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BioWorld - Thursday, July 30, 2026
Home » Topics » Asia-Pacific » China

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FDA accepts Beigene’s first filing outside China; BLA seeks nod for anti-PD-1 tislelizumab

Sep. 21, 2021
By Doris Yu
The FDA has accepted for review Novartis AG and Beigene Ltd.’s BLA filing for the anti-PD-1 monoclonal antibody tislelizumab.
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Chinese flag

New law for off-label drug use passed in China

Sep. 21, 2021
By David Ho and Gina Lee
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies.
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Everest in-licenses BTK inhibitor for renal diseases in $561M deal

Sep. 21, 2021
By Doris Yu
Everest Medicines Ltd. has in-licensed a Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of renal diseases from Suzhou Sinovent Pharmaceuticals Co. Ltd. and Sinomab Bioscience Ltd. in a deal worth up to $561 million. Everest gained global rights to develop, produce and commercialize the candidate, XNW-1011.
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New law for off-label drug use passed in China

Sep. 16, 2021
By David Ho and Gina Lee
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies.
Read More

FDA accepts Beigene’s first filing outside China; BLA seeks nod for anti-PD-1 tislelizumab

Sep. 16, 2021
By Doris Yu
The FDA has accepted for review Novartis AG and Beigene Ltd.’s BLA filing for the anti-PD-1 monoclonal antibody tislelizumab.
Read More
Opportunity compass with Chinese flag
RAPS Regulatory Convergence

China an attractive market, but regulatory uncertainty a source of concern

Sep. 14, 2021
By Mark McCarty
The med-tech market in China has lured many device makers and investors into doing business there despite concerns about intellectual property (IP) theft. While some of those IP theft worries have eased, China’s National Medical Products Administration (NMPA) is still implementing an order that came into force June 1, creating an environment of massive regulatory uncertainty that will force device makers to navigate carefully when attempting to access the world’s largest med-tech market.
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Coronavac product packaging

Chinese vaccines show promise as booster shots as more study results shared

Sep. 14, 2021
By Doris Yu
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge. Those who have received the third dose of Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, showed 2.5-fold higher neutralizing potency against the Delta variant, compared to COVID-19 convalescents and two-dose vaccinees.
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Computer chip over digital background with China flag

China’s new personal information protection law challenges company access to user data

Sep. 14, 2021
By Doris Yu
China’s Personal Information Protection Law (PIPL) will take effect on Nov. 1, 2021, making it harder for tech firms, including health care companies, to access and use consumers’ personal information. The PIPL was officially passed by the National People’s Congress on Aug. 20.
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Minhai wins approval for 13-valent pneumococcal conjugate vaccine in China

Sep. 14, 2021
By David Ho
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
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Minhai wins approval for 13-valent pneumococcal conjugate vaccine in China

Sep. 13, 2021
By David Ho
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
Read More
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