Asia-Pacific

East, South, South-East, Central Asia plus Australasia.
Biotech

BellaSeno pivotal trial enrols 30 women for absorbable breast scaffold

The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
Biologics

GNI Group completes JPY 44.8bn acquisition of Ayumi Pharmaceutical

GNI Group has acquired Ayumi Pharmaceutical from Blackstone, adding an 83% Japanese acetaminophen market share to its four-region biopharma platform.
GNI Group has acquired Ayumi Pharmaceutical from Blackstone, adding an 83% Japanese acetaminophen market share to its four-region biopharma platform.

LENZ Therapeutics signs fifth ex-US VIZZ deal with Arrotex

LENZ Therapeutics has licensed VIZZ to Australia's largest pharma distributor, marking its fifth international partnership for the FDA-approved presbyopia eye drop.
LENZ Therapeutics has licensed VIZZ to Australia's largest pharma distributor, marking its fifth international partnership for the FDA-approved presbyopia eye drop.

HUTCHMED fanregratinib hits 42.5% ORR in pivotal ICC Phase II

HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.
HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.
Biologics

Sanofi's Wayrilz wins Japan approval for immune thrombocytopenia

Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
Biologics

BioCardia targets Japan PMDA submission for CardiAMP by end of 2026

BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
Biologics
Regulatory Science

Sanofi wins Japan approval for Sarclisa subcutaneous formulation

Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
Regulatory Science

Nicox NCX 470 clears China pre-submission review ahead of dual NDA push

Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
Cell & Gene Therapy

SL Bio completes SPAC merger, lists on Nasdaq as SL Science

The Taiwan-based cell therapy company closes its Horizon Space SPAC combination, debuting on Nasdaq under ticker SLBT with a $5.6bn implied valuation.
The Taiwan-based cell therapy company closes its Horizon Space SPAC combination, debuting on Nasdaq under ticker SLBT with a $5.6bn implied valuation.
Pharmaceuticals
Regulatory Science

HUTCHMED sovleplenib hits Phase III primary endpoint in wAIHA

ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
Regulatory Science

Telitacicept wins NMPA conditional approval for IgA nephropathy

China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.
China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.
Regulatory Science

Telitacicept wins NMPA approval for Sjögren's disease in China

RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI
RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI
Biotech

GNI Group to acquire Ayumi Pharmaceutical in ¥44.8bn deal

The Tokyo-listed biopharmaceutical group is buying Blackstone's Japanese specialty pharma asset to build a cross-Pacific commercial platform.
The Tokyo-listed biopharmaceutical group is buying Blackstone's Japanese specialty pharma asset to build a cross-Pacific commercial platform.
Regulatory Science

Iovance wins TGA approval for lifileucel in advanced melanoma

Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.
Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.
Cell & Gene Therapy
Biotech

Legend Biotech reports 100% ORR in Phase 1 in vivo CAR-T NHL trial

LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
Diagnostics

BeyondSpring plinabulin triple shows durable NSCLC benefit

Phase 2 data presented at ASCO 2026 show a 58% two-year survival rate in metastatic NSCLC patients with acquired resistance to checkpoint inhibitors.
Phase 2 data presented at ASCO 2026 show a 58% two-year survival rate in metastatic NSCLC patients with acquired resistance to checkpoint inhibitors.
Regulatory Science

Amplia launches Phase 2b narmafotinib trial in pancreatic cancer

Amplia Therapeutics is initiating a daily-dosing Phase 2b study of its FAK inhibitor narmafotinib in advanced pancreatic cancer, with enrolment due by Q4 2026.
Amplia Therapeutics is initiating a daily-dosing Phase 2b study of its FAK inhibitor narmafotinib in advanced pancreatic cancer, with enrolment due by Q4 2026.
Diagnostics

VVT Med publishes ScleroSafe peer-reviewed trial data

A 30-patient Mumbai study reported 92% vein occlusion at 90 days and no serious adverse events for VVT Med's catheter-directed sclerotherapy system.
A 30-patient Mumbai study reported 92% vein occlusion at 90 days and no serious adverse events for VVT Med's catheter-directed sclerotherapy system.
Digital Health

Simple Charm positions AI beauty devices as a biotech-grade play

Topband-backed Simple Charm claims professional-grade precision for home beauty devices via AI facial recognition and ultrasonic technology.
Topband-backed Simple Charm claims professional-grade precision for home beauty devices via AI facial recognition and ultrasonic technology.
Bioprocessing

InterCure posts NIS 270m revenue in 2025 as war recovery accelerates

Israel's Canndoc parent reported 13% revenue growth and a twelfth consecutive half-year of positive Adjusted EBITDA as it rebuilt from the October 2023
Israel's Canndoc parent reported 13% revenue growth and a twelfth consecutive half-year of positive Adjusted EBITDA as it rebuilt from the October 2023
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