BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL)

IndustryPRwire -- BeiGene announced that three of its innovative oncology medicines have been included in the updated National Reimbursement Drug List (NRDL) by the China National Healthcare Security Administration (NHSA), including its internally-developed anti-PD-1 antibody tislelizumab, its internally-developed BTK inhibitor BRUKINSA® (zanubrutinib), and XGEVA® (120-mg denosumab) from its strategic collaboration with Amgen.

Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene Commented “The NRDL’s inclusion of tislelizumab, BRUKINSA, and XGEVA will help expand access to these high-quality oncology treatments across China and alleviate the financial burden for many cancer patients and their families. We believe this could have a profound impact on patients in the country that is home to roughly one-quarter of the world’s new cancer patients every year, We are appreciative of our team’s efforts and our collaboration with Amgen in developing and commercializing these medicines, and understand that this accomplishment would not have been possible without China’s commitment to innovative, high-quality treatments through ongoing drug reform and the Healthy China initiative.”

“With these NRDL inclusions, BeiGene is making significant strides towards our mission, which at its core is to expand access to and improve affordability of impactful innovative medicines for patients around the world. We look forward to more exciting progress on this endeavor,” added Dr. Wu.

The following conditionally approved indications have been included in the updated NRDL:

  • Tislelizumab for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies (approved in December 2019);
  • Tislelizumab 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 (approved in April 2020);
  • BRUKINSA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (approved in June 2020);
  • BRUKINSA for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least one prior therapy (approved in June 2020); and
  • XGEVA for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity (Amgen obtained approval of XGEVA in China in May 2019).

As part of its broad development program, BeiGene expects to work with the NHSA for potential NRDL inclusion in future expanded indications for these medicines. The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted and is reviewing a total of four supplemental new drug applications (sNDAs) or supplemental biologics applications (sBLAs) for tislelizumab and BRUKINSA, including:

  • Tislelizumab for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy (accepted in April 2020);
  • Tislelizumab for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy (accepted in June 2020);
  • Tislelizumab for previously treated patients with unresectable hepatocellular carcinoma (HCC) (accepted in July 2020); and
  • BRUKINSA for patients with relapsed/refractory (R/R) Waldenstr├Âm’s macroglobulinemia (WM) (accepted in October 2020, under priority review).

XGEVA has also received conditional approval in China for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM), which was not eligible for 2020 NRDL considerations as it was approved after the cutoff date.

In addition, the following NDAs or BLAs for product candidates in BeiGene’s pipeline have been accepted by the CDE and are currently under review, including:

  • Pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (accepted in July 2020, under priority review);
  • KYPROLIS® (carfilzomib), from BeiGene’s strategic collaboration with Amgen, in combination with dexamethasone for the treatment of patients with R/R MM who have received at least two prior therapies (accepted in November 2019); and
  • QARZIBA®▼ (dinutuximab beta), from BeiGene’s collaboration with EUSA Pharma, for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of R/R neuroblastoma with or without residual disease (accepted in November 2020, under priority review).

BeiGene Management Update Conference Call and Webcast Information

BeiGene will host an investor and analyst conference call and webcast to provide additional information on the NRDL listings on Monday, December 28 at 7:00 p.m. EST.

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