Industry

South Korea ​Launches Formal Review Process for COVID-19 Vaccine ‍Adverse reaction‌ Claims

Seoul, south Korea – A new system for‌ evaluating and compensating individuals⁣ experiencing ⁣adverse ‍reactions following COVID-19 vaccination took ‌effect today, October 23rd, under the “Special Act on Compensation for Damage from‌ COVID-19 Vaccination, etc.” The Korea Disease control and Prevention Agency (KDCA) will now formally review applications, aiming for consistent ⁢and fair support for citizens who experienced health issues after vaccination.

the KDCA⁢ has assembled⁣ committees comprised of experts in medicine, pharmacy, immunology, microbiology, public management, ​sociology, and law to‍ assess‌ claims from multiple perspectives. Deliberations will focus on the temporal relationship between vaccination and adverse events, estimates of causal links, and detailed support project standards.

New applicants-those who haven’t previously ⁢sought compensation-will have their cases initially reviewed by the Damage Compensation ⁤Committee.Individuals disagreeing with the committee’s decision ⁢can file a single⁤ objection ⁣with the KDCA Director, ‍via their local public health center, within 90 days of notification. These⁤ objections will be reviewed by a separate reconsideration ​committee.

Those who previously applied for compensation have until October 23rd of next year-one year after the law’s enactment-to request a reconsideration,⁤ which will be directly handled by the reconsideration committee, bypassing the initial⁤ Damage Compensation committee review. Decisions made by the reconsideration committee are final; no further appeals are permitted.

Individuals who received a⁢ compensation decision under the ‘infectious ‍Disease Prevention and Control Act’ and subsequently pursued a final court ruling are ineligible for retrial under the new act.

Prior to the act’s implementation, the KDCA provided ‍online training to staff at public health centers, which serve as the primary point of contact for applicants.

“We will do our best⁣ to ensure that compensation and support for citizens⁢ who participated in vaccination in the process of overcoming the COVID-19⁤ crisis are consistent with the purpose of the enactment of the ‘COVID-19 Damage Compensation Special Act’,” stated Lim Seung-gwan, Director of the KDCA.

HLB’s Rivoceranib & Camrelizumab Combination Therapy Demonstrates Significant Benefit in Liver cancer Treatment, Published in ‘Teh⁢ Lancet’

HLB⁤ Group announced​ that recent clinical trial results, published in the prestigious medical ⁢journal ​ The Lancet, demonstrate a‌ more than doubled survival⁢ period without ⁢cancer recurrence or progression for ‍patients with resectable hepatocellular carcinoma (HCC) when ⁣treated with a combination of riboceranib and ‍camrelizumab both⁤ before and after surgery, compared⁤ to surgery ‌alone.

This marks the first exhibition of the effectiveness of ​this combination therapy in patients‍ with early and mid-stage HCC suitable‌ for surgical intervention. HLB emphasizes the potential for rivoceranib and camrelizumab to be⁤ applied across the entire liver cancer treatment cycle,‍ extending beyond its current use in advanced stages.

The Phase 2/3, multicenter,‌ randomized clinical ‌trial ‍was spearheaded by⁢ HLB’s Chinese partner, Hengseo Pharmaceutical,‍ and involved 294 patients with resectable‌ HCC at ‍high or ⁤medium risk of recurrence, across 16 hospitals in China. Participants were randomly assigned to either a surgery-only group or a perioperative‍ treatment⁤ group⁤ receiving rivoceranib and camrelizumab ⁤before and after⁢ surgery.

Results showed a median ‌event-free ​survival⁤ (EFS) of 42.1 months in the perioperative treatment group – more than double the 19.4 months observed in the surgery-only group. Furthermore, the pathological‍ response rate (MPR) – indicating the proportion of patients with less than half of viable cancer cells remaining⁣ in surgically ⁤removed ⁢tissue – was 35% in the treatment group, over ​four times higher than the 8% in the ⁢surgery-only group.

Grade 3 or​ higher ‌treatment-related adverse events⁤ occurred in 38% of the perioperative treatment group, a rate the company notes is consistent with ​combination targeted therapy ​and immunotherapy, and deemed manageable with a ⁣safety profile comparable to⁢ existing studies.

HLB​ and Hengseo ‌Pharmaceutical have, through this study, validated a sequential immunotherapy and targeted therapy approach before and after surgery in a ⁤global Phase 3 clinical⁢ trial.HLB states‌ that this is the first instance of systemic therapy establishing itself as a standard treatment option for⁤ HCC prior to or following surgical resection.

The study was published in the ‘online⁢ First’ section of The Lancet website, signifying its importance‍ and the need for rapid dissemination of the findings.

“This clinical trial ‌presents a new treatment option in the field ⁣of ⁣liver cancer ⁣that ‍goes beyond the​ existing ⁢treatment of surgery alone,” stated Yonghae Han, Chief Technology Officer (CTO) of HLB Group. “If the scope of use of rivoceranib + camrelizumab combination therapy is expanded to pre- and post-surgery, the market scope can be greatly expanded, ‌so future ‌new drug approvals will be⁣ expanded and global clinical trials​ will be conducted. It will be an vital basis for establishing strategy.”