BEIJING, China, and CAMBRIDGE, Mass., Oct. 24, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160),
a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and
immuno-oncology drugs for the treatment of cancer, today announced the acceptance by the China National Medical Products
Administration (NMPA) of a new drug application (NDA) for zanubrutinib, an investigational Bruton's tyrosine kinase (BTK)
inhibitor, for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL). Zanubrutinib was discovered in BeiGene’s research facilities in Beijing, China, and is being developed globally by
BeiGene as a monotherapy and in combination with other therapies to treat various hematologic malignancies. In August, the NMPA
accepted BeiGene’s first NDA for zanubrutinib for the treatment of patients with R/R mantle cell lymphoma (MCL).
“Our team has made three NDA submissions in China this year, including two for zanubrutinib and one for
tislelizumab, our investigational anti-PD-1 antibody. We are hopeful that these submissions, if approved, could further transform
BeiGene as well as bring important new treatment options to cancer patients,” commented John Oyler, co-founder, CEO and Chairman of
BeiGene.
“We are delighted that the submission for zanubrutinib in patients with relapsed/refractory CLL/SLL was accepted by
the NMPA in China, and we are excited to announce the top-line pivotal data for zanubrutinib in these patients, which demonstrated
a high overall response rate of 80 percent despite a relatively short follow-up. These results in China are also consistent with
the data from our global studies,” said Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd.
The NDA is supported by an extensive clinical, non-clinical and chemistry, manufacturing and control (CMC) data
package, including the results from a 91-patient single-arm pivotal Phase 2 study in Chinese patients with R/R CLL/SLL treated with
zanubrutinib, dosed at 160 mg orally twice daily. An independent review of response data from this study, with a data cut-off of
June 15, 2018 and a median follow-up of 9.1 months, showed an overall response rate (ORR) of 80 percent, inclusive of complete
response (2%), partial response (39%), and partial response with lymphocytosis (40%). The median duration of response has not been
reached, as a majority of the responders remain in a response. The safety profile was consistent with previously reported clinical
data for zanubrutinib. Updated data with additional follow-up of the patients in the study will be submitted to the NMPA as an
additional document of the NDA and are planned to be presented at an upcoming medical conference.
Zanubrutinib was recently granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the
treatment of patients with Waldenström macroglobulinemia (WM). BeiGene plans to submit an NDA to the FDA for zanubrutinib as a
potential treatment for patients with WM in the first half of 2019 based on results from a global Phase 1 study.
Zanubrutinib is being evaluated in a broad global registration program, including a fully enrolled Phase 3 clinical
trial in patients with WM, comparing zanubrutinib with ibrutinib, the currently approved BTK inhibitor for WM. Zanubrutinib is also
being studied in comparison to bendamustine/ rituximab in a Phase 3 clinical trial in patients with previously untreated CLL/SLL,
as well as in a pivotal randomized Phase 2 trial in combination with GAZYVA (obinutuzumab) in patients with R/R follicular
lymphoma. In China, besides the pivotal Phase 2 trials in R/R MCL and R/R CLL/SLL, BeiGene has completed enrollment in a pivotal
Phase 2 clinical trial in patients with WM. BeiGene also plans to initiate a Phase 3 trial comparing zanubrutinib to ibrutinib in
patients with R/R CLL/ SLL.
About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of non-Hodgkin lymphoma, a type of
blood cancer, that arise from B lymphocytes. CLL and SLL are essentially the same disease, with the only difference being the
location where the cancer primarily occurs.i When most of the cancer cells are located in the bloodstream and the bone
marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are
located mostly in the lymph nodes, the disease is called SLL.ii
About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is
currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other
therapies to treat various B cell malignancies.
About BeiGene
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and
immuno-oncology cancer therapeutics. With a team of over 1,700 employees in China, the United States, Australia and Switzerland,
BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also
working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets
ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA®
(azacitidine) in China under a license from Celgene Corporation.iii
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws, including statements regarding BeiGene’s advancement of, and anticipated clinical
development, regulatory milestones and commercialization of zanubrutinib. Actual results may differ materially from those indicated
in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy
and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or
marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and
marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved;
BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on
third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene's
ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates,
as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on
Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings
with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release,
and BeiGene undertakes no duty to update such information unless required by law.
i “Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma” Fact Sheet, Lymphoma Research Foundation. Accessed at:
https://www.lymphoma.org/wp-content/uploads/2018/04/LRF_FACTSHEET_CLL_SLL.pdf
ii “Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,” Lymphoma Research Foundation. Accessed at:
https://www.lymphoma.org/aboutlymphoma/cll/
iii ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene
Corporation.
