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MarketScreener Homepage  >  Equities  >  Hong Kong Stock Exchange  >  Shanghai Henlius Biotech, Inc.    2696   CNE100003N76

SHANGHAI HENLIUS BIOTECH, INC.

(2696)
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INSIDE INFORMATION ANNOUNCEMENT - MARKETING AUTHORIZATION APPLICATION (MAA) FOR HLX02 (TRASTUZUMAB FOR INJECTION, EU TRADE NAME: ZERCEPAC) BEING APPROVED BY THE EUROPEAN COMMISSION (EC)

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07/29/2020 | 12:10am EDT

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)

INSIDE INFORMATION ANNOUNCEMENT

MARKETING AUTHORIZATION APPLICATION (MAA) FOR HLX02 (TRASTUZUMAB FOR INJECTION, EU TRADE NAME: ZERCEPAC®)

BEING APPROVED BY THE EUROPEAN COMMISSION (EC)

  1. INTRODUCTION
    This announcement is made by Shanghai Henlius Biotech, Inc. (the "Company") pursuant to Rule 13.09 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited ("Listing Rules") and the Inside Information Provisions (as defined in the Listing Rules) under Part XIVA of the Securities and Futures Ordinance (Chapter 571, Laws of Hong Kong).
    The board of directors of the Company (the "Board") is pleased to announce that Marketing Authorization Application ("MAA") for HLX02 (trastuzumab for injection, EU trade name: Zercepac®) ("HLX02") submitted by Accord Healthcare S.L.U., a wholly-owned subsidiary of the Company's business partner Accord Healthcare Limited ("Accord"), has recently been approved by the European Commission ("EC"). HLX02 is potentially for the treatment of HER2-positiveearly-stage breast cancer, HER2-positive metastatic breast cancer and untreated HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. Upon being approved, a centralized marketing authorization in respect of HLX02 is granted in all EU Member States as well as in Iceland, Liechtenstein and Norway (each a European Economic Area (EEA) country).
  2. BASIS FOR THE APPROVAL
    The approval of EC is mainly based on the review of a series of study data of HLX02, including analytical characterization studies, preclinical studies and clinical studies. These data prove that HLX02 and reference listed drug (Herceptin®) are highly similar in terms of quality, safety and efficacy.
    In April 2020, Shanghai Henlius Biopharmaceutical Co., Ltd. (上海復宏漢霖生物製藥有 限公司), a wholly-owned subsidiary of the Company, received two Certificates of GMP Compliance of a Manufacturer from Poland's Chief Pharmaceutical Inspector. The Company's drug substance (DS) line and drug product (DP) line for HLX02 trastuzumab biosimilar at Xuhui District, Shanghai have successfully passed the Good Manufacturing Practice (GMP) on-site inspection by the EU. In May 2020, the MAA of HLX02 submitted by Accord Healthcare S.L.U. was adopted a positive opinion and recommended approval for MAA from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

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  1. ABOUT HLX02
    HLX02 is a monoclonal antibody biosimilar independently developed by the Company in accordance with the guiding principles on biosimilar in the PRC and EU, for the treatment of HER2-positiveearly-stage breast cancer, HER2-positive metastatic breast cancer and untreated HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. In April 2019, the NDA of HLX02 was accepted by the National Medical Products Administration ("NMPA") and has been assigned to the priority review and approval list by the NMPA.
    As of the date of this announcement, the trastuzumab available in the EU and Iceland, Liechtenstein and Norway (each an EEA country) include Herceptin® of Roche, Herzuma® of Celltrion, Ontruzant® of Samsung Bioepis, etc. According to the information provided by IQVIA MIDASTM (IQVIA is a world-leading provider of professional medical and health information and strategic consultation), in 2019, the sales of trastuzumab in the EU and Iceland, Liechtenstein and Norway (each an EEA country) were approximately USD1.368 billion.
    WARNING STATEMENT REQUIRED BY RULE 18A.05 OF THE RULES GOVERNING THE LISTING OF SECURITIES ON THE STOCK EXCHANGE OF HONG KONG LIMITED: We may not be able to ultimately commercialise HLX02 successfully. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.

On behalf of the Board

Shanghai Henlius Biotech, Inc.

Qiyu CHEN

Chairman

Hong Kong, 29 July 2020

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, 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.

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Disclaimer

Shanghai Henlius Biotech Inc. published this content on 29 July 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 July 2020 04:10:15 UTC

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Financials
Sales 2020 707 M 102 M 102 M
Net income 2020 -776 M -111 M -111 M
Net Debt 2020 2 049 M 294 M 294 M
P/E ratio 2020 -36,6x
Yield 2020 -
Capitalization 28 068 M 4 029 M 4 029 M
EV / Sales 2020 42,6x
EV / Sales 2021 15,0x
Nbr of Employees 1 172
Free-Float 18,8%
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Mean consensus BUY
Number of Analysts 10
Average target price 61,52 CNY
Last Close Price 51,06 CNY
Spread / Highest target 41,1%
Spread / Average Target 20,5%
Spread / Lowest Target 0,73%
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Managers
NameTitle
Shi Gao Liu Chief Executive Office & Executive Director
Wen Jie Zhang President
Qi Yu Chen Chairman
Rong Li Feng Chairman-Supervisory Board
Zi Dong Zhang Chief Financial Officer
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