South Korea streamlines biosimilar review, clinical trials
South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes.

South Korea streamlines biosimilar review, clinical trials
South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes.
Amplia halts enrollment in phase II pancreatic cancer trial
Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX (mFOLFIRINOX), which is being administered in combination with lead compound narmafotinib (AMP-945), a focal adhesion kinase inhibitor.
Five-drug VIPOR regimen shows promise in aggressive blood cancer
Deep molecular advances are enabling precision medicine for the field of hematology, Wyndham Wilson said during a plenary session at the 2026 Korean Society of Hematology International Conference March 26.
News in brief
BioWorld Asia briefs for April 7, 2026
Biopharma financings nearly double vs. 2025 to $25.1B
Total biopharma financings reached $25.14 billion in the first quarter (Q1) of 2026, nearly doubling the $13.12 billion in the Q1 2025. The early 2026 total comes in above the $13.19 billion recorded in 2023 and $13.66 billion in 2022, though it remains below the $38.27 billion during the same period in 2021 and $47.25 billion in 2024.
Hematopoietic stem cell research points to leukemia’s early roots
Hematopoietic stem cell research over the past century has shown that leukemia may be driven by an invisible hand of inflammation. The bone marrow and inflammation, then, may hold the keys to preventing blood cancers, according to John E. Dick’s plenary session at the 2026 Korean Society of Hematology International Conference, held March 26, 2026.
Sector tariff now more than a threat – for some Rx companies
After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies.
Best of BioWorld: Q1
A selection of top news from January through March 2026.

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Analysis and data insight

Biopharma deal value jumps 60% to start 2026
Deals and M&A
Biopharma deal value reached $61.17 billion in the first two months of 2026, roughly a 60% increase from the $38.11 billion logged in the same period of 2025 and marking the strongest early year total in BioWorld’s records. The surge was driven by unusually strong activity in both months, with...
Latest benchmark shows 35% decline in antibiotics pipeline in past 5 years
Infection
Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever.
Wave of deals lifts large-cap biopharma stocks
The BioWorld Biopharmaceutical Index finished 2025 up 24.07%, building slightly on its 23% gain recorded at the end of November. While the increase trailed the Nasdaq Biotechnology Index’s 32.4% rise for the year, it outperformed the broader Dow Jones Industrial Average, which advanced 12.97%.
China tops US in January drug approvals
Regulatory
U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January.

Financings

Excalipoint closes $68.7M seed round for cancer T-cell engagers
Newco news
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.

Australia

Australia’s R&D reset puts biotech translation in focus
Regulatory
Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.

Australia publishes first clinical practice guideline for psychedelics
Clinical
Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain works in progress.
Mixed phase II results still point to path forward for AISA-021
Clinical
Although Aisa Pharma Inc’s cilnidipine (AISA-021) failed to meet the primary endpoint, multiple secondary endpoints showed statistically significant improvement in treating sclerosis-associated Raynaud's phenomenon, potentially positioning the drug for a phase III program in a disease with no...

China

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD
Clinical
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
China-developed triple incretin enters global diabetes race
Clinical
A next-generation triple incretin therapy jointly developed by Novo Nordisk A/S and China’s United Biotechnology outperformed semaglutide in a phase II trial, signaling intensifying competition in the GLP-1 obesity and diabetes market.
Simcere’s rademikibart meets phase III endpoints in atopic dermatitis
Clinical
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
Braveheart finds phase II positive for cardiac myosin inhibitor
Clinical
Braveheart Bio Inc. reported positive results from an open-label randomized phase II dose-ranging study of BHB-1893 (HRS-1893) in obstructive hypertrophic cardiomyopathy. Results presented at the American College of Cardiology’s Annual Scientific Session and Expo in New Orleans showed BHB-1893...
Simcere’s PD-L1/IL-15 bispecific sees early edge in bladder cancer
Clinical
Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.

Regulatory

China’s Qyuns moves IL-17 biologic toward first approval
Immune
Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and...

Newco news

Harbour Biomed spins out newco in $1.2B CTLA-4 deal
Deals and M&A
Harbour Biomed is spinning out newco Solstice Oncology and is outlicensing its CTLA-4 antibody, porustobart (HBM-4003), to the newco in a cash and equity deal worth more than $1.2 billion.

Quantx raises $85M to advance oral immunology drugs
Financings
After closing an oversubscribed $85 million series B round, Quantx Biosciences Inc. is gearing up to begin clinical trials of its two lead immunology compounds, a STAT6 oral small-molecule inhibitor and an IL-17 oral small-molecule inhibitor.
AI meets antibody design: Galux draws $29M series B for drug R&D
Financings
Galux closed a ₩42 billion (US$29 million) series B round Feb. 10, led by Yuanta Investment to bring AI-driven “rational design” to the protein drug development process, already heavily influenced by human engineering.

Science

Targetable ‘high-plasticity cell state’ important for cancer progression, drug resistance
Cancer
Cancer cells expand through mutations – but not just through mutations. They also change their behavior in the absence of underlying genetic alterations. Such plasticity helps the cells both adapt to the cellular stress fueled by out-of-control...
Sea anemone venom acts as a senolytic tool against cancer
Aging
The sea anemone Stichodactyla helianthus, which carpets the Caribbean seafloor, may hold the key to eliminating the senescent cells that survive cancer therapy. A collaboration led by Spanish scientists across several international research...
In 2025, autoimmune work notches scientific, economic successes
Deals and M&A
In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity.
Romidepsin offers hope for high-risk neuroblastoma
Cancer
Australian researchers have found a drug combination that can bypass the cellular defenses in neuroblastoma that lead to relapse, and the discovery could lead to better treatment strategies for children whose cancers have stopped responding to...
HIV remission after heterozygous CCR5Δ32 stem cell transplant
Cancer
2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1,...
Adenosine surge is common thread in ketamine and ECT response
Neurology/psychiatric
Researchers from the Chinese Institute for Brain Research, the Chinese Academy of Medical Sciences, and their collaborators have identified adenosine as the driving force behind the rapid, fast-acting antidepressant effects of ketamine and...

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