CSTONE PHARMA-B

CStone Pharmaceuticals announced the submission of a clinical trial application in Australia for CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody targeting various solid tumors. CS2009's design enhances anti-tumor activity and reduces systemic toxicity, with potential to replace current anti-PD-(L)1 therapies. The first-in-human study will commence in Australia in early 2025, followed by expansion to China and the United States.

CStone Pharmaceuticals to present promising CS5001 data at ASH Annual Meeting, showing 43.5% objective response rate in advanced B-cell lymphoma.

MHRA approves CStone Pharmaceuticals’ sugemalimab, branded as Eqjubi, for first-line treatment of metastatic non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy. The approval is based on the GEMSTONE-302 study results showing significant survival benefits. Sugemalimab blocks PD-1 protein to enhance immune response against cancer cells. This follows the European Commission’s approval of the drug as Cejemly for the same indication.

MHRA approves sugemalimab (Eqjubi) as first-line treatment for metastatic NSCLC in UK, following EU approval. Sugemalimab, in combination with platinum-based chemotherapy, showed 9.0 months PFS vs 4.9 months in placebo group, per GEMSTONE-302 trial. CStone plans global expansion and additional regulatory applications for sugemalimab.

UK MHRA approves sugemalimab for first-line treatment of metastatic NSCLC, marking its second international authorization after the EU. The approval is based on the Phase 3 GEMSTONE-302 trial, which showed significant PFS and OS benefits. CStone plans further regulatory applications and partnerships in Western Europe, Latin America, Middle East, and Southeast Asia.

The ADC market, driven by technological advancements and personalized medicine, is expected to reach ~USD 26 billion by 2030 with a CAGR of ~14%. North America leads due to high cancer incidence and strong biopharmaceutical sector. Key players include F. Hoffmann-La Roche Ltd, DAIICHI SANKYO COMPANY, LIMITED, and Pfizer Inc. The market is dynamic, influenced by regulatory frameworks and innovation in linker technologies and payloads.

DelveInsight's 'Hepatocellular Carcinoma Pipeline Insight 2024' report details 90+ companies developing 95+ pipeline drugs for HCC, with therapies in various stages of clinical development, including collaborations and regulatory approvals.