In a historic step for the Egyptian pharmaceutical industry that reinforces its global leadership, the Thai Food and Drug Administration (Thai FDA) has officially approved Ravidasvir as a safe and effective treatment against the hepatitis C virus (HCV).
This approval is part of a robust clinical and regulatory ecosystem spearheaded by the Thai FDA, organically linked with the Government Pharmaceutical Organization (GPO), scientific expertise centres, and clinical trial sites in prestigious Thai hospitals and institutions, including King Chulalongkorn Memorial Hospital, Bamrasnaradura Infectious Diseases Institute, Nakornping Hospital, and Maharaj Nakorn Chiang Mai Hospital.
The drug has demonstrated clinical efficacy in Thailand and Malaysia when used as a combination therapy, taken orally once daily for 12 weeks alongside the antiviral sofosbuvir, resulting in the patient’s complete cure.
The new treatment was engineered for accessibility. Clinical trials have demonstrated high levels of safety and efficacy, even in hard-to-treat cases and among patients co-infected with both HCV and HIV. Furthermore, the jointly developed drug has demonstrated a strong capacity to reduce and prevent the development of treatment resistance.
Notably, Thailand is the third country globally to register Ravidasvir, following Malaysia and Egypt, which registered it in 2021. This development is the culmination of a continuous journey of sustainable supply and access, bridging registration, regulation, and manufacturing. The drug’s registration also actualizes the strategic Memorandum of Understanding (MoU) signed in June 2025 between Pharco Pharmaceuticals, the Drugs for Neglected Diseases initiative (DNDi), and Thailand’s Government Pharmaceutical Organization (GPO) to support the drug’s official launch in the Thai market.
Commenting on this breakthrough, Dr. Sherine Helmy, Chairman of Pharco Pharmaceuticals, stated: “The approval of Ravidasvir for the treatment of viral hepatitis C represents a strategic addition to the global efforts aimed at eliminating HCV. I look forward to seeing this close collaboration with our partners contribute to providing an effective treatment for a broader segment of patients, bringing us closer to an HCV-free world, and ensuring that all patients are empowered to access this safe and effective drug.”
Dr. Graciela Diap, HCV Project Leader at DNDi, said: “This approval is a crucial step in expanding treatment options in Thailand. It opens the door to better access to life-saving treatments for tens of thousands of people, ensures greater supply security, and effectively prevents treatment resistance — bringing us meaningfully closer to our shared goal of hepatitis C elimination.”
This project is a true and successful embodiment of the South-South strategic collaboration model, which emerged to overcome the reality prior to 2016. At that time, first-generation direct-acting antivirals were exorbitantly priced, placing a heavy financial burden on the national health budgets of low- and middle-income countries. With the dawn of the “Ravidasvir era” research institutions and industrial partners joined forces to provide a safe, affordable treatment alternative that meets public health needs. The research, development, and pharmaceutical manufacturing of this drug were driven by Pharco Pharmaceuticals, the Malaysian Ministry of Health, the Thai Ministry of Public Health, and DNDi.
Hepatitis C constitutes a massive global and local challenge, as well as a growing health burden in most countries. Data indicate that there are approximately 350,000 people living with chronic HCV infection in Thailand, while World Health Organization (WHO) statistics show that 50 million people are infected globally. The world witnesses about one million new infections and more than 240,000 deaths annually, mostly due to complications from cirrhosis and liver cancer.
To combat this threat — which can remain asymptomatic for many years — Thailand launched its ambitious national strategy: Hepatitis C Elimination in Thailand by 2030. This strategy rests firmly on two core pillars: providing affordable, accessible cures and implementing mass proactive screening campaigns. These efforts have already resulted in screening 1.83 million people, with a national commitment to reach 42 million by 2030.
The development of Ravidasvir was supported and funded by a broad network of international partners, including Médecins Sans Frontières (MSF) International (including MSF-TIC), UK International Development, FIND funded by Unitaid, the Swiss Agency for Development and Cooperation (SDC), Thailand’s NSTDA, the Starr International Foundation, Foundation ARPE, and Pharmaniaga Berhad of Malaysia, alongside other institutions and individuals whose shared vision drove this medical innovation forward.
This achievement integrates the efforts of institutions with a rich and distinguished legacy. Pharco Pharmaceuticals, founded in 1984 in Alexandria, Egypt, is a leading developer and producer of over 450 pharmaceutical products exported to more than 50 countries, specializing in antibiotics, soft gelatine capsules, and penicillin, and committed to improving global access to safe, effective, and affordable healthcare. The Government Pharmaceutical Organization (GPO), a Thai state enterprise under the Ministry of Public Health, complements this effort by manufacturing and distributing essential medicines, including antiretrovirals, and exporting them to countries such as Cambodia, Laos, Myanmar, Malaysia, Singapore, Bangladesh, Nigeria, and Hong Kong.
Founded in 2003, DNDi anchors this alliance as a not-for-profit medical research organization focused on gender equity, climate-impacted diseases, and paediatric health. It has successfully delivered 14 new treatments — saving millions of lives — across diseases including sleeping sickness, leishmaniasis, dengue fever, and hepatitis C. In a promising step toward further international expansion, DNDi and its partners plan to expand Ravidasvir’s registration into Latin American markets soon.
The approval of Ravidasvir is more than just a medical breakthrough — it is a renewed message of hope for millions of patients worldwide. Thanks to this unique strategic alliance between the countries of the Global South, we are taking steady steps today toward a future where hepatitis C is no longer a public health threat, reaffirming our unwavering commitment to providing equitable, innovative, and affordable healthcare for all, ensuring a future where no one is left behind.