SHANGHAI, March 18 (Xinhua) -- In November 2023, fruquintinib, a new anti-tumor drug developed by Chinese pharmaceutical company HUTCHMED, was approved by the U.S. Food and Drug Administration (FDA) and prescribed in the United States within 48 hours following its approval.

This is the first small-molecule anticancer drug approved in the United States which was developed by a Shanghai pharmaceutical company, and also the first overseas prescription of an innovative drug developed in Shanghai, according to the Science and Technology Commission of Shanghai Municipality.

Fruquintinib, a medicine for the treatment of metastatic colorectal cancer, is among several domestic innovative drugs that were launched in overseas markets in 2023, including Tislelizumab developed by BeiGene and Toripalimab by Junshi Biosciences.

"The year 2023 can be called a milestone year for the overseas launch of domestically produced innovative drugs. Not only did an unprecedented number of drugs go overseas, but also several significant breakthroughs were achieved," said Li Ning, CEO of Junshi Biosciences.

Li added that the increasing share of large molecule drugs, known as biopharmaceuticals, in global markets, as well as the growing number of drugs entering the U.S. market, exemplify these breakthroughs.

The brisk momentum continued into 2024. Chinese pharmaceutical companies forged 18 out-licensing deals in January this year, skyrocketing by 260 percent compared to the same period in 2023.

Chinese innovative drugs have two channels to go global. Some companies independently conduct clinical studies abroad and apply for market approval, eventually gaining authorization to distribute the drugs.

Alternatively, some companies partner with foreign companies to pitch their products overseas, including through out-licensing deals. They sell the rights to commercialize their drugs globally to foreign companies, allowing the latter to take charge of the clinical development, application for market approval, manufacturing and marketing.

Going overseas is no easy task. "The competition for domestically produced innovative drugs to expand overseas is fierce. If you want to penetrate overseas markets, in addition to gaining approval for marketing, you need to achieve commercial success," said Su Weiguo, CEO of HUTCHMED. Under such circumstances, apart from developing high-quality drugs, choosing the right path to enter different markets is crucial, Su added.

In the case of fruquintinib, the drug has chosen to enter a mainstream market with vast demand but meager supply. Su said that the unmet demand of patients in the United States is among the factors contributing to the success of fruquintinib overseas.

"Advanced colorectal cancer is a grave medical challenge. Its global incidence and mortality rates are on the rise, but effective new drugs are not in place. In the United States, the past decade saw not one new drug for treating the disease getting approved," Su said.

Partnering with foreign companies is another path to go overseas, especially for small and medium-sized innovative drug developers. In November 2023, British pharmaceutical company AstraZeneca and Chinese company Eccogene entered into an exclusive license agreement for ECC5004, a glucagon-like peptide 1 receptor agonist discovered by Eccogene for the treatment of obesity, diabetes, and other conditions.

AstraZeneca announced that Shanghai had become the fifth global strategic hub for the company, alongside hubs in the United States, Sweden and Britain, at the 2024 Shanghai Bio-Pharmaceutical Industry International Development Conference held in February.

The British pharmaceutical company also plans to assist 30 Shanghai enterprises to go global in 2024, promoting cross-border cooperation and exchanges in pharmaceutical innovation through two-way visits.

Looking into the future, Chinese innovative drugs can expand beyond the United States and European markets. "We are closely following developments in the Pacific-rim and Indian Ocean-rim markets, and we plan to promote the launch of Chinese innovative drugs in the Republic of Korea (ROK), the Middle East and Southeast Asian countries," Li Ning said. Enditem

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