UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

 

Date of Report (Date of earliest event reported):   March 2, 2017

 

BEIGENE, LTD.

(Exact name of registrant as specified in its charter)

 

Cayman Islands
(State or other jurisdiction
of incorporation)

 

001-37686
(Commission File Number)

 

98-1209416
(I.R.S. Employer Identification No.)

 

c/o Mourant Ozannes Corporate Services (Cayman) Limited

94 Solaris Avenue, Camana Bay

Grand Cayman KY1-1108

Cayman Islands

(Address of principal executive offices) (Zip Code)

 

+1 (345) 949 4123

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


 

Item 8.01                                            Other Events.

 

On March 2, 2017, BeiGene, Ltd. (the “Company”) issued a press release announcing the dosing of the first patient in a pivotal clinical trial of BGB-3111, an investigational Bruton’s Tyrosine Kinase inhibitor, designed to investigate the efficacy and safety of BGB-3111 in Chinese patients with relapsed or refractory mantle cell lymphoma. The full text of the Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01                                            Financial Statements and Exhibits.

 

(d)          Exhibits.

 

Exhibit No.

 

Description

99.1

 

Press Release issued on March 2, 2017

 

2


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

BEIGENE, LTD.

 

 

 

 

Date: March 2, 2017

By:

/s/ Howard Liang

 

Name:

Howard Liang

 

Title:

Chief Financial Officer and Chief Strategy
Officer

 

3


 

Exhibit Index

 

Exhibit No.

 

Description

99.1

 

Press Release issued on March 2, 2017

 

4

Exhibit 99.1

 

BeiGene,Ltd.

 

 

BeiGene Announces Initiation of Pivotal Study in China

 

for BTK Inhibitor, BGB-3111

 

BEIJING, March 2, 2017 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the dosing of the first patient in a pivotal clinical trial of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, in Chinese patients with relapsed or refractory mantle cell lymphoma (MCL). BGB-3111 is also currently being evaluated in a global Phase III study in comparison with ibrutinib for the treatment of patients with Waldenström’s Macroglobulinemia.

 

“We are pleased to announce the beginning of the first pivotal clinical trial of BGB-3111 in China. BGB-3111 has been under clinical investigation since August 2014, and over 300 patients with various B-cell malignancies have been treated with BGB-3111 in Australia, New Zealand, the United States, Korea, and China,” commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

 

“The initiation of the first pivotal trial in China with one of our portfolio compounds is an important step towards our goal of advancing innovative cancer treatments for patients in China,” commented Lai Wang, Ph.D., Head of China Development.

 

The Phase II single-arm, open-label, multi-center study is designed to investigate the efficacy and safety of BGB-3111 in patients with relapsed or refractory MCL. The study’s primary endpoint is the objective response rate, defined as achievement of either a partial response or complete response at any time on study drug. Secondary endpoints include progression free survival, duration of response, time to response, safety, and tolerability. Professor Jun Zhu of the Beijing Cancer Hospital is the lead principal investigator of the trial.

 


 

About BGB-3111

 

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib (the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency) based on biochemical assays , higher exposure than ibrutinib based on their respective Phase I experience, and sustained 24-hour BTK occupancy in both the blood and the lymph node.

 

About BeiGene

 

BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 300 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients.

 

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 the encouraging clinical data of BGB-3111, the potential implications of these data for the future development of BGB-3111, and BeiGene’s advancement of, and anticipated clinical development and regulatory milestones and plans related to BGB-3111. 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; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene’s ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene’s reliance on third parties to conduct preclinical studies and clinical trials; 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.

 

Investor/Media Contact

 

Lucy Li, Ph.D.

+1 781-801-1800

ir@beigene.com

media@beigene.com