Oncology Products with Purpose
Shorla Oncology’s innovative oncology pipeline addresses drug shortages and treatments inadequate for the target population by reinventing & rethinking existing oncology medications with the goal of improving the lives of patients around the globe.
Our development strategy of rethinking approved pharmaceuticals primarily through the 505 (b)(2) regulatory pathway provides a focused strategy that can dramatically reduce clinical burden, cost & risk while maximizing speed to market.
At Shorla Oncology we have built a flexible go-to-market strategy, enabling us to commercialize our oncology portfolio in a cost-efficient manner coupling in-house expertise and market leading external commercial partners. With this highly adaptable team & infrastructure we can remain flexible and assess the optimal commercialization strategy on a case-by-case basis to maximize the return on investment for our oncology portfolio.
Shorla Oncology plans to have 2 products on market & 3+ products in development by end of year 2024.
Shorla Oncology have successfully completed the filing of our New Drug Application (‘NDA’) with the US Health Authority, the Food and Drug Administration (‘FDA’) on our oncology drug SH-105. This positive step strengthens our efforts to bring SH-105 to market benefiting women suffering from breast and ovarian cancer. A significant milestone on Shorla Oncology’s journey of bringing innovative oncology products to the market.
Shorla Oncology have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (FDA) on our third oncology drug SH-110. This proprietary product will have a significant benefit to patients suffering from brain cancer ultimately reducing treatment burden and providing a palatable age appropriate treatment. The clinical trial to support NDA filing will commence later this year.
Shorla Oncology have entered into a licensing agreement and strategic partnership to obtain an exclusive license to register and commercialize SH-201, the first palatable oral solution of the related chemotherapeutic agent in the U.S. SH-201 is an oral solution treatment that slows or stops the growth of certain forms of leukemia (such as acute lymphoblastic leukemia and chronic myeloid leukemia). The NDA submission is planned for Q1 2024.
SH-114 is a preferred regimen for both Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in various mono & combination settings.