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Shilpa Medicare Subsidiary Gets US FDA Orphan Drug Designation for Rare Blood Cancer Biologic
Shilpa Biologicals, a subsidiary of Shilpa Medicare, has achieved a major milestone with the US FDA granting Orphan Drug Designation (ODD) to its monoclonal antibody for treating rare blood cancers. The designation covers Essential Thrombocythemia (ET) and Polycythemia Vera (PV), conditions with high unmet medical needs. This regulatory status provides the company with development support, tax credits, and potential market exclusivity upon final approval. The company is now progressing toward IND-enabling studies to initiate first-in-human clinical trials.
Key Highlights
US FDA grants Orphan Drug Designation for a flagship biologic targeting ET and PV rare blood cancers.
Designation provides commercial incentives including tax credits and potential 7-year market exclusivity.
The biologic targets immune-evasion pathways, offering a differentiated profile from existing JAK inhibitors.
Shilpa Biologicals and mAbTree Biologics to advance the program to IND-enabling studies and human trials.
Milestone validates Shilpa Medicare's R&D capabilities in the high-value biologics and critical care space.
💼 Action for Investors
Investors should view this as a positive long-term development that strengthens the company's specialized R&D pipeline. Monitor future updates regarding IND filings and clinical trial progress as these will be the next major valuation catalysts.
HILINFRA Independent Director Om Prakash Shrivastava Resigns Effective Jan 28, 2026
Highway Infrastructure Limited (HILINFRA) has announced the resignation of Mr. Om Prakash Shrivastava from his position as a Non-Executive Independent Director, effective January 28, 2026. Mr. Shrivastava was a significant contributor to the board, serving on five key committees including the Audit, Nomination and Remuneration, and the Initial Public Offer Committee. The company has confirmed that there are no material reasons for his resignation other than those provided in his formal letter. This transition will require the company to appoint a new independent director to maintain regulatory compliance and committee oversight.
Key Highlights
Resignation of Mr. Om Prakash Shrivastava (DIN: 10173322) as Non-Executive Independent Director.
Effective date of cessation is the close of business hours on January 28, 2026.
The director served on 5 committees: Audit, NRC, Stakeholder Relationship, CSR, and IPO Committee.
Confirmation provided that no other material reasons exist for the resignation.
💼 Action for Investors
Investors should monitor the company's upcoming filings for the appointment of a replacement director to ensure the board's independence and committee functions remain robust. This is a routine management change and does not currently signal any operational issues.
HILINFRA Commences Toll Operations at Kaza Plaza; Order Book Reaches ₹1,209 Cr
Highway Infrastructure Limited (HIL) has commenced toll operations at the Kaza Fee Plaza on NH-16, marking its largest-ever single toll mandate valued at ₹328.77 crore. The Kaza Plaza is a high-traffic corridor and is recognized as the highest-earning public-funded toll plaza in South India, generating approximately ₹27 crore in monthly collections. This commencement has significantly boosted the company's total order book to ₹1,209 crore, with the tollways segment growing by 404% since March 2025. The project follows an asset-light model, ensuring immediate revenue generation and improved cash flow visibility for the next year.
Key Highlights
Commenced ₹328.77 crore toll operations contract at Kaza Fee Plaza, the largest in company history.
Total consolidated order book strengthened to ₹1,209 crore as of January 2026.
Tollways collection order book grew by ~404% from ₹114 crore in March 2025 to ₹575 crore.
EPC order book increased by 52% during the same period, reaching ₹633 crore.
Kaza Plaza generates the highest monthly toll in South India at approximately ₹27 crore.
💼 Action for Investors
Investors should monitor the company's execution efficiency and the impact of this high-value contract on upcoming quarterly earnings. The significant 404% growth in the tolling order book suggests a strong shift toward high-cash-flow operational revenue.
Highway Infrastructure Starts ₹328.77 Cr Toll Operations; Order Book Hits ₹1,144 Cr
Highway Infrastructure Limited (HIL) has commenced toll operations at the Kaza Fee Plaza in Andhra Pradesh, its largest single contract to date valued at ₹328.77 crore. This operational milestone has propelled the company's tollways order book to ₹510 crore, a 348% increase since March 2025. The total consolidated order book now stands at ₹1,144 crore, with the EPC segment also growing 52% to ₹633 crore. This asset-light project on the high-traffic NH-16 corridor is expected to provide immediate revenue and strong cash flow visibility.
Key Highlights
Execution of largest-ever toll contract worth ₹328.77 crore at Kaza Fee Plaza
Tollways order book grew 348% from ₹114 crore to ₹510 crore since March 2025
Total consolidated order book reached ₹1,144 crore, enhancing revenue visibility
EPC order book increased 52% to ₹633 crore during the same period
Project covers an 82.5 km stretch on the strategically important NH-16 corridor
💼 Action for Investors
The significant scale-up in the tolling vertical and robust order book growth signal strong near-term growth; investors should monitor execution margins and contract renewals.