Sorafenib Tosylate

New Delhi: The India-UK free trade agreement does not dilute New Delhi's right to issue compulsory licences (CLs) and does not introduce any new preconditions for their issuance, an official said on Friday. The agreement was signed on July 24 in London. The official said that the sovereign authority to issue such licences remains entirely with the Government of India, as per existing law. "The agreement's reference to voluntary licensing simply acknowledges global best practices that encourage collaborative solutions. It does not limit or dilute India's well-established right to issue CLs under a section of the Indian Patents Act, 1970," the official said. The remarks are important as economic think tank GTRI has stated that India has accepted language in the intellectual property chapter of the free trade agreement with the UK that subtly curtails its ability to issue compulsory licences, a critical tool for accessing life-saving technologies during emergencies. As per WTO (World Trade Organisation) agreement, a compulsory license can be invoked by a national government allowing someone else to produce a patented product or process without the consent of the patent owner in public interest. Only one CL has been issued so far for the cancer drug Nexavar (2012) and that too under exceptional public health circumstances. "The FTA does not create any new precondition for issuing CLs. The sovereign authority to issue such licenses remains entirely with the Government of India, as per existing law," the official said. India's patent law continues to be recognized globally for balancing public health needs with innovation incentives.. "The free trade pact does not alter this balance and in fact, it reaffirms India's policy autonomy," the government official said adding the pact's provision on disclosure of commercial working of patents is fully consistent with India's existing legal regime and the evolving needs of a modern innovation ecosystem. The official added that the India-UK trade agreement marks a new era of cooperation that supports both affordable access to medicines and high standards of innovation and IP protection.

July 07, 2025 -- Yiviva, a clinical-stage biotechnology company pioneering systems biology-driven therapeutics, announced data from its multi-regional, randomized, double-blind, placebo-controlled Phase 2b study of sorafenib (SORA) with or without YIV-906 in advanced hepatocellular carcinoma (HCC) patients with chronic hepatitis B (HBV+). Results were highlighted in an American Society of Clinical Oncology (ASCO) Annual Meeting (May 30-June 3) abstract and presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Annual Congress 2025 (July 2-July 5) poster. Presented by Dr. Ghassan Abou-Alfa MD, JD, MBA, PhD(hc), medical oncologist at Memorial Sloan Kettering Cancer Center, the study demonstrated improvements in both efficacy and tolerability for patients treated with YIV-906 plus sorafenib versus sorafenib monotherapy. 4.1 months vs. 3.5 months in the intention-to-treat (ITT) analysis Median Overall Survival (mOS): 14.3 months vs 7.5 months Median Time to Tumor Progression (mTTP): 5.59 months vs. 2.33 months Safety and Tolerability: Patients on the YIV-906 arm patients demonstrated greater duration of treatment exposure and continuation and were able to remain on treatment longer More than 250 GI (liver, pancreatic, colorectal, rectal) cancer patients treated in YIV-906 clinical studies have demonstrated proof-of-concept efficacy and safety. YIV-906 is a novel multi-targeted modality developed using a systems biology approach. YIV-906 increases the therapeutic index by acting as an immunomodulator in the tumor microenvironment (TME) and potentiating antitumor activity YIV-906 reprograms and primes the TME (STING, IFNg, IFNb, P-IRF3) and enhances innate immunity by polarizing and increasing M1 like macrophage infiltration and enhancing apoptosis. YIV-906 enhances adaptive immunity by promoting T-cell activation (promoting NFAT, inhibiting SHP1 and SHP2), modulating immune checkpoints (PD1/PDL1), reducing immune tolerance (by suppressing IDO), YIV-906 increases safety and reduces non-hematological toxicities by cytoprotecting the gastrointestinal tract by reducing GI inflammation (NF-kB, COX2, iNOS, IL-6), promoting damaged tissue repair (Wnt pathway), and reducing pain (NK1). “These results demonstrate the obligation to further study YIV-906’s potential to benefit hepatocellular carcinoma patients with hepatitis B who have limited treatment options,” said co-principal investigator Prof. Dr. Ghassan Abou-Alfa. “YIV-906 could broaden the therapeutic index and improve efficacy, safety and tolerability, and merits further clinical exploration with other studies and standards-of-care as a potential new treatment modality and paradigm.” The Phase 2b study (NCT04000737) randomized (2:1) patients (n=62) with treatment-naïve, advanced HBV-positive HCC, Child-Pugh A, BCLC Stage B or C, and ECOG ≤1 to either the YIV-906 + sorafenib arm or the placebo + sorafenib arm. Patients were enrolled in multiple regions (United States, Mainland China, Hong Kong, Taiwan) and the study was conducted from January 2020 to November 2024. The primary endpoint was progression free survival (PFS); secondary endpoints included overall survival (OS), time to progression (TTP), objective response rate (ORR), diseases control rate (DCR), safety and tolerability, and quality of life (QoL). More detailed information is available through 2025 ASCO Abstract # e16244 and ESMO GI Poster #P172. The study was sponsored by Yiviva with grant support from the Henry Bronson Endowment of Yale University, National Foundation for Cancer Research, Asian Fund for Cancer Research, and China 13-5 National Major Scientific and Technological Special Project for Significant New Drug Development. YIV-906 (formerly known as PHY906 or KD018) is a patented, orally administered investigational drug that acts as a pan-adjuvant improving the efficacy and safety for a broad spectrum of cancer drugs and regimens (including chemotherapies, immunotherapies, radiation, and cell therapies). YIV-906 has been studied in nine clinical trials in solid tumors (hepatocellular carcinoma, pancreatic cancer, colorectal cancer, and rectal cancer) with data demonstrating the potential for YIV-906 to improve overall survival and/or progression-free survival and reduce non-hematological toxicities (including diarrhea, nausea, vomiting, fatigue, and hand-foot syndrome). YIV-906 was inspired by an 1800-year-old traditional medicine and is being developed under the United States Food and Drug Administration’s (FDA) botanical drug regulatory pathway. The FDA has granted YIV-906 two Orphan Drug Designations (ODD) for the treatment of hepatocellular carcinoma and pancreatic cancers. Yiviva is committed to developing innovative medicines using a multi-targeted systems biology approach to improve survival and quality of life for patients with cancer and other serious diseases. The platform biotechnology company was launched with Yale University and Henry Bronson Professor of Pharmacology and Medicine Yung-Chi Cheng as co-founders, with teams in the United States and Asia. The content above comes from the network. if any infringement, please contact us to modify.