GSK Signs Exclusive Collaboration with SBP Group to Strengthen Commercialization of Bepirovirsen in China; Artiva Announces Strong Early AlloNK® Results and FDA Alignment for Pivotal Rheumatoid Arthritis Trial in 2026; FDA Reviews LEQEMBI IQLIK Subcutaneous Starting Dose Under Priority Review Pathway; ParcelBio Announces Programmable mRNA Platform Amid $13M Capital Infusion; Entrada Therapeutics Reports Promising Topline Efficacy and Safety Results for ENTR-601-44 in Duchenne Muscular Dystrophy

GSK Signs Exclusive Collaboration with SBP Group to Strengthen Commercialization of Bepirovirsen in China

GSK plc revealed an exclusive strategic partnership with Sino Biopharmaceutical, through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., aimed at supporting the launch and expansion of bepirovirsen in mainland China. Bepirovirsen, currently under priority regulatory review in China, is being developed as a potential first-in-class therapy for chronic hepatitis B (CHB).

As one of China’s leading hepatitis B players, CTTQ brings an extensive liver disease portfolio and a commercial network that spans over 5,000 healthcare institutions nationwide. The company has been instrumental in improving hepatitis B diagnosis and treatment across the country.

Through this alliance, GSK’s scientific innovation will be combined with CTTQ’s strong local market presence and execution capabilities to help expand patient access to bepirovirsen more rapidly. Under the terms of the agreement, CTTQ will oversee importation, distribution, hospital market access, and both promotional and non-promotional activities for the therapy in mainland China. GSK will continue to serve as the marketing authorisation holder and will retain responsibility for regulatory oversight, quality assurance, pharmacovigilance, and global medical strategy. The partnership also gives GSK the opportunity to assess selected early-stage pipeline assets from the SBP Group for potential collaborations beyond China.

Chronic hepatitis B remains a major public health focus in China. The country’s latest National Action Plan for the Prevention and Treatment of Viral Hepatitis (2025–2030) has identified functional cure as a central treatment objective. Functional cure refers to sustained clearance of hepatitis B viral DNA and hepatitis B surface antigen (HBsAg) from the bloodstream for at least six months after discontinuation of therapy. Achieving this outcome is linked to a substantially lower risk of severe long-term complications, including liver cancer.

Bepirovirsen received Breakthrough Therapy designation in China in August 2021 and was accepted for Priority Review in April 2026. The filing is backed by encouraging data from the Phase III B-Well 1 and B-Well 2 studies, which showed statistically significant and clinically meaningful functional cure outcomes.

Artiva Shares Positive Initial AlloNK® Data Across Autoimmune Indications and Advances Toward Phase 3 Rheumatoid Arthritis Study

Artiva Biotherapeutics reported encouraging early clinical findings from ongoing studies assessing AlloNK® (AB-101) in combination with rituximab. Based on the April 3, 2026, cutoff, the preliminary dataset comprised 21 patients with refractory rheumatoid arthritis (RA) who had completed at least 12 weeks of follow-up, including 13 patients monitored for six months, across the company’s Phase 2a basket study and an investigator-sponsored basket trial focused on B-cell-mediated autoimmune disorders. The expanded autoimmune cohort further included 11 patients with Sjögren’s disease (SjD) and five with systemic sclerosis (SSc), among whom seven SjD patients and four SSc patients had reached at least six months of follow-up.

The company also confirmed that it has reached an agreement with the U.S. Food and Drug Administration on the design of a single registrational randomized controlled study for AlloNK in refractory RA. The planned trial is expected to enroll around 150 RA patients who previously showed inadequate responses to at least two biologic or targeted synthetic DMARDs from different therapeutic classes. Participants are anticipated to be randomized in a 2:1 ratio to receive either AlloNK plus rituximab or rituximab alone, with an ACR50 response at six months designated as the primary endpoint.

As of April 30, 2026, over 70 autoimmune disease patients had begun treatment with AlloNK across active clinical studies, supported by more than 40 activated clinical sites worldwide. Treatments have been administered entirely in outpatient settings, with most patients managed through community rheumatology practices, reinforcing the operational readiness for Artiva’s planned Phase 3 registrational trial in refractory RA.

LEQEMBI IQLIK Receives FDA Priority Review Update for Subcutaneous Starting Dose in Early Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has extended the review timeline by three months for the supplemental Biologics License Application (sBLA) seeking approval of a once-weekly subcutaneous formulation of LEQEMBI (lecanemab-irmb; brand name: LEQEMBI® IQLIK™) as an initiation dose for patients with early Alzheimer’s disease. The revised Prescription Drug User Fee Act (PDUFA) target date is now set for August 24, 2026.

The extension follows the FDA’s request for additional information during the ongoing review process. The agency classified the submission as a major amendment to the sBLA, thereby requiring additional time to complete its assessment. Importantly, the FDA has not identified any issues related to the approvability of LEQEMBI IQLIK as an initiation therapy.

According to Eisai and Biogen, the extensive clinical evidence supporting subcutaneous administration of LEQEMBI across various studies and dosing schedules reinforces the potential of LEQEMBI IQLIK as an initiation treatment option. This follows the FDA’s approval of the subcutaneous maintenance dosing regimen in August 2025.

LEQEMBI has already secured approvals from more than 50 health authorities globally, underscoring growing regulatory confidence in the therapy for early Alzheimer’s disease. Eisai and Biogen stated that they will continue working closely with the FDA throughout the review process and remain focused on delivering this treatment advancement to patients and caregivers, offering greater flexibility in anti-amyloid therapy administration.

ParcelBio Launches Programmable mRNA Platform Following $13M Funding Round

ParcelBio announced this week that it has secured $13 million in seed funding through a round led by Breyer Capital, with participation from General Catalyst, Y Combinator, Metaplanet, SurgePoint Capital, ZAKA VC, and other investors. The newly raised capital will be used to further develop the company’s proprietary Amplified and Prolonged EXpression mRNA (APEXm™) platform and progress its pipeline, including an in vivo CAR T candidate for autoimmune disorders alongside programs in oncology and encoded protein therapeutics.

The biotechnology firm, focused on creating a next-generation class of long-lasting mRNA therapeutics, plans to officially introduce its APEXm platform and present preclinical findings at the American Society of Gene and Cell Therapy Annual Meeting, taking place in Boston from May 11–15. According to the company, the presented data will show that APEXm RNA delivers substantially stronger and more sustained protein expression compared with an existing clinical-stage mRNA design, while also achieving more effective target-cell depletion in in vivo CAR T models.

Unlike circular RNA-based technologies and other alternative approaches that can increase manufacturing challenges or compromise expression efficiency, ParcelBio’s platform retains a straightforward linear RNA structure. The company believes this design enhances manufacturability while supporting broad applicability across multiple proteins and cell types, enabling potential use in immune cell programming and protein replacement therapies.

ParcelBio’s lead program is centered on developing in vivo CAR T therapies aimed at eliminating pathogenic B cells implicated in autoimmune diseases, with the objective of delivering profound B-cell depletion and long-term, treatment-free remission. By supporting prolonged CAR expression without relying on viral vectors or ex vivo cell engineering, the company hopes to create scalable, ready-to-use therapeutic options. Beyond autoimmune indications, the platform is also being advanced for applications in oncology and encoded protein therapeutics.

Entrada Therapeutics Reports Positive Topline Data from Cohort 1 of Phase 1/2 ELEVATE-44-201 Trial of ENTR-601-44 in Duchenne Muscular Dystrophy

Entrada Therapeutics reported positive topline findings from Cohort 1 of the double-blind, placebo-controlled, multiple ascending dose (MAD) segment of the Phase 1/2 ELEVATE-44-201 trial. The study is evaluating ENTR-601-44 in ambulatory patients aged 4–20 years with Duchenne muscular dystrophy (DMD) caused by mutations in the DMD gene suitable for exon 44 skipping. In Cohort 1, participants were randomized in a 3:1 ratio to receive either three 6 mg/kg doses of ENTR-601-44 — the company’s lead DMD investigational therapy — or placebo. Muscle biopsies were collected during screening and again six weeks after the final dose.

Treated participants in Cohort 1 had an average age of 9.3 years, while the mean age at disease onset was 2.2 years. In line with the study protocol, all participants remained ambulatory and were maintained on stable steroid regimens. Baseline dystrophin levels in both the placebo and treatment groups were lower than those observed in competing exon 44 skipping studies, an important point given that higher baseline dystrophin levels are typically associated with stronger treatment responses.

The therapy demonstrated a favorable safety and tolerability profile, with no serious adverse events (SAEs) or treatment-related discontinuations reported. Kidney function markers also remained within normal ranges throughout the study.

All participants from Cohort 1 have advanced into the open-label Phase 2 extension, where they will receive six additional 6 mg/kg doses of ENTR-601-44. Meanwhile, enrollment and dosing are underway in Cohort 2, which is evaluating three 12 mg/kg doses of ENTR-601-44 versus placebo. The company plans to release data from the Cohort 1 open-label phase and the Cohort 2 MAD study by the end of 2026, followed later by results from Cohort 3, which is testing doses up to 18 mg/kg.