• Time of issue:2024-04-18 19:27

(Summary description)On the evening of April 17, Joincare(Joincare Pharmaceutical Group Industry Co., Ltd) announced that its innovative drug product, TG-1000 capsules, reached the main research endpoints in a multi-center Phase III clinical trial. The company will soon communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration regarding the marketing application for the drug to treat influenza, advancing the drug's market launch process.   TG-1000 is an innovative Class 1 antiviral drug, a new type of cap-dependent endonuclease inhibitor, suitable for patients aged 12 and above with uncomplicated acute infections of influenza A and B.   Public information shows that Joincare  is an innovative scientific research-based integrated pharmaceutical group, focusing on the development of innovative drugs and high-barrier complex formulations.   In recent years, the company has been deeply involved in key therapeutic areas such as respiratory and digestive system diseases, continuously expanding its product line and R&D pipeline in advantageous fields through a development model that combines independent research and development, external introduction, and cooperative development.   TG-1000 capsules, introduced by Joincare  in March of last year, is a significant innovative drug. Early research data indicate that the drug has the characteristics of rapid onset, long virus suppression time, good tolerance, and is unaffected by food when taken orally, effectively inhibiting both influenza A and B viruses.   In September last year, Joincare  initiated a Phase III clinical trial for TG-1000 capsules. The Phase III clinical study was a multi-center, randomized, double-blind clinical trial, with the main endpoint being the time to alleviation of all influenza symptoms within 15 days of treatment. Preliminary statistical analysis results show that the drug met the main efficacy indicators with statistical difference (P<0.0001) and no serious adverse reactions related to the drug occurred, demonstrating good clinical performance and higher safety.   Influenza, as a common viral infectious disease worldwide, can lead to 300,000-500,000 severe cases and 290,000-650,000 respiratory disease-related deaths globally each year during the seasonal epidemic.   Antiviral drugs are one of the important means of treatment and control of influenza. If TG-1000 capsules are successfully approved and launched, they will further strengthen Joincare product layout in the field of influenza and help the company to capture a high ground in the domestic antiviral 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 when 'innovative drugs' were written into the government work report for the first time, bringing excellent development opportunities for innovative drugs.   Joincare  has also made forward-looking arrangements for the layout of innovative drugs in multiple fields.   In addition to the smooth progress of the clinical trials for the new antiviral drug TG-1000 capsules, Joincare  has also reached several important strategic cooperations in the advantageous respiratory field, achieving multi-dimensional coverage from injectables, inhalation formulations to oral small molecule innovative drugs.   Among them, the new drug for asthma treatment DBM-1152A, the oral new drug for asthma N91115, and the oral drug for chronic obstructive pulmonary disease - Bayer's small molecule inhibitor have all entered Phase I clinical trials; the injections QX008N and BA2101 for the treatment of asthma, chronic obstructive pulmonary disease, and other respiratory system diseases have respectively entered Phase Ib and Phase II clinical trials.   In addition, Joincare  has successfully introduced the analgesic new drug FZ008-145, expanding the company's R&D layout in the field of analgesics.   FZ008-145 is the world's second and China's first highly selective second-generation Nav1.8 inhibitor, intended for the treatment of pain, expected to have the advantages of strong efficacy and non-addictive analgesia, and has been approved to start clinical trials.