Raichur, India: Shilpa Biocare Pvt Ltd, a wholly owned subsidiary of Shilpa Medicare Limited (BSE/NSE: SHILPAMED), a global innovative pharma company and CDMO, today announced a strategic equity partnership with Gate2Brain, S.L. (“Gate2Brain”), a biotechnology company pioneering peptide-shuttle therapeutics for central nervous system (CNS) diseases. Under the terms of the agreement, Shilpa becomes a strategic shareholder of Gate2Brain and its dedicated CMC, manufacturing, and regulatory partner for G2B-002 — Gate2Brain’s lead program in brain cancer.
G2B-002 has been granted Orphan Drug Designation (ODD) by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), underscoring its potential in rare and aggressive pediatric and adult brain tumors. The candidate is designed to target diffuse intrinsic pontine glioma (DIPG) and pediatric glioblastoma (pGBM) — two of the most lethal childhood brain cancers, with very limited treatment options today. G2B-002 delivers SN-38, a potent anticancer agent, across the blood-brain barrier (BBB) via Gate2Brain’s proprietary MiniAp4 peptide shuttle.
In preclinical studies, the MiniAp4 peptide shuttle has demonstrated up to 100-fold greater brain drug transport versus conventional approaches in animal models. The platform has also shown potent preclinical activity across a broader range of rare pediatric cancers — including Ewing sarcoma, rhabdomyosarcoma, and neuroblastoma — supporting its potential beyond G2B-002’s lead indications.
G2B-002 has the potential to improve efficacy while reducing systemic side effects. Clinical batches are expected as early as next year, with first-in-human trials anticipated to commence by FY28.
Market Opportunity
G2B-002 is positioned to address sizeable and high-need oncology markets. Key reference market data:
- Glioblastoma treatment market: estimated at approximately USD 3.01 billion in 2025 and projected to reach USD 6.48 billion by 2035, at a CAGR of 7.97% (Source: Precedence Research, 2026).
- Pediatric brain tumor market: estimated at approximately USD 1.55 billion in 2024 and projected to reach USD 2.47 billion by 2031, at a CAGR of 6.9% (Source: Coherent Market Insights, 2024).
- Diffuse intrinsic pontine glioma (DIPG) market: estimated at approximately USD 603.7 million in 2025 and projected to reach USD 1.2 billion by 2035, at a CAGR of 7.1% (Source: Market Research Future, 2026).
Beyond brain tumors, the broader applicability of Gate2Brain’s MiniAp4 peptide-shuttle platform across other rare pediatric cancers — and its potential extension to additional CNS therapeutic categories — further expands the long-term commercial opportunity.
This transaction marks Shilpa’s fourth strategic equity partnership of its kind, reinforcing a deliberate strategy of investing in differentiated innovation and building a portfolio of high-potential therapeutic assets that drive long-term value creation for shareholders and society.
Vishnukant Bhutada, Managing Director, Shilpa Medicare Ltd: “Gate2Brain’s blood-brain-barrier technology is among the most differentiated CNS-delivery platforms we have evaluated.
Becoming a strategic shareholder allows Shilpa to participate in long-term value creation while contributing the
manufacturing and regulatory depth required to bring G2B-002 to first-in-human studies and extend its application to other molecules and therapy categories.”
Meritxell Teixidó Turà, CEO, Gate2Brain: “This partnership gives G2B-002 a clear, de-risked path to the clinic and validates our peptide-shuttle platform with a top-tier oncology partner. Aligning Shilpa’s manufacturing and regulatory capabilities with our science is the right structure to deliver this program — and the next ones — to patients.”
