CHINA — Swiss pharmaceutical giant Roche has made a significant investment of US$70 million in Zion Pharma to acquire an oral HER2 tyrosine kinase inhibitor.

HER2, the human epidermal growth factor receptor 2, has become a popular target for cancer drug developers, and Roche aims to expand its portfolio of HER2-targeting therapies with this latest addition.

While Roche already offers antibody drugs such as Herceptin, Perjeta, and Kadcyla, the Zion small molecule presents a unique advantage: its ability to penetrate the blood-brain barrier.

This breakthrough potential opens doors for treating or preventing the spread of cancer to the brain in patients with HER2-positive metastatic breast cancer.

Studies have shown that approximately 50% of these patients develop brain metastasis during the course of their disease, resulting in reduced quality of life and shorter survival.

Under the agreement, Roche will take charge of the development and manufacturing of ZN-A-1041, the Zion candidate.

If the molecule successfully reaches the market, Roche will handle its commercialization and pay Zion royalties based on sales.

To facilitate a seamless transition, Zion, with offices in Hong Kong, Suzhou, and Shanghai, will assist in completing an ongoing Phase I trial before handing over further responsibilities to Roche.

Roche initially connected with Zion through its dedicated Asia partnering team, and subsequently, the global team led by James Sabry became involved.

In addition to the initial investment, Zion could potentially earn up to US$610 million more from the deal, contingent on the successful development and commercialization of ZN-A-1041.

The race to develop effective treatments targeting HER2, the human epidermal growth factor receptor 2, has gained considerable momentum in the pharmaceutical industry.

HER2-positive cancers, including breast, gastric, and others, have presented a significant unmet medical need, leading to intense research and development efforts by various companies.

Roche, with its existing franchise of HER2-targeting therapies, has established a strong presence in this field.

The competition to develop effective treatments targeting HER2, the human epidermal growth factor receptor 2, extends beyond Roche.

AstraZeneca and Seagen have also joined the race, focusing on novel molecules that can effectively target HER2 and provide enhanced treatment options for patients.

AstraZeneca, a renowned global biopharmaceutical company, has made significant strides in HER2-targeted therapy with their product, Enhertu.

This therapy has shown promise in treating patients traditionally characterized as HER2-negative.

Seagen, a biotechnology company renowned for its expertise in targeted cancer therapies, is actively engaged in the development of HER2 molecules.

Leveraging their proficiency in antibody-drug conjugate (ADC) technology, Seagen aims to create innovative therapies that specifically target HER2-positive cancers.

Their flagship product, TUKYSA (tucatinib), received approval from the U.S. FDA in April 2020. It is used in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases who have received prior anti-HER2-based regimens in the metastatic setting.

Furthermore, Seagen’s TUKYSA achieved accelerated approval from the U.S. FDA in January 2023. This approval allows for its use in combination with trastuzumab for adult patients with RASwild-type, HER2-positive unresectable, or metastatic colorectal cancer.

The collective efforts of pharmaceutical companies like Roche, AstraZeneca, and Seagen bring hope for the future, where HER2-targeted therapies play a pivotal role in transforming the lives of individuals affected by HER2-positive malignancies.

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