Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.
Shanghai Henlius Biotech, Inc.
上海復宏漢霖生物技術股份有限公司
(A joint stock company incorporated in the People's Republic of China with limited liability)
(Stock Code: 2696)
UPDATE ANNOUNCEMENT
IN RELATION TO THE COLLABORATION AND LICENSE
ARRANGEMENT WITH KG BIO
-
INTRODUCTION
Reference is made to the announcement (the "Announcement") issued by Shanghai Henlius Biotech, Inc. (the "Company") on 12 September 2019 in relation to the entering into of the Term Sheet with KG Bio for the collaboration arrangement for the Company's HLX10, a recombinant humanised monoclonal antibody against PD-1 being developed by the Company. Unless otherwise defined, capitalised terms used herein shall have the same meanings as those defined in the Announcement.
The Board of Directors of the Company is pleased to announce that on 30 September 2019, the Company entered into the Exclusive License Agreement (the "Exclusive License Agreement") with KG Bio. - MAJOR TERMS OF THE EXCLUSIVE LICENSE AGREEMENT
Parties | the Company (as Licensor); and KG Bio (as Licensee) |
Licensed Products | Pharmaceutical products that contains at least the HLX10 as |
an active ingredient, in relation to (i) the first monotherapy | |
for the treatment of solid tumour (MSI-high), provided that | |
this monotherapy is not approved by regulatory authority in | |
Indonesia, KG Bio is allowed to choose another monotherapy, | |
(ii) the two combination therapies in respect of which the | |
Licensee has agreed to sponsor through paying the relevant | |
milestone payments and funding of the relevant clinical | |
trials, and (iii) two new indications Licensee may in license | |
in accordance with the Exclusive License Agreement (each a | |
"Relevant Indication"). | |
Licensor will solely control, in its discretion, all development | |
activities related to HLX10 outside the Territory and shall use | |
commercially reasonable efforts to obtain and maintain market | |
approval for the Licensed Products in the PRC, and Licensee | |
shall be responsible for conducting all necessary activities | |
relating to obtaining and maintaining marketing approval for | |
Licensed Products in relation to the Relevant Indications in the | |
Territory. |
1
Collaboration and License Licensor will grant Licensee exclusive rights to | ||
(a) | use and reference the dossiers (technical, medical and | |
scientific submissions, applications, registrations, | ||
authorizations and approvals, all related correspondence | ||
with the regulatory authority and all documents | ||
referenced in the complete regulatory chronology) of | ||
the Licensed Product and related intellectual property | ||
and know-how of the Licensor to apply for marketing | ||
approvals in each country in the Territory, and | ||
(b) | commercialise the Licensed Product in the Territory | |
Licensor shall manufacture and supply the Licensed Product to | ||
Licensee for use in the development and commercialisation of | ||
the Licensed Products in the Territory. | ||
Territory | Each of Philippines, Indonesia, Malaysia, Singapore, Thailand, | |
Laos, Myanmar, Cambodia, Brunei and Vietnam | ||
Milestone Payments | Total | milestone payments for the license of the Licensed |
and Royalties | Product in the Territory comprise: | |
(1) | non-creditable payment of US$10 million within 45 | |
calendar days upon receipt of request for payment from | ||
Licensor, | ||
(2) | regulatory milestone payments not exceeding US$22 | |
million, within 60 business days after the date of | ||
achievement of the relevant milestones. Regulatory | ||
milestones refer to (a) the successful completion of the | ||
clinical study report for the first Phase 2/3 global study | ||
for HLX10 for a Relevant Indication or first Phase 2/3 | ||
China-based study for HLX10 for a Relevant Indication | ||
which has a position indication of being approved based | ||
on formal consultation with regulatory authority in the | ||
Territory, (b) obtaining the biologics license application | ||
approval for a Relevant Indication in the Territory and | ||
(c) obtaining marketing approval for each of the two new | ||
indications of HLX10 Licensee elects to in-license (other | ||
than the two combination therapies mentioned below); | ||
and | ||
(3) | after commercialisation of relevant Licensed Products, | |
commercial sales milestone payments not exceeding | ||
US$650 million depending on the level of cumulative net | ||
sales of Licensed Products. |
The Licensee shall also pay US$10 million to fund the trials of two combination therapies to be initiated and performed by Licensor.
Licensee will also pay to the Licensor fixed royalty of 15% or 18% of the annual net sales depending on the level of annual net sales of Licensed Products.
2
Term | The term of the Exclusive License Agreement shall commence |
on 30 September 2019 and will be valid for 10 years from the | |
first launch of any of the Licensed Product in the Territory, and | |
shall be automatically renewed every five years for a period of | |
five years, unless terminated earlier according to the Exclusive | |
License Agreement. |
- INFORMATION ABOUT HLX10
HLX10 is a recombinant humanised monoclonal antibody against PD-1 that the Company is developing to treat solid tumours and haematological tumours. As at the date of this announcement, the Company has obtained IND approvals for HLX10 in the US, China Mainland and Taiwan, and has commenced a Phase 2 clinical trial in China Mainland for HLX10 monotherapy. The Company is also exploring the possibility of developing HLX10 to treat HBV and has obtained an IND from TFDA for the HBV indication. In addition, HLX10 + Chemo (Cisplatin+5-FU) combination therapy is currently undergoing Phase 3 clinical trials for late stage mESCC, HLX10 + Chemo (Carboplatin+Nab-paclitaxel) combination therapy is currently undergoing Phase 3 clinical trials for late stage sqNSCLC, HLX10 + Chemo (Carboplatin+Etoposide) combination therapy is currently undergoing Phase 3 clinical trials for previously-untreatedextensive-stage SCLC and HLX10 + HLX04 (for HCC indication) has completed the first case of drug administration to patients in a Phase 2 clinical trial.
On behalf of the Board
Shanghai Henlius Biotech, Inc.
Qiyu CHEN
Chairman
Hong Kong, 30 September 2019
As at the date of this announcement, the board of directors of the Company comprises Dr. Scott Shi-Kau Liu as the executive director, Mr. Qiyu Chen as the chairman and non-executive director, Mr. Yifang Wu, Mr. Jiemin Fu, Dr. Aimin Hui and Ms. Xiaohui Guan as the non-executive directors, and Mr. Tak Young So, Dr. Lik Yuen Chan, Dr. Guoping Zhao and Mr. Ruilin Song as the independent non-executive directors.
3
Attachments
- Original document
- Permalink
Disclaimer
HKEx - Hong Kong Exchanges and Clearing Ltd. published this content on 30 September 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 September 2019 11:32:04 UTC