Adlai Nortye & ASK Pharm Forge $230M Pan-RAS Cancer Drug Alliance

SINGAPORE – December 29, 2025 – In a significant move to tackle one of oncology's most elusive targets, clinical-stage biotechnology firm Adlai Nortye has entered into an exclusive licensing agreement with Chinese pharmaceutical powerhouse ASK Pharm. The deal, valued at up to RMB 1.6 billion (approximately USD 230 million), grants ASK Pharm the rights to develop, manufacture, and commercialize AN9025, a novel pan-RAS inhibitor, in mainland China, Hong Kong, and Macao.

This strategic partnership underscores a growing trend of cross-border collaborations aimed at accelerating the development of innovative cancer therapies for the world's largest patient populations. Adlai Nortye will receive an upfront payment and near-term milestones exceeding $20 million, plus tiered royalties, while retaining rights to AN9025 in all other global markets. The collaboration aims to fast-track a potentially best-in-class treatment for a wide range of cancers driven by RAS mutations, a family of genes long considered “undruggable.”

Targeting the "Undruggable" RAS Oncogene

RAS gene mutations are one of the most common drivers of cancer, appearing in approximately 30% of all human tumors, including a high percentage of deadly pancreatic, lung, and colorectal cancers. For decades, the smooth, spherical structure of the RAS protein offered no clear pockets for therapeutic molecules to bind to, earning it a notorious reputation among drug developers.

Recent breakthroughs have led to the approval of drugs targeting specific RAS mutations, such as KRAS G12C. However, these therapies only address a fraction of RAS-driven cancers, leaving a vast unmet need for patients with other mutations. Adlai Nortye’s AN9025 represents a next-generation approach. As an oral, small-molecule pan-RAS(ON) inhibitor, it is designed to shut down a broad spectrum of RAS mutations while they are in their active, cancer-promoting “ON” state.

“We are delighted to partner with ASK Pharm on the development of AN9025, a differentiated pan-RAS (ON) inhibitor with the potential to be best-in-class,” said Yang Lu, Chairman and Chief Executive Officer of Adlai Nortye. “This collaboration represents a meaningful step forward in advancing the clinical and commercial potential of AN9025 and underscores the value of our RAS-targeted drug discovery platform.”

Preclinical data has been promising, showing that AN9025 potently and durably inhibits the growth of various RAS-mutant cancer cell lines. The company has reported that its compound demonstrates comparable or superior efficacy against benchmark agents in its class, suggesting a competitive edge in a highly dynamic field. Adlai Nortye expects to initiate the first Phase I clinical study for AN9025 in the first quarter of 2026.

A Strategic Alliance for the World's Largest Cancer Market

The partnership is as much a strategic business decision as it is a scientific one. By joining forces with ASK Pharm, Adlai Nortye gains an established and powerful ally in Greater China, a region that is not only the world's second-largest pharmaceutical market but also home to the largest number of cancer patients. The oncology drug market in China is projected to surpass $69 billion by 2026, driven by an aging population, increased access to healthcare, and a regulatory environment that is rapidly embracing innovation.

ASK Pharm is well-positioned to capitalize on this opportunity. Founded in 2003, the company has a robust track record in developing and commercializing complex therapeutics. Its capabilities were recently demonstrated with the 2025 approval and launch of Limertinib, a third-generation EGFR inhibitor for non-small cell lung cancer, which it brought to market with a partner. With a deep pipeline that includes multiple late-stage oncology assets and a nationwide commercialization network, ASK Pharm provides the infrastructure and regional expertise essential for navigating the complex Chinese market.

Mr. Jingfei Ma, Director and General Manager of ASK Pharm, framed the deal as a transformative step for his company. “This partnership marks a pivotal milestone in our strategic innovation upgrade, signaling our decisive move into frontier innovation with high entry barriers,” he stated. “By leveraging our complementary strengths in R&D, clinical development, and commercialization, we aim to accelerate the development of AN9025 project... ultimately delivering high-value therapeutic solutions to patients in China and around the world.”

The Financial Blueprint and Pipeline Validation

For Adlai Nortye, a global company with R&D hubs in both the U.S. and China, the agreement provides a significant infusion of non-dilutive capital. The potential $230 million total consideration, including over $20 million in initial payments and future high single-digit to mid-teens royalties, offers a financial runway to advance its broader pipeline without ceding equity.

More importantly, the deal serves as a powerful external validation of its RAS-targeting discovery platform. This platform is a cornerstone of Adlai Nortye's strategy, which focuses on two key pillars: next-generation immunotherapies and RAS-targeting therapies. Beyond AN9025, the company is also developing AN4035, an antibody-drug conjugate (ADC) designed to deliver a potent pan-RAS inhibitor directly to tumors expressing the CEACAM5 marker. This dual-pronged attack on RAS-driven cancers highlights the company's commitment to solving this long-standing challenge.

The company's other strategic pillar includes AN4005, a first-in-class oral PD-L1 inhibitor, and AN8025, a novel tri-functional protein aimed at modulating both T-cells and antigen-presenting cells. The capital from the ASK Pharm deal can be redeployed to advance these promising assets, strengthening Adlai Nortye's overall position as an emerging innovator in oncology.

Navigating the Path to Patients in China

Successfully bringing a novel drug to market in China requires more than just compelling science; it demands sophisticated navigation of a rapidly evolving regulatory landscape. In recent years, China's National Medical Products Administration (NMPA) has implemented sweeping reforms to accelerate the approval of innovative medicines, transforming the country into a key destination for global clinical trials. China now accounts for over a quarter of all clinical trial activity worldwide.

This is where ASK Pharm's local expertise becomes invaluable. The company's experience in securing NMPA approvals and achieving inclusion on the National Reimbursement Drug List (NRDL)—a critical step for ensuring broad patient access—will be instrumental in maximizing AN9025's potential in the region. The partnership allows Adlai Nortye to de-risk the complex and resource-intensive process of regional development and commercialization.

With the Phase I trial slated to begin in early 2026, this collaboration sets the stage for a coordinated clinical strategy. By combining Adlai Nortye's innovation with ASK Pharm's execution capabilities, both companies aim to significantly shorten the timeline from lab to clinic for millions of Chinese patients with RAS-mutant cancers who currently have limited treatment options.