Qilu Pharmaceutical's Gefitinib Tablets Achieve Exclusive First-to-File Generic Launch in the U.S. Market

On May 3, Qilu Pharmaceutical's Gefitinib Tablets successfully launched in the U.S. market, becoming the first generic Gefitinib Tablets to be marketed and the only one currently available in the United States. This marks the 22nd formulation product of Qilu Pharmaceutical to achieve commercial sales in the U.S.

Breaking Foreign Monopolies, Bravely Shouldering Social Responsibility

As a "blockbuster" first-line targeted drug for the treatment of non-small cell lung cancer, the original gefitinib tablet has long monopolized the market in China since its launch. After six years of dedicated research and overcoming various technical challenges, Qilu Pharmaceutical successfully developed a generic drug product clinically equivalent to the original. At the end of 2016, Qilu Pharmaceutical's Gefitinib Tablets (Yiruike®) were the first domestically produced generic to gain approval for marketing in China.

After the launch of Yiruike, it has brought more and more affordable treatment options to cancer patients in China, fundamentally solving the accessibility issue of this drug and significantly reducing the medication burden on ordinary people. In recent years, Qilu Pharmaceutical has actively participated in national drug procurement initiatives, taking practical actions to address the issue of "high drug costs" for the public. Currently, Qilu Pharmaceutical has a total of 56 selected varieties.

Guided by international development strategies, focusing on the global market

To date, Qilu Pharmaceutical's products have been exported to more than 90 countries and regions worldwide. Despite the severe impact of the global COVID-19 pandemic and the hindered development of the pharmaceutical industry, Qilu Pharmaceutical achieved an export value of $920 million in 2022, marking a逆势 increase of 21% year-on-year.

The United States is the core battleground for top global pharmaceutical companies and also the "touchstone" to test their true strength. Qilu Pharmaceutical has been winning market favor with its first-class quality and stable supply capabilities, standing out in fierce market competition. Currently, nearly half of Qilu Pharmaceutical's products sold in the U.S. rank first in sales, with several products holding over 50% of the market share.

Continuous Innovation, Safeguarding Human Health

"Making high-quality domestically produced drugs affordable for the common people" has been the relentless pursuit of Qilu Pharmaceutical. Adhering to the corporate mission of "expressing our love through technology," in recent years, Qilu Pharmaceutical has remained committed to addressing clinical needs, continuously increasing R&D investment. Through ongoing innovation, the company keeps launching high-quality drugs that are "within reach and accessible" for ordinary citizens. In 2022, Qilu Pharmaceutical invested nearly 4 billion yuan in R&D, placing it at the forefront of the industry. Currently, the company has nearly 300 products under development, covering major disease areas such as oncology, cardiovascular and cerebrovascular diseases, psychiatry, and neurology.

In the future, Qilu Pharmaceutical will continuously enhance its innovation capabilities and core competitiveness, striving to bring more high-quality medicines to benefit patients worldwide and safeguard human health.

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