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Jiankang Yuan TG-1000 capsules achieve breakthrough progress; the anti-influenza virus drug sector is poised to welcome a blockbuster product
Published Time：
2024-04-18
On the evening of April 17, Jiankangyuan issued an announcement stating that the multi-center Phase III clinical trial of its innovative drug product, TG-1000 capsules, had met its primary endpoint. The company will soon communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) regarding the marketing application for this drug to treat influenza, and will push forward the drug's listing process.
TG-1000 is a novel first-class anti-influenza drug, a new type of cap-dependent endonuclease inhibitor, suitable for patients aged 12 years and older with uncomplicated acute infection of influenza A and B.
Public information shows that Jiankangyuan is an innovative and research-oriented comprehensive pharmaceutical group focusing on the development of innovative drugs and high-barrier complex preparations.
In recent years, the company has been deeply involved in key therapeutic areas such as respiratory and digestive system diseases. Through a research and development model that combines independent research and development, external introduction, and collaborative development, it continuously expands the product line and research and development pipeline in the company's advantageous fields.
TG-1000 capsules are a blockbuster innovative drug introduced by Jiankangyuan last March. Early research data show that the drug has the characteristics of rapid onset, long viral suppression time, good tolerability, and oral administration unaffected by food, and can effectively inhibit both influenza A and B viruses.
Last In September, Jiankangyuan launched the Phase III clinical trial of TG-1000 capsules. This Phase III clinical study is a multi-center, randomized, double-blind clinical trial, and the primary endpoint is the time to resolution of all influenza symptoms within 15 days of treatment. Preliminary statistical analysis results show that the drug met the primary efficacy indicators and had a statistically significant difference (P<0.0001), and no drug-related serious adverse reactions occurred. The clinical trial performed well and showed higher safety.
Influenza, as a common viral infectious disease in the world, can cause 3 to 5 million severe cases and 290,000 to 650,000 deaths related to respiratory diseases worldwide every influenza season.
Anti-influenza drugs are one of the important means of treating and controlling influenza, such as The subsequent successful approval and listing of TG-1000 capsules will further strengthen Jiankangyuan's product layout in the influenza field and help the company seize the commanding heights of the domestic anti-influenza drug market.
In the past two years, the layout of innovative drugs has become one of the main tracks for pharmaceutical companies to compete, especially this year “Innovative drugs” were written into the government work report for the first time, ushering in an excellent development opportunity for innovative drugs.
Jiankangyuan has also proactively carried out innovative drug layout work in multiple fields.
In addition to the anti-influenza drug In addition to the smooth clinical progress of TG-1000 capsules, Jiankangyuan has also achieved a number of important strategic cooperations in its advantageous respiratory field, achieving multi-dimensional coverage from injections and inhalation preparations to oral small molecule innovative drugs.
Among them, the dual-target new drug for asthma treatment DBM-1152A, the new oral drug N91115 for asthma treatment, and the oral drug - Bayer small molecule inhibitor for chronic obstructive pulmonary disease have all entered Phase I clinical trials; the injection QX008N and BA2101 for the treatment of asthma, chronic obstructive pulmonary disease and other respiratory diseases have entered Phase Ib and Phase II clinical trials respectively.
In addition, Jiankangyuan has successfully introduced the analgesic new drug FZ008-145, expanding the company's research and development layout in the field of analgesia.
FZ008-145 It is the world's second and China's first highly selective second-generation Nav1.8 inhibitor, intended for the treatment of pain, is expected to have the advantages of strong and non-addictive analgesia, Currently It has been approved for clinical trials. 。
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