| |DECEMBER 20248INDIA POISED TO EXPORT OVER 50 PERCENT OF PHARMA PRODUCTIONTYRA BIOSCIENCES RECEIVES FDA NOD FOR TYRA-300 PHASE 2 TRIALIn the previous year, approximately half of India's pharmaceutical and biological products were sent overseas, signaling a significant change towards a pharmaceutical industry focused on exports as India nears exporting over 50 percent of its output.Prime Minister Narendra Modi highlighted the government's healthcare expansion with the initiation of five significant pharmaceutical projects, which required a total greenfield investment of 5,000 crore. Chawla mentioned that this is a component of the larger PLI (Production Linked Incentive) program, which has attracted total investments of around ?35,000 crore in 55 projects, with an additional 30 projects in progress. This investment drive aims to boost India's self-reliance in pharmaceuticals, achieve import substitution, and create export earnings.Arunish Chawla, Secretary of the Department of Pharmaceuticals, predicts that India's pharmaceutical and meditech sector, valued at around $70 billion, is set to almost double by 2030.Chawla pointed out that India's economic and employment landscape will benefit greatly from the rapidly developing CRDMO ecosystem, driving growth.He noted, "The CRDMO industry in our country is now growing at 12-14 percent," providing opportunities for graduates, engineers, and technicians as the industry scales up its research and manufacturing capabilities.India has also made notable strides in achieving a trade balance in bulk drug imports and exports. "For the first time in the closing year, we reached a trade balance between imports and exports as far as bulk drugs are concerned," Chawla emphasised. POTyra Biosciences, Inc., a biotechnology company in the clinical development stage, revealed that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for TYRA-300, enabling the company to move forward with a phase 2 clinical study of TYRA-300 for children with achondroplasia (BEACH301).TYRA-300 is a promising experimental oral inhibitor that targets FGFR3 specifically, aiming to sidestep the side effects linked to inhibiting FGFR1, FGFR2, and FGFR4. TYRA-300 is currently under assessment for metastatic urothelial cancer in the SURF301 trial, with interim clinical proof-of-concept results presented at the ENA 2024 conference."IND clearance to proceed with BEACH301 is a significant milestone for the achondroplasia community and for TYRA, as we move into the clinic to treat our first rare skeletal dysplasia indication," said Todd Harris, CEO of TYRA. "We believe FGFR3 is the right target for achondroplasia, with almost one hundred percent of cases being driven by a specific mutation in the FGFR3 gene. TYRA-300 has the potential to precisely engage FGFR3 to potentially achieve a higher annualized growth velocity, and lead to important functional outcomes and clinical benefits such as improvements in reach, gait and spinal disease."Harris continued, "The currently available therapy is a once-daily injection that delivers modest increases in annualized growth velocity. As a highly selective FGFR3 inhibitor, we are hopeful that TYRA-300 may provide an improved therapeutic option for achondroplasia, and we are excited about our opportunity to potentially deliver improvements with our differentiated oral therapy in BEACH301." POTOP STORIES
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