Usynova Partners with AstraZeneca for KRASG12D Inhibitor UA022 in Global Development and Commercialization Agreement

Usynova announced a licensing agreement with AstraZeneca for the clinical-stage small molecule KRASG12D inhibitor UA022. Under the agreement, AstraZeneca will gain exclusive global rights to develop and commercialize UA022.

As per the agreement, Usynova will receive an upfront payment of $24 million, potential milestone payments of up to $395 million for development and commercialization, and sales royalties. UA022 has demonstrated potent anti-cancer activity and good safety in preclinical models. Currently, there are no approved KRASG12D inhibitors available worldwide.

AstraZeneca Expanding Presence in China

In recent years, there has been a growing trend of Chinese innovative drugs making their way to international markets through various avenues such as licensing-out and global partnerships.

As of late November, several domestically developed innovative drugs have made headlines for their international expansion, including two collaborations with AstraZeneca.

On November 9th, AstraZeneca announced an exclusive licensing agreement with CStone Pharmaceuticals, acquiring global rights to CStone's next-generation oral GLP-1 product ECC5004 for over $2 billion. This move indicates AstraZeneca's intention to strengthen its presence in the weight-loss drug market, which has seen significant growth in recent years.

In addition to licensing agreements, AstraZeneca has achieved success with its own new drugs in China.

On November 14th, AstraZeneca announced the approval and market launch of its anti-cancer drug durvalumab in China, making it the first approved drug for the treatment of biliary tract cancer in China. Durvalumab is a selective, high-affinity human IgG1 monoclonal antibody that blocks the interaction of programmed death-ligand 1 (PD-L1) with programmed cell death protein 1 (PD-1) and CD-80, stimulating anti-tumor T-cell activity. It had previously gained approval in China for the first-line treatment of non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer.

Furthermore, according to AstraZeneca's recently published 2023 Q3 quarterly report, the company has performed well in the Chinese market, with revenue of $4.495 billion in the first three quarters, accounting for 14% of AstraZeneca's total global revenue. The Chinese market is expected to be a key area for AstraZeneca's future expansion.

What Sets Usynova and UA022 Apart?

Established in January 2020, Usynova focuses on two major areas: cancer and autoimmune diseases. The company develops innovative drugs with global independent intellectual property rights, targeting new targets and mechanisms of action. Currently, Usynova has several cancer-related and autoimmune disease drugs in clinical development.

The key asset in the agreement, UA022, is an effective and selective oral small molecule drug targeting the KRASG12D mutation. KRAS mutations occur at a high frequency in various cancer types, with KRASG12D being the most common KRAS mutation, accounting for approximately 26% of all KRAS mutations. It is prevalent in pancreatic cancer, colorectal cancer, non-small cell lung cancer, among others. However, there are currently no approved treatment options specifically targeting KRASG12D, leaving these patients in need of new therapeutic choices. UA022 has demonstrated potent anti-cancer activity, good safety, and favorable oral bioavailability in preclinical models. UA022 is the second domestically developed KRAS drug to expand globally and the only KRASG12D inhibitor to do so. Usynova plans to advance IND applications in China and the United States in 2023.

It is worth mentioning that WuXi AppTec participated in the discovery and validation process of UA022.

As a biotech company founded less than four years ago, the fact that Usynova has gained the attention of multinational pharmaceutical company AstraZeneca demonstrates the immense potential of Chinese innovation in the pharmaceutical industry, which is now being recognized worldwide.