【Pharmaceutical Network Corporate News】Minoxidil Topical Solution Approved, New Specification of Isosorbide Mononitrate Sustained-Release Tablets Receives FDA Approval… Lunan Pharmaceutical Group Corporation, as a comprehensive pharmaceutical group, has ushered in multiple pieces of good news at the beginning of 2024.
It is reported that recently, the Huifa® Minoxidil Lotion (Specification: 5% (60 ml: 3.0 g)) produced by Lunan Better Pharmaceutical Co., Ltd. has been approved for marketing as a Class A over-the-counter drug by the National Medical Products Administration, with the approval number: H20243099. Relevant person in charge of Lunan Pharmaceutical stated that the Minoxidil Lotion has the effects of vasodilation, promoting hair growth, anti-inflammation, anti-allergy, and stimulating hair regrowth. It features convenient use, minimal toxic side effects, and portability. Its approval for marketing will bring good news to a large number of patients suffering from hair loss.
Data show that minoxidil is a peripheral vasodilator that can promote blood circulation in the scalp, increase blood supply to hair follicles, and thereby promote hair growth. It dilates blood vessels, promotes metabolism in the scalp, and has an anti-inflammatory effect. Additionally, it can promote hair growth and improve symptoms of hair loss. The clinical indications are that this product is for male use only, to treat male pattern baldness and alopecia areata.
Recently, Lunan Pharmaceutical announced that the application for adding 30mg and 60mg specifications to the Isosorbide Mononitrate Sustained-Release Tablets produced by its subsidiary, Shandong New Era Pharmaceutical, has been approved by the U.S. Food and Drug Administration (FDA), obtaining the license for market sale in the United States. Lunan Pharmaceutical stated that the approval of this product for sale in the U.S. indicates that the quality of Xinkang has reached an internationally high standard.
Data show that Isosorbide Mononitrate Sustained-Release Tablets are used for the treatment of coronary heart disease, mixed angina pectoris, and myocardial infarction. They are rapidly and completely absorbed orally, with no first-pass liver effect.
Since 2024, the group has submitted three new drug applications for clinical trials, including Compound Cetirizine Iodine Buccal Tablets and LNF2008 Monoclonal Antibody Injection, which are first-time submissions.
Looking back at the just-passed year of 2023, Lunan Pharmaceutical also continuously received good news: the group had 12 new products approved; nine products were awarded in the eighth and ninth rounds of national procurement in China; the cumulative sales of the biologic drug Pegylated Human Granulocyte Stimulating Factor Injection in Chinese public medical institutions exceeded 140 million yuan; seven new drugs applied for clinical trials for the first time, six of which have obtained clinical trial approvals, and more.
In addition, according to the data, from 2021 to date, Lunan Pharmaceutical Group (including subsidiaries) has had 28 new products approved for marketing, involving 26 chemical drugs and 2 biologics, distributed across 9 major categories. Moreover, from 2021 to 2023, first-to-market generic drugs were approved each year, demonstrating strong competitive capability in launching generics.
It is reported that in recent years, Lunan Pharmaceutical Group has continuously expanded its product line, with new products being successively submitted for market approval. To date, 51 high-end generic drugs and one biological drug are under review for production. In addition, starting from 2018, the number of Class 1 and Class 2 new drugs applied for and approved for clinical trials by the group has been increasing. So far, 20 new drugs (counted by product name) have been submitted for clinical trials.
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