Novartis, Pfizer, and Fosun Henlius Launch New Drugs; Innovent’s CLDN18.2-Targeted ADC IBI343 Granted Breakthrough Therapy Designation

May 09, 2024 21:08 CST Updated 21:08

Henlius

Innovative Biopharmaceutical Company

Innovent

High-end Biologics Developer

Pfizer

Pharmaceutical R&D Developer

ImmunityBio

Developer of Immunotherapy Products

Recently,NovartisIptacopan Capsules (complement factor B inhibitor) approved by NMPA for marketing in China, indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.In the Phase III APPOINT-PNH study, 82.3% of patients treated with iptacopan achieved a ≥2 g/dL increase in hemoglobin levels from baseline without the need for transfusions over 24 weeks.The blood transfusion avoidance rate reached 94.8%.At the end of last year, the new drug was approved for marketing by the FDA. It is the first oral monotherapy for PNH.

Recently，PfizerGene therapy Beqvez approved by FDA for marketing, used to treat adult patients with moderate to severe hemophilia B.In the Phase III BENEGENE-2 study, compared with the FIX prophylactic treatment regimen, a single dose of Beqvez reached the primary endpoint. The mean annualized bleed rate (ABR) for all patients decreased from 4.43 during the pre-treatment period to 1.3 (a 71% reduction, P<0.0001).The annualized infusion rate also decreased by 92% (P<0.0001).It is reported that Beqvez is priced at $3.5 million, the same as the gene therapy Hemgenix for hemophilia B.

Recently,Shanghai Henlius Biotech, Inc.Trastuzumab Biosimilar HANQUYOU (Hercessi) Approved by FDA for Marketing – Indicated for Adjuvant Treatment of HER2-Overexpressing Early Breast Cancer, HER2-Overexpressing Metastatic Breast Cancer, and HER2-Overexpressing Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma. In an international Phase III clinical trial evaluating HANQUYOU versus the originator product for HER2-positive recurrent/metastatic breast cancer, no clinically meaningful significant differences in efficacy and safety were observed between HANQUYOU and the originator trastuzumab.

Recently,Innovent BioCLDN18.2 (claudin18.2)-targeted ADC Drug IBI343 Granted Breakthrough Therapy Designation by CDE for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Positive for Claudin (CLDN) 18.2 After at Least Two Systemic Therapies

Recently,Caliway BiopharmaceuticalsKang Pei Biotechnology Co., Ltd.'s Potential "First-in-Class" Fat-Dissolving Injection CBL-514 Shows Positive Results in Phase II Trial CBL-0201EFP for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP, aka Cellulite).At weeks 2 and 4 after a single injection, the severity score of cellulite in patients' legs decreased by 2.0 ± 0.9 points (P = 0.00049) and 2.6 ± 1.5 points (P = 0.00169), respectively, which was statistically significant.More than 50% of patients showed at least one grade improvement in cellulite severity by week 12.The drug has good safety.

ImmunityBioImmunityBio's IL-15 superagonist Anktiva (nogapendekin alfa inbakicept) achieved positive results in the QUILT 3.055 study for the treatment of patients with relapsed or refractory non-small cell lung cancer (NSCLC). Data showed that Anktiva, in combination with checkpoint inhibitors, significantly extended overall patient survival and restored the effectiveness of checkpoint inhibitors. On April 22, the FDA approved Anktiva for marketing in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) accompanied by carcinoma in situ (CIS).

Editor: chun