google-site-verification: googled3ad79e48fba1031.html Made in China: New and Potentially Lifesaving Drugs – Raidar Gist
Tuesday , December 11 2018
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Made in China: New and Potentially Lifesaving Drugs

Chi-Med is awaiting more data. But if further tests get positive results, the company will apply for what is known as breakthrough therapy designation from the United States Food and Drug Administration.

It still needs to run Phase 3 trials, the last step before seeking full approval from the F.D.A., but breakthrough therapy status would allow the final stage to be sped up. The trials involve drugs being tested, often against placebos, for their safety and effectiveness on as many as several thousand patients.

Laura Nelson Carney, an Asia-Pacific health care analyst at Bernstein Research, said that based on the industry average, the probability of success in Phase 3 trials is 60 to 70 percent.

If all goes according to plan, regulatory approval could come in late 2019, at the earliest, said Christian Hogg, Chi-Med’s chief executive. “It takes 20 years to get an overnight success, and that’s where we are at the moment,” he said.

The last time China produced a new drug for the global pharmaceutical industry was in the 1970s, when the Chinese scientist Tu Youyou was credited with the discovery of artemisinin after Mao Zedong asked her to come up with a cure for malaria. But global recognition did not come until much later, after the Swiss drug maker Novartis bought the Chinese patent and started producing it in the late 1990s. Ms. Tu was eventually awarded a Nobel Prize in 2015.

That is changing. Along with Chi-Med, another company, BeiGene, is already in Phase 3 trials globally for a drug used to treat a variety of lymphomas, the most common form of blood cancer, and an immunotherapy drug that aims to destroy tumors. It has also teamed up with Celgene and Merck to develop cancer drugs.

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