8-K

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): November 7, 2018  

BEIGENE, LTD.
(Exact Name of Registrant as Specified in Charter)

Cayman Islands	001-37686	98-1209416
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

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:
	[   ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
	[   ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
	[   ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
	[   ]	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [   ]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]

Item 2.02. Results of Operations and Financial Condition.

On November 7, 2018, BeiGene, Ltd. (the “Company”) announced its financial results for the three and nine months ended September 30, 2018. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.

Item 8.01. Other Events.

In its press release dated November 7, 2018, the Company also provided an update on third quarter 2018 and recent business highlights and expected milestones for the remainder of 2018. The information in the press release attached hereto as Exhibit 99.1 set forth under the headings “Recent Business Highlights and Upcoming Milestones” and “Forward-Looking Statements” is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

On November 7, 2018, the Company issued a press release announcing that the first patient was dosed in a global Phase 3 clinical trial of its investigational BTK inhibitor zanubrutinib compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The full text of this press release is filed as Exhibit 99.2 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 by BeiGene, Ltd. on November 7, 2018
99.2	Press release issued by BeiGene, Ltd. on November 7, 2018

The portions of Exhibit 99.1 incorporated by reference into Item 8.01 of this Current Report on Form 8-K are being filed pursuant to such item. The remaining portions of Exhibit 99.1 are being furnished pursuant to Item 2.02 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release issued by BeiGene, Ltd. on November 7, 2018
99.2	Press release issued by BeiGene, Ltd. on November 7, 2018

SIGNATURE

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: November 7, 2018	By:	/s/ Scott A. Samuels
		Scott A. Samuels
		Senior Vice President, General Counsel

EX-99.1

EXHIBIT 99.1

BeiGene Reports Third Quarter 2018 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, Nov. 07, 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 reported recent business highlights and financial results for the third quarter and first nine months of 2018.

“We now have three new drug applications currently under review with the China National Medical Products Administration, for zanubrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, as well as mantle cell lymphoma, and for tislelizumab in patients with relapsed/refractory classical Hodgkin’s lymphoma. Our team has accomplished a great deal advancing these promising oncology treatments towards potential commercial availability in China,” said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene.

“The milestones this quarter pave the way for an exciting upcoming year that could further transform BeiGene,” continued Oyler. “We expect to launch two innovative internally developed products in China, as well as have results from our global head-to-head study comparing zanubrutinib to ibrutinib in 2019.”

Recent Business Highlights and Upcoming Milestones

Clinical Programs

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

• We are engaged in a series of continuing discussions with national regulatory authorities regarding new drug applications (NDAs) for zanubrutinib in Waldenström's macroglobulinemia (WM) and other indications. We had previously announced a plan, based on discussions with the U.S. Food and Drug Administration (FDA), to file for accelerated approval in WM in the first half of 2019. Based on recent discussions with the FDA regarding our filing plans, we are revising guidance around the timing of our first NDA filing for zanubrutinib in the United States. We now expect to submit an initial NDA for zanubrutinib in the United States in 2019 or early 2020;
  
  
• Submitted and received acceptance from the China National Medical Products Administration (NMPA) for our NDA for patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL);
  
  
• Submitted and received acceptance by the NMPA for our NDA for patients with R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);
  
  
• Initiated a global head-to-head Phase 3 trial versus ibrutinib in R/R CLL or SLL;
  
  
• Announced updated results from the Phase 1 clinical trial in patients with WM that were presented at the 10^th International Workshop on Waldenström's Macroglobulinemia (IWWM). These data, in 73 evaluable patients with WM, continued to demonstrate that zanubrutinib was associated with high rates of overall (92%), major (82%) and very good partial response (VGPR; 41%) and was generally well-tolerated; and
  
  
• Announced preliminary results from the Phase 1 clinical trial in Chinese patients with B-cell lymphomas from an oral presentation at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO).

Expected Upcoming Milestones in 2018

• Present full results of the pivotal Phase 2 trial in Chinese patients with R/R MCL in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting, taking place December 1 to 4, 2018 in San Diego, CA;
  
  
• BeiGene will hold an investor webcast from ASH on Monday, December 3, at 8:00 pm PST. A live webcast and replay of the event will be available on BeiGene’s investor website, http://ir.beigene.com;
   
• Present updated safety and activity data from a global Phase 1 study in patients with MCL at ASH; and
  
  
• Initiate a global Phase 2 trial in patients with R/R marginal zone lymphoma (MZL).

Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

• Submitted and received acceptance from the China NMPA of our first NDA for tislelizumab as a treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL);
  
  
• Announced preliminary results from the Phase 2 clinical trial in China of tislelizumab combined with chemotherapy as first-line treatment in patients with advanced lung cancer; and announced preliminary results of tislelizumab from the Phase 1/2 clinical trial in China in patients with non-small cell lung cancer from presentations at CSCO and the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC);
  
  
• Announced preliminary results from the Phase 1/2 trial in China in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors at CSCO;
  
  
• Completed enrollment in the Phase 2 pivotal trial in China for urothelial bladder cancer; and
   
• Initiated the following trial:
  
  °  A Phase 2 trial in Chinese patients with MSI-H or dMMR solid tumors.

Expected Upcoming Milestones in 2018

• Present data from the pivotal Phase 2 trial of tislelizumab in Chinese patients with R/R cHL in an oral presentation at ASH;
  
  
• Present updated data from expansion cohorts in the Phase 1 trial at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) congress; and
  
  
• Initiate additional global randomized frontline pivotal Phase 3 clinical trials in gastric and esophageal cancers in 2018 or early 2019, as well as additional pivotal trials in China in 2019.

Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

• Announced preliminary clinical data from an ongoing Phase 1 trial of pamiparib in combination with temozolomide in patients with locally advanced or metastatic solid tumors that were presented at the European Society for Medical Oncology (ESMO) 2018 Congress.

Expected Upcoming Milestones in 2018

• Present Phase 1/2 trial data on pamiparib in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or recurrent/refractory glioblastoma in an oral presentation at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), being held November 15-18 in New Orleans, LA.

Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

• Initiated a Phase 1 trial in China and Australia in combination with tislelizumab in patients with advanced solid tumors.

Commercial Programs in China

• Generated $38.45 million in product revenue from sales in China of ABRAXANE^®, REVLIMID^® and VIDAZA^® in the third quarter of 2018, a 22% increase quarter-over-quarter, and 146% growth compared to the fourth quarter of 2017, the first full quarter following the license of these products from Celgene; and
   
• Received national reimbursement in China from the State Medical Insurance Administration (SMIA) for VIDAZA^® (azacitidine for injection) for the treatment of patients with intermediate-2 / high-risk myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) with 20-30% bone marrow blasts and chronic myelomonocyte leukemia (CMML).

Corporate Developments

• Announced a global clinical collaboration with MEI Pharma, Inc. to evaluate the safety and efficacy of MEI's ME-401, an investigational PI3K delta inhibitor, in combination with zanubrutinib for the treatment of patients with B-cell malignancies;
  
  
• Announced a global clinical collaboration with SpringWorks Therapeutics to evaluate the safety, tolerability, and preliminary efficacy of combining lifirafenib and SpringWorks Therapeutics' investigational MEK inhibitor, PD-0325901, in patients with advanced solid tumors; and
  
  
• Appointed Dr. Jian (Jonathan) Liu as Senior Vice President of Bio-Manufacturing. Prior to joining BeiGene, Dr. Liu served on the Senior Leadership Team of Johnson & Johnson (J&J) Global Pharmaceutical Development & Manufacturing Sciences (PDMS) and China R&D, respectively, responsible for PDMS business strategy development and regional execution.

Third Quarter 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $2.10 billion as of September 30, 2018, compared to $1.40 billion as of June 30, 2018 and $837.52 million at December 31, 2017. The increase from the last quarter was primarily due to the net proceeds of $869.71 million from our global offering and listing on the Hong Kong Stock Exchange. Cash, cash equivalents, restricted cash and short-term investments as of September 30, 2018 include approximately $143.16 million held by our 95%-owned joint venture, BeiGene Biologics, to build a commercial biologics manufacturing facility under construction in Guangzhou, China, which includes restricted cash of $36.26 million related to BeiGene Biologics’ secured deposits.

Cash used by operations for the three months ended September 30, 2018 was $132.19 million, compared to cash generated by operations of $6.60 million for the same period in 2017. The increase in the use of cash was primarily attributable to the continued ramp-up in operating expenses in support of our ongoing and newly initiated late-stage pivotal clinical programs, preparation for regulatory filings and commercial launch of our late-stage drug candidates, and organizational growth, offset in part by revenue from product sales in China; in the prior period in 2017, cash generated by operations reflected receipt of the up-front payment from Celgene Corporation in connection with our license agreement for tislelizumab. Capital expenditures for the three months ended September 30, 2018 were $26.72 million, compared to $18.79 million for the same period in 2017. The increase was primarily attributable to the continued buildout of our manufacturing facility in Guangzhou.

Revenue for the three months ended September 30, 2018 was $54.20 million, compared to $220.21 million in the same period in 2017. The decrease is primarily attributable to the upfront payment recognized in the prior year period under our collaboration agreement with Celgene for tislelizumab.

• Product revenue from sales of ABRAXANE^®, REVLIMID^® and VIDAZA^® in China totaled $38.45 million for the third quarter of 2018, compared to $31.43 million for the three months ended June 30, 2018, and $8.82 million for the three months ended September 30, 2017 (which only included one month of product sales following the in-license from Celgene), respectively.
  
  
• Collaboration revenue totaled $15.76 million for the third quarter of 2018, compared to $21.38 million for the three months ended June 30, 2018, and $211.39 million for the three months ended September 30, 2017, respectively. The decrease, compared to the second quarter of 2018, is primarily due to lower research and development costs in the period on clinical trials that are being reimbursed by Celgene. The decrease, compared to the third quarter of 2017, is due primarily to the upfront revenue recognized in the third quarter of 2017 from the Celgene collaboration. 

Expenses for the three months ended September 30, 2018 were $205.30 million, compared to $105.31 million in the quarter ended September 30, 2017, consisting primarily of the following:

• Cost of sales for the three months ended September 30, 2018 were $8.71 million, compared to $1.94 million in the third quarter of 2017 (which only included one month of sales), an increase of 348.97 percent. Cost of sales relates to the cost of acquiring ABRAXANE^®, REVLIMID^® and VIDAZA^® for distribution in China.  
  
  
• R&D Expenses for the three months ended September 30, 2018 were $147.59 million, compared to $87.66 million in the same period in 2017, an increase of 68.4%. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory filings and commercial launch of our late-stage drug candidates, manufacturing costs related to pre-commercial activities and supply, as well as increases in spending related to our preclinical-stage programs. The overall increase in R&D expenses was also attributable to increased R&D-related employee share-based compensation expense, which was $15.52 million for the three months ended September 30, 2018, compared to $10.38 million for the same period in 2017, due to increased headcount and a higher share price.
  
  
• SG&A Expenses for the three months ended September 30, 2018 were $48.82 million, compared to $15.64 million in the same period in 2017, an increase of 212.1%. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our existing commercial products in China and the potential launches of our late-stage drug candidates, higher professional service fees and costs to support our growing operations, and higher SG&A-related share-based compensation expense, which was $9.61 million for the three months ended September 30, 2018, compared to $2.95 million for the same period in 2017, due to increased headcount and a higher share price.
  
  
• Net Loss for the third quarter of 2018 was $144.03 million, or $2.53 per American Depositary Share (ADS), compared to net income of $117.39 million, or $2.79 per ADS in the same period in 2017. For the third quarter of 2018, net loss per ordinary share was $0.19, compared to net income of $0.21 in the same period in 2017.

______________________

Financial Summary

Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)

	As of
	September 30,		December 31,
	2018		2017
	(unaudited)		(audited)
Cash, cash equivalents, restricted cash and short-term investments	$	2,101,072	$	837,516
Accounts receivable		37,372		29,428
Unbilled receivables		4,878		—
Working capital		1,991,771		763,509
Property and equipment, net		111,262		62,568
Total assets		2,408,627		1,046,479
Accounts payable		85,552		69,779
Accrued expenses and other payables		75,882		49,598
Bank loan [1]		49,560		18,444
Shareholder loan		146,409		146,271
Total liabilities		425,196		362,248
Noncontrolling interest		12,985		14,422
Total equity	$	1,983,431	$	684,231
[1]  The bank loan attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd, totaled $40.82 million as of September 30, 2018.

Condensed Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. Dollars, except for number of American Depositary Shares (ADSs) and per ADS data) (unaudited)

		Three Months Ended September 30,						Nine Months Ended September 30,
		2018			2017			2018			2017
Revenue
Product revenue, net	$	38,447		$	8,822		$	93,123		$	8,822
Collaboration revenue		15,755			211,391			46,427			211,391
Total revenues		54,202			220,213			139,550			220,213
Expenses:
Cost of sales – products		(8,706	)		(1,944	)		(19,512	)		(1,944	)
Research and development		(147,590	)		(87,660	)		(421,541	)		(177,678	)
Selling, general and administrative		(48,820	)		(15,641	)		(122,895	)		(35,187	)
Amortization of intangible assets		(188	)		(63	)		(563	)		(63	)
Total expenses		(205,304	)		(105,308	)		(564,511	)		(214,872	)
(Loss) income from operations		(151,102	)		114,905			(424,961	)		5,341
Interest income (expense), net		4,553			(1,785	)		7,997			(3,581	)
Other income, net		1,585			1,103			2,389			1,541
(Loss) income before income taxes		(144,964	)		114,223			(414,575	)		3,301
Income tax benefit		472			3,061			7,252			2,680
Net (loss) income	$	(144,492	)	$	117,284		$	(407,323	)	$	5,981
Less: Net loss attributable to noncontrolling interest		(461	)		(102	)		(1,809	)		(237	)
Net (loss) income attributable to BeiGene, Ltd.	$	(144,031	)	$	117,386		$	(405,514	)	$	6,218
Net (loss) income attributable to Beigene, Ltd. per ADS:
Basic	$	(2.53	)	$	2.79		$	(7.49	)	$	0.15
Diluted	$	(2.53	)	$	2.54		$	(7.49	)	$	0.14
Weighted-average ADSs outstanding:
Basic		56,906,867			42,118,973			54,114,038			40,563,845
Diluted		56,906,867			46,200,975			54,114,038			43,172,139
Net (loss) income per share attributable to BeiGene, Ltd.
Basic	$	(0.19	)	$	0.21		$	(0.58	)	$	0.01
Diluted	$	(0.19	)	$	0.20		$	(0.58	)	$	0.01
Weighted-average ordinary shares outstanding:
Basic		739,789,269			547,546,656			703,482,491			527,329,985
Diluted		739,789,269			600,612,680			703,482,491			561,237,818

Condensed Consolidated Statements of Comprehensive Loss (U.S. GAAP)
(Amounts in thousands of U.S. Dollars) (unaudited)

		Three Months Ended September 30,						Nine Months Ended September 30,
		2018			2017			2018			2017
Net (loss) income	$	(144,492	)	$	117,284		$	(407,323	)	$	5,981
Other comprehensive loss, net of tax of nil:
Foreign currency translation adjustments		(4,217	)		341			(1,912	)		985
Unrealized holding gain, net		354			51			1,402			58
Comprehensive (loss) income		(148,355	)		117,676			(407,833	)		7,024
Less: Comprehensive loss attributable to noncontrolling interests		(486	)		(70	)		(1,812	)		(178	)
Comprehensive (loss) income attributable to BeiGene, Ltd.	$	(147,869	)	$	117,746		$	(406,021	)	$	7,202

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.ⁱ 

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 for BeiGene’s product candidates and product revenue for its products; the advancement of and anticipated clinical development and regulatory milestones for its product candidates; and our plans and the expected milestones under the caption “Recent Business Highlights and Upcoming Milestones”. 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.

Investor Contact	Media Contact
Craig West	Liza Heapes
+1 857-302-5189	+ 1 857-302-5663
ir@beigene.com	media@beigene.com
i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation.

EX-99.2

EXHIBIT 99.2

BeiGene Initiates Global Head-to-Head Phase 3 Clinical Trial of Zanubrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

CAMBRIDGE, Mass. and BEIJING, China, Nov. 07, 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 first patient was dosed in a global Phase 3 clinical trial of its investigational BTK inhibitor zanubrutinib compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

“We continue to be encouraged by data on zanubrutinib in various B-cell malignancies and are excited to further expand the development program for zanubrutinib in CLL and SLL with this Phase 3 trial, which represents the second Phase 3 study directly comparing zanubrutinib to ibrutinib,” said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.

The global Phase 3 open-label trial is expected to enroll approximately 400 patients with relapsed/refractory CLL or SLL across approximately 150 study centers in the U.S., China, Europe, Australia and New Zealand. Patients will be randomized in a one-to-one manner to either zanubrutinib (160 mg orally twice daily) or ibrutinib (420 mg orally once daily). The primary endpoint is overall response rate, as determined by independent central review. Key secondary endpoints include progression-free survival, duration of response, overall survival, patient-reported outcomes, and safety.

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). New drug applications (NDAs) in China for zanubrutinib as a treatment for patients with mantle cell lymphoma (MCL) and for patients with relapsed/refractory CLL or SLL, have been accepted for review by the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA).

Zanubrutinib is being studied in a broad registration program. In addition to this newly initiated Phase 3 trial, it is also being evaluated in a fully enrolled, global Phase 3 clinical trial in patients with WM comparing zanubrutinib to ibrutinib, a global Phase 3 clinical trial in patients with previously untreated CLL, and a pivotal Phase 2 trial in combination with GAZYVA^® (obinutuzumab) in patients with relapsed/refractory follicular lymphoma. In China, in addition to the MCL and CLL filings, BeiGene has completed enrollment in another pivotal Phase 2 clinical trial of zanubrutinib in patients with WM.

For more information about the trial, patients and physicians should email BeiGene at clinicaltrials@beigene.com.

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.¹ 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.²

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.³

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 and regulatory milestones and plans related to 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.

Investor Contact	Media Contact
Craig West	Liza Heapes
+1 857-302-5189	+ 1 857-302-5663
ir@beigene.com	media@beigene.com

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¹ “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

² “Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,” Lymphoma Research Foundation. Accessed at: https://www.lymphoma.org/aboutlymphoma/cll/

³ ABRAXANE^®, REVLIMID^® and VIDAZA^® are registered trademarks of Celgene Corporation.