BMS’s new anti-tumor drug has been approved for marketing; GSK and Acyclovir are advancing clinical trials of their new drugs.

August 18, 2026  Source: drugdu 46

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On August 13 local time , Bristol Myers Squibb ( BMS ) announced that the U.S. FDA has approved its innovative drug Iberdomide ( Zenbexus ) for marketing in combination with the standard treatment regimen (daratumumab + dexamethasone) for the treatment of relapsed or refractory multiple myeloma ( MM ) .
According to the press release, Iberdomide is the first FDA -approved cereblon E3 ubiquitin ligase modulator ( CELMoD ) therapy.

Iberdomide is the first product in BMS' CELMoD pipeline. Previously, the drug received Breakthrough Therapy Designation and Priority Review designation from the FDA for the treatment of relapsed or refractory multiple myeloma.
This approval is based on the results of the Phase III EXCALIBER-RRMM ( NCT04975997 ) study . This was a Phase III , multicenter, two-stage, randomized, open-label study designed to evaluate the efficacy and safety of the Iberdomide plus daratumumab and dexamethasone (ZDd) regimen versus the daratumumab, bortezomib, and dexamethasone (DVd) regimen in patients with relapsed or refractory multiple myeloma ( MM) .
In China, the marketing application for Iberdomide was accepted by the CDE in December 2025 and included in the priority review process. The indication is for the treatment of adult patients with multiple myeloma who have received at least one line of prior therapy , in combination with daratumumab and dexamethasone . Approval is expected in Q4 of this year .

On August 14 , the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that GlaxoSmithKline ( GSK ) registered a phase III , randomized, double-blind, placebo-controlled, three-arm study ( ZENITH-2 ) evaluating the safety and tolerability of Efimosfermin alfa in participants with confirmed or suspected F2 or F3 stage metabolic-associated steatohepatitis ( MASH ) .

Efimosfermin alfa , developed by Boston Scientific , is a potential best-in-class long-acting analogue of FGF21 (fibroblast growth factor 21 ), administered once monthly via subcutaneous injection. The product is designed to modulate key metabolic pathways to reduce liver fat, improve liver inflammation, and reverse liver fibrosis in MASH patients. In May of this year , GSK acquired the global development and commercialization rights to the product in a deal worth up to $ 2 billion, with an upfront payment of $ 1.2 billion.
Aikebaifa's Class 1 new anti-influenza drug approved for clinical trials

On August 13 , Aike Baifa announced that its independently developed Class 1 new drug, AK0406 injection, has been approved by the China National Medical Products Administration ( NMPA ) to conduct clinical trials for influenza prevention. According to the press release, this is the company's first long-acting anti-influenza drug — an Fc conjugate ( AFC ).
AK0406 is an innovative long-acting antiviral drug independently developed by AikeBaifa. By precisely conjugating a highly active antiviral small molecule with an antibody Fc fragment, it achieves long-term prevention and potential therapeutic applications before or after influenza exposure, meeting clinical prevention needs during peak influenza seasons. Preclinical studies show that the drug possesses broad-spectrum, highly active, and long-acting antiviral properties, with comprehensive optimization in structural design, antiviral activity, pharmacokinetics, and production.
In terms of international clinical development, AK0406 was approved by the Australian Human Research Ethics Committee ( HREC ) in February this year to conduct a Phase 1 clinical trial. Currently, the enrollment and dosing of all healthy adult subjects in Australia have been successfully completed, and the trial has entered the follow-up phase.
https://mp.weixin.qq.com/s?__biz=MjM5MTcyMjYxMw==&mid=2651881222&idx=2&sn=8b91c350b421da6ccd3a63f1b746cb46&chksm=ts4ricb1ttqgmyaai571q2he8dsg66uenq9g800q4go11l8hrkst3ney20hgh3glkuhnoekxz3ro

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