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BioWorld - Friday, May 27, 2022
Home » Topics » Asia-Pacific » China

China
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China and U.S. flags

USTR: China falling short of WTO’s market-oriented principles

Feb. 16, 2022
By Mari Serebrov
No Comments
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
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Gavel and block with Chinese flag

China launches strict IP regulations to improve patent quality

Feb. 15, 2022
By Doris Yu
No Comments
The Chinese government has launched a series of regulations regarding intellectual property (IP) to improve the quality of patent applications. “These new IP rules reflect the Chinese government's continuous effort in fighting the long-existing and more severe ‘abnormal patent filing activities’ and ensuring the quality of patent applications with practical restriction measures,” Binxin Li, an IP partner in Fenxun Partners, Baker McKenzie's joint operation platform partner in China, told BioWorld.
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Clinical trial virtual display

Bad news for sintilimab: Trial diversity a must

Feb. 15, 2022
By Mari Serebrov
No Comments
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
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Green approved stamp

Pfizer’s Paxlovid becomes first COVID-19 oral pill approved in China

Feb. 15, 2022
By Doris Yu
No Comments
China’s NMPA has given conditional approval to Pfizer Inc.’s COVID-19 oral pill Paxlovid (nirmatrelvir/ritonavir). The drug was approved for the treatment of adults with mild to moderate COVID-19 and a high risk of progression to severe disease. This includes the elderly, and people with chronic kidney issues, diabetes, cardiovascular, and chronic lung disease.
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Acute myeloid leukemia illustration

Cstone wins first nod for IDH1 inhibitor in China with AML approval

Feb. 15, 2022
By Doris Yu
No Comments
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
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Magnifying glass, FDA concept image

Biosimilars no priority in US FDA pandemic inspections

Feb. 15, 2022
By Mari Serebrov
No Comments
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
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Green approved stamp

Pfizer’s Paxlovid becomes first COVID-19 oral pill approved in China

Feb. 14, 2022
By Doris Yu
No Comments
China’s NMPA has given conditional approval to Pfizer Inc.’s COVID-19 oral pill Paxlovid (nirmatrelvir/ritonavir). The drug was approved for the treatment of adults with mild to moderate COVID-19 and a high risk of progression to severe disease. This includes the elderly, and people with chronic kidney issues, diabetes, cardiovascular, and chronic lung disease.
Read More

Cstone wins first nod for IDH1 inhibitor in China with AML approval

Feb. 10, 2022
By Doris Yu
No Comments
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
Read More
Clinical trial virtual display

Bad news for sintilimab: Trial diversity a must

Feb. 10, 2022
By Mari Serebrov
No Comments
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Read More

Biosimilars no priority in US FDA pandemic inspections

Feb. 9, 2022
By Mari Serebrov
No Comments
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
Read More
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