BeiGene’s BRUKINSA Receives Conditional Approval in China for Rare Lymphoma Treatment

Biotechnology company Beigene Ltd. (BGNE) has received conditional approval for BRUKINSA from the China National Medical Products Administration (NMPA) for treating Waldenström’s macroglobulinemia (WM) in adults. WM is a rare form of lymphoma occurring in less than 2% of non-Hodgkin’s lymphoma patients.

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) and is shown to restrain malignant B cell proliferation in disease-relevant tissues. It is under evaluation in a global clinical program, both as a monotherapy and in combination with other therapies for treating different B-cell malignancies.

Xiaobin Wu, Ph.D., General Manager of China and President of Beigene, said, “With NMPA approval for BRUKINSA, our next-generation BTK inhibitor, we are proud to be able to offer patients, their families, and physicians a new option for treating WM, an incurable disease that can cause significant morbidities.” (See BeiGene stock chart on TipRanks)

Wu added, “This marks BRUKINSA’s third approval for the treatment of B-cell malignancies in China, and we believe it may serve an important role in addressing unmet needs for patients with blood cancers around the world.”

This conditional approval for the therapy was based on data from a Phase 2 trial in China to study its safety and efficacy in WM patients. At a follow-up period of 14.9 months, the major response rate (primary endpoint of the study) was 72.1%.

On June 14, Leerink Partners analyst Andrew Berens reiterated a Buy rating on the stock and increased the price target to $417 (29.6% upside potential) from $388.

Earlier this month, Beigene presented interim data from the Phase 3 ALPINE study that evaluated BRUKINSA Vs. Imbruvica in lymphoma patients. Berens believes the data supports a competitive profile for BRUKINSA in the chronic lymphocytic leukemia (CLL) space and has revised the price target on the stock accordingly.

The other analyst covering the stock, Morgan Stanley’s Matthew Harrison also has a Buy rating on the stock and has increased the price target to $409 (27.1% upside potential) from $357.

The two ratings add up to a Moderate Buy consensus rating. The average BeiGene analyst price target of $413 implies 28.3% upside potential. Shares have surged 75.4% over the past year.

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