the small-moleculeinhibitor RX208 targeting V600E mutation in human BRAF protein (the "Licensed Product") (product code of the Company: HLX208)
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Licensed Product
NeuPharma (as the licensor)
the Company (as the licensee); and

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)

VOLUNTARY ANNOUNCEMENT

ENTERING INTO THE LICENSE AGREEMENT WITH

NEUPHARMA IN RESPECT OF

SMALL-MOLECULE INHIBITOR RX208 TARGETING V600E

MUTATION IN HUMAN BRAF PROTEIN

  1. INTRODUCTION
    Reference is made to the announcement of Shanghai Henlius Biotech, Inc. (the "Company") dated 28 March 2021 in relation to the entering into of a binding term sheet with Suzhou NeuPharma Co., Ltd.* ("NeuPharma") in respect of a small-molecule inhibitor RX208 targeting V600E mutation in human BRAF protein.
    The board of directors of the Company is pleased to announce that on 11 May 2021, the Company and NeuPharma entered into a drug technology license agreement (the "License Agreement").
  2. PRINCIPAL TERMS OF THE LICENSE AGREEMENT Parties

Cooperation

NeuPharma will grant the Company a sublicensable exclusive license

and License

for related licensed patents and licensed know-how necessary or

reasonably useful for the Company to research, develop, produce and

commercialize the Licensed Product within the Licensed Territory.

At the same time, the Company shall have the right to use the Licensed

Product for any human indications and any types of therapies (including

but not limited to monotherapy, combination therapy or cocktail

therapy).

Licensed Territory

China (including Hong Kong, Macau and Taiwan regions) (the

"Licensed Territory")

Payments and

The Company shall pay NeuPharma:

Royalties

upfront payment of an aggregate of RMB97.5 million depending

on the progress of the entering into of the License Agreement, the

issue of invoices by NeuPharma and the transfer of the technical

documents and materials in respect of the Licensed Products;

regulatory and commercial sales milestone payments of no

more than RMB1.0775 billion in aggregate based on various

development and commercial sales milestones of the Licensed

Product; and

the royalties of 8% to 12% of the annual net sales, which depends

on the level of annual net sales of the Licensed Product in the

Licensed Territory, except for the adjustments and/or deductions

made in accordance with the terms of the License Agreement.

Depending on the effective date of any sublicense, the Company may

need to share the profit from the sublicense with NeuPharma.

Term

Effective from 11 May 2021, until the expiry date of the royalty period

determined in accordance with the License Agreement for all regions in

the Licensed Territory, except for early termination as agreed between

the Company and NeuPharma or as made otherwise in accordance with

the License Agreement.

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  1. INFORMATION ABOUT THE LICENSED PRODUCT
    The Licensed Product is a small-molecule inhibitor targeting the human BRAF protein V600E mutation, which has exhibited excellent drug efficacy and safety in pre-clinical research and is currently in the stage of phase I clinical development. BRAF protein is an important upstream regulator of MAPK/ERK signaling pathway, and its V600E mutation can induce constitutive activity of BRAF protein. It is a potential drug target for a variety of tumors including colorectal cancer, thyroid cancer, melanoma and certain rare diseases including Erdheim-Chester disease (ECD).

On behalf of the Board

Shanghai Henlius Biotech, Inc.

Qiyu CHEN

Chairman

Hong Kong, 11 May 2021

As at the date of this announcement, the board of directors of the Company comprises Mr. Wenjie Zhang as the executive director, Mr. Qiyu Chen as the chairman and non-executive director, Mr. Yifang Wu, Ms. Xiaohui Guan, Dr. Aimin Hui and Mr. Zihou Yan as the non-executive directors, and Mr. Tak Young So, Dr. Lik Yuen Chan, Dr. Guoping Zhao and Dr. Ruilin Song as the independent non-executive directors.

  • For identification purpose only

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Shanghai Henlius Biotech Inc. published this content on 11 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 May 2021 10:51:04 UTC.