Oncology Products with Purpose
Development
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.
Share your needs with us:
Submit your input on products that are in short supply or challenging to handle for our R&D team to consider for pipeline development via Pipeline@ShorlaOncology.com
PIPELINE
Shorla Oncology plans to have 4 products on market & 3+ products in development by end of year 2024.
| Product | Route of Administration | Indication | Formulation & Manufacturing | Clinical Development | Regulatory Filings | Estimated Commercialization |
|---|---|---|---|---|---|---|
| SH-105 | IV | Breast and ovarian cancer | 100% Progress | 100% Progress | 100% Progress | Est. Q4 2024 |
| SH-110 | Oral Liquid | Glioma | 100% Progress | 20% Progress | 0% Progress | Est. Q2 2026 |
| SH-105 | IV | Brain Metastisis in Breast Cancer patients | 100% Progress | 0% Progress | 0% Progress | Est. Q3 2026 |
| SH-201 | Liquid | Chronic Myeloid Leukemia/Acute Lymphoblastic Leukemia/MDS/Gastrointestinal tumors | 100% Progress | 100% Progress | 60% Progress | Est. Q1 2025 |
SH-105
The US Food and Drug Administration (‘FDA’) has approved Shorla Oncology’s New Drug Application (NDA) for TEPYLUTE, formerly SH-105. Bringing TEPYLUTE to market will benefit women suffering from breast and ovarian cancer and serve as a significant milestone on Shorla Oncology’s journey of bringing innovative oncology products to market.
SH-110
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.
SH-201
U.S. FDA has granted acceptance to file for Shorla Oncology’s NDA for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers. The Agency assigned a Prescription Drug User Fee Act (“PDUFA”) action date of November 30, 2024.