BeiGene, Hansoh Pharma, and Contini Pharma Report Significant Advances with New Drug Approvals and Submissions

May 14, 2026 18:51 CST Updated 18:51

BeOne Medicines

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

BeOne Medicines® Receives Accelerated Approval from U.S. FDA

5Month14Day,BeOne Medicines announced, BeiJoy®(Sotoclax,BEQALZI™) Obtain U.S.FDAAccelerated approval for the treatment of patients who have previously received at least two lines of systemic therapy[Containing Bruton's Tyrosine Kinase（BTK）Inhibitor]Recurrent or Refractory (R/R) Mantle Cell Lymphoma (MCL) Adult patients.

Public information shows,Sotorasib is a product inBCL-2（BCellLymphoma2）A New Generation with Cornerstone Potential in Target Research and DevelopmentBCL-2Inhibitors, whose R&D design aims to enhanceBCL-2The goal is to optimize inhibitors in terms of molecular potency and selectivity, and their pharmacological properties are also promising.PromotionEffectiveness, Tolerance, and Convenience of Medication.

It is reported that,This accelerated approval of Sotoclax is based onBGB-11417-201（NCT05471843）Ⅰ/ⅡThe efficacy and safety data from the study support the findings, which have been presented in the67The American Society of Hematology Annual Meeting (ASH) were published. The independently reviewed data on drug efficacy are as follows:

Overall Response Rate (ORR）：52%（95% CI: 42-62）

Complete Remission (CR) Rate:16%（95% CI: 9.1-24.0）

Median Time to Resolution (TTR）：1.9Months

Median Duration of Response (DOR）：15.8Months (95% CI：7.4Months toNE), the median follow-up time was11.9Months (data not yet fully mature)

Safety: Sotoclax monotherapy was generally well tolerated.

Whether this indication remains approved depends on the ongoingCELESTIAL-RRMCLConfirmatory Test (NCT06742996) Can confirm its clinical benefit.FDASotoclax has been granted Breakthrough Therapy Designation for this indication.BTD), as well as Fast Track Designation and Orphan Drug Designation.

Hansoh Pharma's Fourth-Generation EGFR TKI Proposed for Breakthrough Therapy Designation

5Month13On [date], the Center for Drug Evaluation of the National Medical Products Administration (CDE) Official website announcement,Hansoh Pharma's self-developed1New Drug ClassHS-10504The drug is proposed to be included in the breakthrough therapy program, with the proposed indication being epidermal growth factor receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Treatment failure accompanied byEGFR C797SLocally advanced or metastatic non-small cell lung cancer with mutations (NSCLC）。

It is reported that,HS-10504 It is a new, highly efficient, and highly selective fourth-generation product independently developed by Hansoh Pharma.EGFR TKI, TargetingEGFR Both sensitive mutations and drug-resistant mutations can play a role. The compound specifically overcomes those caused by the third generation.EGFR-TKI Drug Resistance Mutation (C797S) serine residue at the site, and the first/Second-generation resistance mutation (T790M) The spatial hindrance effect induced by.

Currently,EGFR-TKI Has been widely used forEGFR Mutation Advanced StageNSCLC First-line treatment. However, in patients receivingEGFR-TKI After treatment, most patients will develop acquired resistance, leading to disease progression. The mechanisms of resistance are complex, especially with the third generationEGFR-TKI More significant after treatment.

Among them,C797SMutation is caused byEGFROne of the main mechanisms by which mutations cause acquired resistance. After first-line treatment with osimertinib,EGFR C797SMutations account for approximately7%; After using osimertinib as a second-line treatment, this proportion is approximately14%. In addition, in other third-generationEGFR TKI(including Aumetinib and Fometinib) have also been reported. Fourth generationEGFR TKIIs expected to provide a new treatment option for such patients.

Another "World's First" Class 1 New Drug Submitted for Marketing Approval in China

5Month13Day, according toCDEThe latest update on the official website shows that Beijing Kangtini Pharmaceutical Co., Ltd. has applied for1New Drug Hydroxyni Capsule Marketing Application Accepted.2026Year3Month5Recently, this drug has been included in the priority review category, with the proposed indication: for the treatment of chronic hepatitis B-related liver fibrosis and early-stage liver cirrhosis.

Public information shows that hydroxynitone (R&D codeF351) is a self-developed anti-fibrotic candidate drug by Beijing Contec Pharmaceuticals, and it is a structural analog of the marketed anti-pulmonary fibrosis drug pirfenidone. This drug was previously2021Year3Monthly CoverCDEInclude“Breakthrough Therapy Drug”。

Hydronitone, as the world's first chemical anti-liver fibrosis new drug to enter the registration phase, marks a milestone in its development progress.Currently, there are no globally approved drugs specifically effective for hepatic fibrosis, and hydroxynitone is expected to benefit patients with chronic hepatitis B (CHB) The first treatment option that directly reverses fibrosis for patients with related liver fibrosis. By reversing fibrosis, it may reduce the risk of cirrhosis, liver failure, and liver cancer, improving patients' quality of life. InMASHExploration in liver fibrosis caused by other etiologies is expected to further broaden its range of indications.

Proofread by: Fan Xiaoyan

Layout: Yu Yuanze

Review: Ma Fei