复宏汉霖HLX14地舒单抗120mg规格NDA获NMPA受理：拥挤赛道的程序性进展，无短线交易价值

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
NEW DRUG APPLICATION (NDA)
FOR 120 MG (1.7 ML) PER VIAL STRENGTH OF
BIOSIMILAR OF DENOSUMAB HLX14 (RECOMBINANT ANTI-RANKL
HUMAN MONOCLONAL ANTIBODY INJECTION) HAS BEEN ACCEPTED
BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA)
A.

INTRODUCTION
This announcement is made by Shanghai Henlius Biotech, Inc. (the “Company”, together
with its subsidiaries, the “Group”) 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 (the“Board”) of the Company is pleased to announce that, recently,
the New Drug Application (NDA) for the 120 mg (1.7 mL) per vial strength of a biosimilar
of denosumab HLX14 (recombinant anti-RANKL human monoclonal antibody injection)
(“HLX14”) independently developed by the Group, has been accepted by the Center for Drug
Evaluation of the National Medical Products Administration (NMPA).
This New Drug Application (NDA) covers the following indications: (1) Bone Metastases
from Solid Tumors and Multiple Myeloma: For the treatment of patients with bone metastases
from solid tumors or multiple myeloma, to delay or reduce the risk of skeletal-related events
(pathological fracture, spinal cord compression, radiation therapy to bone, or surgery to
bone); and (2) Giant Cell Tumor of Bone: For the treatment of giant cell tumor of bone
that is unresectable or for which surgical resection is likely to result in severe functional
impairment, including adults and adolescent patients with a mature skeleton (defined as
having at least one mature long bone and body weight ≥45 kg).

1

B.

BACKGROUND OF AND BASIS FOR SUBMISSION
The New Drug Application (NDA) for HLX14 was primarily based on data generated from
HLX14 compared with its reference drugs, including analytical similarity studies, non-clinical
and clinical comparative studies. These data demonstrated that HLX14 at the 120 mg
(1.7 mL) per vial strength is highly similar to its reference drug in terms of quality, safety,
and efficacy.

C.

ABOUT HLX14
HLX14 is a denosumab biosimilar independently developed by the Group. In the second
half year of 2025, two products of HLX14 (trade names in the United States and Europe:
BILDYOS ® and BILPREVDA ®) were approved for marketing in the United States, the
European Union and the United Kingdom, respectively. In March 2026, such products were
approved for marketing in Canada (trade names in Canada: BILDYOS® and TUZEMTY®).
BILDYOS® is indicated for osteoporosis and all other indications for which the reference
products have been approved in the local market, while BILPREVDA®/TUZEMTY ® is
indicated for cancer-related bone disease and all other indications for which the reference
products have been approved in the local market. In December 2025, the New Drug
Application (NDA) for HLX14 (60 mg/1.0 mL) was accepted by the Center for Drug
Evaluation of the National Medical Products Administration (NMPA).

D.

MARKET CONDITION
According to the latest data from IQVIA MIDASTM (provided by IQVIA, which is a global
provider of professional information and strategic consulting services for the pharmaceutical
and healthcare industry), the sales value of denosumab worldwide for the year of 2025 was
approximately US$8.092 billion.
On behalf of the Board
Shanghai Henlius Biotech, Inc.
Wenjie Zhang
Chairman

Hong Kong, 11 September 2026

As at the date of this announcement, the board of directors of the Company comprises Mr. Wenjie
Zhang as the chairman and non-executive director, Dr. Jun Zhu as the executive director, Mr. Qiyu
Chen, Mr. Yuqing Chen, Ms. Xiaohui Guan, Dr. Yi Liu and Dr. Xingli Wang as the non-executive
directors, and Mr. Tak Young So, Dr. Lik Yuen Chan, Dr. Ruilin Song and Mr. Yihao Zhang as the
independent non-executive directors.

2

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性
或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴
該等內容而引致的任何損失承擔任何責任。

Shanghai Henlius Biotech, Inc.
上海復宏漢霖生物技術股份有限公司
（於中華人民共和國註冊成立的股份有限公司）

（股份代號：2696）

自願公告
地舒單抗生物類似藥HLX14（重組抗RANKL全人單克隆抗體注射液）
120mg(1.7ml)/瓶規格的上市註冊申請(NDA)獲國家藥品監督管理局
(NMPA)受理
A. 緒言
本公告由上海復宏漢霖生物技術股份有限公司（「本公司」，連同其附屬公司
統稱「本集團」）自願作出，以告知本公司股東及潛在投資者本公司最新業務
更新。
本公司董事會（「董事會」）欣然宣佈，近日，本集團自主研發的地舒單抗生
物類似藥 HLX14（重組抗 RANKL 全人單克隆抗體注射液）
（「HLX14」）就
120mg(1.7ml)/瓶規格的上市註冊申請(NDA)獲國家藥品監督管理局(NMPA)
藥品審評中心受理。
本次上市註冊申請(NDA)涉及的適應症包括：(1)實體腫瘤骨轉移和多發性骨
髓瘤：用於實體腫瘤骨轉移患者或多發性骨髓瘤患者的治療，以延遲或降低
骨相關事件（病理性骨折、脊髓壓迫、骨放療或骨手術）的發生風險；及(2)骨
巨細胞瘤：用於治療不可手術切除或者手術切除可能導致嚴重功能障礙的骨
巨細胞瘤，包括成人和骨骼發育成熟（定義為至少1處成熟長骨且體重≥45kg)
的青少年患者。

1

B. 申報背景及依據
本次 H L X14 的上市註冊申請 ( NDA) 主要基於 H L X14 對比其參照藥產生的
數據，包括分析相似性研究、非臨床和臨床對比研究。這些數據論證了
120mg(1.7ml)/瓶規格的HLX14與其參照藥在質量、安全性和有效性方面的高
度相似。

C. 關於HLX14
HLX14 是本集團自主研發的地舒單抗生物類似藥，2025 年下半年，HLX14
兩個產品（美國及歐洲商品名：BILDYOS ® 以及BILPREVDA ®）分別於美國、
歐盟及英國獲批上市；2026年3月，該等產品（加拿大商品名：BILDYOS ® 及
TUZEMTY ®）於加拿大獲批上市。BILDYOS ® 可用於骨質疏鬆症等原研產品
於當地已獲批准的所有適應症，BILPREVDA ® /TUZEMTY ® 可用於骨相關事
件等原研產品已獲批准的所有適應症。2025年12月，HLX14 (60 mg/1.0 mL)
規格的上市註冊申請(NDA)獲國家藥品監督管理局(NMPA)藥品審評中心受
理。

D. 市場情況
根據IQVIA MIDAS TM 的最新數據（由IQVIA提供，IQVIA是全球醫藥健康產
業專業信息和戰略諮詢服務提供商），2025 年度，地舒單抗產品於全球範圍
內的銷售額約為80.92億美元。
代表董事會
上海復宏漢霖生物技術股份有限公司
主席
Wenjie Zhang
香港，二零二六年九月十一日

於本公告日期，本公司董事會包括主席及非執行董事Wenjie Zhang先生，執行董
事朱俊博士，非執行董事陳啟宇先生、陳玉卿先生、關曉暉女士、劉毅博士及
Xingli Wang博士以及獨立非執行董事蘇德揚先生、陳力元博士、宋瑞霖博士及
Yihao Zhang先生。

2