On April 13, the Class I innovative drug P-CAB tigora raw tablet (trade name: Taixinzan), which was independently developed and applied by Luoxin Pharmaceutical, was approved by the State Drug Administration for the treatment of reflux disease. Esophagitis (Reflux Esophagitis, RE). This is the first national class I innovative drug in Linyi, the first national class I chemical innovative drug in Shandong Province, and the first self-developed potassium-competitive acid blocker (P-CAB) in China.
In recent years, Linyi Science and Technology Bureau, in accordance with the overall deployment of the Municipal Party Committee and the Municipal Government, has focused on the high-quality development of the pharmaceutical industry. Relying on key backbone enterprises such as Luoxin Pharmaceutical, it has continued to increase the construction of high-end scientific and technological innovation platforms, The introduction of high-level scientific and technological talents and the efforts to tackle key scientific and technological projects have effectively improved the independent innovation level of related enterprises in the pharmaceutical industry. At present, a total of 38 scientific and technological innovation platforms such as key laboratories and technological innovation centers have been deployed and constructed in the city’s pharmaceutical industry, and 13 key R&D projects at or above the provincial level have been implemented, with a support fund of 102 million yuan, and successively won the National Science and Technology Award. 11, and 54 provincial science and technology awards.
Luoxin Pharmaceutical, as a leading enterprise in drug R&D and production in Linyi City, always adheres to the strategic policy of “prospering the enterprise through science and technology”, and has successively built 15 scientific and technological innovation platforms, and 13 projects have been included in the national “enterprise development”. Major scientific and technological projects of “Major New Drug Creation”, 4 products were included in the “National Key New Product Program”, 12 products were included in the “National Torch Program”, 168 projects were included in the “National Generic Chemical Drug Special Project, Shandong Province” Major scientific and technological innovation projects, key R&D plans in Shandong Province, technological innovation projects in Shandong Province, etc., “Establishment and application of key technology systems for chemical drug crystal forms”, “Key technologies and industrialization of common cephalosporins such as cefoxidone sodium” 2 projects won the second prize of the National Science and Technology Progress Award, and 8 provincial science and technology awards. In 2021, China’s first children-specific expectorant spray “Luorunchang Ambroxol Hydrochloride Spray” was approved for marketing; 8 products including pantoprazole sodium for injection and omeprazole sodium for injection passed generic drugs Consistency evaluation; 5 products including tadalafil tablets and ticagrelor tablets were approved for marketing; 5 products including levalbuterol inhalation solution were approved by the US FDA for abbreviated new drug applications.
It is reported that the research and development process of Class I innovative original drugs is extremely difficult, and there is a “Thirty Effect”, that is, the research and development takes more than ten years, the investment exceeds 1 billion US dollars, and the success rate is less than 1/10. P-CAB tigola raw tablet is a major high-tech achievement supported by the national “Major New Drug Creation” scientific and technological major project and a major scientific and technological innovation project in Shandong Province. It is mainly used for the treatment of reflux esophagitis. It has the characteristics of rapid onset in 30 minutes, strong and lasting acid suppression, and convenient administration. It brings a new medication option for the treatment of reflux esophagitis and improving the quality of life of patients. The launch of the drug not only makes up for the pain points such as the short half-life of PPI treatment and the low mucosal healing rate caused by insufficient acid suppression, but also the first dose is fully effective, strong and lasting acid suppression, and it is not affected by meals, which brings better benefits to patients. It is expected to replace PPI as the mainstream drug for acid suppression in the future. It is predicted that when only two indications are considered, the peak sales of tigola raw tablets in a single year are expected to reach 2 billion to 3 billion yuan.
Qilu Yidian correspondent Zhao Xin Taoyuan