翰森制药阿美替尼重新递交欧盟上市申请并获EMA受理，集中审批启动

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.

Hansoh Pharmaceutical Group Company Limited
翰森製藥集團有限公司
(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 3692)

VOLUNTARY ANNOUNCEMENT
MARKETING AUTHORIZATION APPLICATION OF AUMOLERTINIB
IN THE EU RESUBMITTED AND VALIDATED BY THE EMA
Reference is made to the announcement of Hansoh Pharmaceutical Group Company Limited (the
“Company”, together with its subsidiaries, the “Group”) dated September 27, 2026 in respect of
the update on the marketing authorization status of Aumolertinib, marketed as Aumseqa® outside
China, in the European Union (the “EU”). Unless the context otherwise requires, capitalized words
and expressions used herein shall have the same meanings as defined in the said announcement.
The board of directors (the “Board”) of the Company announces that, on September 29, 2026, the
Group resubmitted the marketing authorization application (the “MAA”) of innovative medicine
Aumolertinib in the EU to the European Medicines Agency (the “EMA”), and, on October 7,
2026, the EMA has validated the new MAA and the centralized review procedure has officially
commenced. The indications are for: (i) the first-line treatment of adult patients with advanced
non-small cell lung cancer (“NSCLC”) whose tumours have Epidermal Growth Factor Receptor
(“EGFR”) exon 19 deletions or exon 21 (L858R) substitution mutations; and (ii) the treatment of
adult patients with advanced EGFR T790M mutation positive NSCLC.
By Order of the Board
Hansoh Pharmaceutical Group Company Limited
Zhong Huijuan
Chairlady
Hong Kong, October 11, 2026

As at the date of this announcement, the Board comprises Ms. Zhong Huijuan as chairlady
and executive director, Ms. Sun Yuan and Dr. Lyu Aifeng as executive directors, and Mr. Lin
Guoqiang, Mr. Chan Charles Sheung Wai, Ms. Yang Dongtao and Mr. Yan Jia as independent
non-executive directors.

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，概不對因本公告全部或任何部份內容而產生或因倚
賴該等內容而引致的任何損失承擔任何責任。

Hansoh Pharmaceutical Group Company Limited
翰森製藥集團有限公司
（於開曼群島註冊成立的有限公司）

（股份代號：3692）

自願公告
阿美替尼重新遞交歐盟上市許可申請
並獲歐洲藥品管理局確認受理
茲提述翰森製藥集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）日期為
二零二六年九月二十七日之公告，內容有關阿美替尼（海外商品名：Aumseqa®）於
歐盟(EU)上市許可狀態更新。除文義另有所指外，本公告所用詞彙及表述與上述
公告所界定者具有相同涵義。
本公司董事會（「董事會」）宣佈，於二零二六年九月二十九日，本集團向歐洲藥
品管理局（「EMA」）重新遞交創新藥阿美替尼於歐盟的上市許可申請（「MAA」），
且於二零二六年十月七日，EMA 已確認受理該新 MAA 並正式啟動集中審批程
序，適應症為：(i) 具有表皮生長因子受體（「EGFR」）外顯子 19 缺失或外顯子
21(L858R)置換突變的晚期非小細胞肺癌（「NSCLC」）成人患者的一線治療，以及
(ii)EGFR T790M突變陽性的晚期NSCLC成人患者的治療。
承董事會命
翰森製藥集團有限公司
主席
鍾慧娟
香港，二零二六年十月十一日

於本公告日期，董事會成員包括主席兼執行董事鍾慧娟女士、執行董事孫遠女士
及呂愛鋒博士；以及獨立非執行董事林國強先生、陳尚偉先生、楊東濤女士及嚴
嘉先生。