NXP200 / Haisco, Nuvectis Pharma - LARVOL DELTA

Nuvectis Announces NXP200 Granted Breakthrough Therapy Designation in China for BRAF V600-Mutant, Recurrent or Progressive, High-Grade Glioma (The Manila Times) - "'In parallel, we continue to advance NXP200 toward a U.S. IND submission in the fourth quarter of 2026.'"

Breakthrough therapy • IND • High Grade Glioma

Clinical Activity and Safety of Novel Brain-Penetrant BRAF Inhibitor HSK42360 in BRAF V600-Mutated Gliomas: Initial Results from a Phase 1 Study (ESMO 2026) - No abstract available

Clinical • P1 data • Brain Cancer • Glioma • Oncology • Solid Tumor

HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Nuvectis Expands Pipeline with Haisco Licensing Agreement for Two Clinical-Stage Drug Candidates (NVCT) (Yahoo Finance) - "Under the agreement, Nuvectis will acquire ex-China rights to NXP100, a Complement Factor B inhibitor, and NXP200, a next-generation BRAF inhibitor...The company said the addition of the two candidates advances its transition into a late-stage clinical development business while diversifying its therapeutic focus beyond oncology alone...As part of the transaction, Haisco will receive upfront and near-term payments of up to $40 million....The agreement also includes the potential for up to $1.421 billion in development, regulatory and commercial milestone payments, in addition to tiered royalties on future product sales."

Licensing / partnership • Colorectal Cancer • IgA Nephropathy • Lupus Nephritis • Melanoma • Non Small Cell Lung Cancer • Paroxysmal Nocturnal Hemoglobinuria

Novel brain-penetrant BRAF paradox breaker HSK42360 demonstrates promising antitumor activity in patients with BRAF-mutant glioma (AACR 2026) - P1 | "In a Vemurafenib plus Cetuximab-resistant colorectal cancer model, HSK42360 monotherapy outperformed the combination therapy and showed synergistic effects with the MEK inhibitor Trametinib. HSK42360 demonstrated significant efficacy in preclinical glioma PDX and resistant models, along with promising clinical antitumor activity in BRAF V600-mutant glioma patients, both treatment-naïve and previously treated with BRAF inhibitors. It was well-tolerated with a manageable safety profile, offering a new therapeutic paradigm for BRAF-mutant glioma."

Clinical • Late-breaking abstract • Brain Cancer • Colorectal Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • BRAF

Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation (clinicaltrials.gov) - P1 | N=159 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1 trial • Oncology • Solid Tumor • BRAF

HSK42360: A potent, brain permeable, BRAF paradox breaker for the treatment of BRAF-driven cancers (AACR 2024) - "Further characterization showed that HSK42360 did not induce homodimer or heterodimer of CRAF with CRAF or BRAF and thereby blocked reactivation of the MAPK pathway in HCT116 cells, whereas Dabrafenib significantly induced RAF dimerization and MAPK reactivation. Surprisingly, HSK42360 demonstrated promising antitumor effects in the first gen-resistant NRASmA375(NRASQ61K, BRAFV600E) CDX model, supporting its use as a follow-on therapy for current BRAFi resistance. Collectively, these preclinical studies validated that HSK42360 is a novel brain-permeable BRAF paradox breaker that exhibits outstanding antitumor activity in brain metastasis and RAF dimer-driven resistance."

Brain Cancer • Breast Cancer • CNS Tumor • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Glioma • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Thyroid Gland Carcinoma • BRAF

Phase 1 study of brain-penetrant BRAF inhibitor HSK42360 in adult patients with BRAF V600-mutated advanced solid tumors or recurrent primary central nervous system tumors (SNO 2025) - P1 | "An approved BRAF V600E inhibitor combined with a MEK inhibitor, had ORRs of 33% and 50% in BRAF V600E-mutated high-grade glioma (HGG) and low-grade glioma (LGG), respectively (dabrafenib US Prescribing Information, 2025). HSK42360 demonstrated a favorable safety profile and a high ORR in patients with BRAF V600-mutant PCNST. This trial is ongoing."

Clinical • Metastases • P1 data • Brain Cancer • CNS Tumor • Glioma • High Grade Glioma • Oncology • Solid Tumor

Phase 1 study of brain-penetrant BRAF inhibitor HSK42360 in adult patients with BRAF V600-mutated advanced solid tumors or recurrent primary central nervous system tumors (WFNOS 2025) - P1 | "An approved BRAF V600E inhibitor combined with a MEK inhibitor, had ORRs of 33% and 50% in BRAF V600E-mutated high-grade glioma (HGG) and low-grade glioma (LGG), respectively (dabrafenib US Prescribing Information, 2025). HSK42360 demonstrated a favorable safety profile and a high ORR in patients with BRAF V600-mutant PCNST. This trial is ongoing."

Clinical • Metastases • P1 data • Brain Cancer • Oncology • Solid Tumor

Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation (clinicaltrials.gov) - P1 | N=159 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1 trial • Brain Cancer • Pediatrics • Solid Tumor • BRAF

A phase 1, multicenter, open-label study of HSK42360, a brain-penetrant BRAF inhibitor, in patients with BRAF V600-mutated solid tumors. (ASCO 2025) - P1 | "HSK42360 monotherapy was well tolerated without unexpected safety issues. Preliminary efficacy data demonstrate favorable activity of HSK42360 in pts with BRAF V600-mutated solid tumors, including primary CNS tumors. Clinical trial information: NCT06536400."

Clinical • P1 data • Brain Cancer • CNS Tumor • Ganglioglioma • Glioma • Oncology • Solid Tumor

Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation (clinicaltrials.gov) - P1 | N=316 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor • BRAF