中国生物制药TQB6426 GPC3 ADC获FDA IND批准进入美国临床阶段

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(Incorporated in the Cayman Islands with limited liability)
Website: www.sbpgroup.com
(Stock code: 1177)

VOLUNTARY ANNOUNCEMENT
APPLICATION FOR CLINICAL TRIAL ON TQB6426 “GPC3 ADC” APPROVED
BY FDA
The board of directors (the “Board”) of Sino Biopharmaceutical Limited (the “Company”, together
with its subsidiaries, the “Group”) announces that TQB6426 “GPC3 antibody-drug conjugate (ADC)”,
a national Category 1 new drug self-developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
(“CTTQ”), a subsidiary of the Group, has received an investigational new drug (IND) approval from the
U.S. Food and Drug Administration (FDA), intended for advanced malignant tumors.
GPC3 is a glycoprotein located on the cell membrane surface, which is barely expressed in normal adult
tissues but is highly expressed in hepatocellular carcinoma (HCC) and serves as a biomarker for clinical
diagnosis. Furthermore, GPC3 expression is up-regulated in lung squamous cell carcinoma, ovarian
cancer, and other malignancies, positioning it as a highly promising target for targeted therapy and
immunotherapy. Currently, no GPC3-targeting ADC has been approved for marketing worldwide, and
most candidates in this class remain in pre-clinical or early-stage clinical development, highlighting a
substantial unmet clinical needs.
Pre-clinical studies have demonstrated that TQB6426 exhibits potent target-binding affinity and
selective cytotoxicity against tumor cells. It also demonstrates strong bystander killing activity and
in vivo anti-tumor efficacy, both of which are superior to those of similar candidates, demonstrating
best-in-class (BIC) potential. As an ADC, TQB6426 utilizes its GPC3-targeting antibody to achieve
targeted delivery, thereby precisely delivering the cytotoxic payload to tumor cells. After eliminating
GPC3-positive tumor cells, it further kills GPC3-negative tumor cells through a potent bystander effect,
effectively overcoming tumor heterogeneity and expanding anti-tumor coverage. Moreover, the specific
and high expression of GPC3 in HCC and other solid tumors provides a crucial biological foundation for
achieving “precise delivery and targeted tumor killing”.

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Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related
deaths. In 2022, there were an estimated 870,000 new cases of liver cancer worldwide, with 760,000
deaths. Without effective intervention measures, the number of new cases are expected to increase to
1.52 million and the number of deaths to 1.37 million by 2050, nearly doubling. Among them, China
accounts for approximately 42.4% of all global cases. Liver cancer is characterized by insidious onset
and rapid progression, approximately 64% of patients are already at an intermediate or advanced stage at
initial diagnosis, losing the chance for curative treatment. Even among early-stage patients who undergo
curative surgery, the five-year recurrence rate remains as high as 70%. Current targeted therapies,
immunotherapies, and combination regimens provide only limited survival benefit for patients with
intermediate or advanced disease, highlighting a substantial unmet clinical needs. The development of
ADC drugs targeting GPC3, which combines tumor-specific recognition with potent cytotoxic killing,
is expected to provide a novel therapeutic paradigm for patients with GPC3-positive HCC. Furthermore,
GPC3 expression in other solid malignancies may enable TQB6426 to extend benefit to a broader patient
population with solid tumors.
The Group will accelerate the Phase I clinical trial of TQB6426 to evaluate the safety, tolerability,
pharmacokinetic profile, and preliminary efficacy in patients with advanced malignant tumors, with the
aim of providing new treatment options for patients with HCC and other solid tumors in the world as
early as possible.
By order of the Board
Sino Biopharmaceutical Limited
Tse, Theresa Y Y
Chairwoman
Hong Kong, 3 September 2026

As at the date of this announcement, the Board of the Company comprises five executive directors,
namely Ms. Tse, Theresa Y Y, Mr. Tse Ping, Ms. Cheng Cheung Ling, Mr. Tse, Eric S Y and Mr. Tse
Hsin and six independent non-executive directors, namely Mr. Lu Zhengfei, Ms. Lu Hong, Mr. Zhang
Lu Fu, Dr. Li Kwok Tung Donald, Dr. Chen Lieping and Dr. Lu Bai.

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（於開曼群島註冊成立之有限公司）
網站：www.sbpgroup.com
（股份編號：1177）

自願公告
TQB6426「GPC3 ADC」臨床試驗申請獲FDA批准
中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團附
屬公司正大天晴藥業集團股份有限公司（「正大天晴」）自主研發的國家1類新藥TQB6426「GPC3抗體藥
物偶聯物(ADC)」已獲得美國食品藥品監督管理局(FDA)的新藥臨床試驗(IND)批准，擬用於晚期惡性
腫瘤。
GPC3是一種位於細胞膜表面的糖蛋白，在正常成人體內幾乎不表達，但在肝細胞癌(HCC)中高表
達，是臨床診斷的生物標誌物。此外，GPC3還在肺鱗癌、卵巢癌等癌症中表達上調，是極具潛力的
靶向與免疫治療靶點。目前，全球尚無靶向GPC3的ADC藥物獲批上市，同類候選產品整體處於臨床
前及早期臨床探索階段，巨大臨床需求亟待滿足。
臨床前研究數據顯示，TQB6426展現出良好的靶點結合能力和腫瘤細胞特異性殺傷功能，優於同類
產品的強效旁觀者殺傷活性和動物體內抗腫瘤活性，展現出同類最優(BIC)開發潛力。作為ADC藥
物，TQB6426依托特異性靶向GPC3的抗體端實現靶向遞送，將細胞毒性有效載荷精準遞送至腫瘤細
胞，並在殺傷GPC3陽性表達腫瘤細胞後，通過強效的旁觀者殺傷效應進一步殺傷GPC3陰性表達的
腫瘤細胞，有效克服腫瘤異質性，擴大抗腫瘤覆蓋範圍；而GPC3在肝細胞癌等實體瘤的特異性高表
達特徵，為藥物實現「精準遞送、靶向殺傷」提供了重要的生物學基礎。

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肝癌是全球第六大常見癌症，也是癌症相關死亡的第三大原因。2022年全球新發肝癌病例87萬例，
死亡病例76萬例，如不採取有力干預措施，預計到2050年新發病例將增加至152萬例，死亡病例將
增加至137萬例，近乎翻倍。其中，中國約佔全世界病例的42.4%。肝癌起病隱匿、進展迅速，約
64%的患者初診時已處於中晚期，失去根治性治療機會；早期患者接受根治性切除術後，5年復發率
仍高達70%。現有靶向、免疫及聯合方案為中晚期患者帶來的生存獲益仍然有限，存在巨大未滿足
臨床需求。以GPC3為靶點開發ADC藥物，將腫瘤特異性識別與高效細胞毒性殺傷相結合，有望為
GPC3陽性表達肝細胞癌患者提供全新的治療路徑。同時，GPC3在其他部分實體瘤中的表達，也為
TQB6426惠及更廣泛的實體腫瘤患者提供可能。
本集團將加速TQB6426的I期臨床試驗，評估其在晚期惡性腫瘤患者中的安全性、耐受性、藥代動力
學特徵及初步療效，盡早為全球肝細胞癌及更多實體瘤患者提供新的治療選擇。
承董事會命
中國生物製藥有限公司
主席
謝其潤
香港，二零二六年九月三日

於本公告日期，本公司董事會包括五位執行董事，即謝其潤女士、謝炳先生、鄭翔玲女士、謝承潤
先生及謝炘先生，以及六位獨立非執行董事，即陸正飛先生、魯紅女士、張魯夫先生、李國棟醫
生、陳列平博士及魯白博士。

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