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BioWorld - Friday, June 19, 2026
Home » Authors » Marian (YoonJee) Chu

Articles by Marian (YoonJee) Chu

Keytruda Qlex

US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors

Sep. 23, 2025
By Marian (YoonJee) Chu
No Comments
The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.
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IPO, coins, financial chart

Genfleet raises $234M with Hong Kong IPO

Sep. 23, 2025
By Marian (YoonJee) Chu
No Comments
Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price.
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Celltrion building and skyline

Celltrion to buy Lilly’s cGMP plant for $330M, invest up to $1B

Sep. 23, 2025
By Marian (YoonJee) Chu
No Comments
Celltrion Inc. announced plans to acquire from Eli Lilly and Co. a Branchburg, N.J.-based biologics cGMP facility for $330 million up front, with plans to invest up to a total of ₩1.4 trillion (US$1 billion) in plant acquisition and expansion.
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Keytruda Qlex

US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors

Sep. 22, 2025
By Marian (YoonJee) Chu
No Comments
The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.
Read More
IPO, coins, financial chart

Genfleet raises $234M with Hong Kong IPO

Sep. 19, 2025
By Marian (YoonJee) Chu
No Comments
Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price.
Read More
Globe showing Asia-Pacific region
Asia Bio 2025

Piecing mosaic of APAC regulations key to Asia biotech growth

Sep. 18, 2025
By Marian (YoonJee) Chu
No Comments
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
Read More
Red blood cells in an artery with cholesterol

Kalexo enters dyslipidemia fray with preclinical siRNA candidate

Sep. 18, 2025
By Marian (YoonJee) Chu
No Comments
Mabwell Bioscience Co. Ltd. and Aditum Bio Management Co. LLC announced, in after-market hours Sept. 17, an agreement to forge a new company called Kalexo Bio Inc. and load the biotech with a preclinical dyslipidemia asset via a potential $1 billion global license deal.
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Globe showing Asia-Pacific region
Asia Bio 2025

Piecing mosaic of APAC regulations key to Asia biotech growth

Sep. 16, 2025
By Marian (YoonJee) Chu
No Comments
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
Read More
Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 16, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
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Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 15, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
Read More
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