Key Takeaway:
- Lupin Limited receives approval from China’s drug regulator for oseltamivir oral suspension, marking its first entry into the Chinese market.
- The drug targets influenza A and B treatment and prevention, with a paediatric-focused formulation to improve access for young patients.
- The approval, in partnership with Yabao Pharmaceuticals, supports Lupin’s global expansion and strengthens its presence in a major pharmaceutical market.
Lupin Limited said Monday that China’s drug regulator has approved its oseltamivir phosphate oral suspension with Yabao Pharmaceuticals, marking a major Lupin China approval milestone and the first product launch in the Chinese market, and expanding paediatric influenza treatment access.
First China Approval Marks Lupin Milestone
Lupin said China’s National Medical Products Administration approved the shortened marketing authorization application for oseltamivir phosphate oral suspension, 6 mg/ml, submitted with Yabao Pharmaceuticals. The company said the Lupin China approval marks its first launch in China and a key step in its global expansion.
The drug is used to treat influenza A and B in patients aged 2 weeks and older and to prevent influenza in people aged 1 year and older. Lupin said the oral suspension is aimed at improving access to affordable treatment, especially for children.
Fabrice Egros, Lupin’s head of corporate development, said the approval opens a major market for the company and supports its push into paediatric care.
“We are very pleased to have received approval for oseltamivir oral suspension in China,” Egros said. “It is a strategic step for our entry into one of the world’s largest pharmaceutical markets.”
Yabao Partnership Expands Paediatric Reach
Yabao Pharmaceuticals, which Lupin described as a leader in China’s paediatric drug market, is partnering on the launch. The companies said the collaboration is designed to strengthen access to quality, affordable medicines for children in China.
Wei Ren, president of Yabao, said the Lupin China approval highlights the partners’ shared goals and long-term plans.
“We are pleased to announce the official approval of oseltamivir oral suspension in China,” Ren said. “It marks an important milestone in our partnership with Lupin.”
Ren said Yabao plans to continue expanding its research and development portfolio for medicines for children and adults with chronic diseases. Lupin said the approval reinforces its commitment to delivering medicines at a lower cost without sacrificing quality.
Oseltamivir Targets Influenza Treatment And Prevention
Oseltamivir phosphate is an antiviral medicine commonly used to treat and prevent flu. Lupin said the oral suspension format is especially important for paediatric patients because it provides a practical option for younger children who may not take tablets easily.
The company said the Lupin China approval broadens its global footprint and strengthens its position in a major pharmaceutical market. It added that the product will support access to influenza treatment and prevention in a country with a large paediatric population and significant demand for affordable medicines.
Lupin and Yabao did not provide sales projections or a launch date in the announcement. The companies said the Lupin China approval is a milestone in a partnership they expect to build on in the Chinese market.
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