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SEC Comment Letter for BeOne Medicines Ltd. (ONC, BEIGF) (CIK 0001651308) (ONC) — Jul 12, 2017

BeOne Medicines Ltd. (ONC, BEIGF) (CIK 0001651308)
Date: July 12, 2017 · CIK: 0001651308 · Accession: 0000000000-17-024435

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
March 22, 2017
Author
/s/ Suzanne Hayes
Form
UPLOAD
Company
BeOne Medicines Ltd. (ONC, BEIGF) (CIK 0001651308)

Letter

Mail Stop 4546 July 1 2, 2017 VIA E -mail John V. Oyler Chief Executive Officer and Chairman BeiGene, Ltd. c/o Mourant Ozannes Corporate Services (Cayman) Limited 94 Solaris Avenue, Camana Bay Grand Cayman Cayman Islands

Re: BeiGene, Ltd. Form 10-K Filed March 22, 2017 File No. 001 -37686

Dear Mr. Oyler :

We have reviewed your filing an d have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure.

Please respond to these comments within ten busine ss days by providing the requested information or advis e us as soon as possible when you will respond. If you do not believe our comments app ly to your facts and circumstances , please tell us why in your response.

After reviewing your response to these comments, we may have additional comments. Our Clinical -Stage Drug Candidates, page 7 1. The tables included on pages 7 and 8 do not clearly d epict the development status of your product candidates. For example:

 To depict the stage of development, you have used the terms “Dose Escalation,” “Dose Expansion,” “Registration Trials,” “CTA Approval” and “Dose Confirmation/E xpansion.” These terms a re not defined and it is not clear how these terms correlate with the phases of clinical development described later in your document.  It is not clear from your tables how many phases of clinical development remain. Your table should depict all trials com pleted and all trials you must conduct prior to approval.  The first table on page 8 depicts the trials in China. It is unclear where the trials depicted in the other tables occurred.

John V. Oyler BeiGene, Ltd. July 1 2, 2017 Page 2

 With respect to the columns labeled “Potential Differentiation,” it is n ot clear what you are differentiating.

In future filings, please revise your tables to address these issues.

2. We note your disclosure on page 34 that initial analysis of data from your Phase 1 trials suggests that BGB -283 is well -tolerated with a favorabl e safety profile. In future filings, please remove references to “favorable” safety profiles. Your characterization that your drug candidate’s safety profile is “favorable” is a conclusion that is within the authority of the applicable regulatory authority .

PRC Regulation, page 61

3. We note your disclosures on page 63 that you “may” file an application for special examination and approval at the Clinical Trial Application stage, that registration applications for your four lead product candidates are filed under Category 1 and that the CFDA has approved your Clinical Trial Applications for your four lead product candidates. In future filings, please clarify the status of your registration applications, including whether you have secured special examina tion and approval under applicable regulations for any of your product candidates.

We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff.

Please contact Christine Westbrook at (202) 551 -5019 or me at (202) 551 -3675 with any questions.

Sincerely,
/s/ Suzanne Hayes
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

Show Raw Text
Mail Stop 4546
July 1 2, 2017
VIA E -mail
John V. Oyler
Chief Executive Officer and Chairman
BeiGene, Ltd.
c/o Mourant Ozannes Corporate Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman
Cayman Islands

Re: BeiGene, Ltd.
 Form 10-K
Filed March 22, 2017
File No. 001 -37686

Dear Mr. Oyler :

We have reviewed your filing an d have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.

Please respond to these comments  within ten busine ss days by providing the requested
information or advis e us as soon as possible when you will respond.  If you  do not believe our
comments app ly to your facts and circumstances , please tell us why in your response.

After reviewing your response to these comments, we may have additional comments.
Our Clinical -Stage Drug Candidates, page 7
1. The tables included on pages 7 and 8 do not clearly d epict the development status of
your product candidates.  For example:

 To depict the stage of development, you have used the terms “Dose Escalation,”
“Dose Expansion,” “Registration Trials,” “CTA Approval” and “Dose
Confirmation/E xpansion.”  These terms a re not  defined and it is not clear how these
terms correlate with the phases of clinical development described later in your
document.
 It is not clear from your tables  how many phases of clinical development remain.
Your table should depict all trials com pleted and all trials you must conduct prior to
approval.
 The first table on page 8 depicts the trials in China.  It is unclear where the trials
depicted in the other tables occurred.

John V. Oyler
BeiGene, Ltd.
July 1 2, 2017
Page 2

  With respect to the columns labeled “Potential Differentiation,” it is n ot clear what
you are differentiating.

In future filings, please revise your tables to address these issues.

2. We note your disclosure on page 34 that initial analysis of data from your Phase 1 trials
suggests that BGB -283 is well -tolerated with a favorabl e safety profile. In future filings,
please remove references to “favorable” safety profiles. Your characterization that your
drug candidate’s safety profile is “favorable” is a conclusion that is within the authority
of the applicable regulatory authority .

PRC Regulation, page 61

3. We note your disclosures on page 63 that you “may” file an application for special
examination and approval at the Clinical Trial Application stage, that registration
applications for your four lead product candidates are filed under Category 1 and that the
CFDA has approved your Clinical Trial Applications for your four lead product
candidates. In future filings, please clarify the status of your registration applications,
including whether you have secured special examina tion and approval under applicable
regulations for any of your product candidates.

We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.

Please contact Christine Westbrook  at (202) 551 -5019  or me at (202) 551 -3675  with any
questions.

Sincerely,

 /s/ Suzanne Hayes
 Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance