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    BGNE   US07725L1026


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BeiGene Receives Positive CHMP Opinion for BRUKINSA« (Zanubrutinib) for the Treatment of Adults with Waldenstr÷mĺs Macroglobulinemia

09/20/2021 | 04:29pm EST

BeiGene announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy. The positive CHMP opinion is based on results from the randomized, Phase 3 ASPEN clinical trial, evaluating BRUKINSA compared to ibrutinib in patients with relapsed or refractory (R/R) or treatment-naïve (TN) WM who are unsuitable for chemo-immunotherapy. Based on the modified Sixth International Workshop on Waldenström’s Macroglobulinemia (IWWM-6) response criteria (Treon 2015), the combined complete response (CR) +VGPR rate in the overall intention-to-treat (ITT) population was 28.4% with BRUKINSA (95% CI: 20, 38), compared to 19.2% with ibrutinib (95% CI: 12, 28). While this difference was not statistically significant, BRUKINSA did achieve numerically higher VGPR rates and trends towards increased response quality. BRUKINSA demonstrated a more favorable safety profile compared to ibrutinib with lower frequency of certain adverse events, including atrial fibrillation or flutter (2.0% vs. 15.3%) minor bleeding (48.5% vs 59.2%) and major hemorrhage (5.9% vs 9.2%). Of the 101 patients with WM treated with BRUKINSA, 4% of patients discontinued due to adverse events, and adverse events leading to dose reduction occurred in 14% of patients. Following the CHMP positive opinion, the European Commission will consider BeiGene’s marketing application, with a final decision expected within 67 days of receipt of the CHMP opinion. The decision will be applicable to all 27 member states of the EU plus Iceland and Norway. WM is a rare lymphoma representing approximately 1% of all non-Hodgkin’s lymphomas and typically progresses slowly after diagnosis. The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved. Throughout Europe, the estimated incidence rate of WM is approximately seven for everyone million men and four for every one million women. The Phase 3 randomized, open-label, multicenter ASPEN clinical trial (NCT03053440) evaluated zanubrutinib versus ibrutinib in people with relapsed or refractory (R/R) or treatment-naïve (TN) WM. The primary objective was to establish superiority of zanubrutinib compared to ibrutinib as demonstrated by the proportion of people achieving complete response (CR) or very good partial response (VGPR). Secondary endpoints included major response rate, duration of response and progression-free survival, and safety, measured by incidence, timing and severity of treatment-emergent adverse events. The pre-specified analysis populations for the trial included the overall population (n=201) and R/R patients (n=164). Exploratory endpoints included quality of life measures. The study includes two cohorts, a randomized cohort (cohort 1) consisting of 201 patients with a MYD88 mutation (MYD88MUT) and a non-randomized cohort (cohort 2) in which 28 patients with MYD88 wild-type (MYD88WT) received zanubrutinib because they have historically responded poorly to ibrutinib therapy.

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Financials (USD)
Sales 2021 1 184 M - -
Net income 2021 -1 240 M - -
Net cash 2021 3 103 M - -
P/E ratio 2021 -26,3x
Yield 2021 -
Capitalization 32 613 M 32 613 M -
EV / Sales 2021 24,9x
EV / Sales 2022 21,9x
Nbr of Employees 7 600
Free-Float 67,7%
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Mean consensus BUY
Number of Analysts 14
Last Close Price 347,53 $
Average target price 435,26 $
Spread / Average Target 25,2%
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Managers and Directors
John V. Oyler Chairman & Chief Executive Officer
Xiao Bin Wu President & Chief Operating Officer
Julia Wang Chief Financial & Accounting Officer
Jane E. Huang Chief Medical Officer-Hematology
Lai Wang Global Head-Research & Development
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