Lunan Pharmaceutical Receives Tentative FDA Approval for Zoledronic Acid Concentrated Injection Solution; Awaiting Domestic Approval

　　【Pharmaceutical Network Product Information] Recent news, Lunan Pharmaceutical Group Corporation received the ANDA TENTATIVE APPROVAL LETTER for Zoledronic Acid Injection Concentrate from the U.S. FDA. This drug is also the 7th formulation approved in the U.S. by the company.
 

Zoledronic acid is a new and highly effective third-generation bisphosphonate bone resorption inhibitor, mainly functioning to inhibit bone resorption, reduce the recruitment and activation of osteoclasts, suppress the activity of osteoclasts, and increase osteoclast apoptosis.
 

It is reported that the injectable zoledronic acid concentrate solution was previously developed by Novartis. Its indications include use in combination with standard anti-tumor drug therapy for the treatment of skeletal damage in patients with bone metastases from solid tumors and multiple myeloma, as well as for the treatment of hypercalcemia of malignancy (HCM). The market scale of zoledronic acid injection is relatively large, with global sales reaching $570 million in 2022 and sales in China reaching 1.426 billion yuan.
 

It is reported that the product produced by Lunan Pharmaceutical on the same production line and with the same process has already submitted a marketing authorization application in China (acceptance number: CYHS2201794) in October 2022. It is currently under review and is expected to become the first domestically produced zoledronic acid concentrate solution to gain simultaneous approval in both China and the United States.
 

In addition to the approval of Zoledronic Acid Concentrated Solution for Injection in the United States, since 2024, Lunan Pharmaceutical and its subsidiaries have been receiving good news continuously.
 

In February, Minoxidil Lotion by Lunan Better Pharmaceutical was approved for market by the National Medical Products Administration as a Class A over-the-counter drug. This is a peripheral vasodilator that can promote blood circulation in the scalp, increase blood supply to hair follicles, and thereby promote hair growth.
 

On February 16, Lunan Pharmaceutical announced that the U.S. FDA approved the application of its subsidiary, Shandong New Era Pharmaceutical, to add 30mg and 60mg specifications for its Isosorbide Mononitrate Sustained-Release Tablets, granting marketing authorization in the United States. Isosorbide Mononitrate Sustained-Release Tablets are used for the treatment of coronary heart disease, mixed angina pectoris, and myocardial infarction, with rapid and complete oral absorption and no hepatic first-pass effect. The trade name of Lunan Pharmaceutical's Isosorbide Mononitrate Sustained-Release Tablets is "Xinkang," which was approved for marketing in China in 2002.
 

In the past 2023, the group had a total of 12 new products approved, including Apixaban Tablets, Tadalafil Tablets, and Lenvatinib Mesylate Capsules. In the eighth and ninth rounds of national procurement in China, nine products were successfully selected, including Argatroban Injection, Amoxicillin Clavulanate Potassium Tablets, Ketorolac Tromethamine Injection, Enoxaparin Sodium Injection, and Somatostatin for Injection in the eighth round, as well as Omeprazole Sodium Bicarbonate Capsules, Omeprazole Sodium Bicarbonate, Fulvestrant Injection, and Ivabradine Hydrochloride Tablets. The first marketed biologic drug, Pegfilgrastim Injection, achieved cumulative sales exceeding 140 million yuan in Chinese public medical institutions.
 

In addition, Lunan Pharmaceutical Group Corporation is also actively laying out innovative drugs. Since 2018, the number of Class 1 and Class 2 new drugs applied for and approved for clinical trials by the group has been continuously increasing. Up to now, 20 new drugs (counted by product name) have applied for clinical trials, with a comprehensive layout in biologics, chemical drugs, and traditional Chinese medicine. In 2023, the group applied for clinical trials for seven new drugs, all of which were first-time applications, and six of them have already received clinical trial approvals.
 

It is reported that Lunan Pharmaceutical has now developed into a large comprehensive pharmaceutical group that integrates the production, research, and sales of traditional Chinese medicine, chemical medicine, and biopharmaceuticals. Its revenue has exceeded 10 billion yuan for five consecutive years, with tax payments surpassing 1 billion yuan. According to the group's development plan of "doubling in three years, exceeding 100 billion yuan in ten years," it aims to achieve a production value of over 100 billion yuan and tax contributions of more than 10 billion yuan by 2028.
 

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