Asia-Pacific

East, South, South-East, Central Asia plus Australasia.
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
Pharmaceuticals

InnoCare doses first patient in Phase III orelabrutinib SLE trial

InnoCare has initiated a registrational Phase III study of its BTK inhibitor orelabrutinib in SLE, backed by promising Phase IIb data showing a 57% SRI

The Phase III study is a randomised, double-blind, placebo-controlled, multicentre design. The primary endpoint is the SLE Response Index-4 (SRI-4) response rate at Week 52 — the same validated composite measure used in the preceding Phase IIb programme.

InnoCare's confidence in advancing to Phase III rests on a Phase IIb readout in which orelabrutinib 75 mg once daily produced a statistically significant improvement in SRI-4 response versus placebo at Week 48, recording rates of 57.1% against 34.4% (p < 0.05). The results were achieved under stringent steroid-tapering requirements, which the company argues makes the signal more clinically meaningful than comparisons in which corticosteroid use was unrestricted.

The Biotech Times Editorial Team  · 
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