Shanghai And Hong Kong,, August 19, 2025 / Prnewswire / – Antengene Corporation Limited (“Antengene”. Its ADC CLDN18.2 Discovered internally, ATG-022, obtained a designation of revolutionary therapy by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of CLDN18.2 Positive, HER-2 Negative non-noticeable or metastatic received the reference at least during the conduct of driving.
To provide additional details on the latest ATG-022 clinical data, the Antengene management team will organize a call conference August 20, 2025 (Wednesday), 9 a.m. to 10 a.m. (Beijing time).
Ways to participate:
1 and 1 Website: https://s.comein.cn/5Hgdc8k2
2 Conference call:
(Dial-in from China)
Continental of China: + 86-4001510269
Global: + 86-01021377168
(Dial-in abroad)
Hong Kong, China: + 852-51089680
Hong Kong, China: + 852-800931266
Taiwan,, China: + 886-277083288
Global: + 86-01021377168
UNITED STATES: + 1-2087016888
Access code: 303021
Management participants:
Doctor Jay Mei
Founder, President and CEO
M. Donald Lung
Financial director
Mr. Kavin Cao
Vice-President of Business and Secretary of the Board of Directors
Dr Bing Hou
Vice-president, head of the science of discovery and translational medicine
Doctor Godfrey Guo
Vice-president, clinical development
The designation of revolutionary therapy, introduced by the NMPA, is a key initiative aimed at accelerating the development and approval of innovative drugs which offer significant clinical advantages. With this designation, ATG-022 will receive priority revision resources, reducing the overall research and development calendar and allowing faster access to patients in China. This follows the granting of the Food and Drug Administration (FDA) of the designation of orphan drugs (odd) at ATG-022 for the treatment of gastric and pancreatic cancers, highlighting its high clinical potential through several types of tumors.
In the current Phase I / II study in progress, the data show that ATG-022 has demonstrated a significant anti-tumor activity and a favorable safety profile in patients with gastric or gastroesophageal adenocarcinoma through high, weak and ultra-up CLDN18.2 levels of expression.
- CLDN18.2 moderate to high expression (IHC 2+> 20%)
- 2.4 mg / kg of cohort
- Objective response rate (orr): 40% (12/30), including 1 full response (CR)
- Disease control rate (DCR): 90% (27/30)
- Survival without median progression (MPFs): 6.97 months
- PFS rate of 6 months: 51.1%
- Overall survival rate at 9 months: 82.7%
- Operating system rate at 12 months: 66.2%
- 1.8 mg / kg of cohort
- Orr: 40% (10/25), including 1 CR
- DCR: 84% (21/25)
- CLDN18.2 Low and ultra-basic expression (IHC 2+ ≤ 20%)
- Efficient dose range of 1.8-2.4 mg / kg
- Orr: 33.3% (6/18), including 1 CR
- DCR: 50% (9/18)
- In particular, some responding patients had levels of expression of CLDN18.2 less than 5%, highlighting the robust anti-tumor activity of ATG-022 in the populations of low and ultra-faible expression.
To date, three patients in the study have reached the CR during treatment, with a case observed in each of the three aforementioned cohorts (that is to say the two dose levels in the expressive cohorts moderate at CLDN18.2 and the express-expressor cohort with low and ultra-faible). This broad spectrum antitumor activity positions ATG-022 as a new potential treatment option for a larger patient population compared to other therapies targeted by CLDN18.2.
Antengene is currently leading the phase II dose expansion stage of ATG-022 on the continent of China And AustraliaThe program is now entering the clinical validation stage from the middle to the end. The company will continue to advance the clinical development of ATG-022 in gastric cancer while exploring its potential in other CLDN18.2 tumors. For indications for gastric cancer, the development strategy extends to the first third line treatment:
- First line treatment (CLDN18.2 IHC 1+ ≥ 1%, PD-L1 CPS ≥ 1%): ATG-022 in combination with pembrolizumab and chemotherapy (capx / folfox)
- Second line treatment (CLDN18.2 IHC 1+ ≥ 1%, PD-L1 CPS ≥ 1%): ATG-022 in combination with pembrolizumab
- Third line treatment (CLDN18.2 IHC 2+): ATG-022 Monotherapy, covering patients in different levels of expression CLDN18.2, including CLDN18.2 Moderate to high (2+> 20%), and low and ultra-basic expressors (2+ ≤20%)
In addition, the current phase II study includes a basket cohort covering several types of tumors. In a certain subtype of gynecological tumor, the 7 patients who had undergone at least one evaluation of efficiency have demonstrated a withdrawal of tumor, indicating a significant clinical potential for ATG-022 in other positive tumors CLDN18.2. This cohort remains open for registration and monitoring, and the continuous generation of data should further strengthen the Robust value proposal of ATG-022 on several types of tumors.
About antengene
Antengene Corporation Limited (“Antengene”. Its Pipeline spans from Preclinical to Commercial Stages and Includes Several In-House Discovered Programs, Including ATG-022 (CLDN18.2 ADC), ATG-037 (Oral CD73 inhibitor), ATG-101 (PD-L1 × 4-1bb bispecific antibody), ATG-031 (CD24-Targeting Macrophage Activator), and ATG-042 (Oral inhibitor PRMT5-MTA).
Antengene has also developed Fangager ™, a owner T cell platform High up 2.0 with a “2 + 1” biaison for low-express targets, hiding horses and owners’ CD3 sequences with rapid / deactivated efficiency to minimize cytokine release syndrome (CRS) and improve efficiency. These characteristics support the large applicability of the platform between autoimmune diseases, solid tumors and indications of hematological malignant tumors.
To date, Antengene has obtained 31 Approval of Investigation of New Medicines (IND) in the United States and Asiaand submitted new drug requests (NDAS) in 11 Asia-Pacific markets. Its main commercial asset, XPOVIO® (SELINEXOR), is approved on the continent of ChinaTaiwan China, Hong Kong ChinaMacao China, South Korea,, Singapore,, Malaysia,, Thailand,, Indonesia And Australia.
Prospective declarations
Prospective declarations made in this article only concern events or information on the date on which declarations are made in this article. Unless the law required, we have no obligation to update or publicly revise all prospective declarations, whether following new information, future or otherwise, after the date on which declarations are made or to reflect the occurrence of unforeseen events. You must read this article completely and because of the understanding that our real results or performance can be materially different from what we expect. In this article, declarations or references to our intentions or those of our administrators or our company are made on the date of this article. All of these intentions could modify in the light of future development. For a more in -depth discussion of these factors and others which could ensure that future results differ considerably from any prospective declaration, please consult the other risks and uncertainties described in the annual report of the company for the finished financial year December 31, 2024And the documents subsequently submitted to the Hong Kong Stock Exchange.
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