Moving forward in the midst of the epidemic, Deqi Pharmaceutical submitted an ATG-018 phase I clinical trial application in Australia

- ATG-018 is aIndependently developed by Deqi Pharmaceutical R&D teamAn oral ATR small molecule inhibitor that targets the DNA damage response (DDR) pathway.

- This phase I clinical trial aims to evaluate ATG-018 for treatmentAdvanced solid tumors and hematologic tumorsPatient safety, pharmacological properties, and initial efficacy.

- ATG-018 is expected to beFirst in Australia to enter clinical phaseAn oral ATR small molecule inhibitor.

Shanghai and Hong Kong, China, April 27, 2022 — Deqi Pharmaceutical Co., Ltd. (abbreviation), a leading innovative biopharmaceutical company in the commercialization stage dedicated to the development, production and sale of first-in-class and/or best-in-class hematologic and solid tumor therapies“Deqi Pharmaceuticals”, Hong Kong Stock Exchange stock code: 6996.HK) announced today,The company has submitted an ATG-018 phase I (ATRIUM study) clinical trial application for the treatment of patients with advanced solid tumors and hematological tumors to the Australian Human Research Ethics Committee (HREC).

The main purpose of the study was to evaluate the safety and tolerability of ATG-018 monotherapy to determine the recommended dose for phase II and evaluate the initial efficacy of this therapy if possible; the secondary purpose was to determine the pharmacological properties of ATG-018.

ATG-018 is an oral, potent, selective ATR small molecule inhibitor.ATG-018 can inhibit the ability of tumor cells to repair DNA damage by inhibiting ATR (ataxic capillary dilatation and Rad3-related) kinase. This mechanism is also known as synthetic death.

Dr. Shan Bo, Chief Scientist of Deqi PharmaceuticalHe said, “ATG-018, which acts on the DDR pathway, is one of Deqi Pharmaceutical's first self-developed products to enter the clinical development stage. Since many tumors have DDR pathway disorders, DDR inhibitors have become a popular field in tumor drug development and clinical research, and their potential to treat drug-resistant and advanced tumors is particularly prominent. The highly differentiated characteristics of ATG-018 allow it to be used as a single agent, and can be used in combination with multiple drugs, which is expected to bring significant clinical benefits to cancer patients around the world.”

Dr. Kevin Lynch, Chief Medical Officer of Deqi Pharmaceuticals“We are delighted to submit an HREC review application for the Phase I protocol of this clinical trial for ATG-018,” he said. The application is fully supported by preclinical data showing the efficacy of ATG-018 as a single agent in a solid tumor model, its bioavailability as an oral drug, and a potential biomarker. The use of biomarkers in research will facilitate patient enrollment and provide an effective tool for tracking and observing patients throughout the process. As we are about to carry out this research, I would like to thank all the researchers at the research center for their unremitting efforts and the support and preparation work provided by the Deqi Pharmaceutical R&D team. ”

About ATRIUM Research

ATRIUM is a multicenter, open phase I dose exploratory clinical study to evaluate ATG-018 monotherapy for the treatment of patients with advanced solid tumors and hematologic tumors. The main purpose of the study was to evaluate the safety and tolerability of ATG-018, confirm the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) and/or bioeffective dose of ATG-018 as a single drug, and evaluate the initial efficacy of the drug when conditions permit; the secondary purpose was to determine the pharmacological properties of ATG-018. As a phase I clinical trial, the safety of treatment will be closely followed throughout the study.

About ATG-018

ATG-018 is an oral, potent, and selective small-molecule inhibitor acting on ataxic capillary dilatation and Rad3-related (ATR) kinase, independently developed by Deqi Pharmaceutical's R&D team. ATR kinase belongs to the phosphoinositol 3 kinase related family. Targeted inhibition of ATR kinase can increase the accumulation of single strand breaks, which is important for tumor cells that depend on DNA damage response (DDR). Preclinical studies have shown potential for treating solid tumors (including gastric cancer, esophageal cancer, and squamous cell carcinoma) and hematologic tumors (including chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma [DLBCL], and multiple myeloma [MM]) as a single agent of ATR inhibitors and combination therapy with other drugs (including DDR inhibitors).

A preclinical research poster published at the 2022 American Association for Cancer Research and Research (AACR 2022) indicated that ATG-018 showed single-agent efficacy in multiple in vivo models and in vitro trials of solid tumors/hematologic tumors lacking homologous recombination. Furthermore, the study also discovered several gene expression changes associated with ATG-018 sensitivity. These differential genes have the potential to become predictive biomarkers. These data suggest that ATG-018 has therapeutic potential for cancer patients with these homologous recombinant deficiences/changes in gene expression.

ATG-018 is a drug under development that has not been approved for marketing by any drug regulatory authority. Deqi Pharmaceuticals has global rights in ATG-018.

About Deqi Pharmaceuticals

Deqi Pharmaceutical Co., Ltd. (“Deqi Pharmaceutical”, Hong Kong Stock Code: 6996.HK) is a leading biopharmaceutical company driven by R&D and has entered the commercialization stage. It is committed to providing patients in the Asia-Pacific region and the world with the most advanced treatments to treat tumors and other life-threatening diseases. Since it was officially put into operation in 2017, we have established a rich product pipeline that continues to expand from pre-clinical to clinical stages through cooperative introduction and independent research and development. Currently, Deqi Pharmaceutical has 15 products under development. Of these, 5 products have interests in the Asia-Pacific region, including the Greater China market, and 10 products have global interests. Deqi Pharmaceutical has obtained 23 clinical approval documents (INDs) in the US and various Asia-Pacific markets and submitted 6 new drug marketing applications (NDAs), including selinisol/ATG-010/ XPOVIONew drug marketing applications have been approved in China, South Korea, Singapore and Australia. Deqi Pharmaceutical will“Healers know no boundaries, innovation lasts forever”As a vision, we focus on early R&D, clinical research, drug production and commercialization of first-in-class and best-in-class treatments to address urgent clinical needs.

Forward-looking statements

The forward-looking statements made herein relate only to events or materials on the day the statement was made herein. Except as required by law, we are not responsible for updating or publicly amending any forward-looking statements or unanticipated events after the date the forward-looking statements are made, regardless of whether new information, future events, or other circumstances arise. Please read this article carefully and understand that our actual future results or performance may differ materially from expectations. The statements or references in this article relating to the intentions of any director or the Company were made on the date of publication of this article. Any such intention is subject to change due to future developments. For further discussion of these factors and other factors that may cause future results to differ materially from any forward-looking statements, please refer to the section entitled “Risk Factors” in our periodic report to the Hong Kong Stock Exchange and other risks and uncertainties described in our annual report for the year ended 31 December 2021, and subsequent documents submitted to the Hong Kong Stock Exchange.

- Invented by Internal R&D Team at Antengene, ATG-018 is an orally-available, small molecule ATR inhibitor that targets DNA Damage Response (DDR) pathways.

- The Phase I study will evaluate the safety, pharmacology and preliminary considerations of ATG-018 in patients with Advanced solid diagnosis and hematologic malignancies.

- ATG-018 has the potential as The first orally-available, small molecule ATR inhibitor inhibitor clinical development in Australia.

Shanghai and Hong Kong, PRC, April 27, 2022 -- Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceuticals company dedicated to first-in-class and/or best-in-class therapeutics in hematology and oncology, today developing and commercialising that it has been filed a clinical trial application with the Human Research Ethics Committee (HREC) in Australia in order to assess the Phase I ATRIUM trial of ATG-018 in patients with advanced solid research and hematologic malignancies.

The primary objective of the study is to evaluate the safety and tolerability of ATG-018 as monotherapy to assess the appropriate dose for Phase II studies and preliminary studies , if available; the secondary objective is to characterize the pharmacology of ATG-018.

ATG-018 is an easily available, potent, selective small molecule ATR inhibitor. ATG-018 injects the ATR (ataxia telangiectasia mutated and RAD3-related) kinase, thus inhibiting cancer cells' ability to repair induced DNA, in a mechanism also known as synthetic lethality.

Dr. Bo Shan, Chief Scientific Officer of Antengene Exams, “ATG-018, One of Antengene's First Intensive Programs to Reach the Clinic, Targets the DDR Pathway that is deregulated in many outcomes. DDR affects a significant area of drug development and clinical research in oncology, especially in resistant or advanced diseases. The symptoms profile of ATG-018 may enable it to be used as monotherapy and open the door for novel collaborations and combination regimens that could benefit cancer patients around The world.”

Dr. Kevin Lynch, Chief Medical Officer of Antengene , “Antengene is very difficult to submit the ATG-018 Phase I Protocol for HREC review, based on its solid preclinical data package including treatment as a monotherapy in solid tumor models, oral bio-availability and potential biomarkers The use of biomarker-clinical studies may clinical trial enrollment and provide an additional tool to monitor patients during the trial. As we prepare for the start of this important study, I want to thank all of the investigator sites for their support and suggestions, and everyone in Antengene's R&D organization for their Incurred in the preparation for this study.”

About the ATRIUM Trial

The ATRIUM trial is a Phase I multi-center, open-label, dose finding study of ATG-018 monotherapy in patients with advanced solid therapy or hematologic malignancies. The primary objective of the study is to evaluate the safety and tolerability of ATG-018 and to assess the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and/or biologically effective dose of ATG-018 monotherapy and preliminary treatment, if available; the secondary objective is to characterize the pharmacology of ATG-018. As a Phase I study, there will be intensive safety monitoring the trial.

About ATG-018

Measured by the Internal R&D Team at Antengene, ATG-018 is an oral, potent, selective small molecule inhibitor targeting ataxia telangiectasia and RAD3-related (ATR) kinase. ATR Kinase Combines to the Phosphoinositide 3 kinase-related family. Inhibitory ATR kinase leads to treating damage of single-strand DNA breaks, inhibiting cancer for tumor cells which relies on DNA damage repair (DDR). Preclinical studies have suggested that ATR inhibitor monotherapy or combination with other drugs (including DDR agents) could be therapeutic strategies for solid therapy ( including chronic lymphocytic leukemia (CLL) and hematologic malignancies (chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma [DLBCL] and multiple myeloma [MM]).

According to a preclinical poster treating at AACR 2022, ATG-018 has potent in vitro and in vivo monotherapy treating in solid tumor/hematologic cancer models with certain Homologous recombination reactions. These data were supported by a series of genetic alterations that correlated with ATG-018 sensitivity and could be potential predictive biomarkers. Taken together, these data suggest that ATG-018 could be a potent therapeutic agent for patients with such homologous recombination deficiencies/genetic alterations.

ATG-018 is a development stage product candidate and is not approved by any regulatory agency. Antengene has global rights to ATG-018.

About Antengene

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative first-in-class/best-in-class Therapeutic Medicines for Cancer and Other Life-causing Diseases Driven by its vision of “Adopting Patients Beyond Borders”, Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has investigated 23 investigational new drug (IND) approvals in the US and in Asia, proposed 6 new drug applications (NDAs) in multiple Asia Pacific Markets, with the NDA for selinexor/ATG-010/xpovio Approved in China, South Korea, Singapore and Australia. Leveraging Pharmaceuticals as Well as Medicinal Drug Discovery, Antengene has built a broad and aggressive pipeline of 15 clinical and pre-clinical assets. Antengene has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.

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The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. except as required by law, we agree no longer to update or revise any forward-looking statements, whether as a result of new information, future events or discussions, after THE DATE ON WHICH THE STATEMENTS ARE MADE OR TO REFLECT THE DISCLAIMED OF UNPRESENTED EVENTS. You should read this article AND WITH THE UNDERSTANDING THAT OUR FUTURE ACTUAL RESULTS OR PERFORMANCE MAY BE MATERIALLY DIFFERENT FROM WHAT WE EXPECT. In this article, statements of, or references to, our opinions or those of any of our directors or our company are made as of the date of this article. Any of these may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ material from any forward-looking statement, see the section titled “Risk Factors” in our Periodic Reports filed with the Hong Kong Stock Exchange and the Other Risks and Unavoidable Incentives in the Company's Annual Report for December 31, 2021, and proposed filings With the Hong Kong Stock Exchange.