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The research and development capabilities of domestic pharmaceutical companies continue to improve, and domestically produced drugs are constantly receiving approvals overseas.
Source:JINDUN MEDICAL | Author:JINDUN MEDICAL | Published time: 2023-05-17 | 326 Views | Share:

Recently, the generic drug "Mesalazine Delayed-Release Tablets (1.2g)" developed by Xuantai Pharmaceuticals has obtained approval from the US FDA (ANDA217337). Additionally, Xuantai Pharmaceuticals has also submitted the ANDA application for this product to the China National Medical Products Administration in July 2022, which is currently under review and approval.


Public information shows that Mesalazine is a first-line drug for the induction and maintenance of mild to moderate ulcerative colitis. It can inhibit the activation of various inflammatory cells in the intestines and protect the intestinal mucosa from damage. There are already multiple formulations and specifications of Mesalazine products available globally, with Mesalazine Delayed-Release Tablets (1.2g) alone accounting for over 40% of the overall Mesalazine market share in the United States, with sales of nearly 200 million tablets and approximately 600 million USD.


In fact, it is not uncommon for domestic drugs to be approved overseas. In recent years, the overseas market has become an important market for many domestic pharmaceutical companies to explore new markets and increase their performance. It is understood that this year, news of domestic innovative drugs, generic drugs, clinical approvals, market launches, and orphan drug certifications overseas has been continuously reported.


For example, on April 19th, Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received a notification from the US FDA stating that the New Drug Application (ANDA) for Tacrolimus Capsules submitted by Zhongmei Huadong to the US FDA has been approved. Tacrolimus Capsules developed by Zhongmei Huadong were approved for the domestic market in 2008. Data shows that in 2022, Tacrolimus achieved global sales of 2.655 billion USD, with sales in the US market reaching 450 million USD.


On April 13th, Yabao Pharmaceutical announced that its wholly-owned subsidiary, Beijing Yabao Biopharmaceutical Co., Ltd., received a notification from the US FDA stating that the ANDA application for Celecoxib Capsules submitted by Yabao Biopharmaceutical to the US FDA has been approved. Celecoxib Capsules are mainly used for relieving symptoms and signs of osteoarthritis, adult rheumatoid arthritis, ankylosing spondylitis, and treating acute pain in adults.


On April 4th, it was reported that Qingfei Detoxification Granules have recently been approved for over-the-counter sales in Canada. In addition to the indications approved in China, the Canadian Health Department has added a new indication for "those with symptoms of influenza-like illness," based on relevant research results, expanding the scope of existing indications. Currently, Qingfei Detoxification Granules have completed the full approval process, including product registration, production certification, and trade sales license, allowing for legitimate entry into the pharmaceutical market in that country.


The increasing number of domestically produced drugs receiving approval overseas demonstrates the innovative capabilities and quality recognition of domestic drugs in foreign markets. However, it is important to note that there are still many challenges for domestic pharmaceutical companies to overcome when entering overseas markets, such as the need to adapt strategies to different national conditions and establish brand effects. Therefore, gaining a larger market share in overseas markets remains a challenging task.