Bengaluru, 12th March 2024: Gennova Biopharmaceuticals Ltd., announces the launch of India’s first paediatric pack size of pegaspargase – HAMSYL – Junior, which will now be available in a 1500 IU pack size. This marks a significant milestone in advancing healthcare for Indian children suffering from an orphan disease called Acute Lymphoblastic Leukaemia (ALL), a rare and challenging form of blood cancer primarily affecting children. An orphan disease, in medical terms, is a condition that impacts a small population, making research and development challenging.

Gennova’s commitment to addressing ALL began in 2014 with the introduction of HAMSYL®, an affordable and quality-assured pegaspargase available in 3750 IU pack size. Notably, this product supported access to the needs of patients against a time-consuming and cumbersome process of importing the drug and reduced the cost of the then-available standard of care in terms of drug pricing, in the fight against ALL. Initially approved for the second-line treatment of ALL, HAMSYL® received recognition for its safety and efficacy in real-world patients. This paved the way for its approval as a first-line therapy in 2019, a testament to its demonstrated bioequivalence with the innovator molecule.

Following the HAMSYL® launch, Gennova’s engagement with Key Opinion Leaders in paediatric haematology revealed the need for a different pack size specifically made for children. In response, Genova introduced HAMSYL Junior, involving subsequent new drug applications with CDSCO, New Delhi, to modify the pack size. This will not only suit the smaller body size but also prevent wastage.

Speaking on the launch Dr. Sanjay Singh, CEO, Gennova Biopharma Limited, said: “Gennova is answering the nation’s call, developed pegaspargase, making essential pediatric oncology treatment accessible in India. With the launch of HAMSYL Junior, we triumph over cost barriers, advancing ALL management in line with global standards. This launch marks a pivotal step in our mission to democratize healthcare, ensuring universal access and responsiveness to diverse patient needs.”

With a 1500 IU pack size and a 2.0 mL fill volume, HAMSYL Junior ensures optimal dosing while retaining the same API strength (750 IU/mL), marking a significant stride in providing paediatric patients in India with a specifically designed and accessible treatment.