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BioWorld - Saturday, December 20, 2025
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Regulatory actions for March 4, 2025

March 4, 2025
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Ardelyx, Astrazeneca, Bioarctic, Celltrion, Innovent, Sanofi, Takeda.
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In the clinic for March 4, 2025

March 4, 2025
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Biocity, Cstone, Delta-Fly, Innocare, Yoltech.
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Other news to note for March 4, 2025

March 4, 2025
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Biond Biologics, Carsgen, Eisai, Epimab, Hansoh, Holling Bio-Pharma, Infex, Idorsia, Ligand, Medigene, Nxera, Sanofi, Sciclone, Silence, Venus Remedies, Ucarsgen.
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Appointments and advancements for March 4, 2025

March 4, 2025
New hires and promotions in biopharma in Asia-Pacific, including: Sinovac.
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Financings for March 4, 2025

March 4, 2025
Biopharmas in Asia-Pacific raising money in public or private financings: Innocan.
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3D rendering of drug linked to antibody

Hummingbird migrates ADCs, tech to newco Callio’s $187M debut

March 4, 2025
By Marian (YoonJee) Chu
Antibody-drug conjugate (ADC)-focused Callio Therapeutics debuted on March 3 with the closing of a $187 million series A financing round based on cancer drug technology and assets in-licensed from Hummingbird Bioscience Pte Ltd.
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Illustration of tumor
Immuno-oncology

Fapon’s immunocytokine FP-008 gains IND clearance for solid tumors

March 4, 2025
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals January 2025

Astrazeneca, Vertex, Axsome secure US FDA approvals in January

Feb. 25, 2025
By Amanda Lanier
The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
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Various pills laid across a target

Pharmaceuticals named as tariff target, starting at 25%

Feb. 25, 2025
The prospect of U.S. tariffs on pharmaceuticals became more than just speculation this week, with President Donald Trump saying those tariffs likely would begin at 25% and climb over the year. His comments came in response to a question at a Feb. 18 news conference that followed the signing of two unrelated executive orders. Asked about the planned rate for tariffs on semiconductors and pharmaceuticals, Trump responded that it would be 25% and higher and it would “go very substantially higher over [the] course of a year.”
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Infant exam

China prioritizes mental health, pediatric care in 2025

Feb. 25, 2025
By Marian (YoonJee) Chu
China’s National Health Commission is designating a three-year period from 2025 to 2027 as the “years of pediatric and mental health services,” in line with a new pledge to achieve eight initiatives in the health care sector aimed at servicing underserved populations.
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