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MarketScreener Homepage  >  Equities  >  Shanghai Stock Exchange  >  Shanghai Fosun Pharmaceutical Group Co., Ltd.    600196   CNE000000X38

SHANGHAI FOSUN PHARMACEUTICAL GROUP CO.,

(600196)
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Shanghai Fosun Pharmaceutical : OVERSEAS REGULATORY ANNOUNCEMENT - Announcement in Relation to the Progress of New Drug Application Filing by Fosun Kite Biotechnology Co., Ltd.*

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03/15/2020 | 06:52am 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.

上 海 復 星 醫 藥( 集 團 )股 份 有 限 公 司

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*

(a joint stock limited company incorporated in the People's Republic of China with limited liability)

(Stock Code: 02196)

OVERSEAS REGULATORY ANNOUNCEMENT

This announcement is made pursuant to Rule 13.10B of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.

The following sets out the ''Announcement in Relation to the Progress of New Drug Application Filing by Fosun Kite Biotechnology Co., Ltd.*'' published by Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (the ''Company'') on the website of the Shanghai Stock Exchange, for your reference only. The following is a translation of the abovementioned announcement solely for the purpose of providing information. Should there be any discrepancies, the Chinese version will prevail.

By order of the Board

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*

Chen Qiyu

Chairman

Shanghai, the People's Republic of China

15 March 2020

As at the date of this announcement, the executive directors of the Company are Mr. Chen Qiyu, Mr. Yao Fang and Mr. Wu Yifang; the non-executive directors of the Company are Mr. Xu Xiaoliang and Ms. Mu Haining; and the independent non- executive directors of the Company are Mr. Jiang Xian, Dr. Wong Tin Yau Kelvin, Ms. Li Ling and Mr. Tang Guliang.

  • for identification purposes only

Stock code: 600196

Stock abbreviation: Fosun Pharma

Announcement No.: 2020-028

Bond code: 136236

Bond abbreviation: 16 Fosun 01

Bond code: 143020

Bond abbreviation: 17 Fosun 01

Bond code: 143422

Bond abbreviation: 18 Fosun 01

Bond code: 155067

Bond abbreviation: 18 Fosun 02

Bond code: 155068

Bond abbreviation: 18 Fosun 03

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* Announcement in Relation to the Progress of New Drug Application Filing by Fosun Kite Biotechnology Co., Ltd.*

The board of directors (the "Board") of the Company and all members of the Board warrant that this announcement does not contain any false information, misleading statement or material omission, and severally and jointly accept full responsibility for the truthfulness, accuracy and completeness of the contents herein contained.

I. Overview

Pursuant to the public announcement by the Center for Drug Evaluation under National Medical Products Administration (''NMPA''), Fosun Kite Biotechnology Co., Ltd.* (復星凱特生物 科技有限公司) ("Fosun Kite"; as at the date of this announcement, Shanghai Fosun Pharmaceutical Industrial Development Company Limited* (上海復星醫藥產業發展有限公司), a wholly-owned subsidiary of the Company, holding 50% of its share), a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (the "Company")'s New Drug Application (NDA) filing for Axicabtagene Ciloleucel (FKC876, an autologous CD19-directedCAR-T cell injection) has been granted priority review status.

II. Research Progress of the Product

The local production of the Product is conducted following the technology transfer of the autologous CD19-directedCAR-T cell injection (YESCARTA®) of Kite Pharma, Inc. ("Kite Pharma", a controlling subsidiary of Gilead Sciences, Inc.) in the United States, mainly for the treatment of adult patients with relapsed and refractory large B-cell lymphoma (including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-gradeB-cell lymphoma and DLBCL arising from follicular lymphoma). In October 2017, YESCARTA® was approved for marketing in the United States by the U.S. Food and Drug Administration (FDA). It is the world's first approved CAR-T cell therapy for adult patients with certain types of non-Hodgkin lymphoma (NHL). In August 2018, the commercialization of YESCARTA® in Europe was approved by the European Medicines Agency (EMA).

Fosun Kite initiated the technology transfer of the Product from Kite Pharma, and obtained technical and commercial rights in mainland China, Hong Kong SAR and Macau SAR, and proposed to carry out localized production in PRC (excluding Hong Kong and Macau SAR and Taiwan Region, similarly hereinafter). In August 2018, the Product obtained the Investigational

1

New Drug (IND) approval from NMPA. As at the date of this announcement, the bridging clinical trial of the Product for the treatment of adult patients with relapsed and refractory large B-cell lymphoma has been completed in PRC, and its New Drug Application (NDA) filing has been accepted by NMPA.

As at the date of this announcement, no same-class drug with the same target has been approved for marketing in PRC. The other CAR-T product has been approved by FDA so far is KYMRIAH® of Novartis Pharma Schweiz AG, which has the same target CD19 as Fosun Kite's FKC876 for the treatment of acute lymphoblastic leukemia in children and young adults (aged between 2 and 25) and relapsed/refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma) in adults. According to the financial reports issued by Gilead Sciences, Inc. and Novartis Pharma Schweiz AG, the global sales of YESCARTA® and KYMRIAH® in 2019 amounted to approximately US$456 million and US$278 million, respectively.

As at the end of January 2020, the cumulative R&D investment of Fosun Kite for the Product was approximately RMB474 million (including patent and technology license fee, unaudited) at this stage.

III. Risk Warning

The Product is subject to obtaining NDA approval and GMP certification before its commercial production can be carried out. The grant of priority review status for the drug commercialization registration will not have a material impact on the results of the Group (the Company and its subsidiaries) at this moment.

Due to the characteristics of pharmaceutical industry, the production of various products/drugs and the specific sales volume after production in the future may be affected by factors including changes in market conditions with great uncertainties. Investors are reminded of the investment risks.

Announcement is hereby given.

Board of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*

15 March 2020

* For identification purposes only

2

Disclaimer

Shanghai Fosun Pharmaceutical (Group) Co. Ltd. published this content on 15 March 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 March 2020 11:51:02 UTC

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Sales 2020 32 408 M 4 631 M 4 631 M
Net income 2020 3 526 M 504 M 504 M
Net Debt 2020 13 549 M 1 936 M 1 936 M
P/E ratio 2020 25,6x
Yield 2020 1,15%
Capitalization 85 253 M 12 178 M 12 182 M
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EV / Sales 2020 3,05x
Nbr of Employees 31 370
Free-Float 62,3%
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Mean consensus OUTPERFORM
Number of Analysts 10
Average target price 31,82 CNY
Last Close Price 35,54 CNY
Spread / Highest target 18,2%
Spread / Average Target -10,5%
Spread / Lowest Target -39,6%
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Managers
NameTitle
Yi Fang Wu President, CEO & Executive Director
Qi Yu Chen Co-Chairman
Fang Yao Co-Chairman
Qian Ren Chairman-Supervisory Board
Xiao Hui Guan CFO, Chief Accountant Officer & Senior VP