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BioWorld - Sunday, May 22, 2022
Home » Topics » Asia-Pacific » China

China
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James Jungkue Lee, CEO, Bridge Biotherapeutics

Bridge Biotherapeutics secures second IPF candidate, targets IND by late 2022

March 15, 2022
By Gina Lee
No Comments

Bridge Biotherapeutics Inc. has signed an exclusive option-to-license agreement for Cellionbiomed Inc.’s preclinical ion channel modulator, BBT-301, thus adding a second idiopathic pulmonary fibrosis (IPF) candidate to its fibrotic diseases portfolio. The company hopes to enter the clinic with the drug in the U.S. by the end of 2022.


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Three China firms named to US SEC list under HFCAA

March 15, 2022
No Comments
Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA).
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SEC identifies firms for tougher audits, including three biopharmas

March 15, 2022
By Gina Lee
No Comments
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd.
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Pfizer authorizes China Meheco Group rights to commercialize Paxlovid in China

March 15, 2022
By Doris Yu
No Comments
Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir and ritonavir), which won conditional approval from China’s NMPA earlier this year.
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Psychotherapist evaluates patient using VR therapy for acrophobia

Neuton Health’s VR therapy for acrophobia receives NMPA class II approval

March 14, 2022
By Zhang Mengying
No Comments
Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world.
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SEC identifies firms for tougher audits, including three biopharmas

March 14, 2022
By Gina Lee
No Comments
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd.
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Pfizer authorizes China Meheco Group rights to commercialize Paxlovid in China

March 14, 2022
By Doris Yu
No Comments
Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir and ritonavir), which won conditional approval from China’s NMPA earlier this year.
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Three China firms named to US SEC list under HFCAA

March 11, 2022
No Comments
Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA).
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Chinese flag, pills

China NMPA speeds up NDA reviews to encourage new drug development

March 11, 2022
By Doris Yu
No Comments
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) in China.
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Salubris raises $32M to continue work on cardiovascular candidate

March 11, 2022
By Doris Yu
No Comments
Salubris Biotherapeutics Inc. has raised $32 million in financing from its parent company, Shenzhen Salubris Pharmaceuticals Co. Ltd., for the development of its cardiovascular candidate. Funds will be used to continue efforts in an ongoing phase Ib trial and to initiate two additional phase Ib studies in 2022, as well as to expand the company’s pipeline.
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