BeiGene's Global First Launch of Novel Drug, Domestic Class 1 New Drug Recommended for Priority Review, and GSK's Hepatitis B Drug Achieves Positive Phase III Results

Jan 07, 2026 18:14 CST Updated 18:14

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

GSK

Pharmaceutical R&D Manufacturer

BeOne Medicines' Self-Developed New Drug Achieves Global Launch in China

1Month6Day, BeOne Medicines New GenerationBCL2Inhibitor Sotoclax Tablets (Baiyue Da)®) Obtain national drugSupervisionBureau (NMPA) Granted Conditional Approval for Marketing in China, Used for Treating Patients Who Have Previously Received at Least Bruton's Tyrosine Kinase (BTK) inhibitors, as part of a systemic treatment for chronic lymphocytic leukemia (CLL）/Small Lymphocytic Lymphoma (SLL) adult patients, as well as those who have previously received at least two systemic treatments (includingBTKInhibitor) in relapsed or refractory mantle cell lymphoma (MCL) adult patients. Previously, the marketing applications for these two indications had beenNMPACenter for Drug Evaluation (CDE) Included in the priority review process.

ScreenshotSource：National Medical Products Administration

Sotoclax was approved in China for the first time,Becoming the first and only treatment option in ChinaMCLTheBCL2Inhibitors, Expected to Rewrite ChinaBThe clinical treatment landscape in the field of malignant cell tumors.

Made in China 1 New Drug Class Proposed for Priority Review

1Month6Day,CDE The official website shows that Tongyuan Kang has filed for the drug, Axitinib Mesylate Tablets (TY-9591 Tablets) Proposed for Priority Review for Use with Epidermal Growth Factor Receptor (EGFR) Exon19 Missing (19DEL) or exon21（L858R) substitution mutation, accompanied by central nervous system (CNS) Locally advanced or metastatic non-small cell lung cancer (NSCLC) First-line treatment for adult patients.

Screenshot source:CDE Official Website

Edotinib is a deuterated osimertinib derivative,ForNew Generation of CNS-Active Third-Generation EGFR-TKI, which can potently and selectively inhibitEGFR Sensitive Mutation (EGFRm+) and T790M Drug resistance mutation.

GSKNew Hepatitis B DrugⅢPeriodClinicalTestResultsPositive

1Month7Day,GSK Announced that its two pivotalⅢPeriodClinicalTrialB-Well 1（NCT05630807) andB-Well 2（NCT 05630820) Achieved positive results.

Screenshot source: Corporate official website

B-Well 1And B-Well 2Two trials evaluated antisense oligonucleotides. （ASO） Bepirovirsen Treatment of Chronic Hepatitis B（CHB） The efficacy, with a total of29 National1800 Multiple patients participatedTest。

Bepirovirsen（GSK836) is produced byGSKAndIonisCo-developed byASO, capable of inhibitingHBsAg During protein expression, throughTLR8Stimulate immune response and activate the immune system to clear viruses from the circulatory system.

The results showed,B-Well The trial met the primary endpoint,BepirovirsenDemonstrated a statistically significant and clinically meaningful functional cure rate.Bepirovirsen The functional cure rate of combined standard therapy was significantly higher than that of standard therapy alone. The results of all ranked endpoints were statistically significant, including baseline surface antigen (HBsAg）≤1000 IU/mlThe efficacy of this group of patients was more significant. In addition,Bepirovirsen It has an acceptable safety and tolerability profile, consistent with results reported in other studies.