Nearly 70% of New Drug Trials in China Are Class 1 Innovative Drugs; Two Domestic Class 1 New Drugs Approved in May

　　【Pharmaceutical Network Industry DynamicsRecently, the Center for Drug Evaluation of the National Medical Products Administration released the "Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2023)." The report shows that in 2023, the total number of clinical trials registered on the Drug Clinical Trial Registration and Information Disclosure Platform exceeded 4,000. Among them, Class 1 innovative drug trials accounted for nearly 70% of the total new drug clinical trial registrations.
 

In recent years, the pharmaceutical industry has been seeking high-quality development, with active research and development of innovative drugs. The Report shows that innovation and efficiency coexist in China's new drug clinical trials. In 2023, among 2,323 new drug clinical trials, a total of 1,606 trials were registered for Category 1 drugs (including the original registration classification), accounting for 69.1% of the total number of new drug clinical trial registrations. In terms of indications, 40.6% of the clinical trials for Category 1 innovative drugs were for anti-tumor drugs. In 2023, Phase I and Phase III clinical trials for Category 1 anti-tumor innovative drugs accounted for 50.9% and 12.9%, respectively.
 

According to reports, in recent years, China has made remarkable progress in the research and development and approval of innovative drugs. In accordance with the relevant provisions of the Drug Administration Law, the National Medical Products Administration conducted emergency review and approval through a special drug approval procedure, and conditionally approved the marketing of multiple Class 1 innovative drugs.
 

In addition, according to the summary, since entering May this year, two more domestically produced Class 1 innovative drugs have been approved for marketing in China. For instance, on May 20, the website of the National Medical Products Administration announced that Betapharma (Shanghai) Co., Ltd.'s Class 1 innovative drug, Rezivertinib Mesylate Capsules (trade name: Ruibida), has been approved for marketing. This medicine is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and whose tumors have been confirmed to carry the EGFR T790M mutation.
 

Data show that Rizetinib Mesylate is an epidermal growth factor receptor (EGFR) kinase inhibitor that irreversibly inhibits EGFR mutants (such as EGFR T790M, L858R). The drug's market launch provides a new treatment option for adult patients with non-small cell lung cancer.
 

On the same day, the website of the National Medical Products Administration also showed that the Class 1 innovative drug, Pregabalin Besylate Capsules (trade name: Simening), submitted by Haisco Pharmaceutical Group, was approved for marketing. This medicine is used to treat diabetic peripheral neuropathic pain in adults. Data shows that Pregabalin Besylate is a structural derivative of the inhibitory neurotransmitter γ-aminobutyric acid (GABA). The approval of this drug provides a new treatment option for adult patients with diabetic peripheral neuropathic pain.
 

In May, two imported Class 1 innovative drugs were approved for marketing in China. According to the announcement on the website of the National Medical Products Administration (NMPA) on May 20, the NMPA approved, through the priority review and approval process, the marketing of the Class 1 innovative drug combination pack of injectable sulbactam sodium and injectable durlobactam sodium (brand name: Ding Youle/XACDURO), submitted by Entasis Therapeutics, Inc. This drug is indicated for treating hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii-calcoaceticus complex-sensitive isolates in patients aged 18 years and above. According to the announcement on the NMPA website on May 11, the NMPA approved, through the priority review and approval process, the marketing of the Class 1 innovative drug ripretinib capsules (brand name: Ao Kaile/AUGTYRO), submitted by Bristol-Myers Squibb Company. The drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are ROS1-positive.
 

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