The innovative muscle loosening antagonist omexone sodium successfully declared an NDA

On Friday August 30, Hangzhou Omer announced that it has successfully submitted an NDA to the NMPA for Omexone Sodium, a class of innovative drugs developed in collaboration with Xianju Pharmaceutical. As a class of innovative muscle relaxation antagonists, omexone sodium is expected to quickly penetrate and replace sodium dextroxide with its excellent safety data. We expect peak sales of omexone sodium to exceed 2 billion yuan. Considering that the collection risk has been cleared and the specialty formulation has entered an intensive approval cycle, the accelerated release of the class +1 the new drug omexone sodium has already declared an NDA. We expect the company's net profit to be 0.683/0.838/1.068 billion yuan for 24-26, and a target price of 16.03 yuan under the segmented valuation method. “Purchase” is recommended.

Combats the target muscle relaxant against major sulfuric glucosamine

Omexone sodium is used to reverse neuromuscular blockade (muscle relaxation antagonism) induced by rocuronium bromide or vecuronium bromide as the benchmark for MSD (US$1.8 billion worldwide). 4M22 has now been approved by more than 10 companies since its first domestic prototype was launched, and it is expected that it will soon face pressure to collect. Omexone sodium is a direct benchmark for sugengucose sodium, and as Me Better, it is expected that it will quickly replace it after completing initial market education. According to the cooperation agreement with Omer, 1) Xianju Pharmaceutical holds the Omexone sodium API approval and is exclusively responsible for the production of raw pharmaceutical formulations; 2) Omexone sodium preparations are exclusively sold by Xianju Pharmaceutical in China (with the exception of 5 provinces).

Omexone sodium is expected to make up for the shortcomings in the safety of sulgenglucose sodium

Glucosamine is a specific muscle relaxation antagonist, but clinically, it has side effects such as allergic reactions, abnormal cardiac function, and bleeding, and was rejected by the FDA 3 times as a result. In addition, there is also 0.2% re-arrow poisoning, which has a safety risk of causing muscle relaxation again. The effective rate of administration of Japanese sulfuric glucosamine was 90.6%, and 9.4% was not effective. Chiral acetylamino groups are added to the a-carbon of omexone sodium carboxylate, so that 20% or more chiral carbon atoms are added?? -In the cell nucleus of cyclodextrins, spatial resistance around carboxyl groups is enhanced, and some of their effects are effectively blocked or limited, which is expected to improve safety issues.

Excellent clinical data for omexone sodium phase III

Omexone head-to-head sulgenglucose sodium was used to reverse rocuronium-induced neuromuscular blockade in phase III clinical trials: a. In terms of efficacy, omexone sodium group vs. sulgenglucose sodium group: 1) the ratio of TOF recovery to 0.9 within 5 minutes was 98.7% vs 100%, respectively; 2) The time from the start of medication until TOF recovered to 0.9 was 2.4 minutes vs 1.9 minutes, respectively. Pharmacodynamically, omexone sodium is comparable to sugenglucose sodium. b. In terms of safety, the omexone sodium group and sugenglucose sodium group 1) showed 2 cases (1.3%) vs 4 cases (2.6%) of grade 3 SAE or drug-related SAE, with no 4/5 SAE; 2) allergic reaction 0% vs 1.1%, then toxic arrow 0% vs 1.1%, heart rate drop 1.9% vs 3.2%, and laryngospasm 0% vs. 0.6%, respectively. Comprehensive efficacy and safety results. From a benefit-risk perspective, omexone sodium is superior to sugenglucose sodium.

Risk warning: R&D progress falls short of expectations, product release falls short of expectations, policy risks.