Product Pipelines
Focusing on unmet clinical needs, we commit to developing better drugs for better lives. We have robust product lines in therapeutic fields of anesthesia, cardiovascular diseases and eye diseases, which include 1 product in NDA stage, 3 products in clinical stage and 5 products in pre-clinical stage.
As non-clinical and clinical data show, adamgammadex can rapidly reverse different levels of rocuronium-induced neuromuscular blockade in 3 minutes, and significantly reduce the risk of respiratory depression caused by residual neuromuscular blockade and the incidence of postoperative complications.
Pooled data of completed Phase II and Phase III studies on the efficacy of adamgammadex in reversing rocuronium-induced moderate neuromuscular blockade shows, adamgammadex is of greater safety compared with sugammadex in aspects of allergic reactions, recurarization and laryngospasm (0% vs 2.81%, P=0.024).
Two pivotal Phase III clinical trials (indicated for reversing rocuronium-induced moderate and deep neuromuscular blockade) of adamgammadex in China have been completed, and the NDA application is expected to be submitted to The National Medical Products Administration (NMPA) in 2024. Meanwhile, the End-of-Phase II (EOP2) meeting with the FDA has been held successfully, and the multi-regional clinical trials (MRCT) in the US, Japan and Europe are scheduled to initiated in 2024.
Identifier No. | Phase | Study Title |
CTR20213282 | Phase III | Pivotal Phase III clinical studies of adamgammadex sodium in reversing deep neuromuscular blockade |
CTR20211477 | Phase III | Pivotal Phase III clinical studies of adamgammadex sodium in reversing moderate neuromuscular blockade |
Phase IIb | Phase IIb clinical studies of adamgammadex sodium in reversing rocuronium-induced deep neuromuscular blockade Link CDE | |
CTR20191479 | Phase IIa | Phase IIa clinical studies of adamgammadex sodium in reversing rocuronium-induced deep neuromuscular blockade |
CTR20181917 | Phase II | Phase II clinical studies of adamgammadex sodium in reversing rocuronium-induced moderate neuromuscular blockade |
CTR20180893 | Phase I | Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Adamgammadex Sodium for Injection in Healthy Subjects |
CTR20170503 | Phase I | Phase I Dose escalation clinical studies of adamgammadex sodium for injection |
Preclinical studies indicated that Aom0499 can effectively reverse cisatracurium-induced neuromuscular blockade through new target and new mechanism. Once marketed, Aom0499 will become a formidable competitor to Bridion® of Merck Sharp & Dohme in all aspects and be far ahead of other neuromuscular reversal agents around the world.
With Aom0498 and Aom0499, Aomo will cover more than 90% of market share for neuromuscular reversal agents in the world and become the only pharmaceutical company who owns reversal agents for nondepolarizing muscular relaxants and benzylisoqunoline muscular relaxants.
Aom0777 is a new-generation ultra-short-acting sedative with new structure developed by Aomo for procedural sedation/anesthesia adopted in all types of endoscopic procedures including gastroscopy, colonoscopy, hysteroscopy, fibreoptic bronchoscopy, induction and maintenance of general anesthesia in hospitalized surgical patients, and sedation in the ICU.
Aom0777 is an innovative sedative anesthetic drug with desired efficacy and safety profiles, which is obtained by innovative design of molecular structure and precise drug screening. Aom0777 has rapid onset and rapid recovery, without accumulation risk after long time application. Compared with marketed sedative anesthetic drugs, Aom0777 is of better safety, has less impact on hemodynamics and respiratory depression, and has a wider therapeutic window.
The druggability of Aom0777 has been validated, and the pre-IND studies are expected to be completed at Q1 2024, and the IND applications both in China and the US will be initiated accordingly.
Identifier No. | Phase | Study Title |
NCT05650528 | Phase I | QG101-23-0 Capsules SAD and MAD Study in Healthy Subjects |
Identifier No. | Phase | Study Title |
NCT05555758 | Phase I | Aom0319 MAD Study in Healthy Subjects |
Aom0304 is a New Chemical Entity developed by Aomo for the treatment of hypertrophic cardiomyopathy. Preclinical studies have shown that Aom0304 is effective in improving the thickness of left ventricular wall during diastolic and systolic periods, which displays therapeutic effect on cardiac hypertrophy.
Aom0187 is a New Chemical Entity of Aomo for the treatment of dry eye disease. Preclinical data indicated that Aom0187 can not only significantly improve symptoms of dry eye on animal models, but also has good therapeutic effects. Aom0187 is currently under preclinical evaluation and is expected to enter clinical stage in 2024.
|