Head of Global Compensation

Antengene receives Clinical Trial approval in Australia for Phase I ATTRACT study of ATG-201 (CD19 x CD3 TCE) in B cell-related autoimmune diseases. Release date: 2026-08-25 Shanghai and Hong Kong, PRC, August 25, 2026 - Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, today announced that the Phase I ATTRACT study of its proprietary ATG-201, a CD19/CD3 bispecific T-cell engager antibody for B cell-related autoimmune diseases, has received approval from the Human Research Ethics Committee (HREC) in Australia, and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA). ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body's own immune system for precise and potent action. This is a Phase I clinical study designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. The study will consist of two phases: dose escalation and dose expansion. The primary objectives of the study are to evaluate the safety and tolerability of ATG-201 monotherapy and to determine its recommended Phase II dose (RP2D). Secondary objectives include evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, immunogenicity, preliminary efficacy of ATG-201. Antengene and UCB have entered into an agreement that grants UCB worldwide exclusive rights to further develop, manufacture, and commercialize ATG-201, and access to its associated manufacturing technology in relation to ATG-201. Antengene will conduct the phase I clinical trials in China and Australia. The clinical trial approval in Australia, following the clearance of ATG-201's clinical trial application by China's NMPA in June this year, marks an important advancement in Antengene's multi-regional development strategy for ATG-201. Together, these milestones demonstrate Antengene's ability to execute efficiently across key clinical markets and reflect the company's forward-looking approach to building ATG-201 into a potential global program for B cell-related autoimmune diseases. As Antengene continues to expand its innovation focus beyond oncology and hematology into autoimmune diseases, the company remains committed to addressing areas of significant unmet medical need and to developing differentiated, potentially first-in-class and/or best-in-class therapies for patients worldwide. About Antengene Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages, with key investigational candidates including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 x 4-1BB bispecific antibody), ATG-125 (B7-H3 x PD-L1 bispecific ADC), ATG-207 (αCD3-TGF-β bifunctional fusion protein), as well as T cell engager (TCE) programs developed using Antengene's proprietary AnTenGager(R) platform. AnTenGager(R), is Antengene's proprietary TCE 2.0 platform, featuring "2+1" bivalent binding for low expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies, with programs targeting CD19 x CD3 (ATG-201 for B cell-related autoimmune diseases; partnered with UCB), CDH6 x CD3 (ATG-106 for ovarian cancer and kidney cancer; partnered with K2 Therapeutics established by MPM BioImpact), ALPPL2 x CD3 (ATG-112 for gynecological tumors, digestive system malignancies, bladder cancer and NSCLC), LY6G6D x CD3 (ATG-110 for microsatellite-stable colorectal cancer), GPRC5D x CD3 (ATG-021 for multiple myeloma), LILRB4 x CD3 (ATG-102 for acute myeloid leukemia and chronic myelomonocytic leukemia) and FLT3 x CD3 (ATG-107 for acute myeloid leukemia). To date, Antengene has obtained 34 investigational new drug (IND) approvals in the U.S. and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO(R)(selinexor), is approved in the Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). Forward-looking statements 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, Antengene undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that its actual future results or performance may be materially different from what Antengene expect. In this article, statements of, or references to, its intentions or those of any of its Directors or its Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2025, and the documents subsequently submitted to the Hong Kong Stock Exchange.

8/19/2026 - federal Court dismisses manufacturers' broader challenges to HRSA's STD entity certification process, leaving process intact. On August 14, 2026, the United States District Court for the District of Columbia issued a dispositive Memorandum Opinion ("Opinion") in the litigation brought by Amgen, Eli Lilly, Genentech, and UCB against HRSA. The litigation challenges HRSA's certification and recertification of entities that qualify for the 340B Program under Section 340B(a)(4)(K) of the Public Health Service Act ("Act") based on their receipt of sexually transmitted disease funding through a state or local government under Section 318 of the Act ("STD covered entities"). The Opinion avoided tackling the most impactful issues raised by the litigation, including whether: * STD covered entities qualifying for the 340B program solely based on receipt of in-kind funding are eligible; * STD covered entities may provide 340B drugs for conditions not directly related to the treatment of STDs; * STD covered entities must be primarily devoted to the treatment of STDs to qualify for the 340B program; and * HRSA's process for certifying and recertifying STD covered entities is unlawful. The Opinion solely invalided certain registrations tied to Sagebrush Health Services of its contracted partners on the basis that a "sub-sub-recipient" is ineligible to be registered by HRSA as an STD covered entity. The cases brought by the four drug manufacturers challenged HRSA's certifications and recertifications of STD covered entities: * that render services unrelated to the treatment of STDs; * that provide 340B drugs to patients for conditions not directly related to the treatment of STDs; * that receive their Section 318 funds from a subgrantee other than a unit of state or local government ("sub-sub grantees"); * that receive in-kind funding (rather than dollars) from a unit of state or local government; and * on the basis that HRSA failed to follow statutory requirements in the development of its STD entity certifications and recertifications. Community Care Resources of Florida ("CCRF"), a non-profit STD entity in Florida, intervened in support of HRSA as an intervenor-defendant in the litigation to represent the interests of STD entities in the case, and Powers represented CCRF. The manufacturers moved for summary judgment in their favor on each of its claims, and the government and CCRF cross-moved for summary judgment to dismiss each of the claims. CCRF did not defend the sub-sub grantee claim described above. Chief Judge James E. Boasberg issued the Opinion. The Opinion focused on the sub-sub grantee issue and declined to review the manufacturers' other theories regarding STD covered entity certifications and recertifications. Instead, the Court limited its analysis to the Sagebrush registrations identified in the manufacturers' complaints, concluding that invalidating those clinics' certifications provided the manufacturers with the appropriate relief and made it unnecessary to address their broader challenges to HRSA's certification process. The Opinion will largely be seen as a victory for HRSA and STD covered entities because of what it did not do. STD covered entities feared that the Court might interpret the 340B statute in such a way as to preclude eligibility for entities that solely receive "in-kind" funds from state or local governments, or that it might limit 340B drug utilization to drugs that specifically treat STDs (which also could have had significant impacts on Ryan White HIV/AIDS Clinics), or that it might limit eligibility to entities that primarily focus on the treatment of STDs. Perhaps most worrisome, the Court could have ruled that HRSA's entire STD covered entity certification and recertification process is invalid and declared all STD covered entity registrations void. All of those disruptive outcomes were avoided in the Opinion. As a result, the Opinion, unless appealed and set aside, will result in the decertification of the Sagebrush Health Services registrations at issue in the suit. HRSA would likely also decertify other sub-sub grantee STD covered entities. Therefore, Rwc-340b believe the suit will not impact any other STD covered entities. Finally, it is notable that the Court dismissed other manufacturer claims "without prejudice," which signals that manufacturers may bring similar claims against HRSA in the future. Powers will continue to monitor developments regarding this litigation. Please contact Powers' drug pricing team, or your lead Powers attorney, if you have any questions.

UCB, a global biopharmaceutical company, has been named a winner of the 2026 Metro Atlanta Top Workplaces Award by Axios. The recognition, based on confidential employee feedback, comes as UCB expands its Georgia presence through a $2 billion investment in a new biomanufacturing campus in Gwinnett County. The facility is expected to create more than 330 permanent, highly skilled jobs and generate an estimated $5 billion in economic impact. UCB has maintained its US headquarters in metro Atlanta for over 30 years and currently employs more than 400 people in Georgia. The award was given to fewer than 60 organisations with 159-499 employees across metro Atlanta, based on surveys administered by third-party firm Energage.