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Group Real-Time Dynamics And Cutting-Edge Information In The Field Of One Health
Health Yuan's R&D pipeline is steadily delivering results. A new specification has been added for the first-to-market levalbuterol hydrochloride inhalation solution.
Published Time：
2022-04-22
Recently, HealthGen (600380.SH) announced that it has received the "Drug Supplement Application Approval Notification" from the National Medical Products Administration for Levosalbutamol Hydrochloride Nebulization Solution (3ml:1.25mg), approving the addition of the 3ml:1.25mg specification. As of the announcement date, the cumulative R&D investment in Levosalbutamol Hydrochloride Nebulization Solution (Lishutong) is approximately RMB 39.5016 million.
This product is based on HealthGen's already approved Levosalbutamol Hydrochloride Nebulization Solution (specifications: 3ml:0.63mg, 3ml:0.31mg, approval numbers: H20193279, H20205016), with an application for a new specification of 3ml:1.25mg. The acceptance date of the initial registration application for this drug was August 25, 2021 (acceptance number: CYHB2101735).
As early as September 27, 2019, HealthGen launched the first domestically registered Class 3 Levosalbutamol Hydrochloride Nebulization Solution (Lishutong), becoming the first Levosalbutamol inhalation preparation to be launched in China.
It is introduced that the active ingredient, Levosalbutamol Hydrochloride, is a short-acting β2-receptor agonist that produces bronchodilation and is mainly used to treat or prevent bronchospasm caused by reversible airway obstructive diseases in adults and children over 6 years old. According to IQVIA's sample statistics, the estimated terminal sales of Levosalbutamol Hydrochloride Nebulization Solution in China in 2021 was approximately RMB 181 million.
HealthGen's R&D pipeline layout and management follows a "differentiated" competitive strategy , focusing on both innovation and success rate, enabling its rich R&D pipeline reserves to be successfully and steadily realized. On the one hand, HealthGen focuses on pragmatism, starting with the R&D of improved drugs, striving to accelerate and increase the launch of new products, and continuously strengthening the sustainable profitability of its product matrix; on the other hand, HealthGen takes a long-term perspective, firmly and steadily deploying cutting-edge technologies such as AI drug molecular design and synthetic biology, giving the group's R&D pipeline innovation, success rate, and efficiency an important endogenous driving force for long-term sustainable development.
In 2021, HealthGen's R&D investment was 1.85 billion yuan, a year-on-year increase of 46.75%, accounting for 11.63% of revenue. In addition to the current key project of the recombinant novel coronavirus fusion protein vaccine ("V-01"), HealthGen has comprehensively deployed respiratory disease treatment products, with more than 40 research projects underway, and the R&D progress of key inhalation products is also relatively advanced. Among them, Tobramycin Inhalation Solution (first-in-class), Formoterol Fumarate Inhalation Solution (nationally encouraged variety), and Terbutaline Sulfate Nebulization Solution have been filed for production; Formoterol Fumarate Inhalation Aerosol, Salmeterol/Fluticasone Inhalation Powder Aerosol, and Mometasone/Formoterol Inhalation Aerosol have been launched clinical research, and subsequent product delivery has rich highlights.
From: "Phoenix.com"
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