(Yicai) May 14 -- BeOne Medicines said that the biopharmaceutical giant's innovative drug for relapsed or refractory mantle cell lymphoma has received accelerated approval by the United States Food and Drug Administration.

Beqalzi (sonrotoclax) was approved for the treatment of patients with R/R MCL after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor, becoming the first new BCL2 inhibitor approved in a decade in the US and the only one approved for MCL, BeOne announced yesterday.

Beqalzi is a foundational BCL2 inhibition designed for greater potency and selectivity, with potential to improve efficacy, tolerability, and convenience over others in the class, the company explained.

MCL is a rare and often aggressive type of non-Hodgkin lymphoma. In the US, about 3,300 new cases of MCL are diagnosed each year, according to data provided by BeOne. While many patients respond to initial therapy, relapse is common, and outcomes after progression can be poor, particularly after prior treatment with a BTK inhibitor.

The accelerated approval of Beqalzi introduces a new targeted mechanism to the MCL treatment landscape and reinforces the importance of expanding therapeutic choices for patients as the disease evolves, the company noted.

"BeOne is leading the advancement and enhancement of BCL2 inhibition to revolutionize how we treat patients living with B-cell malignancies," said Amit Agarwal, chief medical officer, hematology, at BeOne. "Today's approval of Beqalzi represents critical progress for patients with mantle cell lymphoma and reinforces our strategy of building foundational medicines designed to raise the standard of care in B-cell malignancies."

The FDA granted Breakthrough Therapy Designation for sonrotoclax in this indication, as well as Fast Track Designation and Orphan Drug Designation, BeOne disclosed.

The FDA's accelerated approval is a pathway provided by the regulator for serious or life-threatening diseases with unmet medical needs, allowing new drugs to be approved for marketing based on preliminary evidence and surrogate endpoints. Developers are still required to submit additional clinical data post-approval to confirm the drug's efficacy.

Chinese regulators approved Beqalzi for two indications in January, one of which is the same as the one approved by the FDA.

BeOne's shares [SHA: 688235] closed 4.3 percent down at CNY249.70 (USD36.79) in Shanghai today, after trading more than 1.6 percent higher earlier. The stock was weighed down by a broad market selloff, as investors rushed to lock in profits amid solid gains over the past one and a half months. The benchmark Shanghai Composite Index ended the day 1.5 percent lower. Its Hong Kong-listed stock [HKG: 6160] fell 1.7 percent to HKD184.70 (USD2358), with the Hang Seng Index unchanged.

Editor: Futura Costaglione