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BioWorld - Friday, December 5, 2025
Home » Authors » Elise Mak

Articles by Elise Mak

Hutchmed debuts in Hong Kong with $537M IPO, shares jump 53%

June 30, 2021
By Elise Mak and Angie Ling
Hutchmed Ltd., already listed in the U.S. and London, returned to home soil June 30 for a third IPO on the Hong Kong Stock Exchange that reaped HK$4.17 billion (US$537.2 million). The Hong Kong-based company is currently looking to score its first FDA approval to tap the U.S. market after three China approvals.
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Hightide’s HTD-1801 meets primary endpoint in phase II trial for PSC

June 30, 2021
By Elise Mak
Hightide Therapeutics Inc. presented top-line results of its lead program, HTD-1801, from a multicenter phase II trial in primary sclerosing cholangitis (PSC), which showed the drug candidate reduced alkaline phosphatase levels compared to placebo.
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Japan flag doctor

Poxel and Sumitomo Dainippon win Japan approval for new type 2 diabetes drug

June 29, 2021
By Elise Mak and Gina Lee
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.
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Green approved stamp

China grants first CAR T approval to Fosun Kite

June 29, 2021
By Elise Mak
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
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Green approved stamp

Hutchmed earns NMPA approval for savolitinib amid IPO plan

June 29, 2021
By Elise Mak
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
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Poxel and Sumitomo Dainippon win Japan approval for new type 2 diabetes drug

June 24, 2021
By Elise Mak and Gina Lee
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.
Read More

Hutchmed earns NMPA approval for savolitinib amid IPO plan

June 23, 2021
By Elise Mak
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Read More
Green approved stamp

China grants first CAR T approval to Fosun Kite

June 23, 2021
By Elise Mak
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Read More
HKEX exterior

CAR T developer Carsgen debuts on HKEX with $400M IPO, targets BCMA first

June 22, 2021
By Elise Mak
CAR T specialist Carsgen Therapeutics Holdings Ltd.’s shares started trading on the Hong Kong Stock Exchange on June 18, helping the company raise HK$3.1 billion (US$400 million) from an IPO that will allow it to advance its phase II-stage BCMA CAR T therapy candidate, CT-053, in multiple markets.
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Hifibio closes $75M series D to move TNFR2 and OX-40 candidates to the clinic by 2021

June 22, 2021
By Elise Mak
Multinational antibody specialist Hifibio Therapeutics Inc. closed an oversubscribed $75 million series D financing round to move its anti-TNFR2 antibody HFB-200301 and the anti-OX-40 antibody HFB-301001 to phase I trials by the end of this year.
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