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BioWorld - Monday, May 25, 2026
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Regulatory actions for April 28, 2026

April 28, 2026
Regulatory snapshots for biopharma and med tech in Asia-Pacific, including global submissions and approvals, and other regulatory decisions and designations: Asia-Pacific: Astellas, Biocon, CGbio, Clinuvel, GSK, Merck, Specialised, TCM.
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Other news to note for April 28, 2026

April 28, 2026
Biopharma and med-tech happenings in Asia-Pacific, including deals and partnerships, and other news in brief: Abbvie, Asahi Kasei, Aicuris, Cathworks, Exicure, Medtronic, Nxera.
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In the clinic for April 28, 2026

April 28, 2026
Clinical updates for biopharma and med tech in Asia-Pacific, including data readouts and publications: Alterity, Dayspring, Eisai, Merck, Miracell, Noxopharm, Ractigen.
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Appointments and advancements for April 28, 2026

April 28, 2026
New hires and promotions in the biopharma and med-tech industries in Asia-Pacific, including: Atmo, Ena Respiratory.
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Acute myeloid leukemia illustration

Delta-Fly eyes NDA path despite AML phase III miss

April 21, 2026
By Tamra Sami
No Comments
Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.
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Lung cancer illustration

FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

April 21, 2026
By Marian (YoonJee) Chu
No Comments
The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.
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Lung cancer illustration
AACR 2026

Xuanzhu shares dip despite phase III ALK inhibitor data

April 21, 2026
By Marian (YoonJee) Chu
No Comments
Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.
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HKEX exterior

Mabwell turns to Hong Kong to fund ADC ambitions

April 21, 2026
By Tamra Sami
No Comments
Following its 2022 debut on Shanghai’s STAR Market, Mabwell (Shanghai) Bioscience Co. Ltd. is aiming to raise up to HK$1.44 billion (US$184.78 million) in an IPO on the Hong Kong Stock Exchange to advance its Nectin4-targeting antibody-drug conjugate (ADC) 9MW-2821 (bulumtatug fuvedotin).
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White tablet imprinted with dollar sign

Pricing standoff leaves Australian patients in limbo

April 21, 2026
By Tamra Sami
No Comments
A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.
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Ayele Dilion Mashiah, CEO, Remedy
Newco news

Remedy pushes ‘cell-free’ secretome therapy for IPF into phase I

April 21, 2026
By Marian (YoonJee) Chu
No Comments
“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January.
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