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BioWorld - Saturday, December 27, 2025
Home » Topics » Drugs » Enzyme

Enzyme
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AI-generated illustration of enzyme activity
Endocrine/metabolic

Syntis Bio advances oral enzyme replacement therapies toward IND filing

June 11, 2024
Syntis Bio Inc. has announced its launch, with a focus on advancing a pipeline of oral therapies engineered for optimization in the small intestine and a portfolio of enzyme replacement therapies to treat orphan metabolic and broad digestive disorders.
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Test tube, dropper, DNA illustration
Endocrine/metabolic

US orphan drug status granted to Hanmi and GC Biopharma candidate for Fabry disease

May 28, 2024
The U.S. FDA has granted orphan drug status to HM-15421 (GC-1134A, LA-GLA) for the treatment of Fabry disease.
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Joshua Smiley, president and chief operating officer, Zai Lab

Zai Lab exec buys stock as Augtyro, Vyvgart SC advances in China

May 21, 2024
By Marian (YoonJee) Chu
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
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FDA issues CRL on rivoceranib-camrelizumab combo in liver cancer

May 21, 2024
By Marian (YoonJee) Chu
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
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Dong-A ST invests ₩25B in Ildong subsidiary, inks cancer deal

May 21, 2024
By Marian (YoonJee) Chu
To strengthen its cancer pipeline, South Korea’s Dong-A ST Co. Ltd. made a strategic investment of ₩25 billion (US$18.45 million) in Seocho-gu, Seoul-based Idience Co. Ltd., a cancer-focused subsidiary of Ildong Pharmaceutical Co. Ltd. on May 20.
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Dong-A ST invests ₩25B in Ildong subsidiary, inks cancer deal

May 20, 2024
By Marian (YoonJee) Chu
To strengthen its cancer pipeline, South Korea’s Dong-A ST Co. Ltd. made a strategic investment of ₩25 billion (US$18.45 million) in Seocho-gu, Seoul-based Idience Co. Ltd., a cancer-focused subsidiary of Ildong Pharmaceutical Co. Ltd. on May 20. The equity buyout makes Dongdaemun-gu, Seoul-based Dong-A ST the second largest shareholder of Idience, following Ildong Pharmaceutical. The two companies also shook on a co-development deal for Idience’s lead cancer asset, venadaparib (IDX-1197).
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FDA issues CRL on rivoceranib-camrelizumab combo in liver cancer

May 17, 2024
By Marian (YoonJee) Chu
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
Read More
Joshua Smiley, president and chief operating officer, Zai Lab

Zai Lab exec buys stock as Augtyro, Vyvgart SC advances in China

May 16, 2024
By Marian (YoonJee) Chu
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
Read More

Aribio scores $770M deal in China for Alzheimer’s drug candidate

March 26, 2024
By Marian (YoonJee) Chu
South Korean biopharma Aribio Co. Ltd. signed a $770 million deal to sign off exclusive rights to its early Alzheimer’s disease drug, AR-1001 (mirodenafil), in China. The exclusive deal for marketing rights will total about ¥5.59 billion (US$770 million), which includes a non-refundable up-front payment of ₩120 billion (US$90 million) and potential milestone payments, along with royalties.
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Aribio scores $770M deal in China for Alzheimer’s drug candidate

March 25, 2024
By Marian (YoonJee) Chu
South Korean biopharma Aribio Co. Ltd. signed a $770 million deal to sign off exclusive rights to its early Alzheimer’s disease drug, AR-1001 (mirodenafil), in China. The exclusive deal for marketing rights will total about ¥5.59 billion (US$770 million), which includes a non-refundable up-front payment of ₩120 billion (US$90 million) and potential milestone payments, along with royalties.
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