--- title: "BeOne Wins First-in-Class U.S. FDA Nod for BCL2 Drug in Relapsed Mantle Cell Lymphoma" type: "News" locale: "en" url: "https://longbridge.com/en/news/286330888.md" description: "BeOne Medicines Ltd has received accelerated U.S. FDA approval for BEQALZI (sonrotoclax), the first BCL2 inhibitor for adults with relapsed mantle cell lymphoma after prior therapies. The drug shows a 52% overall response rate and a 16% complete response rate in trials. This approval, supported by Breakthrough and Orphan designations, enhances treatment options for patients facing this aggressive lymphoma. Analysts rate BeOne stock as a Buy with a price target of HK$290.00, reflecting confidence in the company's innovative therapies for blood cancers." datetime: "2026-05-13T23:37:16.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/286330888.md) - [en](https://longbridge.com/en/news/286330888.md) - [zh-HK](https://longbridge.com/zh-HK/news/286330888.md) --- # BeOne Wins First-in-Class U.S. FDA Nod for BCL2 Drug in Relapsed Mantle Cell Lymphoma ### Claim 55% Off TipRanks - Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions - Discover top-performing stock ideas and upgrade to a portfolio of market leaders with Smart Investor Picks BeOne Medicines Ltd ( (HK:6160) ) has provided an update. BeOne Medicines has secured accelerated U.S. FDA approval for BEQALZI (sonrotoclax), the first and only BCL2 inhibitor indicated for adults with relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor. The drug was engineered to offer enhanced potency, selectivity, and a favorable pharmacologic profile, positioning it as a next-generation backbone therapy in this high‑need setting. The approval is based on Phase 1/2 trial data showing a 52% overall response rate, a 16% complete response rate, rapid median time to response of 1.9 months, and generally well-tolerated safety in heavily pretreated patients. As a targeted option in a rare and aggressive lymphoma with limited post-BTK choices, BEQALZI’s entry, supported by Breakthrough, Fast Track and Orphan designations, strengthens BeOne’s standing in hematologic oncology and may materially expand treatment options and hope for U.S. patients and families confronting repeated relapse. The most recent analyst rating on (HK:6160) stock is a Buy with a HK$290.00 price target. To see the full list of analyst forecasts on BeOne Medicines Ltd stock, see the HK:6160 Stock Forecast page. **More about BeOne Medicines Ltd** BeOne Medicines Ltd. is a Switzerland-incorporated biopharmaceutical company focused on developing next-generation targeted therapies for B-cell malignancies. Its pipeline includes BCL2 inhibitors such as BEQALZI (sonrotoclax), designed to improve efficacy, tolerability, and convenience for patients with difficult-to-treat blood cancers, including mantle cell lymphoma. **Average Trading Volume:** 3,898,585 **Technical Sentiment Signal:** Buy **Current Market Cap:** HK$285B Find detailed analytics on 6160 stock on TipRanks’ Stock Analysis page. ### Related Stocks - [ONC.US](https://longbridge.com/en/quote/ONC.US.md) - [VHT.US](https://longbridge.com/en/quote/VHT.US.md) - [XLV.US](https://longbridge.com/en/quote/XLV.US.md) - [IXJ.US](https://longbridge.com/en/quote/IXJ.US.md) - [BIB.US](https://longbridge.com/en/quote/BIB.US.md) - [IBB.US](https://longbridge.com/en/quote/IBB.US.md) - [XBI.US](https://longbridge.com/en/quote/XBI.US.md) - [FBT.US](https://longbridge.com/en/quote/FBT.US.md) - [IBBQ.US](https://longbridge.com/en/quote/IBBQ.US.md) - [LABU.US](https://longbridge.com/en/quote/LABU.US.md) - [SBIO.US](https://longbridge.com/en/quote/SBIO.US.md) - [ARKG.US](https://longbridge.com/en/quote/ARKG.US.md) - [PBE.US](https://longbridge.com/en/quote/PBE.US.md) - [IHE.US](https://longbridge.com/en/quote/IHE.US.md) - [BBH.US](https://longbridge.com/en/quote/BBH.US.md) - [06160.HK](https://longbridge.com/en/quote/06160.HK.md) - [688235.CN](https://longbridge.com/en/quote/688235.CN.md) - [BGNE.US](https://longbridge.com/en/quote/BGNE.US.md) ## Related News & Research - [BeOne Medicines Wins Conditional FDA Nod For Cancer Drug In Rare Blood Cancer](https://longbridge.com/en/news/286453582.md) - [BeOne Medicines’ BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma | ONC Stock News](https://longbridge.com/en/news/286297796.md) - [](https://longbridge.com/en/news/286458336.md) - [BeOne TV drug ad hit by FDA over ‘misleading suggestions’](https://longbridge.com/en/news/286293523.md) - [BeOne's Venclexta challenger Beqalzi nets FDA approval](https://longbridge.com/en/news/286315985.md)