Chen, academician of the Chinese Academy of Engineering.
Thus, YKYY017 is garnering an increasing amount of attention.
Public information shows that YKYY017 aerosol inhalation is a polypeptide drug jointly developed by Youcare Pharmaceutical Group and the Institute of Pathogenic Biology of Chinese Academy of Medical Sciences for the treatment of novel coronavirus infection. It is a polypeptide small-molecule compound composed of 43 amino acids and a coronavirus membrane fusion inhibitor. It is based on the seven-peptide repeat sequence 2 (HR2) of the S2 subunit of coronavirus and acts on the HR1 region of the S protein S2 subunit of SARS-CoV-2 virus. It can competitively interact with the virus HR1 region to form heterologous hexa-helical bundle structures, thereby inhibiting the formation of the homologous hexa-helical bundle structures between the HR1 and HR2 structural domains of the virus itself, blocking the fusion process of the virus with the host cell, exerting antiviral activity, and having broad-spectrum.
As an inhalable polypeptide drug for anti-novel coronavirus, YKYY017 not only adopts new therapeutic targets, but also provides new treatment options for COVID-19 patients through the nebulizer administration method and mode of action, making it significantly innovative in the field of COVID-19 treatment.
Thanks to the joint efforts of all parties, the development of YKYY017 has made remarkable progress. The drug was approved by the National Medical Products Administration on November 29, 2022, and quickly entered clinical trials. It successfully completed the Phase I clinical trial on July 5, 2023, fully verifying the good drug resistance and safety of YKYY017 in healthy subjects. After entering Phase II clinical trials, YKYY017 showed significant clinical effects. The first subject was enrolled on September 21, 2023, and all subjects completed the trial smoothly by February 18, 2024. The preliminary clinical results are inspiring, and YKYY017 has demonstrated significant clinical effects in the treatment of COVID-19, bringing significant benefits to patients.
It is worth mentioning that YKYY017 has obtained clinical trial approvals from the US FDA and clinical trial registrations from the Australian TGA. This is not only a milestone achievement of Youcare Pharmaceutical Group in the field of new drug research and development, but also an important embodiment of its international new drug research and development strategy.
As the sponsor of this drug, Youcare Pharmaceutical Group's R&D goal is also clear. It hopes to develop a first-class innovative drug based on unsatisfied clinical needs that is broad-spectrum, efficient, safe, and has complete independent intellectual property rights, which can cope with the possibility of continuous mutation and long-term existence of novel coronaviruses in the future.
▲ Chairman of Youcare Pharmaceutical Group Co., Ltd., Yu Weishi.
With its unique position, mechanism of action, clinical design, and good safety, YKYY017 shows great potential and value in the field of COVID-19 treatment. To a certain extent, its research and development is not only innovative, but also of great strategic significance, which has been unanimously recognized by the DMC project and participating experts.
2. YKYY017's multiple unique significance
As this highly anticipated anti-coronavirus polypeptide drug gradually reveals its multiple unique significance, a series of questions follow - can YKYY017 "fight"? How to "fight"? Behind these questions, it not only concerns the new action mechanism of the drug, but also involves which new problems it can solve, as well as the current progress and effectiveness. All of these urgently require powerful clinical results.
It is worth noting that in the field of COVID-19 treatment, the challenge of virus mutation leading to drug failure has been a long-term issue, but YKYY017 has successfully solved this problem with its unique mechanism of action.
From the perspective of pharmacological mechanism of action, YKYY017 aerosol inhalation is the latest generation of coronavirus membrane fusion inhibitor. Its mechanism of action is to exert antiviral activity by inhibiting the membrane fusion pathways of cell surface and endocytosis, which is different from the target of the current COVID-19 therapies. It is less affected by coronavirus mutations and has significant inhibitory effects on the original strain of novel coronaviruses and various popular mutant strains (such as Delta, Omicron BA.1, Omicron BA.2, Omicron BA.4, and Omicron BF.7). This broad-spectrum feature enables it to maintain effectiveness in the face of constantly mutating viruses.
In addition to its unique pharmacological action, YKYY017 also innovates in its administration mode. In the view of attending researchers, nebulizer administration, which is a common form of treating respiratory tract infections, is more acceptable to patients than taking pills, especially among young people, and is also effective for the upper respiratory symptoms caused by COVID-19.
In clinical trials, YKYY017 also has many highlights. Yin Ping, head of the School of Public Health at Huazhong University of Science and Technology, pointed out that the clinical research of YKYY017 adopts a novel adaptive design, that is, Phase II/III seamless design, which realizes the close connection between dose exploration and confirmatory trial. In the first stage, the experiment selects the more effective dose group by comparing two dose groups, and directly enters the Phase III confirmatory clinical trial. In this process, Phase II mainly lays the groundwork for dose exploration of Phase III trial. Preliminary data shows that YKYY017 has shown good trends in safety, efficacy, and dose-effect relationship, laying a solid foundation for the subsequent Phase III trials.
In conclusion, YKYY017, with its unique position, mechanism of action, clinical design, and good safety, has shown great potential and value in the field of COVID-19 treatment. To a certain extent, its research and development is not only innovative, but also of great strategic significance, which has been unanimously recognized by the DMC project and participating experts.
▲ Chairman of the project DMC, Professor Li Taisheng of Peking University First Hospital.
Returning to the essence of the pharmaceutical industry, the good clinical performance of Youcare Pharmaceutical Group's YKYY017 aerosol inhalation in Phase II clinical trials preliminarily verifies its unique advantages and safety in COVID-19 treatment, and also indicates that domestic pharmaceutical companies are expected to take a new step forward in the field of COVID-19 treatment.
Source: E-Drug Manager