On May 30, the CDE website showed that two new drugs were submitted for marketing approval, respectively.NaldemedineAndInebilizumab，CHIATAI TIANQINGAndHansoh PharmaEach owns partial rights to these two new drugs.Screenshot source: CDE official websiteInebilizumab is a humanized CD19 monoclonal antibody that was first approved for marketing in the United States in June 2020, for the treatment of neuromyelitis optica spectrum disorder (NMOSD) positive for anti-AQP4 antibodies.（NMOSD）Adult patients. It was first approved for marketing in China in March 2022 and becameChina's FirstNMOSD Medical Insurance Medication.May 2019,Hansoh PharmaIn$220 millionCHIATAI TIANQING and Viela Bio have reached a collaboration to gain the rights for developing and commercializing Inebilizumab in China, for the treatment of NMOSD as well as other potential inflammatory/autoimmune and hematological malignancy indications.Screenshot source: Insight databaseBased on publicly available information and clinical trial progress, the Insight database infers that the indication submitted for marketing approval in China this time isMyasthenia Gravis。MINT is a randomized, double-blind, multicenter, placebo-controlled, Phase III study.(Including an open-label period), aimed to evaluate the efficacy and safety of Inebilizumab in adult patients with myasthenia gravis. The primary endpoint was at Week 26 in the overall study population.Myasthenia Gravis Daily Living Scale（MG-ADL）Change in Score Relative to Baseline。In March 2025, the results of the MINT trial were announced. The results at week 26 showed that the trial met its primary endpoint, which was for the total study population.The MG-ADL score with inebilizumab showed a statistically significant change from baseline compared to the MG-ADL score with placebo.（-4.2 vs -2.2）。 Results from Week 52 showed that patients who were positive for acetylcholine receptor autoantibodies and received inebilizumab treatment(AChR+) Patients' MG-ADL scores continued to improve compared to the placebo group.. In the AChR+ subgroup,72.3% of patients in the Inebilizumab group had an improvement of 3 points or more in the MG-ADL score., while the proportion in the placebo group was 45.2%.
Compared with the placebo group at 52 weeks, the inebilizumab groupQuantitative Myasthenia Gravis Scoring Scale (QMG) Score changes significantly from baseline(Adjusted difference: -4.3), receiving inebilizumab treatmentThe QMG score improvement rate for AChR+ patients was 69.2%., while the proportion was 41.8% in patients receiving placebo treatment.
Screenshot source: CDE official websiteNaldemedine（Naldemedine）It is a peripheral μ-opioid receptor antagonist developed by Shionogi & Co., Ltd., the parent company of Ping An Shionogi, which can act on peripheral tissues.(Especially the enteric nervous system)In China, by antagonizing the physiological effects of opioids on the enteric nervous system, regulate intestinal peristalsis and secretory activity, fundamentally treatingOpioid-Induced Constipation（OIC）。Currently, the drug has been approved for marketing in the United States, the European Union, Japan, Taiwan, China, and Hong Kong, China. This is the first approval of the drug in China.For the first timeReport listing, for treatmentOpioid-Induced Constipation。This New Drug Application is based on a Phase III clinical trial conducted in China targeting OIC patients.（CTR20220673）The good results. The trial was first registered in March 22, the first patient completed enrollment in August, and the trial was completed in September 24. The specific research results have not been disclosed yet.Screenshot source: Insight databaseIt is worth mentioning that in January 2025, CHIATAI TIANQING and Ping An Yanoichi Co., Ltd.(Ping An Shionogi)Sign an exclusive market promotion agreement. Accordingly,CHIATAI TIANQING Obtains Exclusive Marketing Rights for Naldemedine in China for an Initial Period of Eleven Years.
Opioid drugs are widely used clinically as analgesics and are recommended by the World Health Organization as therapeutic agents for relieving cancer pain. However, clinical practice has found that long-term use can lead to various adverse reactions, with 50%-80% of patients using opioid drugs experiencing the adverse reaction of OIC.
Currently in China,OIC patients still lack targeted treatment options., mainly through lifestyle changes(Such as increasing dietary fiber), and a limited number of treatment strategies such as opioid conversion, laxatives/stool softeners to improve. If nalmedine can be approved for marketing in China, it will fill the gap in the treatment of OIC in China.
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