Manufacturers across Brazil, China, India, Indonesia, Malaysia, Nigeria, Uganda, Ukraine and Vietnam sign sublicence agreements to develop and manufacture generic versions of Roche’s baloxavir marboxil under MPP’s voluntary licence, helping diversify manufacturing capacity and strengthen pandemic preparedness. 

 

New York – The Medicines Patent Pool (MPP) today announced the signing of sublicence agreements with eleven manufacturers across nine countries to develop and manufacture generic versions of baloxavir marboxil, an innovative antiviral treatment for influenza, under MPP’s voluntary licensing agreement with Roche. 

The manufacturers include four manufacturers with a global presence – Laurus Labs and MSN in India, and Desano and Guilin Pharma (Fosun) in China – alongside seven regionally focused manufacturers with Biolab & co.in Brazil, Kimia Farma in Indonesia, Hovid in Malaysia, Fidson in Nigeria, Qcil in Uganda, Lekhim in Ukraine and Stellapharm in Vietnam. 

The announcement of the sublicensees comes as global leaders gather at United Nations General Assembly in New York, to discuss pandemic prevention, preparedness and response. At the side event, “Advancing pandemic preparedness through voluntary licensing, technology transfer, and local production,” organised by MPP with the support of Roche, representatives from governments, industry, international organisations, manufacturers and civil society discussed how to strengthen the systems and partnerships needed before the next health emergency.

This work has been made possible by the strong and sustained support of Unitaid and the Swiss Agency for Development and Cooperation (SDC) and closely aligns with their shared priorities to expand equitable access, strengthen regional manufacturing and bolster pandemic preparedness.

The sublicence agreements mark an important step in translating the voluntary licence signed by MPP and Roche in May 2026 into concrete action to support product development, expand manufacturing capacity, and enable future access. By building a geographically diverse manufacturing base in advance, the licensing approach aims to diversify supply pathways for influenza treatment, support regional production, and strengthen preparedness for future outbreaks and pandemics.

Charles Gore, Executive Director at MPP, said:
“We are now moving into implementation with manufacturers across multiple regions. This is exactly the kind of work that needs to happen before, rather than during, a health emergency. We will now work closely with these manufacturers to support product development and regulatory approval, with the aim of making quality-assured generic baloxavir available as quickly as possible. By combining global manufacturing capacity with regionally focused production, we are helping build a more geographically diverse and resilient supply base for the future.”

Tamara Schudel, Vice President and Head of Global Policy, Roche, said:
“Moving from our initial agreement to actual sublicensing manufacturers today marks an important milestone and demonstrates what is possible when organisations lean in with trust, pragmatism, and a shared goal. It also demonstrates that voluntary partnerships are a critical pillar in pandemic preparedness enabling a rapid and effective response. We are grateful to the Medicines Patent Pool and the manufacturing teams for their partnership; their dedication and technical collaboration will help build the diverse, resilient supply pathways needed for better pandemic preparedness and faster response.”

Aggrey Aluso, Director for Africa, Resilience Action Network International, said:
“Pandemic preparedness is about acting before a crisis hits. Strengthening regional manufacturing and building diverse supply and access pathways now can help ensure that low- and middle-income countries are not left waiting for essential tools when the next health emergency occurs. The progress on baloxavir is a practical example of the kind of preparedness we need.”

Under the voluntary licence, manufacturers can develop, manufacture and supply generic versions of baloxavir marboxil in 129 countries, covering nearly all low- and middle-income countries, subject to regulatory authorisation. The agreement also provides manufacturers with access to a technical data package, reference products for bioequivalence studies and other support intended to facilitate regulatory approval and accelerate availability. 

Following an open Expression of Interest process launched after the signing of the licence in May 2026, MPP assessed applicants against established criteria, including their technical and regulatory capacities and commitment to develop and manufacture quality-assured baloxavir products. 

The selection of both global and regionally focused manufacturers combines established manufacturing capabilities with a more geographically diverse production base. This approach can help strengthen supply resilience while building production capacity closer to the regions and populations that products are intended to serve. 

More about the baloxavir marboxil licence: MPP baloxavir licence webpage

 

Manufacturer quotes

Satyanarayana Chava, Founder & CEO, Laurus Labs: “We are pleased to partner with Roche and Medicines Patent Pool to expand access to Baloxavir, an important treatment for Influenza. This licence reflects our shared commitment to making high-quality, affordable medicines accessible globally. At Laurus Labs, we are proud to contribute our capabilities towards this public health initiative and advance our purpose of ‘Chemistry for Better Living.”

An Xiaoxia, President, Desano Group: “Desano Group has long been dedicated to the R&D and manufacturing of medicines for public health crises, with a particular focus on antiviral. We are honored to obtain the licence for baloxavir. We will leverage our global manufacturing, regulatory and supply‑chain capabilities to accelerate its development, registration and supply to benefit patients in LMICs, and make this clinically valuable medicine more accessible and affordable to those in need.”

Bharat Reddy, Executive Director, MSN Laboratories: “We believe access to quality medicines should not be limited by geography. As influenza continues to be a significant public health concern, expanding access to Baloxavir Marboxil is an important step towards addressing this need. Through our partnership with Roche and the Medicines Patent Pool, we aim to make this targeted antiviral treatment more accessible across India and emerging markets, contributing to better health outcomes for patients worldwide.”

Ong Van Dung, General Director, Stellapharm:“The lessons we have learned from the pandemic over the past several years have taught us something deeply important: when a health crisis strikes, access to essential medicines can mean the difference between hope and despair, between protecting a life and losing one. For Stellapharm, being part of this initiative is therefore about much more than manufacturing medicines. It is ultimately about people. Every life matter, and every person, regardless of where they live, deserves the chance to live a healthier life. We hope to contribute not only to pandemic preparedness today, but also to a more resilient and equitable future for all communities around the world.“
Valeriy Pechaev, Chairman of Supervisory Board, Lekhim JSC : “Only one pill to beat the flu.”
Biola Adebayo, Managing Director and CEO, Fidson Healthcare Plc. : “Biolab & Co. is honoured to have been selected by the Medicines Patent Pool for baloxavir marboxil. Roche’s decision to license it through the MPP puts the technology in the hands of manufacturers in Brazil and in other countries. Influenza returns every year, and every so often it returns as something much harder to handle.  Biolab & Co. is one of the most prescribed pharmaceutical companies in Brazil, with a broad portfolio across therapeutic areas built over 29 years. Being part of this means putting our manufacturing base, our knowledge and our relationship with the medical community to work on strengthening the country’s readiness for future health emergencies. We are proud of the responsibility that comes with it.”

David Ho, Managing Director, Hovid Berhad:  “Being selected as one of the sublicensees under this important initiative, and the first from Malaysia, is both a privilege and a significant milestone for Hovid. This collaboration reflects the confidence placed in our quality standards, manufacturing capabilities, and regulatory expertise. It is also closely aligned with our commitment to providing quality and affordable medicines to a wider population. We are proud to support global efforts to expand access to essential medicines and strengthen pandemic preparedness in the regions we serve.” 

Ajay Kumar Pal, Chief Executive Officer, Qcil, said: “This sublicence gives Qcil an opportunity to apply its manufacturing and regulatory experience to an important influenza treatment for low- and middle-income countries. Working with MPP, and with support from Roche under the voluntary licence, we will now begin the development work required for a quality-assured generic version. This partnership can widen access to treatment while strengthening manufacturing capacity in Africa and preparedness for future influenza outbreaks.”

The press release is also available in French.

See press release from May 2026 – MPP and Roche sign licence agreement to expand access to influenza treatment in low- and middle-income countries

 

Notes to Editors – Manufacturers selected to support development and supply  

Biolab & Co.

Biolab & Co. is a Brazilian pharmaceutical group focused on science, innovation and health, with operations spanning human and animal health and nutrition. The group comprises six brands and a portfolio of more than 900 products, supported by four production facilities and two Research, Development and Innovation (RD&I) centres in Brazil. Biolab & Co. also operates in Canada, where it markets products and maintains an RD&I centre. With more than 50 international partnerships and over 400 patent applications, the group is committed to developing innovative therapeutic solutions that positively impact society.

Desano

Shanghai Desano is a vertical integrated international pharmaceutical group company specialized in R&D, manufacturing and marketing of FPP, APIs and intermediates as well as CDMO services to global customers. Desano has established large-scale and multi-purpose professional production capabilities of FPPs, APIs and intermediates with global-standard and industry-leading quality and EHS system, providing a one-stop CDMO service from process development and optimization, clinical sample preparation to commercial production for global customers.

Fidson Healthcare Plc 

Fidson Healthcare Plc is Nigeria’s leading pharmaceutical company, committed to improving access to quality healthcare products across Africa. With a world-class manufacturing facility and a robust quality management system, the company maintains a diversified portfolio of registered Prescription-Only Medicines (POMs) and Over-the-Counter (OTC) products spanning multiple therapeutic classes. Fidson is dedicated to adding value to life through innovation, operational excellence, and sustainable growth. Beyond that, the company offers formulation & development and contract manufacturing services, playing a critical role in advancing healthcare outcomes and strengthening local pharmaceutical manufacturing capacity across Africa.

Guilin Pharmaceutical Co. 

Established in 1958, Guilin Pharmaceutical Co., Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., is a China-based pharmaceutical company specialising in the R&D, production and supply of chemical medicines and APIs. Its products are exported to more than 40 countries, particularly across Africa and Southeast Asia. 

Guilin Pharma is a leading manufacturer of antimalarial medicines. Its Artesun® (artesunate for injection) is recommended by WHO as a first-line treatment for severe malaria. By the end of 2025, the company had supplied more than 440 million doses worldwide, treating over 88 million patients. Guilin Pharma is also a major supplier of antimalarial medicines to the Global Fund, UNICEF, WHO and African governments. 

Hovid

Hovid Berhad is a global pharmaceutical manufacturer with over 80 years of healthcare heritage. Headquartered in Ipoh, Malaysia, Hovid develops, manufactures, and markets a broad portfolio of pharmaceutical, consumer healthcare, and dietary supplement products, serving customers in more than 50 countries worldwide. 

Kimia Farma

Kimia Farma is the oldest pharmaceutical industry company in Indonesia, established by the Dutch East Indies government in 1817. Today, as a key subsidiary of the state-owned healthcare holding company PT Bio Farma (Persero), Kimia Farma operates a fully integrated, end-to-end healthcare ecosystem. Its business spans upstream pharmaceutical manufacturing and chemical synthesis to downstream distribution and logistics. The company powers a vast nationwide retail healthcare network featuring over 1,200 pharmacies, health clinics, and diagnostic laboratories. 

Laurus Labs 

Laurus Labs is an India-based, research-driven pharmaceutical and biotechnology company with expertise in the development and manufacture of active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). Founded in 2005, the company operates more than 15 facilities and has experience supplying quality-assured medicines globally, including in areas such as HIV, oncology and cardiovascular diseases. Laurus also provides contract development and manufacturing services and is expanding its capabilities across biotechnology and other advanced therapies.

LEKHIM 

LEKHIM Group of Pharmaceutical Companies is a modern pharmaceutical company, which takes leading positions amongst Ukrainian pharmaceutical enterprises in research, manufacturing and sales of high quality and accessible medicines of all therapeutic groups, manufactured according to GMP guidelines. LEKHIM was founded in 1992. LEKHIM Group supplies its products to 25 countries, including CIS countries, EU, Asia, and Africa. The LEKHIM Group’s portfolio includes more than 150 medicinal products (tablets, capsules, solutions for injections in ampoules and pre-filled syringes, powders for injections in vials, powders in sachets, suppositories, oral solutions), as well as veterinary products.

MSN

MSN Laboratories is a research-driven, fully integrated pharmaceutical company founded in 2003, with a mission to make high-quality medicines accessible and affordable worldwide. The group operates 27 manufacturing facilities across India, the USA, and Indonesia, supported by a unified R&D ecosystem spanning API and finished dosage development. With over 1,000 patents filed globally, 250+ ANDA submissions, and a leading position in US DMF filings, MSN has established a strong global presence. With a portfolio of 600+ APIs and 400+ finished dosage forms across 35+ therapeutic areas, MSN serves over 100 million patients across more than 100 countries. Driven by innovation, integrated capabilities, and a commitment to access, MSN continues to advance its vision of making quality medicines accessible to people around the world.

Qcil

Quality Chemical Industries Limited is a publicly listed Ugandan pharmaceutical manufacturing company established in 2005, dedicated to producing high-quality, affordable medicines. As a leading African producer of WHO-prequalified malaria and HIV treatments, Qcil’s vision is to be a centre of excellence in the manufacturing of quality, affordable, accessible medicines for Africa.

Stellapharm

Stellapharm is a Vietnam-based pharmaceutical manufacturer focused on the development and manufacturing of generic medicines. With over 25 years of experience in the pharmaceutical industry, Stellapharm has served millions of people around the world by providing quality-assured and affordable medicines. From its humble beginnings in Vietnam, Stellapharm has grown into a strong regional manufacturing hub that meets internationally recognized standards and serves global markets. Through its growing international footprint, Stellapharm is committed to contributing to a more sustainable pharmaceutical supply chain and supporting equitable access to medicines. 

 

Media contact: 

Gelise McCullough

+41 79 685 64 36 (Geneva)

gmccullough@medicinespatentpool.org