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Home » Authors » Marian (YoonJee) Chu

Marian (YoonJee) Chu

Articles

ARTICLES

Chinese flag and pills

China NMPA approves 40 innovative new drugs in 2023

Feb. 29, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
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Science and medicine icons with head made of computer code

CG Bio claims majority stake in Inosys Korea

Feb. 28, 2024
By Marian (YoonJee) Chu
South Korea’s Cell & Growth Factor Biotechnology Co. Ltd. (CG Bio) became the largest shareholder of Busan-based Inosys Korea after claiming a 34.7% stake in the embattled orthopedic implant med-tech firm.
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Scientists working in Samsung Bioepis lab

Keytruda biosimilars ramp up; Samsung Bioepis starts phase I

Feb. 27, 2024
By Marian (YoonJee) Chu
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
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Skytyphoid

SK Bio wins WHO prequalification for typhoid conjugate vaccine

Feb. 27, 2024
By Marian (YoonJee) Chu
SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, Skytyphoid (NBP-618), on Feb. 23. Skytyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier.
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Aribio gains UK approval to start phase III trial of Alzheimer’s drug

Feb. 27, 2024
By Marian (YoonJee) Chu
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
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Alteogen headquarters

Alteogen names MSD as partner in revised, potential $3.8B+ deal

Feb. 27, 2024
By Marian (YoonJee) Chu
In a surprise reveal that propelled stocks by 25%, Alteogen Inc., of Daejeon, South Korea, named MSD International Business GmbH as its counterpart in a near-$4 billion technology transfer agreement inked in 2020, while upping terms of the deal.
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Hun-taek Kim, CEO and founder, Tiumbio

With three lead assets, Tiumbio tackles rare and incurable diseases

Feb. 27, 2024
By Marian (YoonJee) Chu
Hun-taek Kim founded Tiumbio Co. Ltd. in 2016 after spending more than two decades at a major chemical and life science firm, SK Chemicals Co. Ltd. “The prospects for our three major assets are very bright, and the probability of failure is low,” CEO Kim told BioWorld.
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Skytyphoid

SK Bio wins WHO prequalification for typhoid conjugate vaccine

Feb. 26, 2024
By Marian (YoonJee) Chu
SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, Skytyphoid (NBP-618), on Feb. 23. Skytyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier.
Read More

Aribio gains UK approval to start phase III trial of Alzheimer’s drug

Feb. 26, 2024
By Marian (YoonJee) Chu
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
Read More
Alteogen headquarters

Alteogen names MSD as partner in revised, potential $3.8B+ deal

Feb. 23, 2024
By Marian (YoonJee) Chu
In a surprise reveal that propelled stocks by 25%, Alteogen Inc., of Daejeon, South Korea, named MSD International Business GmbH as its counterpart in a near-$4 billion technology transfer agreement inked in 2020, while upping terms of the deal.
Read More
View All Articles by Marian (YoonJee) Chu

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