AN9025 Enters Greater China Market: Adlai Nortye Secures Landmark Deal with ASK Pharma for Revolutionary RAS-Targeting Therapy

2025-12-31 14:37:36

Adlai Nortye Ltd. has completed a strategic licensing agreement that grants ASK Pharma exclusive development and commercialization rights for AN9025 across mainland China, Hong Kong and Macao. This partnership represents a major expansion for the pan-RAS inhibitor, which targets one of oncology’s most persistent challenges.

Unlocking RAS Mutations: The Clinical Opportunity

RAS mutations rank among the most prevalent drivers of solid tumors, yet have historically proven exceptionally difficult to target therapeutically. Adlai Nortye’s AN9025 addresses this gap as an orally-administered small-molecule inhibitor engineered to combat a wide range of RAS mutations. Preliminary laboratory research demonstrates robust and sustained antitumor effects in pancreatic, lung and colorectal adenocarcinomas. Notably, the candidate’s efficacy profiles match or exceed comparable agents currently in development within this drug class.

The company plans to launch a Phase I human trial during the opening quarter of 2026, marking a critical inflection point for clinical validation.

Financial Framework and Partnership Terms

Under the licensing arrangement, ASK Pharma secures complete rights to develop, manufacture and market AN9025 throughout the licensed territory. Adlai Nortye retains full global rights outside Greater China while positioning itself to receive substantial financial returns.

The deal structure includes:

Upfront cash payment plus near-term regulatory milestone payments totaling more than USD 20 million
Total potential compensation reaching RMB 1.6 billion (approximately USD 230 million)
Tiered royalty structure spanning high single-digit to mid-teens percentages based on regional net sales

Strategic Rationale and Long-Term Vision

ASK Pharma General Manager Jingfei Ma characterized the collaboration as a “pivotal milestone” that strengthens the company’s commitment to sophisticated oncology drug development. “Our combined capabilities in research, clinical advancement, and market access position us to accelerate AN9025’s development trajectory while reinforcing our current therapeutic portfolio,” Ma explained.

Adlai Nortye CEO Yang Lu emphasized AN9025’s differentiated profile as a potentially best-in-class RAS-targeted option. “This collaboration advances both the clinical and commercial pathways for AN9025 and validates our specialized RAS-focused discovery engine,” Lu stated. He noted that the partnership will expand treatment availability for patients whose cancers harbor RAS mutations—a patient population with substantial unmet therapeutic needs.

Expanding the RAS-Focused Pipeline

Beyond AN9025, Adlai Nortye’s oncology portfolio encompasses AN4035, a therapeutic antibody-drug conjugate targeting CEACAM5. This candidate delivers a potent pan-RAS inhibitor directly to tumor cells and currently remains in preclinical phases. Earlier research highlighted significant antitumor activity in CEACAM5-positive, RAS-dependent cancer models.

Market Performance

ANL’s share price has fluctuated between $0.87 and $2.99 throughout the preceding twelve months. Following the partnership announcement, the stock surged 76% in pre-market trading, reaching $2.88, reflecting investor enthusiasm for the strategic milestone and AN9025’s clinical potential.

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