礼邦医药AP308治疗IgA肾病的美国IND获FDA批准

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Alebund Pharmaceuticals (Jiangsu) Limited
禮邦醫藥（江蘇）股份有限公司

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

(Stock Code: 09637)

VOLUNTARY ANNOUNCEMENT
INVESTIGATIONAL NEW DRUG APPLICATION FOR AP308 FOR THE
TREATMENT OF IgA NEPHROPATHY CLEARED BY THE U.S. FOOD AND
DRUG ADMINISTRATION
This announcement is made by Alebund Pharmaceuticals (Jiangsu) Limited (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 Group.
The board of directors of the Company (the “Board”) is pleased to announce that the Company
recently received clearance of its Investigational New Drug (“IND”) application for AP308, a firstin-class engineered recombinant IgA protease, from the U.S. Food and Drug Administration (the
“FDA”) to initiate a first-in-human clinical trial of AP308 for the treatment of IgA nephropathy
(“IgAN”). To the Company’s knowledge, AP308 is the first IgA protease-based drug candidate
for IgAN to enter clinical development. The Company plans to initiate the clinical trial in the near
term.
ABOUT AP308
AP308 is a first-in-class engineered recombinant IgA protease aiming for the functional cure of
IgAN. The drug is developed based on an IgA protease derived from Thomasclavelia ramosa , a
human commensal bacterium, and can cleave IgA1, galactose-deficient IgA1 (Gd-IgA1), polymeric
IgA and IgA immune complexes, and directly clears IgA immune complexes and complement C3
already deposited in the glomeruli; in preclinical studies, it acted within minutes without affecting
other immunoglobulins such as IgG and IgM. In January 2022, Alebund worked together with
Peking University First Hospital (“PUFH”) on developing IgA proteases into potential IgAN
treatment and entered into a license agreement with PUFH. The Company has since developed
and nominated AP308 as a drug candidate using its proprietary Long-Acting Protease Engineering
Platform. The platform displays excellent stability and developability, extends circulating half-life,
reduces renal clearance, and lowers immunogenicity while preserving the protease ’ s potent
cleavage activity against IgA1, thereby enabling long-acting, low-frequency dosing. The Company
holds the global rights to develop, manufacture, and commercialize AP308.

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PRECLINICAL DATA
In a humanized mouse model of IgAN, once-weekly subcutaneous dosing of AP308 over an
eight-week treatment period reduced circulating human IgA and IgA immune complexes by
approximately 80% relative to controls; at the end of treatment, histological examination confirmed
that glomerular IgA deposits were almost completely cleared, proteinuria decreased significantly,
and kidney pathology improved markedly, while repeated dosing produced no signals of liver or
kidney toxicity and no significant increase in anti-drug antibody titers. In a separate paired preand post-treatment design, a single dose completely cleared pre-existing chronic glomerular IgA
and complement C3 deposits within seven days. These preclinical results were published in May
2026 in Kidney International, the official journal of the International Society of Nephrology (Shen
X, et al. 2026;110:463-476; available at: https://doi.org/10.1016/j.kint.2026.04.020).
IgA NEPHROPATHY
IgAN is the most common primary glomerulonephritis worldwide. It is characterized by the
deposition of IgA-containing immune complexes in the glomeruli, which leads to inflammation
and progressive kidney damage. Long-term cohort studies in China and the United Kingdom
show that, under current treatment strategies, median kidney survival is approximately 11 to 12
years and most patients progress to end-stage renal disease within 10 to 15 years of diagnosis,
with approximately 60% of patients in the Chinese cohort reaching end-stage renal disease within
15 years. According to China Insights Consultancy, there were approximately 9.5 million IgAN
patients globally in 2025, including approximately 5.1 million in China — more than half of the
global total and the largest IgAN patient population in the world. However, strategies to directly
clear IgA immune complexes already deposited in the kidney remain to be further explored. By
directly cleaving and clearing pathogenic IgA and IgA immune complexes that have already
been deposited in the glomeruli, AP308 represents a differentiated therapeutic approach with the
potential to address this unmet medical need in the treatment of IgAN.
By order of the Board
Alebund Pharmaceuticals (Jiangsu) Limited
Dr. Gavin Guoyao Xia
Chairman of the Board, executive Director and
Chief Executive Officer
Hong Kong, September 8, 2026

As of the date of this announcement, the Board comprises (i) Dr. Gavin Guoyao Xia, Jin Tian,
M.D., Ms. Wang Yun and Dr. Zhang Huading as executive Directors; (ii) Dr. Lu An as a
non-executive Director; and (iii) Dr. Xu Runhong, Dr. Zhui Chen and Mr. Leung Chi Wai as
independent non-executive Directors.

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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。

Alebund Pharmaceuticals (Jiangsu) Limited
禮邦醫藥（江蘇）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：09637）

自願公告
AP308治療IgA腎病的新藥臨床試驗申請
獲美國食品藥品監督管理局批准
本公告由禮邦醫藥（江蘇）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有關本集團的最新業務發展。
本公司董事會（「董事會」）欣然宣佈，本公司近日就 AP308（一款同類首創工程
化重組 IgA 蛋白酶）的新藥臨床試驗（「IND」）申請獲美國食品藥品監督管理局
（「FDA」）批准，將啟動一項AP308用於治療IgA腎病（「IgAN」）的首次人體臨床試
驗。就本公司所知，AP308為首個獲准開展臨床試驗的IgA蛋白酶類IgAN候選藥
物。本公司計劃於近期啟動該臨床試驗。

關於AP308
AP308 是一款旨在實現IgA腎病功能性治癒的同類首創工程化重組IgA蛋白酶。
該藥物基於源自人體共生菌Thomasclavelia ramosa 的IgA蛋白酶開發，可切割
IgA1、半乳糖缺陷型IgA1(Gd-IgA1)、多聚IgA及IgA免疫複合物，並可直接清除
於腎小球的IgA免疫複合物及補體C3沉積；在臨床前研究中可於數分鐘內起效，
且不影響IgG、IgM等其他免疫球蛋白。於2022 年1 月，禮邦醫藥與北京大學第
一醫院（「北大醫院」）就將IgA蛋白酶開發為IgAN潛在療法展開合作，並與北大
醫院訂立授權協議。本公司其後依託自主研發的長效蛋白酶工程平台開發並確
定AP308為候選藥物。該平台具有優異的穩定性及成藥性，並可在保留蛋白酶對
IgA1高效切割活性的同時，顯著延長藥物體內半衰期、降低腎臟清除並減弱免疫
原性，為長效、低頻次給藥奠定基礎。本公司持有AP308的全球開發、生產及商
業化權利。

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臨床前研究數據
在人源化 IgA 腎病小鼠模型中，以每週一次皮下給藥持續八週後，AP308 使循
環中人源 I g A 及 I g A 免疫複合物水平較對照組降低約 80%；治療結束時，組織
學檢查顯示腎小球 IgA 沉積近乎完全清除，蛋白尿顯著下降，腎臟病理顯著改
善，重複給藥未見肝腎毒性信號，抗藥抗體滴度亦無顯著升高。在另一項治療
前後配對設計中，單次給藥後七天內即完全清除已形成的腎小球 IgA 及補體 C3
沉積。上述臨床前研究結果已於 2026 年 5 月在國際腎臟病學會 ( I S N ) 官方期刊
《Kidney International》刊載（Shen X, et al. 2026年，第110卷，第463至476頁；詳
見：https://doi.org/10.1016/j.kint.2026.04.020 ）。

IgA腎病
IgA腎病是全球最常見的原發性腎小球腎炎，以含IgA的免疫複合物沉積於腎小球
為特徵，可引致炎症及進行性腎臟損傷。中國及英國的長期隊列研究顯示，在現
行治療策略下，患者中位腎存活期約11 至12 年，大多數患者於確診後10 至15 年
內進展至終末期腎病，中國隊列中約60%的患者於確診後15年內進展至終末期腎
病。根據灼識諮詢的資料，2025年全球IgAN患者約950萬人，其中中國約510萬
人，佔全球逾半，為全球最大的IgAN患者群體。然而，直接清除已沉積於腎臟的
IgA免疫複合物的治療策略仍有待進一步探索。AP308透過直接切割並清除已沉積
於腎小球的致病性IgA及IgA免疫複合物，為IgA腎病的治療提供了差異化的治療
思路，有望應對這一未被滿足的臨床需求。
承董事會命
禮邦醫藥（江蘇）股份有限公司
董事會主席、執行董事兼首席執行官
Gavin Guoyao Xia博士
香港，2026年9月8日

截至本公告日期，董事會由(i)執行董事Gavin Guoyao Xia博士、Jin Tian醫生、汪
昀女士及張華丁博士；(ii)非執行董事魯安博士；及(iii)獨立非執行董事徐潤紅博
士、Zhui Chen博士及梁智維先生組成。

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