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    BGNE   US07725L1026

BEIGENE, LTD.

(BGNE)
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BeiGene Announces Inclusion in the China National Reimbursement Drug List of Tislelizumab in Three New Indications, BRUKINSA? (Zanubrutinib) in One New Indication, and the First Listing for Pamiparib

12/02/2021 | 11:00pm EST

BeiGene announced that three of its medicines have been added to the most recent National Reimbursement Drug List (NRDL) in China by the National Healthcare Security Administration (NHSA). BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA? (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. The changes to the NRDL will be effective on January 1, 2022. The following indications have been included in the updated NRDL: Tislelizumab is now included in the NRDL in all five of its approved indications ? three new indications in 2021 and two indications included last year: For use in combination with pemetrexed and platinum chemotherapy as a first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), with EGFR genomic tumor aberrations negative and ALK genomic tumor negative (approved in June 2021 and included in the NRDL in 2021); For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy (conditionally approved in June 2021 and included in the NRDL in 2021); For use in combination with paclitaxel and carboplatin as a first-line treatment in patients with unresectable, locally advanced or metastatic squamous NSCLC (approved in January 2021 and included in the NRDL in 2021); For the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (conditionally approved in April 2020 and included in NRDL in 2020); and For the treatment of patients with classical Hodgkin?s lymphoma (cHL) who have received at least two prior therapies (conditionally approved in December 2019 and included in the NRDL in 2020). BRUKINSA is now included in the NRDL in all three of its approved indications ? one new indication in November 2021 and two indications included last year: For the treatment of adult patients with Waldenstr?m?s macroglobulinemia (WM) who have received at least one prior therapy (conditionally approved in June 2021 and included in the NRDL in 2021); For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020); and For the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020). Pamiparib is initially included in the NRDL in its approved indication: For the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (conditionally approved in May and included in the NRDL in 2021). Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc?R on macrophages. In pre-clinical studies, binding to Fc?R on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first approved medicine from BeiGene?s immuno-oncology biologics portfolio and is being further developed globally as a monotherapy and in combination with other agents for the treatment of a broad array of both solid tumor and hematologic cancers. The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. NMPA also granted conditional approval for the treatment of patients with cHL who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic UC with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with HCC who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials. In addition, four supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA and are under review for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC). In the United States, a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022. BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials. In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan. Tislelizumab is not approved for use outside of China.


ę S&P Capital IQ 2021
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Financials (USD)
Sales 2021 1 229 M - -
Net income 2021 -1 191 M - -
Net cash 2021 3 458 M - -
P/E ratio 2021 -21,0x
Yield 2021 -
Capitalization 24 519 M 24 519 M -
EV / Sales 2021 17,1x
EV / Sales 2022 15,2x
Nbr of Employees 7 600
Free-Float 67,7%
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Mean consensus BUY
Number of Analysts 15
Last Close Price 238,64 $
Average target price 410,10 $
Spread / Average Target 71,8%
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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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