Lunan Pharmaceutical Accelerates Global Expansion as Another Drug Receives FDA Approval

　　【Pharmaceutical Network Enterprise NewsIn recent years, with the increase in R&D investment by pharmaceutical companies in China and the enhancement of innovation capabilities, an increasing number of enterprises are accelerating their layout in the international market. Recent news indicates that Shandong New Time Pharmaceutical Co., Ltd., under Lunan Pharmaceutical Group Corporation, has received approval from the U.S. FDA for the Prior Approval Supplement (PAS) application (DA 214115) to add 30mg and 60mg specifications for Isosorbide Mononitrate Sustained-Release Tablets. This means that all three specifications (30mg, 60mg, and 120mg) of the product have been granted marketing approval in the U.S., and the company will also expedite its entry into the international market.
 

Relevant data shows that Xin Kang Isosorbide Mononitrate Sustained-Release Tablets are used for the long-term treatment of coronary heart disease, prevention of vasospastic and mixed angina pectoris, etc. This product is a sustained-release formulation that takes effect rapidly within 1 hour and slowly releases over 23 hours, which can prevent the development of drug resistance. At the same time, it reduces the peak-to-trough difference in blood drug concentration and lowers the incidence of adverse reactions. With once-daily dosing, it reduces the frequency of medication, improves patient compliance, and can meet the needs of patients with chronic conditions such as coronary heart disease and angina pectoris who require long-term medication.
 

In China, the product was approved for marketing in 2002. On May 7, 2021, Lunan Pharmaceutical's Isosorbide Mononitrate Sustained-Release Tablets (Specification: 40mg, Trade Name: Xinkang) were approved by the National Medical Products Administration to pass the consistency evaluation of quality and efficacy for generic drugs.
 

It is worth mentioning that the "Xinkang" project is based on the national major new drug creation project "International Research on Isosorbide Mononitrate Sustained-Release Tablets" (2018ZX09303-012) and completed product development and industrialization on the international pharmaceutical R&D center's controlled-release R&D platform.
 

According to reports, Lunan Pharmaceutical established the International Drug Research and Development Center in 2019, which is also the first window for the group's move towards internationalization. Currently, the R&D center has obtained 3 European formulation approvals, 6 U.S. formulation approvals, 26 emerging market formulation approvals, and 8 CEP certificates; submitted over 40 DMFs in Europe, the U.S., and Japan, and over 50 DMFs in other emerging markets; 6 U.S. ANDAs and 2 European MAs are under review. In addition to the international market, there are 9 China-produced formulation varieties currently under review in China.
 

With the development and launch of more products, it will help accelerate the pace of Lunan Pharmaceutical entering the international market, enhance its brand image both in China and abroad, and lay the foundation for "Lunan Pharmaceutical · Healthy World".
 

Public information shows that Lunan Pharmaceutical, adhering to the business tenet of "benefiting society and creating a better life," persists in continuous innovation, dedicating itself to providing the public with higher-quality medicines and delivering greater value in health services.
 

Since 2024, this pharmaceutical company has been receiving continuous positive news. In addition to the acceleration of product internationalization, it also has products launched in China. Recently, the company's Huifa® Minoxidil Lotion (Specification: 5% (60 ml: 3.0 g)) has been approved for marketing by the National Medical Products Administration as a Class A over-the-counter drug. Minoxidil is a peripheral vasodilator that can promote scalp blood circulation and increase blood supply to hair follicles, thereby promoting hair growth. By dilating blood vessels and promoting scalp metabolism, it can have an anti-inflammatory effect. Additionally, it can promote hair growth and improve symptoms of hair loss. The clinical indication for this product is that it is exclusively for male use, treating male pattern baldness and alopecia areata. The approval and market launch of this product are expected to bring good news to a large number of patients suffering from hair loss.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.