Shanghai Henlius Biotech : VOLUNTARY ANNOUNCEMENT - FIRST PATIENT HAS BEEN DOSED IN A PHASE 2 CLINICAL TRIAL OF RECOMBINANT HUMANISED ANTI-PD-1 MONOCLONAL ANTIBODY INJECTION HLX10 IN COMBINATION WITH RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY INJECTION HLX07 AS THERAPY FOR RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC)

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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

FIRST PATIENT HAS BEEN DOSED IN A PHASE 2

CLINICAL TRIAL OF RECOMBINANT HUMANISED ANTI-PD-1

MONOCLONAL ANTIBODY INJECTION (HLX10) IN COMBINATION WITH RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY INJECTION (HLX07) AS THERAPY FOR RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS

CELL CARCINOMA (HNSCC)

1. INTRODUCTION
   This announcement is made by Shanghai Henlius Biotech, Inc. (the "Company") on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business development of the Company.
   The board of directors of the Company (the "Board") is pleased to announce that, today, the first patient has been dosed in a Phase 2 clinical trial of Recombinant Humanised Anti-PD-1 Monoclonal Antibody Injection ("HLX10") in combination with Recombinant Anti-EGFR Humanised Monoclonal Antibody Injection ("HLX07") as therapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in mainland China (excluding Hong Kong, Macau and Taiwan region, the same as below).
2. DESIGN AND PURPOSE OF THE STUDY
   This is an open-label, Phase 2 clinical study to evaluate the clinical efficacy and safety in HLX10 combined with HLX07 in patients with advanced recurrent or metastatic head and neck tumours. The study primarily aims to assess the objective response rate at week 16 and the safety profile of HLX10 in combination with HLX07 in patients with advanced head and neck squamous cell carcinoma. Secondary objectives include evaluating other efficacy endpoints, immunogenicity and pharmacokinetics file. Exploratory objective includes identifying biomarkers for therapeutic response and/or drug resistance.

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1. DETAILS OF THE STUDY ON THE DRUG CANDIDATES INVOLVED IN THE COMBINATION THERAPY
   HLX10 is an innovative biologic drug independently developed by the Company and is intended to be used for the treatment of solid tumours. Currently, we are further exploring the possibility of it being used to treat chronic hepatitis B. HLX07 is an improved innovative biologic drug targeting EGFR independently developed by the Company and is expected to be used for the treatment of various solid tumour indications such as colorectal cancer and nasopharyngeal cancer. As at the date of this announcement, details in respect of the drug candidates involved in the combination therapy (HLX10 and HLX07) and studies on the relevant combination therapies are as follows:

	Indications	Stage
HLX10	Unresectable or metastatic microsatellite	Phase 2 clinical trial in mainland
	instability-high or mismatch repair-	China
	deficient solid tumour that fails to
	respond to the standard therapy
	Solid tumour	Phase 1 clinical trial in Taiwan region
	Solid tumour	Clinical trial approval obtained in the
	USA
	Chronic hepatitis B	Phase 2 clinical trial in Taiwan region
HLX07	Solid tumour	Phase 1a clinical trial completed in
	Taiwan region
	Solid tumour	Clinical trial approval obtained in the
	USA
	Solid tumour	Phase 1b/2 clinical trial in mainland
	China
HLX10+	Locally advanced/metastatic esophageal	Phase 3 clinical trial in mainland
chemotherapy	squamous cell carcinoma	China
	Locally advanced or metastatic squamous	Phase 3 clinical trial in mainland
	non-small cell lung cancer	China and Turkey (international multi-
	centre trials)
	Untreated extensive-stage small cell	Phase 3 clinical trial in mainland
	lung cancer	China and Turkey (international multi-
	centre trials)
		Phase 3 clinical trial in mainland
	Gastric cancer	China (international multi-centre
		trials)
	Advanced cervical cancer	Phase 2 clinical trial in mainland
	China

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	Indications	Stage
HLX10+HLX04	Advanced solid tumour	Phase	1	clinical	trial	in	mainland
	China
	Advanced hepatocellular carcinoma	Phase	2	clinical	trial	in	mainland
	China
	Metastatic non-squamousnon-small cell	Phase 3	clinical	trial	in mainland
	lung cancer	China
HLX10+HLX07	Recurrent or metastatic head and neck	Phase 2	clinical	trial	in mainland
	squamous cell carcinoma	China

1. MARKET CONDITION
   As at the date of this announcement, no similar combination therapy has received the approval for commercialisation from the National Medical Products Administration in mainland China.
   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 develop and ultimately commercialize HLX10 and HLX07 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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