Hi Adrienne,

Thank you for the submission, we have scheduled IND 125326/0642 DSUR No.5 request
submission for 22-September-2020 (Tuesday).

Please find the below work zone link of draft Form-1571 and Cover Letter for your
review and signature.

Work Zone Link: https://parexel.sharedwork.com/doc/ZD03MTM2MDI0Ng

We are working on the submission. We will let you know in some time.

Hi Adrienne,

Thank you for the update. we will reschedule the submission to 21 September 2020
(Monday).

Hi Julie,

Thank you for the submission request. We have planned IND 125326/0644 - CMC Annual
Report due for 22 September 2020 (Tuesday). Upon receiving all the documents for
the submission, we shall confirm you the timelines for review.

Please find the attached files of draft form and cover letter for your review and
signature.

Hi Cassy,

As per the submission planner tracker provided by Bryan we have planned IND
128234/SN0177 Type C meeting request for BGB-290-302 on 23-Sep-2020 (Wednesday).

Kindly let us know when can we expect the documents for the submission. Upon
receiving all the documents for the submission, we shall confirm you the timelines
for review.

Please find the below work zone link of draft form and cover letter for your review
and signature.

Work zone link: https://parexel.sharedwork.com/doc/ZD03MTQzMzMyNw

Thank you for providing the documents, We shall confirm you the time line for you
review once we have the signed cover letter and form.

Attached are cover letter and form for your review and signature and they were also
uploaded to work zone link provided in previous mail.

Thank you for providing the documents. We will let you know once the submission is
ready for review and approval.
217,256-yellow

� Updated the CL templates (128234,130453, 140222)

H:\Clients\BeiGene\Z-Drive\Project Management\Process Cue Cards\Monthly Forecast
from BeiGene\2020\septemeber

Hi Amena,

Please let us know when can we expect the documents. Upon receiving all the
documents we will let you know once the submission is ready for your review and
approval.

Hi Adrienne,

Thank you for the approval, we will process the submission to FDA and let you know
once the acknowledgements posted.

Hi Renee,

As instructed we have edited the cover Letter as - Cover Letter � 2020-10-15 � New
Investigator Information [new-0010]. The Submission is ready for your review in AWS
Final folder.

Kindly review the same and let us know for any changes. Please find the below
screenshot for your reference.

Thank you for the providing the document. We will notify once the submission is
ready for review.

Hi Anna,

IND 135699/SN0176 - Investigator Update for Study BGB-A317-302 submission is ready

for your review in AWS Final folder. Please review the same and let us know for any
changes.

Path: R:\Final\ind135699\0176

I4V Path: https://i4v-p.beigenecorp.net:8443/I4V?

fromURL=true&application=ind135699&submission=0176&viewType=sequence&dossierFormat=
eCTD&selectedID=_

IND 130453/SN0206 - New Investigator for Study BGB-A317-290-LTE1 submission is

ready for your review in AWS Final folder. Please review the same and let us know
for any changes.

Path: R:\Final\ind130453\0206

I4V Path: https://i4v-p.beigenecorp.net:8443/I4V?

fromURL=true&application=ind130453&submission=0206&viewType=sequence&dossierFormat=
eCTD&selectedID=_

NOTE: Watermark is available in �Bendell-Johanna-20200923-BGB-A317-290-LTE1-

1572.pdf� � Please confirm.
Hi Karen,

Thank you for the mail, unfortunately we don�t have the cover letter and 1571
templates for IND 152268. Hope Bryan Noel or Sandra Rivas can help you in getting
the templates.

Please let us know for more information and do share us the templates if you get
them from BeiGene Team.

Hi Tiffany,

As per the submission planning tracker provided we have planned IND 152541/SN0001
�MRL for Type B for pre-IND 152541 Submission due for 19 November 2020 (Thursday).

Upon receiving all the documents for the submission, we shall confirm you the
timelines for review. Kindly provide us the templates for form and cover letter of
IND 152541.

Hi Magdelyn,

Please let us know when can we expect the documents for the submission. This is due
today Dec 4, 2020.

Hi Anna,

Thank you for the submission request, we have scheduled the submission for Jan 07
next available sequence No: 0021

Dear Ninon,

Thank you for the approval. We will dispatch the submission to FDA and share the
acknowledgements once available.

FKSB-R-MD-023-01

Hi Ninon,

We could see some page disturbances after assinging the documents into eCTD Manager
for both PFS(Part B,D) and AI(A,B&D).

Thank you for the update. We will start creating the sequence, assign the available
documents and send them for your review when we have all the approved documents.